Ondansetron

Ondansetron Manufacturers

• Proficient Rx Lp
  

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  Ondansetron | Proficient Rx Lp

  

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  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  
  Geriatric Use

   The dosage recommendation is the same as for the general population

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8 mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
  
  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron tablet or one 4 mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  
  Geriatric Use

   The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8 mg ondansetron tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron tablet in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  
  Geriatric Use
  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8 mg ondansetron tablets 1 hour before induction of anesthesia.
  
  Pediatric Use
  
  There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  
  Geriatric Use
  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Proficient Rx Lp
  

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  Ondansetron | Ax Pharmaceutical Corp

  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Ondansetron | Lake Erie Medical Dba Quality Care Products Llc

  

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  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron tablets, USP is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m

  . Multiday, single-dose administration of a 24 mg dosage has not been studied.

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8-mg ondansetron tablet, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet, USP or one 4-mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8-mg ondansetron tablet, USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  , one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  There is no experience with the use of ondansetron tablet, USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets, USP 1 hour before induction of anesthesia.

  There is no experience with the use of ondansetron tablets, USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh

  score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Northwind Pharmaceuticals, Llc
  

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  Ondansetron | Northwind Pharmaceuticals, Llc

  

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  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron tablets, USP is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m

  . Multiday, single-dose administration of a 24 mg dosage has not been studied.

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8-mg ondansetron tablet, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet, USP or one 4-mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8-mg ondansetron tablet, USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  , one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  There is no experience with the use of ondansetron tablet, USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets, USP 1 hour before induction of anesthesia.

  There is no experience with the use of ondansetron tablets, USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh

  score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Remedyrepack Inc.
  

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  Ondansetron | Remedyrepack Inc.

  

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  Do not attempt to push ondansetron orally disintegrating tablets, USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy 

  The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use 

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use 

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy 

  The recommended adult oral dosage is one 8-mg ondansetron orally disintegrating tablet, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron orally disintegrating tablet, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use 

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron orally disintegrating tablet, USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron orally disintegrating tablet, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use 

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen 

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet, USP given 3 times a day.

  For total body irradiation

  One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen

  One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen

  One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use 

  There is no experience with the use of, ondansetron orally disintegrating tablets, USP, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use 

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting 

  The recommended dosage is 16 mg given as two 8-mg ondansetron orally disintegrating tablets, USP 1 hour before induction of anesthesia.

  Pediatric Use 

  There is no experience with the use of ondansetron orally disintegrating tablets, USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use 

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function 

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function 

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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  More Info
• Remedyrepack Inc.
  

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  Ondansetron | Remedyrepack Inc.

  

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  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets
  
  Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, remove the tablet from the bottle or PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet.  IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.
  
  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
  
  The recommended adult oral dosage of ondansetron orally disintegrating tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.
  
  Pediatric Use
  
  There is no experience with the use of a 24 mg dosage in pediatric patients.
  
  Geriatric Use
  
  The dosage recommendation is the same as for the general population.
  
  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
  
  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
  
  Pediatric Use
  
  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
  
  Geriatric Use
  
  The dosage is the same as for the general population.
  
  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen
  
  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.
  
  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
  
  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
  
  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
  
  Pediatric Use
  
  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.
  
  Geriatric Use
  
  The dosage recommendation is the same as for the general population.
  
  Postoperative Nausea and Vomiting
  
  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.
  
  Pediatric Use
  
  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.
  
  Geriatric Use
  
  The dosage is the same as for the general population.
  
  Dosage Adjustment for Patients With Impaired Renal Function
  
  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
  
  Dosage Adjustment for Patients With Impaired Hepatic Function
  
  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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  More Info
• Remedyrepack Inc.
  

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  Ondansetron | Remedyrepack Inc.

  

  ---

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron tablets is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8-mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet or one 4-mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8-mg ondansetron tablet given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron tablet in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets 1 hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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  More Info
• Remedyrepack Inc.
  

  ×

  Ondansetron | Remedyrepack Inc.

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets
  
  Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, remove the tablet from the bottle or PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet.  IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.
  
  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
  
  The recommended adult oral dosage of ondansetron orally disintegrating tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.
  
  Pediatric Use
  
  There is no experience with the use of a 24 mg dosage in pediatric patients.
  
  Geriatric Use
  
  The dosage recommendation is the same as for the general population.
  
  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
  
  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
  
  Pediatric Use
  
  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
  
  Geriatric Use
  
  The dosage is the same as for the general population.
  
  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen
  
  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.
  
  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
  
  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
  
  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
  
  Pediatric Use
  
  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.
  
  Geriatric Use
  
  The dosage recommendation is the same as for the general population.
  
  Postoperative Nausea and Vomiting
  
  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.
  
  Pediatric Use
  
  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.
  
  Geriatric Use
  
  The dosage is the same as for the general population.
  
  Dosage Adjustment for Patients With Impaired Renal Function
  
  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
  
  Dosage Adjustment for Patients With Impaired Hepatic Function
  
  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Ondansetron | Remedyrepack Inc.

  

  ---

  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

   

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

   

  There is no experience with the use of a 24 mg dosage in pediatric patients.

   

  The dosage recommendation is the same as for the general population.

   

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

   

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

   

  The dosage is the same as for the general population.

   

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

   

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

   

  The dosage recommendation is the same as for the general population.

   

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

   

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

   

  The dosage is the same as for the general population.

   

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

   

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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• Cardinal Health
  

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  Ondansetron | Bausch & Lomb Incorporated

  

  ---

  For tonometry and other procedures of short duration, instill one or two drops just prior to evaluation. For minor surgical procedures such as foreign body or suture removal, administer one to two drops every five to ten minutes for one to three instillations. For prolonged anesthesia as in cataract extraction, instill one or two drops in the eye(s) every five to ten minutes for three to five doses.

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• Bluepoint Laboratories
  

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  Ondansetron | Preferred Pharmaceuticals, Inc.

  

  ---

  THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.

  In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

  For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For children over 100 lb the usual adult dose should be used.

  The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.

  When used in streptococcal infections, therapy should be continued for 10 days.

  Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration (See ADVERSE REACTIONS).

  If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.

  Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of doxycycline in patients with renal impairment.

  Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required.

  Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydiatrachomatis: 100 mg, by mouth, twice a day for 7 days.

  Nongonococcal urethritis (NGU) caused by C. trachomatis or U. urealyticum: 100 mg, by mouth, twice a day for 7 days.

  Syphilis - early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks.

  Syphilis of more than one year’s duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks.

  Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.

  Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.

  For prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 to 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.

  Inhalational anthrax (post-exposure):

  ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.

  CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.

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• West-ward Pharmaceutical Corp.
  

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  Ondansetron | West-ward Pharmaceutical Corp.

  

  ---

  Prevention of Chemotherapy-Induced Nausea and Vomiting:

  Adult Dosing: The recommended I.V dosage of ondansetron injection, USP for adults is a single 32 mg dose or three 0.15 mg/kg doses. A single 32 mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. The recommended infusion rate should not be exceeded (see OVERDOSAGE).

  With the three-dose (0.15 mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron injection, USP.

  Ondansetron injection, USP should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as precipitate may form.

  Vial: DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING. Ondansetron injection, USP should be diluted in 50 mL of 5% dextrose injection or 0.9% sodium chloride injection before administration.

  Pediatric Dosing: On the basis of the available information (see CLINICAL TRIALS: Pediatric Studies and CLINICAL PHARMACOLOGY: Pharmacokinetics), the dosage in pediatric cancer patients 4 to 18 years of age should be three 0.15 mg/kg doses. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy, subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron injection, USP. The drug should be infused intravenously over 15 minutes. Little information is available about dosage in pediatric cancer patients younger than 6 months of age.

  Dosing information for pediatric cancer patients 6 months to 48 months of age is approved for GlaxoSmithKline Corporation's ondansetron injection. However, due to GlaxoSmithKline's marketing exclusivity rights, this drug product is not labeled for use in this subpopulation of pediatric patients.

  Vial: DILUTE BEFORE USE. Ondansetron injection, USP should be diluted in 50 mL of 5% dextrose injection or 0.9% sodium chloride injection before administration.

  Geriatric Dosing: The dosage recommendation is the same as for the general population.

  Prevention of Postoperative Nausea and Vomiting:

  Adult Dosing: The recommended I.V. dosage of ondansetron injection, USP for adults is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery. Alternatively 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, pre-induction I.V. dose of ondansetron 4 mg, administration of a second I.V. dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Vial: REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Pediatric Dosing; The recommended I.V. dosage of ondansetron injection, USP for pediatric patients (1 month to 12 years of age) is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron injection, USP.

  Dosing information for pediatric surgical patients 1 month to 24 months of age is approved for Glaxo SmithKline Corporation's ondansetron injection. However, due to GlaxoSmithKline's marketing exclusivity rights, this drug product is not labeled for use in this subpopulation of pediatric patients.

  Vial: REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Geriatric Dosing: The dosage recommendation is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function: The dosage recommendation is the same as for the general population. There is no experience beyond the first-day administration of ondansetron.

  Dosage Adjustment for Patients with Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron.

  Stability: Ondansetron injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following I.V. fluids: 0.9% sodium chloride injection, 5 % dextrose injection, 5% dextrose and 0.9% sodium chloride injection, 5% dextrose and 0.45% sodium chloride injection, and 3% sodium chloride injection.

  Although ondansetron injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative. After dilution, do not use beyond 24 hours.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

  HOW SUPPLIED

  ONDANSETRON INJECTION. USP, 2 mg/mL, is supplied as follows:

  NDC 62778-027-01 2-mL single-dose vials (Carton of 5) NDC 62778-028-01 20-mL multidose vial (Carton of 1)

  Store between 20° and 25°C (68° and 77°F). [See USP Controlled Room Temperature]. Protect from light.

  REFERENCES: Britto MR, Hussey EK, Mydlow P, et al. Effect of enzyme inducers on ondansetron (OND) metabolism in humans. Clin Pharmacol Ther. 1997;61:228. Pugh RNH, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Brit J Surg. 1973;60:646-649. Villikka K, Kivisto KT, Neuvonen PJ. The effect of rifampin on the pharmacokinetics of oral and intravenous ondansetron. Clin Pharmacol Ther. 1999;65:377-381. De Witte JL. Schoenmaekers B, Sessler DI, et al. AnesthAnalg. 2001;92:1319-1321. Arcioni R, della Rocca M, RomanÒ R, et al. Anesth Analg. 2002;94:1553-1557.

  Manufactured by:

  HIKMA FARMACêUTICA (PORTUGAL), S.A.
  Estrada do Rio da MÒ, n0 8, 8A e 8B - Fervenca,
  2705 - 906 Terrugem SNT
  PORTUGAL

  for:

  WEST-WARD PHARMACEUTICAL Corp.
  465 Industrial Way West
  EATONTOWN NJ 07724
  USA

  Iss.: Sept.2006

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• Stat Rx Usa
  

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  Ondansetron | Stat Rx Usa

  

  ---

  DOSAGE AND ADMINISTRATION Instructions for Use/Handling ondansetron orally disintegrating tablets:

  Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use:

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron hydrochloride tablet or one 4-mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron hydrochloride tablet or one 4-mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use:

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet given 3 times a day.

  For total body irradiation, one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use:

  There is no experience with the use of ondansetron hydrochloride tablets or ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8-mg ondansetron hydrochloride tablets or two 8-mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use:

  There is no experience with the use of ondansetron hydrochloride tablets or ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Sun Pharmaceutical Industries Limited
  

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  Ondansetron | Sun Pharmaceutical Industries Limited

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets: Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy: The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  
  

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy: The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  
  

  Geriatric Use:

  The dosage is the same as for the general population.
  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen: The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.

  
  

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
  Pediatric Use:

  There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.
  Geriatric Use: The dosage recommendation is the same as for the general population.
  Postoperative Nausea and Vomiting: The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  
  

  Geriatric Use: The dosage is the same as for the general population.
  Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
  Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Major Pharmaceuticals
  

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  Ondansetron | Major Pharmaceuticals

  

  ---

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8 mg Ondansetron Hydrochloride Tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron tablet given three times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron hydrochloride tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8 mg ondansetron hydrochloride tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron hydrochloride tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron hydrochloride tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron hydrochloride tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of Ondansetron Hydrochloride Tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8 mg Ondansetron Hydrochloride Tablets 1 hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of Ondansetron Hydrochloride Tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Pd-rx Pharmaceuticals, Inc.
  

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  Ondansetron | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets:

  Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Ondansetron | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  DOSAGE AND ADMINISTRATION
  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets:

  Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  
  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy
  
  

  Geriatric Use: The dosage is the same as for the general population.

  
  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:
  

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

  
  Dosage Adjustment for Patients with Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Baxter Healthcare Corporation
  

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  Ondansetron | Baxter Healthcare Corporation

  

  ---

  Prevention of Chemotherapy-Induced Nausea and Vomiting Adult Dosing

  The recommended IV dosage of ondansetron for adults is a single 32 mg dose or three 0.15 mg/kg doses. A single 32 mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. The recommended infusion rate should not be exceeded (see OVERDOSAGE). With the three-dose (0.15 mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron.

  Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Vial

  DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING. Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Pediatric Dosing

  On the basis of the available information (see CLINICAL TRIALS, Pediatric Studies and CLINICAL PHARMACOLOGY, Pharmacokinetics), the dosage in pediatric cancer patients 6 months to 18 years of age should be three 0.15 mg/kg doses. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy, subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron. The drug should be infused intravenously over 15 minutes. Little information is available about dosage in pediatric cancer patients younger than 6 months of age.

  Vial

  DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING. Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Geriatric Dosing

  The dosage recommendation is the same as for the general population.

  Prevention of Postoperative Nausea and Vomiting Adult Dosing

  The recommended IV dosage of ondansetron for adults is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, IV dose of ondansetron 4 mg, administration of a second IV dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Vial

  REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Pediatric Dosing

  The recommended IV dosage of ondansetron for pediatric surgical patients (1 month to 12 years of age) is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron.

  Vial

  REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Geriatric Dosing

  The dosage recommendation is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first‑day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child‑Pugh2 score of 10 or greater), a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron.

  Stability

  Ondansetron Injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following IV fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Although Ondansetron Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative. After dilution, do not use beyond 24 hours.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  Precaution

  Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

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• Baxter Healthcare Corporation
  

  ×

  Ondansetron | Baxter Healthcare Corporation

  

  ---

  Prevention of Chemotherapy-Induced Nausea and Vomiting Adult Dosing

  The recommended IV dosage of ondansetron for adults is a single 32 mg dose or three 0.15 mg/kg doses. A single 32 mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. The recommended infusion rate should not be exceeded (see OVERDOSAGE). With the three-dose (0.15 mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron.

  Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Vial

  DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING. Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Pediatric Dosing

  On the basis of the available information (see CLINICAL TRIALS, Pediatric Studies and CLINICAL PHARMACOLOGY, Pharmacokinetics), the dosage in pediatric cancer patients 6  months to 18 years of age should be three 0.15 mg/kg doses. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy, subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron. The drug should be infused intravenously over 15 minutes. Little information is available about dosage in pediatric cancer patients younger than 6 months of age.

  Vial

  DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING. Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Geriatric Dosing

  The dosage recommendation is the same as for the general population.

  Prevention of Postoperative Nausea and Vomiting Adult Dosing

  The recommended IV dosage of ondansetron for adults is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, IV dose of ondansetron 4 mg, administration of a second IV dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Vial

  REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Pediatric Dosing

  The recommended IV dosage of ondansetron for pediatric surgical patients (1 month to 12 years of age) is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron.

  Vial

  REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Geriatric Dosing

  The dosage recommendation is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron.

  Stability

  Ondansetron Injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following IV fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Although Ondansetron Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative. After dilution, do not use beyond 24 hours.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  Precaution

  Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

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• Physicians Total Care, Inc.
  

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  Ondansetron | Physicians Total Care, Inc.

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets 

  Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

   Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy 

  The recommended adult oral dosage of ondansetron hydrochloride tablets is 24-mg administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

   Pediatric Use 

  There is no experience with the use of 24-mg dosage in pediatric patients.

   Geriatric Use 

  The dosage recommendation is the same as for the general population.

   Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy 

  The recommended adult oral dosage is one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron hydrochloride oral solution given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose.

  One 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron hydrochloride oral solution should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

   Pediatric Use 

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron hydrochloride tablet or one 4-mg ondansetron orally disintegrating tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ondansetron hydrochloride oral solution given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron hydrochloride tablet or one 4-mg ondansetron orally disintegrating tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ondansetron hydrochloride oral solution should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

   Geriatric Use 

  The dosage is the same as for the general population.

   Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen 

  The recommended oral dosage is one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron hydrochloride oral solution given 3 times a day.

  For total body irradiation, one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron hydrochloride oral solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron hydrochloride oral solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron hydrochloride oral solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

   Pediatric Use 

  There is no experience with the use of ondansetron hydrochloride tablets, ondansetron orally disintegrating tablets, or ondansetron hydrochloride oral solution in the prevention of radiation-induced nausea and vomiting in pediatric patients.

   Geriatric Use 

  The dosage recommendation is the same as for the general population.

   Postoperative Nausea and Vomiting 

  The recommended dosage is 16 mg given as two 8-mg ondansetron hydrochloride tablets or two 8-mg ondansetron orally disintegrating tablets or 20 mL (4 teaspoonfuls equivalent to16 mg of ondansetron) of ondansetron hydrochloride oral solution 1 hour before induction of anesthesia.

   Pediatric Use 

  There is no experience with the use of ondansetron hydrochloride tablets, ondansetron orally disintegrating tablets, or ondansetron hydrochloride oral solution in the prevention of postoperative nausea and vomiting in pediatric patients.

   Geriatric Use 

  The dosage is the same as for the general population.

   Dosage Adjustment for Patients With Impaired Renal Function 

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

   Dosage Adjustment for Patients With Impaired Hepatic Function 

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Ranbaxy Pharmaceuticals Inc.
  

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  Ondansetron | Ranbaxy Pharmaceuticals Inc.

  

  ---

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron tablets, USP is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m

  . Multiday, single-dose administration of a 24 mg dosage has not been studied.

   

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8-mg ondansetron tablet, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

   

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet, USP or one 4-mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8-mg ondansetron tablet, USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  , one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

   

  There is no experience with the use of ondansetron tablet, USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets, USP 1 hour before induction of anesthesia.

   

  There is no experience with the use of ondansetron tablets, USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh

  score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Cardinal Health
  

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  Ondansetron | Cardinal Health

  

  ---

  Prevention of Chemotherapy-Induced Nausea and Vomiting Adult Dosing

  The recommended IV dosage of ondansetron for adults is a single 32 mg dose or three 0.15 mg/kg doses. A single 32 mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. The recommended infusion rate should not be exceeded (see OVERDOSAGE). With the three-dose (0.15 mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron.

  Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Vial

  DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING. Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Pediatric Dosing

  On the basis of the available information (see CLINICAL TRIALS, Pediatric Studies and CLINICAL PHARMACOLOGY, Pharmacokinetics), the dosage in pediatric cancer patients 6 months to 18 years of age should be three 0.15 mg/kg doses. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy, subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron. The drug should be infused intravenously over 15 minutes. Little information is available about dosage in pediatric cancer patients younger than 6 months of age.

  Vial

  DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING. Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Geriatric Dosing

  The dosage recommendation is the same as for the general population.

  Prevention of Postoperative Nausea and Vomiting Adult Dosing

  The recommended IV dosage of ondansetron for adults is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, IV dose of ondansetron 4 mg, administration of a second IV dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Vial

  REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Pediatric Dosing

  The recommended IV dosage of ondansetron for pediatric surgical patients (1 month to 12 years of age) is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron.

  Vial

  REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Geriatric Dosing

  The dosage recommendation is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first‑day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child‑Pugh2 score of 10 or greater), a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron.

  Stability

  Ondansetron Injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following IV fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Although Ondansetron Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative. After dilution, do not use beyond 24 hours.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  Precaution

  Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

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• Actavis Inc.
  

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  Ondansetron | Actavis Inc.

  

  ---

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron tablets is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8-mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet or one 4-mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8-mg ondansetron tablet given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron tablet in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets 1 hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Pd-rx Pharmaceuticals, Inc.
  

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  Ondansetron | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Instructions for Use/Handling ondansetron orally disintegrating tablets:

  Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use:

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron hydrochloride tablet or one 4-mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron hydrochloride tablet or one 4-mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use:

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet given 3 times a day.

  For total body irradiation, one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use:

  There is no experience with the use of ondansetron hydrochloride tablets or ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8-mg ondansetron hydrochloride tablets or two 8-mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use:

  There is no experience with the use of ondansetron hydrochloride tablets or ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Physicians Total Care, Inc.
  

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  Ondansetron | Physicians Total Care, Inc.

  

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  Prevention of Chemotherapy-Induced Nausea and Vomiting:

  Adult Dosing: The recommended I.V dosage of ondansetron injection, USP for adults is a single 32 mg dose or three 0.15 mg/kg doses. A single 32 mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. The recommended infusion rate should not be exceeded (see OVERDOSAGE).

  With the three-dose (0.15 mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron injection, USP.

  Ondansetron injection, USP should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as precipitate may form.

  Vial: DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING. Ondansetron injection, USP should be diluted in 50 mL of 5% dextrose injection or 0.9% sodium chloride injection before administration.

  Pediatric Dosing: On the basis of the available information (see CLINICAL TRIALS: Pediatric Studies and CLINICAL PHARMACOLOGY: Pharmacokinetics), the dosage in pediatric cancer patients 4 to 18 years of age should be three 0.15 mg/kg doses. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy, subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron injection, USP. The drug should be infused intravenously over 15 minutes. Little information is available about dosage in pediatric cancer patients younger than 6 months of age.

  Dosing information for pediatric cancer patients 6 months to 48 months of age is approved for GlaxoSmithKline Corporation's ondansetron injection. However, due to GlaxoSmithKline's marketing exclusivity rights, this drug product is not labeled for use in this subpopulation of pediatric patients.

  Vial: DILUTE BEFORE USE. Ondansetron injection, USP should be diluted in 50 mL of 5% dextrose injection or 0.9% sodium chloride injection before administration.

  Geriatric Dosing: The dosage recommendation is the same as for the general population.

  Prevention of Postoperative Nausea and Vomiting:

  Adult Dosing: The recommended I.V. dosage of ondansetron injection, USP for adults is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery. Alternatively 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, pre-induction I.V. dose of ondansetron 4 mg, administration of a second I.V. dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Vial: REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Pediatric Dosing; The recommended I.V. dosage of ondansetron injection, USP for pediatric patients (1 month to 12 years of age) is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron injection, USP.

  Dosing information for pediatric surgical patients 1 month to 24 months of age is approved for Glaxo SmithKline Corporation's ondansetron injection. However, due to GlaxoSmithKline's marketing exclusivity rights, this drug product is not labeled for use in this subpopulation of pediatric patients.

  Vial: REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Geriatric Dosing: The dosage recommendation is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function: The dosage recommendation is the same as for the general population. There is no experience beyond the first-day administration of ondansetron.

  Dosage Adjustment for Patients with Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron.

  Stability: Ondansetron injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following I.V. fluids: 0.9% sodium chloride injection, 5 % dextrose injection, 5% dextrose and 0.9% sodium chloride injection, 5% dextrose and 0.45% sodium chloride injection, and 3% sodium chloride injection.

  Although ondansetron injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative. After dilution, do not use beyond 24 hours.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

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• West-ward Pharmaceutical Corp
  

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  Ondansetron | West-ward Pharmaceutical Corp

  

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  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of Ondansetron Hydrochloride Tablets is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8 mg Ondansetron Hydrochloride Tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg Ondansetron Hydrochloride Tablet given three times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg Ondansetron Hydrochloride Tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8 mg Ondansetron Hydrochloride Tablet given 3 times a day.

  For total body irradiation, one 8 mg Ondansetron Hydrochloride Tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg Ondansetron Hydrochloride Tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg Ondansetron Hydrochloride Tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of Ondansetron Hydrochloride Tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8 mg Ondansetron Hydrochloride Tablets 1 hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of Ondansetron Hydrochloride Tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Dispensing Solutions, Inc.
  

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  Ondansetron | Dispensing Solutions, Inc.

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP:

  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use:

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use:

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Dispensing Solutions, Inc.
  

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  Ondansetron | Dispensing Solutions, Inc.

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP:

  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use:

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use:

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Pd-rx Pharmaceuticals, Inc.
  

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  Ondansetron | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets:

  Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Preferred Pharmaceuticals, Inc
  

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  Ondansetron | Preferred Pharmaceuticals, Inc

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets:

    Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

    The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

    The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

    The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

   The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function:

    The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

    In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Stat Rx Usa Llc
  

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  Ondansetron | Stat Rx Usa Llc

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP:

  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use:

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use:

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  ---

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron tablets, USP is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m

  . Multiday, single-dose administration of a 24 mg dosage has not been studied.

   

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8-mg ondansetron tablet, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

   

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet, USP or one 4-mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8-mg ondansetron tablet, USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  , one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

   

  There is no experience with the use of ondansetron tablet, USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets, USP 1 hour before induction of anesthesia.

   

  There is no experience with the use of ondansetron tablets, USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh

  score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets

  With dry hands, remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8mg tablets administered 30 minutes before the start of single day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of ondansetron hydrochloride 24 mg tablets has not been studied.

  Pediatric Use

  There is no experience with the use of 24 mg ondansetron hydrochloride dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron hydrochloride tablets, ondansetron orally disintegrating tablets or ondansetron oral solution in the prevention of radiation induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron hydrochloride tablets, ondansetron orally disintegrating tablets or ondansetron oral solution in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first day administration of ondansetron.

  Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Rebel Distributors Corp
  

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  Ondansetron | Rebel Distributors Corp

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets:

    Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

    The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

    The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

    The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

   The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function:

    The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

    In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Rebel Distributors Corp
  

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  Ondansetron | Rebel Distributors Corp

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP:

  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use:

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use:

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Rebel Distributors Corp
  

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  Ondansetron | Rebel Distributors Corp

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP:

  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use:

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use:

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
  

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  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets

  With dry hands, remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8mg tablets administered 30 minutes before the start of single day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of ondansetron hydrochloride 24 mg tablets has not been studied.

  Pediatric Use

  There is no experience with the use of 24 mg ondansetron hydrochloride dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron hydrochloride tablets, ondansetron orally disintegrating tablets or ondansetron oral solution in the prevention of radiation induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron hydrochloride tablets, ondansetron orally disintegrating tablets or ondansetron oral solution in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first day administration of ondansetron.

  Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  Ondansetron | Dimensional Merchandising Inc.

  

  ---

  • Dr. Perricone recommends applying to face in gentle circular motions in the morning. Microcapsules will slowly release their pigment as they are blended into the skin.
  For sunscreen use:
  • apply liberally 15 minutes before sun exposure.
  • use a water resistant sunscreen if swimming or sweating.
  • reapply at least every 2 hours.
  • not for use on children.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
     • limit time in the sun, especially from 10 a.m.–2 p.m.
     • wear long-sleeved shirts, pants, hats and sunglasses.

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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  Ondansetron | Mylan Institutional Inc.

  

  ---

  Prevention of Nausea and Vomiting Associated with Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8 mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8 mg ondansetron tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8 mg ondansetron tablets one hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first day administration of ondansetron.

  Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets:

  Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m . Multiday, single-dose administration of a 24 mg dosage has not been studied. 2

  There is no experience with the use of a 24 mg dosage in pediatric patients. Pediatric Use:

  The dosage recommendation is the same as for the general population. Geriatric Use:

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy. Pediatric Use:

  The dosage is the same as for the general population. Geriatric Use:

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  , one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day. For total body irradiation

  , one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy. For single high-dose fraction radiotherapy to the abdomen

  , one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given. For daily fractionated radiotherapy to the abdomen

  There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients. Pediatric Use:

  The dosage recommendation is the same as for the general population. Geriatric Use:

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  : Pediatric UseThere is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  The dosage is the same as for the general population. Geriatric Use:

  Dosage Adjustment for Patients with Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded. 2

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  Prevention of Chemotherapy-Induced Nausea and Vomiting
  

  Adult Dosing:

  The recommended IV dosage of Ondansetron Injection for adults is a single 32 mg dose or three 0.15 mg/kg doses.  A single 32 mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy.  The recommended infusion rate should not be exceeded (see OVERDOSAGE).  With the three-dose (0.15 mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy.  Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of Ondansetron Injection.

  Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established.  In particular, this applies to alkaline solutions as a precipitate may form.

  DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY–INDUCED NAUSEA AND VOMITING.  Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Pediatric Dosing:

  On the basis of the available information (see  CLINICAL TRIALS:  Pediatric Studies and CLINICAL PHARMACOLOGY:  Pharmacokinetics), the dosage in pediatric cancer patients 6 months to 18 years of age should be three 0.15 mg/kg doses.  The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy, subsequent doses (0.15 mg/kg are administered 4 and 8 hours after the first dose of ondansetron injection.  The drug should be infused intravenously over 15 minutes.  Little information is available about dosage in pediatric cancer patients younger than 6 months of age.

  DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY - INDUCED NAUSEA AND VOMITING.  Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Geriatric Dosing:

  The dosage recommendation is the same as for the general population.

  Prevention of Postoperative Nausea and Vomiting
  

  Adult Dosing:

  The recommended IV dosage of Ondansetron Injection for adults is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery.  Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults.  While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied.  In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, IV dose of ondansetron 4 mg, administration of a second IV dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Pediatric Dosing:

  The recommended IV dosage of Ondansetron Injection for pediatric surgical patients (1 month to 12 years of age) is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg.  The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery.  Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron injection.

  REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Geriatric Dosing:

  The dosage recommendation is the same as for the general population.

  Dosage Adjustments for Patients With Impaired Renal Function
  

  The dosage recommendation is the same as for the general population.  There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function
  

  In patients with severe hepatic impairment (Child- Pugh2 score of 10 or greater), a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.  There is no experience beyond first-day administration of ondansetron.

  Prevention of Chemotherapy-Induced Nausea and Vomiting
  

  Adult Dosing:

  The recommended IV dosage of Ondansetron Injection for adults is a single 32 mg dose or three 0.15 mg/kg doses.  A single 32 mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy.  The recommended infusion rate should not be exceeded (see OVERDOSAGE).  With the three-dose (0.15 mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy.  Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of Ondansetron Injection.

  Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established.  In particular, this applies to alkaline solutions as a precipitate may form.

  DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY–INDUCED NAUSEA AND VOMITING.  Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Pediatric Dosing:

  On the basis of the available information (see  CLINICAL TRIALS:  Pediatric Studies and CLINICAL PHARMACOLOGY:  Pharmacokinetics), the dosage in pediatric cancer patients 6 months to 18 years of age should be three 0.15 mg/kg doses.  The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy, subsequent doses (0.15 mg/kg are administered 4 and 8 hours after the first dose of ondansetron injection.  The drug should be infused intravenously over 15 minutes.  Little information is available about dosage in pediatric cancer patients younger than 6 months of age.

  DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY - INDUCED NAUSEA AND VOMITING.  Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Geriatric Dosing:

  The dosage recommendation is the same as for the general population.

  Prevention of Postoperative Nausea and Vomiting
  

  Adult Dosing:

  The recommended IV dosage of Ondansetron Injection for adults is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery.  Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults.  While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied.  In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, IV dose of ondansetron 4 mg, administration of a second IV dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Pediatric Dosing:

  The recommended IV dosage of Ondansetron Injection for pediatric surgical patients (1 month to 12 years of age) is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg.  The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery.  Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron injection.

  REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Geriatric Dosing:

  The dosage recommendation is the same as for the general population.

  Dosage Adjustments for Patients With Impaired Renal Function
  

  The dosage recommendation is the same as for the general population.  There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function
  

  In patients with severe hepatic impairment (Child- Pugh2 score of 10 or greater), a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.  There is no experience beyond first-day administration of ondansetron.

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  Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

   

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

   

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

   

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

   

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

   

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

   

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy
  

  Ondansetron injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  
  

  Adults:The recommended adult intravenous dosage of Ondansetron injection is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron injection.

  
  

  Pediatrics:For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron injection is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.2 and 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron injection. The drug should be infused intravenously over 15 minutes.

  2.2 Prevention of Postoperative Nausea and Vomiting
  

  Ondansetron injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Adults: The recommended adult intravenous dosage of Ondansetron injection is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea  and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Pediatrics: For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron injection.

  2.3 Stability and Handling
  

  After dilution, do not use beyond 24 hours. Although Ondansetron injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function
  

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

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  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy
  
  

  Ondansetron injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  
  

  Adults:The recommended adult intravenous dosage of Ondansetron injection is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron injection.

  
  

  Pediatrics:For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron injection is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.2 and 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron injection. The drug should be infused intravenously over 15 minutes.

  2.2 Prevention of Postoperative Nausea and Vomiting
  

  Ondansetron injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Adults: The recommended adult intravenous dosage of Ondansetron injection is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea  and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Pediatrics: For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron injection.

  2.3 Stability and Handling
  

  After dilution, do not use beyond 24 hours. Although Ondansetron injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function
  

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

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  ---

  Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

   

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

   

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

   

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

   

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

   

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

   

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron tablets is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8-mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet or one 4-mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8-mg ondansetron tablet given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron tablet in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets 1 hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

   

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

   

  There is no experience with the use of a 24 mg dosage in pediatric patients.

   

  The dosage recommendation is the same as for the general population.

   

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

   

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

   

  The dosage is the same as for the general population.

   

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

   

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

   

  The dosage recommendation is the same as for the general population.

   

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

   

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

   

  The dosage is the same as for the general population.

   

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

   

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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  Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

   

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

   

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

   

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

   

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

   

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

   

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

   

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

   

  There is no experience with the use of a 24 mg dosage in pediatric patients.

   

  The dosage recommendation is the same as for the general population.

   

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

   

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

   

  The dosage is the same as for the general population.

   

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

   

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

   

  The dosage recommendation is the same as for the general population.

   

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

   

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

   

  The dosage is the same as for the general population.

   

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

   

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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  2.1 Recommended Dosing Schedule

  Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.

  Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets * For adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed-release tablets may be considered. † Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.

  Indication

  Dose

  Frequency

  Short-Term Treatment of Erosive Esophagitis Associated With GERD

  Adults

  40 mg

  Once daily for up to 8 weeks*

  Children (5 Years and Older)

  ≥ 15 kg to < 40 kg

  20 mg

  Once Daily for up to 8 wks

  ≥ 40 kg

  40 mg

  Maintenance of Healing of Erosive Esophagitis

  Adults

  40 mg

  Once daily

  Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

  Adults

  40 mg

  Twice daily†

  2.2 Administration Instructions

  Directions for method of administration are presented in Table 2.

  Table 2: Administration Instructions * Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed.

  Formulation

  Route

  Instructions*

  Delayed-Release Tablets

  Oral

  Swallowed whole, with or without food

  Pantoprazole Sodium Delayed-Release Tablets

  Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.

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  ---

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron tablets is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8-mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet or one 4-mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8-mg ondansetron tablet given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron tablet in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets 1 hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy

  Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Adults: The recommended adult intravenous dosage of Ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron.

  Pediatrics: For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1), and Clinical Pharmacology (12.2, and 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron. The drug should be infused intravenously over 15 minutes.

  2.2 Prevention of Postoperative Nausea and Vomiting

  Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Adults: The recommended adult intravenous dosage of Ondansetron is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Pediatrics: For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron.

  2.3 Stability and Handling

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron Injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  CAUTION: THIS 4 MG/2 ML SINGLE DOSE PREFILLED SYRINGE IS NOT FOR USE IN PEDIATRIC PATIENTS LESS THAN 40 KG. DILUTION IS REQUIRED PRIOR TO ADMINISTRATION FOR CHEMOTHERAPY INDUCED NAUSEA AND VOMITING. 2.4 Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

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  Directions

  .Adult and children 12 years older dissolve one packet in 1/2 glass of water every 4 hours or as directed by your doctor.

  Children under 12 years, consult a doctor

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  Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

   

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

   

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

   

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

   

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

   

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

   

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy

  Ondansetron Injection, USP in prefilled syringes should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration. 

  Adults 

  The recommended adult intravenous dosage of Ondansetron is  three 0.15‑mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron.

  Ondansetron Prefilled Syringe: DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING. 

  Pediatrics 

  For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.2 and 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron. The drug should be infused intravenously over 15 minutes. 

  Ondansetron Prefilled Syringe: THIS 4 MG/2 ML SINGLE DOSE PREFILLED SYRINGE IS NOT FOR USE IN PEDIATRIC PATIENTS LESS THAN 40 KG. DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING.  

  2.2 Prevention of Postoperative Nausea and Vomiting

  Ondansetron Injection, USP should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Adults

  The recommended adult intravenous dosage of Ondansetron is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Ondansetron Prefilled Syringe: REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Pediatrics

  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron.

  Ondansetron Prefilled Syringe: REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING. CAUTION: For pediatric patients less than 40 kg, a full 4 mg dose should not be given [see Dosage and Administration (2.2)].

  2.3 Stability and Handling

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron Injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  CAUTION: THIS 4 MG/2 ML SINGLE DOSE PREFILLED SYRINGE IS NOT FOR USE IN PEDIATRIC PATIENTS LESS THAN 40 KG. DILUTION REQUIRED PRIOR TO ADMINISTRATION FOR CHEMOTHERAPY INDUCED NAUSEA AND VOMITING. 

  Directions for Prefilled Syringe

   

   

  1.  To release plunger rod, grasp syringe and depress rod until it releases from the syringe.

  2.  Attach plunger rod to the syringe barrel by inserting rod into the plunger end and turning clockwise.

   

   

  3.  Remove luer tip cover.

  Attach needle or blunt cannula if applicable.

  4.   Expel air by pushing on the plunger rod.

  Do not touch the syringe tip. Administer Drug.

  NOTE: To prevent needlestick injuries, needles and blunt cannulas should not be recapped, purposely bent, or broken by hand.

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

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  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy

  Ondansetron Injection, USP in prefilled syringes should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration. 

  Adults 

  The recommended adult intravenous dosage of Ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron.

  Ondansetron Prefilled Syringe: DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING.

  Pediatrics 

  For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.2 and 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron. The drug should be infused intravenously over 15 minutes.

  Ondansetron Prefilled Syringe: THIS 4 MG/2 ML SINGLE DOSE PREFILLED SYRINGE IS NOT FOR USE IN PEDIATRIC PATIENTS LESS THAN 40 KG. DILUTE BEFORE USE FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING.

  2.2 Prevention of Postoperative Nausea and Vomiting

  Ondansetron Injection, USP should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Adults

  The recommended adult intravenous dosage of Ondansetron is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Ondansetron Prefilled Syringe: REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING.

  Pediatrics

  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron.

  Ondansetron Prefilled Syringe: REQUIRES NO DILUTION FOR ADMINISTRATION FOR POSTOPERATIVE NAUSEA AND VOMITING. CAUTION: For pediatric patients less than 40 kg, a full 4 mg dose should not be given [see Dosage and Administration (2.2)].

  2.3 Stability and Handling

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron Injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  CAUTION: THIS 4 MG/2 ML SINGLE DOSE PREFILLED SYRINGE IS NOT FOR USE IN PEDIATRIC PATIENTS LESS THAN 40 KG. DILUTION REQUIRED PRIOR TO ADMINISTRATION FOR CHEMOTHERAPY INDUCED NAUSEA AND VOMITING. 

  To Use iSecure™ Syringe 

  1.   Remove green tamper evident band in a clockwise motion.

  2.   Depress (Push) the plunger rod. This will loosen the plunger rod that is located on the outside of the syringe barrel so that the plunger rod can be removed. This will also engage syringe.

  Remove the plunger rod.
  
  

  Insert the plunger rod into the back end of the syringe barrel and turn clockwise 2 to 3 times to attach.
  
  

  BEFORE REMOVING LUER TIP CAP, hold the syringe with tip cap upright. Press syringe plunger until plunger moves slightly. This motion breaks the seal between plunger and syringe barrel.

  3.   Twist the luer tip cap clockwise or counterclockwise to break the tamper evident label. Remove luer tip cap and discard it.

                Expel the air by pushing on the plunger rod.

                Attach needle or blunt cannula if required.

   

  NOTE: To prevent needlestick injuries, needles and blunt cannulas should not be recapped, purposely bent, or broken by hand.

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

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  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron tablets is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8-mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet or one 4-mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8-mg ondansetron tablet given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron tablet in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets 1 hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  ---

  Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (2.1):

  •Adults and Pediatric patients (6 months to 18 years): Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes. The first dose should be administered 30 minutes before the start of chemotherapy. Subsequent doses are administered 4 and 8 hours after the first dose.

  Prevention of Postoperative Nausea and/or Vomiting (2.2):

  Population

  Age

  Ondansetron Injection, USP Dosage

  Intravenous Infusion Rate

  Adults

  > 12 yrs

  4 mg x 1

  over 2 - 5 min

  Pediatrics

  (> 40 kg)

  1 mo. – 12 yrs

  4 mg x 1

  over 2 - 5 min

  Pediatrics

  (≤ 40 kg)

  1 mo. – 12 yrs

  0.1 mg/kg x 1

  over 2 - 5 min

  •In patients with severe hepatic impairment, a total daily dose of 8 mg should not be exceeded. (

  2.4

  )

   

  Ondansetron Injection, USP should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

   

  The recommended adult intravenous dosage of Ondansetron Injection, USP is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection, USP.

   

  For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron Injection, USP is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection, USP. The drug should be infused intravenously over 15 minutes.

   

  Ondansetron Injection, USP should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

   

  The recommended adult intravenous dosage of Ondansetron Injection, USP is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

   

  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron Injection, USP.

   

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron Injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

   

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

   

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  (For children’s dosage and administration, see below.) Dosage should be increased more gradually in debilitated or emaciated patients.

  Elderly Patients: In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reac‑tions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully moni‑tored and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.

  1.To Control Severe Nausea and Vomiting:
  Adjust dosage to the response of the individual. Begin with the lowest recommended dosage.
  Oral Dosage-Tablets: Usually one 5mg or 10mg tablet 3 or 4 times daily. Daily dosages above 40 mgs should be used only in resistant cases.

  2.In Adult Psychiatric Disorders: Adjust dosage to the response of the individual and according to the severity of the condition. Begin with the lowest recom‑mended dose. Although response ordinarily is seen within a day or 2, longer treatment is usually required before maximal improvement is seen.
  Oral Dosage: Non-Psychotic Anxiety--Usual dosage is 5 mg 3 or4 times daily. Do not administer in doses of more than 20mg per day or for longer than 12 weeks.

  Psychotic Disorders including Schizophrenia--Inrelatively mild conditions, as seen in private psychiatric practice or in out patient clinics, dosage is 5 or 10 mg 3 or 4 times daily.

  In moderate to severe conditions, for hospitalized or adequate‑ly supervised patients, usual starting dosage is 10 mg 3 or 4 times daily. Increase dosage gradually until symptoms are con‑trolled or side effects become bothersome. When dosage is increased by small increments every 2 or 3 days, side effects either do not occur or are easily controlled. Some patients respond satisfactorily on 50 to 75mg daily. In more severe dis‑turbances, optimum dosage is usually 100 to 150mg daily.

  DOSAGE AND ADMINISTRATION--CHILDREN

  Do not use in pediatric surgery.
  Children seem more prone to develop extrapyramidal reac‑tions, even on moderate doses. Therefore, use lowest effec‑tive dosage. Tell parents not to exceed prescribed dosage, since the possibility for adverse reactions increases as dosage rises. Occasionally the patient may react to the drug with signs of restlessness and excitement; if this occurs, do not administer additional doses. Take particular precaution in administering the drug to children with acute illnesses or dehydration (see under Dystonias).

  1. Severe Nausea and Vomiting in Children:
  Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or 2 years of age. It should not be used in conditions for which children’s dosages have not been established. Dosage and frequency of administration should be adjusted according to the severity of the symptoms and the response of the patient. The duration of activity following intra‑muscular administration may last up to 12 hours. Subsequent doses may be given by the same route if necessary.

  Oral Dosage: More than 1 day’s therapy is seldom necessary.

  Weight

  Usual Dosage

  Not to Exceed

  under 20 lbs not recommended

   

   

  20 to 29 lbs

  2½ mg 1 or 2 times a day

  7.5 mg per day

  30 to 39 lbs

  2½ mg 2 or 3 times a day

  10 mg per day

  40 to 85 lbs

  2½ mg 3 times a day or 5 mg 2 times a day

  15 mg per day

  2. Children with schizophrenia:
  Oral Dosage: For children 2 to 12 years, starting dosage is 21/2 mg 2 or 3 times daily. Do not give more than 10 mg the first day. Then increase dosage according to patient’s response.
  
  FOR AGES 2 to 5, total daily dosage usually does not exceed 20mg.
  
  FOR AGES 6 to 12, total daily dosage usually does not exceed 25mg.

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  • do not take more than directed (see overdose warning) • do not take more than 10 caplets in any 24-hour period • adults and children 12 years and older: take 2 caplets every 4 hours • children under 12 years of age: do not use Other information • each caplet contains: sodium 4 mg • do not use if blister unit is broken or torn • store at 20-25 °C (68-77 ºF)

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  Prevention of Nausea and Vomiting Associated with Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8 mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8 mg ondansetron tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8 mg ondansetron tablets one hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first day administration of ondansetron.

  Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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  Ondansetron | Remedyrepack Inc.

  

  ---

  Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (2.1):

  •Adults and Pediatric patients (6 months to 18 years): Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes. The first dose should be administered 30 minutes before the start of chemotherapy. Subsequent doses are administered 4 and 8 hours after the first dose.

  Prevention of Postoperative Nausea and/or Vomiting (2.2):

  Population

  Age

  Ondansetron Injection, USP Dosage

  Intravenous Infusion Rate

  Adults

  > 12 yrs

  4 mg x 1

  over 2 - 5 min

  Pediatrics

  (> 40 kg)

  1 mo. – 12 yrs

  4 mg x 1

  over 2 - 5 min

  Pediatrics

  (≤ 40 kg)

  1 mo. – 12 yrs

  0.1 mg/kg x 1

  over 2 - 5 min

  •In patients with severe hepatic impairment, a total daily dose of 8 mg should not be exceeded. (

  2.4

  )

   

  Ondansetron Injection, USP should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

   

  The recommended adult intravenous dosage of Ondansetron Injection, USP is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection, USP.

   

  For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron Injection, USP is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection, USP. The drug should be infused intravenously over 15 minutes.

   

  Ondansetron Injection, USP should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

   

  The recommended adult intravenous dosage of Ondansetron Injection, USP is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

   

  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron Injection, USP.

   

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron Injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

   

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

   

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  ---

  Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (2.1):

  •Adults and Pediatric patients (6 months to 18 years): Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes. The first dose should be administered 30 minutes before the start of chemotherapy. Subsequent doses are administered 4 and 8 hours after the first dose.

  Prevention of Postoperative Nausea and/or Vomiting (2.2):

  Population

  Age

  Ondansetron Injection, USP Dosage

  Intravenous Infusion Rate

  Adults

  > 12 yrs

  4 mg x 1

  over 2 - 5 min

  Pediatrics

  (> 40 kg)

  1 mo. – 12 yrs

  4 mg x 1

  over 2 - 5 min

  Pediatrics

  (≤ 40 kg)

  1 mo. – 12 yrs

  0.1 mg/kg x 1

  over 2 - 5 min

  •In patients with severe hepatic impairment, a total daily dose of 8 mg should not be exceeded. (

  2.4

  )

   

  Ondansetron Injection, USP should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

   

  The recommended adult intravenous dosage of Ondansetron Injection, USP is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection, USP.

   

  For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron Injection, USP is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection, USP. The drug should be infused intravenously over 15 minutes.

   

  Ondansetron Injection, USP should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

   

  The recommended adult intravenous dosage of Ondansetron Injection, USP is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

   

  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron Injection, USP.

   

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron Injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

   

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

   

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  ---

  Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (2.1):

  •Adults and Pediatric patients (6 months to 18 years): Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes. The first dose should be administered 30 minutes before the start of chemotherapy. Subsequent doses are administered 4 and 8 hours after the first dose.

  Prevention of Postoperative Nausea and/or Vomiting (2.2):

  Population

  Age

  Ondansetron Injection, USP Dosage

  Intravenous Infusion Rate

  Adults

  > 12 yrs

  4 mg x 1

  over 2 - 5 min

  Pediatrics

  (> 40 kg)

  1 mo. – 12 yrs

  4 mg x 1

  over 2 - 5 min

  Pediatrics

  (≤ 40 kg)

  1 mo. – 12 yrs

  0.1 mg/kg x 1

  over 2 - 5 min

  •In patients with severe hepatic impairment, a total daily dose of 8 mg should not be exceeded. (

  2.4

  )

   

  Ondansetron Injection, USP should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

   

  The recommended adult intravenous dosage of Ondansetron Injection, USP is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection, USP.

   

  For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron Injection, USP is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection, USP. The drug should be infused intravenously over 15 minutes.

   

  Ondansetron Injection, USP should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

   

  The recommended adult intravenous dosage of Ondansetron Injection, USP is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

   

  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron Injection, USP.

   

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron Injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

   

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

   

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  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets:

  Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Remedyrepack Inc.
  

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  Ondansetron | Remedyrepack Inc.

  

  ---

  Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (2.1):

  Adults and Pediatric patients (6 months to 18 years): Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes. The first dose should be administered 30 minutes before the start of chemotherapy. Subsequent doses are administered 4 and 8 hours after the first dose.

  Prevention of Postoperative Nausea and/or Vomiting (2.2):

  Population Age Ondansetron Injection Dosage Intravenous Infusion Rate Adults > 12 yrs 4 mg x 1 over 2 to 5 min

  Pediatrics

  (> 40 kg) 1 mo. to 12 yrs 4 mg x 1 over 2 to 5 min

  Pediatrics

  (≤ 40 kg) 1 mo. to 12 yrs 0.1 mg/kg x 1 over 2 to 5 min In patients with severe hepatic impairment, a total daily dose of 8 mg should not be exceeded. (2.4)

   

  Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

   

  Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Adults

  The recommended adult intravenous dosage of ondansetron hydrochloride is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Pediatrics

  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron hydrochloride.

   

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron Injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

   

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

   

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  Ondansetron | Rnabaxy Pharmaceuticals Inc.

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets: Tear blisters at perforations to separate. With dry hands, remove the tablet from the bottle or PEEL BACK the paper backing of 1 blister, push the tablet through the foil and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy: The recommended adult oral dosage of ondansetron orally disintegrating tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy: The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen: The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting: The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP:

  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use:

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use:

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Remedyrepack Inc.
  

  ×

  Ondansetron | Remedyrepack Inc.

  

  ---

  Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (2.1):

  Adults and Pediatric patients (6 months to 18 years): Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes. The first dose should be administered 30 minutes before the start of chemotherapy. Subsequent doses are administered 4 and 8 hours after the first dose.

  Prevention of postoperative nausea and/or vomiting (2.2):

  Population
  Age
  Ondansetron 
  Injection Dosage
  Intravenous Infusion Rate
  Adults
  > 12 yrs
  4 mg x 1
  over 2 to 5 min
  Pediatrics
  (> 40 kg)
  1 mo. to 12 yrs
  4 mg x 1
  over 2 to 5 min
  Pediatrics
  (≤ 40 kg)
  1 mo. to 12 yrs
  0.1 mg/kg x 1
  over 2 to 5 min
  In patients with severe hepatic impairment, a total daily dose of 8 mg should not be exceeded. (2.4)

   

  Ondansetron injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Adults: The recommended adult intravenous dosage of ondansetron injection is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron injection.
  
  Pediatrics: For pediatric patients 6 months through 18 years of age, the intravenous dosage of ondansetron injection is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.2 and 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron injection. The drug should be infused intravenously over 15 minutes.

   

  Ondansetron injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

   

  Adults:

  The recommended adult intravenous dosage of ondansetron injection is 4 mg

  undiluted

  administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg

  undiluted

  may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  
  Pediatrics:

  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron injection.

   

  After dilution, do not use beyond 24 hours. Although ondansetron injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

   

  Ondansetron injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

   

  Note:

  Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  
  Precaution:

  Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

   

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients

  [see Clinical Pharmacology (12.3)].

   

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  Ondansetron | Glenmark Generics Inc., Usa

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP:

  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use:

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use:

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Teva Parenteral Medicines, Inc.
  

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  Ondansetron | Fresenius Kabi Usa, Llc

  

  ---

  
  

  The total dose of Acetylcysteine Injection is 300 mg/kg given as 3 separate doses and administered over a total of 21 hours. Please refer to the guidelines below for dose preparation based upon patient weight. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction (see Tables 1 and 2).

  2.1 Administration Instructions (Three-Bag Method: Loading, Second and Third Dose)

  Dosing for Patients who weigh 5 kg to 20 kg ( Table 1):

  Loading Dose: 150 mg/kg diluted in 3 mL/kg of diluent* administered over 1 hr

  Second Dose: 50 mg/kg diluted in 7 mL/kg of diluent* administered over 4 hrs

  Third Dose: 100 mg/kg diluted in 14 mL/kg of diluent* administered over 16 hrs

  Table 1. Three Bag Method Dosage Guide by Weight in Patients 5 kg to 20 kg * Acetylcysteine Injection is compatible with the following diluents; 5% Dextrose in Water, 0.45% Sodium Chloride Injection, and Sterile Water for Injection. Body Weight
  (kg) Bag 1 (loading dose):
  150 mg/kg in 3 mL/kg of diluent *
  infused over 1 hour Bag 2 (second dose):
  50 mg/kg in 7mL/kg of diluent *
  infused over 4 hours Bag 3 (third dose):
  100 mg/kg diluted in 14 mL/kg of diluent *
  infused over 16 hours Acetylcysteine Injection
  Total Dose Diluent volume Acetylcysteine Injection
  Total Dose Diluent volume Acetylcysteine Injection
  Total Dose Diluent volume 5 kg
  750 mg
  15 mL
  250 mg
  35 mL
  500 mg
  70 mL
  10 kg
  1,500 mg
  30 mL
  500 mg
  70 mL
  1,000 mg
  140 mL
  15 kg
  2,250 mg
  45 mL
  750 mg
  105 mL
  1,500 mg
  210 mL
  20 kg
  3,000 mg
  60 mL
  1,000 mg
  140 mL
  2,000 mg
  280 mL
  

  See also Section 2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction

  Dosing for patients who weigh 21 kg to 40 kg ( Table 2):

  Loading Dose: 150 mg/kg diluted in 100 mL of diluent* administered over 1 hr

  Second Dose: 50 mg/kg diluted in 250 mL of diluent* administered over 4 hrs

  Third Dose: : 100 mg/kg diluted in 500 mL of diluent* administered over 16 hrs

  Table 2. Three Bag Method Dosage Guide by Weight in Patients 21 kg to 40 kg * Acetylcysteine Injection is compatible with the following diluents; 5% Dextrose in Water 0.45% Sodium Chloride Injection, and Sterile Water for Injection. Body Weight
  (kg) Bag 1 (loading dose):
  150 mg/kg in 100 mL of diluent *
  infused over 1 hr Bag 2 (second dose):
  50 mg/kg in 250 mL of diluent *
  infused over 4 hrs Bag 3 (third dose):
  100 mg/kg in 500 mL of diluent *
  infused over 16 hrs Acetylcysteine Injection
  Total Dose Acetylcysteine Injection
  Total Dose Acetylcysteine Injection
  Total Dose 21 kg
  3,150 mg
  1,050 mg
  2,100 mg
  30 kg
  4,500 mg
  1,500 mg
  3,000 mg
  40 kg
  6,000 mg
  2,000 mg
  4,000 mg
  

  See also Section 2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction.

  Dosing for patients who weigh 41 kg to 100 kg ( Table 3):

  Loading Dose: 150 mg/kg diluted in 200 mL of diluent* administered over 1 hr

  Second Dose: 50 mg/kg diluted in 500 mL of diluent* administered over 4 hrs

  Third Dose: 100 mg/kg diluted in 1,000 mL of diluent administered over 16 hrs

  Table 3. Three Bag Method Dosage Guide by Weight in Patients 41 kg to 100 kg * Acetylcysteine Injection is compatible with the following diluents; 5% Dextrose 0.45% Sodium Chloride Injection, and Sterile Water for Injection. Body Weight
  (kg) Bag 1 (loading dose):
  150 mg/kg diluted in 200 mL of diluent *
  infused over 1 hr Bag 2 (second dose):
  50 mg/kg diluted in 500 mL of diluent *
  infused over 4 hrs Bag 3 (third dose):
  100 mg/kg diluted in 1,000 mL of diluent *
  infused over 16 hrs Acetylcysteine Injection
  Total Dose Acetylcysteine Injection
  Total Dose Acetylcysteine Injection
  Total Dose 41 kg
  6,150 mg
  2,050 mg
  4,100 mg
  50 kg
  7,500 mg
  2,500 mg
  5,000 mg
  60 kg
  9,000 mg
  3,000 mg
  6,000 mg
  70 kg
  10,500 mg
  3,500 mg
  7,000 mg
  80 kg
  12,000 mg
  4,000 mg
  8,000 mg
  90 kg
  13,500 mg
  4,500 mg
  9,000 mg
  100 kg
  15,000 mg
  5,000 mg
  10,000 mg
  

  Patients Weighing More Than 100 kg

  No specific studies have been conducted to evaluate the use of or necessity of dosing adjustments in patients weighing over 100 kg. Limited information is available regarding the dosing requirements of patients that weigh more than 100 kg. The dose of Acetylcysteine Injection recommended in these patients should be a loading dose of 15,000 mg infused over a period of one hour followed by a first maintenance dose of 5,000 mg over 4 hours and a second maintenance dose of 10,000 mg over 16 hours ( Table 3).

  Continued Therapy beyond 21 Hours

  While there is no clinical trial data to support infusions beyond 21 hours there is literature that supports continued infusion of acetylcysteine in some rare instances. In cases of suspected massive overdose, or with concomitant ingestion of other substances, or in patients with preexisting liver disease, the absorption and/or the half-life of acetaminophen may be prolonged, in such cases consideration should be given to the need for continued infusion of N-acetylcysteine beyond 21 hours. Acetaminophen levels and ALT/AST & INR should be checked before the end of the 21-hour infusion. If acetaminophen levels are still detectable, or in cases in which the ALT/AST are still increasing or the INR remains elevated, the infusion should be continued, and the treating physician should contact a US regional poison center at 1-800-222-1222, or alternatively, a “special health professional assistance line for acetaminophen overdose” at 1-800-525-6115 for assistance with dosing recommendations.

  2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction

  The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as clinically needed. If the volume of the infusion is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure and death. [ see Dosage and Administration (2)]

  As Acetylcysteine Injection is hyperosmolar (2600 mOsmol/L), caution is advised when the diluent volume is decreased as the hyperosmolarity of the solution is increased. See Table 4 below for examples.

  Table 4. Acetylcysteine Injection Concentration and Osmolarity * Osmolarity should be adjusted to a physiologically safe level, (generally not less than 150mOsmol/L in children). Acetylcysteine Injection
  Concentration (mg/mL) Osmolarity in ½
  Normal Saline Osmolarity in D5W Osmolarity in Sterile
  Water for Injection 7 mg/mL 245 mOsmol/L 343 mOsmol/L 91 mOsmol/L * 24 mg/m/L 466 mOsmol/L 564 mOsmol/L 312 mOsmol/L

  Single dose vial, preservative-free, discard unused portion. If vial was previously opened, do not use for intravenous administration.

  Stability studies indicate that the diluted solution is stable for 24 hours at controlled room temperature.

  Note: The color of Acetylcysteine Injection may turn from essentially colorless to a slight pink or purple once the stopper is punctured. The color change does not affect the quality of the product.

  2.3 Renal Impairment
  

  No data are available to determine if a dose adjustment in patients with moderate or severe renal impairment is required.

  2.4 Hepatic Impairment
  

  Although there was a threefold increase in acetylcysteine plasma concentrations in patients with hepatic cirrhosis, no data are available to determine if a dose adjustment in these patients is required. The published medical literature does not indicate that the dose of acetylcysteine in patients with hepatic impairment should be reduced.

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  Ondansetron | Teva Parenteral Medicines, Inc.

  

  ---

  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy

  Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Adults

  The recommended adult intravenous dosage of ondansetron hydrochloride is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron hydrochloride.

  Pediatrics

  For pediatric patients 6 months through 18 years of age, the intravenous dosage of ondansetron hydrochloride is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1), Clinical Pharmacology (12.2, 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron hydrochloride. The drug should be infused intravenously over 15 minutes.

  2.2 Prevention of Postoperative Nausea and Vomiting

  Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Adults

  The recommended adult intravenous dosage of ondansetron hydrochloride is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Pediatrics

  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron hydrochloride.

  2.3 Stability and Handling

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron Injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

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  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets:

  Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  Ondansetron | Sandoz Inc

  

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  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8 mg ondansetron tablet given twice-a-day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron tablet should be administered twice-a-day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8 mg ondansetron tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8 mg ondansetron tablets, 1 hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  ---

  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

   

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

   

  There is no experience with the use of a 24 mg dosage in pediatric patients.

   

  The dosage recommendation is the same as for the general population.

   

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

   

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

   

  The dosage is the same as for the general population.

   

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

   

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

   

  The dosage recommendation is the same as for the general population.

   

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

   

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

   

  The dosage is the same as for the general population.

   

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

   

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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  Hypertension

  In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of enalapril maleate tablets. The diuretic should, if possible, be discontinued for 2 to 3 days before beginning therapy with enalapril maleate tablets to reduce the likelihood of hypotension. (See WARNINGS.) If the patient's blood pressure is not controlled with enalapril maleate tablets alone, diuretic therapy may be resumed.

  If the diuretic cannot be discontinued an initial dose of 2.5 mg should be used under medical supervision for at least 2 hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS and PRECAUTIONS: Drug Interactions.)

  The recommended initial dose in patients not on diuretics is 5 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 10 mg to 40 mg per day administered in a single dose or two divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with enalapril maleate tablets alone, a diuretic may be added. Concomitant administration of enalapril maleate tablets with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (see PRECAUTIONS).

  Dosage Adjustment in Hypertensive Patients with Renal Impairment

  The usual dose of enalapril maleate tablets is recommended for patients with a creatinine clearance > 30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance ≤ 30 mL/min (serum creatinine ≥ 3 mg/dL), the first dose is 2.5 mg once daily. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.

  * See WARNINGS: Anaphylactoid Reactions During Membrane Exposure. † Dosage on nondialysis days should be adjusted depending on the blood pressure response.

  Renal Status

  Creatinine-Clearance
  mL/min

  Initial Dose
  mg/day

  Normal Renal Function

  > 80 mL/min

  5 mg

  Mild Impairment

  ≤ 80 > 30 mL/min

  5 mg

  Moderate to Severe Impairment

  ≤ 30 mL/min

  2.5 mg

  Dialysis Patients*

  —

  2.5 mg on dialysis days†

  Heart Failure

  Enalapril maleate tablets are indicated for the treatment of symptomatic heart failure, usually in combination with diuretics and digitalis. In the placebo-controlled studies that demonstrated improved survival, patients were titrated as tolerated up to 40 mg, administered in two divided doses.

  The recommended initial dose is 2.5 mg. The recommended dosing range is 2.5 mg to 20 mg given twice a day. Doses should be titrated upward, as tolerated, over a period of a few days or weeks. The maximum daily dose administered in clinical trials was 40 mg in divided doses.

  After the initial dose of enalapril maleate tablets, the patient should be observed under medical supervision for at least 2 hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS and PRECAUTIONS: Drug Interactions.) If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of enalapril maleate tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

  Asymptomatic Left Ventricular Dysfunction

  In the trial that demonstrated efficacy, patients were started on 2.5 mg twice daily and were titrated as tolerated to the targeted daily dose of 20 mg (in divided doses).

  After the initial dose of enalapril maleate tablets, the patient should be observed under medical supervision for at least 2 hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS and PRECAUTIONS: Drug Interactions.) If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of enalapril maleate tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

  Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia

  In patients with heart failure who have hyponatremia (serum sodium less than 130 mEq/L) or with serum creatinine greater than 1.6 mg/dL, therapy should be initiated at 2.5 mg daily under close medical supervision. (See DOSAGE AND ADMINISTRATION: Heart Failure, WARNINGS and PRECAUTIONS: Drug Interactions.) The dose may be increased to 2.5 mg b.i.d., then 5 mg b.i.d. and higher as needed, usually at intervals of 4 days or more if at the time of dosage adjustment there is not excessive hypotension or significant deterioration of renal function. The maximum daily dose is 40 mg.

  Pediatric Hypertensive Patients

  The usual recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily. Dosage should be adjusted according to blood pressure response. Doses above 0.58 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients (see CLINICAL PHARMACOLOGY: Clinical Pharmacology in Pediatric Patients).

  Enalapril maleate tablets are not recommended in neonates and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2, as no data are available.

  Preparation of Suspension (for 200 mL of a 1 mg/mL suspension)

  Add 50 mL of Bicitra®† to a polyethylene terephthalate (PET) bottle containing ten 20 mg tablets of enalapril maleate and shake for at least 2 minutes. Let concentrate stand for 60 minutes. Following the 60 minute hold time, shake the concentrate for an additional minute. Add 150 mL of Ora-Sweet SF™† to the concentrate in the PET bottle and shake the suspension to disperse the ingredients. The suspension should be refrigerated at 2° to 8°C (36° to 46°F) and can be stored for up to 30 days. Shake the suspension before each use.

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  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron tablets, USP is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m

  . Multiday, single-dose administration of a 24 mg dosage has not been studied.

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8-mg ondansetron tablet, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet, USP or one 4-mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8-mg ondansetron tablet, USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  , one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  There is no experience with the use of ondansetron tablet, USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets, USP 1 hour before induction of anesthesia.

  There is no experience with the use of ondansetron tablets, USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh

  score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy

  Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Adults: The recommended adult intravenous dosage of Ondansetron Injection is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection.

  Pediatrics: For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron Injection, is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1), Clinical Pharmacology (12.2, 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection. The drug should be infused intravenously over 15 minutes.

  2.2 Prevention of Postoperative Nausea and Vomiting

  Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Adults: The recommended adult intravenous dosage of Ondansetron Injection is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Pediatrics: For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron Injection.

  2.3 Stability and Handling

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.
  Ondansetron Injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.
  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously. 

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)]. 

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  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy

  Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.
  Adults: The recommended adult intravenous dosage of Ondansetron Injection is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection.
  Pediatrics: For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron Injection, is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1), Clinical Pharmacology (12.2, 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection. The drug should be infused intravenously over 15 minutes.

  2.2 Prevention of Postoperative Nausea and Vomiting

  Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.
  Adults: The recommended adult intravenous dosage of Ondansetron Injection is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.
  Pediatrics: For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron Injection.

  2.3 Stability and Handling

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.
  Ondansetron Injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.
  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously. 

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)]. 

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
  
  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.
  
  Pediatric Use
  
  There is no experience with the use of a 24 mg dosage in pediatric patients.
  
  Geriatric Use
  
  The dosage recommendation is the same as for the general population.
  
  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
   
  The recommended adult oral dosage is 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours
  after the first dose. 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
  
  Pediatric Use
  
  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ondansetron oral solution given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ondansetron oral solution should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
  
  Geriatric Use
  
  The dosage is the same as for the general population.
  
  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen
   
  The recommended oral dosage is 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution given 3 times a day.
  
  For total body irradiation, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
  
  For single high-dose fraction radiotherapy to the abdomen, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
  
  For daily fractionated radiotherapy to the abdomen, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
  
  Pediatric Use
  
  There is no experience with the use of ondansetron oral solution in the prevention of radiation-induced nausea and vomiting in pediatric patients.
  
  Geriatric Use
  
  The dosage recommendation is the same as for the general population.
  
  Postoperative Nausea and Vomiting
   
  The recommended dosage is 20 mL (4 teaspoonfuls equivalent to 16 mg of ondansetron) of ondansetron oral solution 1 hour before induction of anesthesia.
  
  Pediatric Use
  
  There is no experience with the use of ondansetron oral solution in the prevention of postoperative nausea and vomiting in pediatric patients.
  
  Geriatric Use
  
  The dosage is the same as for the general population.
  
  Dosage Adjustment for Patients With Impaired Renal Function
   
  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
  
  Dosage Adjustment for Patients With Impaired Hepatic Function
   
  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets
  

  Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, remove the tablet from the bottle or PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet.  IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
  

  The recommended adult oral dosage of ondansetron orally disintegrating tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use
  

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use
  

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
  

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg  ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use
  

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use
  

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen
  

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.
  
  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
  
  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
  
  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use
  

  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use
  

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting
  

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use
  

  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use
  

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function
  

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function
  

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets 

  Do not attempt to push ondansetron orally disintegrating tablets, USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy 

  The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use 

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use 

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy 

  The recommended adult oral dosage is one 8-mg ondansetron orally disintegrating tablet, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron orally disintegrating tablet, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use 

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron orally disintegrating tablet, USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron orally disintegrating tablet, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use 

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen 

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet, USP given 3 times a day.

  For total body irradiation

  One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen

  One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen

  One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use 

  There is no experience with the use of, ondansetron orally disintegrating tablets, USP, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use 

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting 

  The recommended dosage is 16 mg given as two 8-mg ondansetron orally disintegrating tablets, USP 1 hour before induction of anesthesia.

  Pediatric Use 

  There is no experience with the use of ondansetron orally disintegrating tablets, USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use 

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function 

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function 

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Sandoz Inc
  

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  Ondansetron | Sandoz Inc

  

  ---

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8 mg ondansetron tablet given twice-a-day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron tablet should be administered twice-a-day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8 mg ondansetron tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8 mg ondansetron tablets, 1 hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Proficient Rx Lp
  

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  Ondansetron | Qualitest Pharmaceuticals

  

  ---

  Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. Oxycodone hydrochloride and acetaminophen oral solution is given orally.

  Oxycodone Hydrochloride and Acetaminophen Oral Solution:

  The usual adult dosage is 5 mL (one teaspoonful) every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. (Maximum daily dose is 12 teaspoonfuls or 60 mL.)

  Cessation of Therapy

  In patients treated with oxycodone hydrochloride and acetaminophen oral solution for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Oxycodone Hydrochloride and Acetaminophen Oral Solution:

  The usual adult dosage is 5 mL (one teaspoonful) every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. (Maximum daily dose is 12 teaspoonfuls or 60 mL.)

  Cessation of Therapy

  In patients treated with oxycodone hydrochloride and acetaminophen oral solution for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

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  Ondansetron | Auromedics Pharma Llc

  

  ---

  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy
  

  Ondansetron injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  
  
  

  Adults: The recommended adult intravenous dosage of ondansetron injection is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron injection.
  
  Pediatrics: For pediatric patients 6 months through 18 years of age, the intravenous dosage of ondansetron injection is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1), Clinical Pharmacology (12.2, 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron injection. The drug should be infused intravenously over 15 minutes.

  2.2 Prevention of Postoperative Nausea and Vomiting
  

  Ondansetron injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.
  
  Adults: The recommended adult intravenous dosage of ondansetron injection is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.
  
  Pediatrics: For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron injection.

  2.3 Stability and Handling
  

  After dilution, do not use beyond 24 hours. Although ondansetron injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.
  
  Ondansetron injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.
  
  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
  
  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function
  

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

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  Ondansetron | Bryant Ranch Prepack

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP:

  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use:

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use:

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  Ondansetron | Bryant Ranch Prepack

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP:

  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use:

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use:

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  Ondansetron | Northstar Rxllc

  

  ---

  Nitrofurantoin capsules (monohydrate/macrocrystals)should be taken with food.

  Adults and Pediatric Patients Over 12 Years

  One 100 mg capsule every 12 hours for seven days.

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• Clinical Solutions Wholesale
  

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  Ondansetron | Clinical Solutions Wholesale

  

  ---

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron tablets, USP is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m

  . Multiday, single-dose administration of a 24 mg dosage has not been studied.

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8-mg ondansetron tablet, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet, USP or one 4-mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8-mg ondansetron tablet, USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  , one 8-mg ondansetron tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  There is no experience with the use of ondansetron tablet, USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets, USP 1 hour before induction of anesthesia.

  There is no experience with the use of ondansetron tablets, USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh

  score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Cardinal Health
  

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  Ondansetron | Fresenius Medical Care North America

  

  ---

  DELFLEX® peritoneal dialysis solutions are provided for intraperitoneal administration only. The mode of therapy, frequency of treatment, formulation, exchange volume, duration of dwell, and length of dialysis should be selected by the physician responsible for the treatment of the individual patient.

  To avoid the risk of severe dehydration or hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  Additives may be incompatible. Please refer to manufacturer’s product insert. Do not store solutions containing additives.

  For administration see Directions for Use section.

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  Ondansetron | Cardinal Health

  

  ---

  Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels.

  The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydrALAZINE.

  In a few resistant patients, up to 300 mg of hydrALAZINE daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydrALAZINE combined with a thiazide and/or reserpine or a beta blocker may be considered. However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.[/S]

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  Ondansetron | Glaxosmithkline Consumer Healthcare Lp

  

  ---

  this product does not contain directions or complete warnings for adult use • do not take more than directed (see overdose warning) • find right dose in chart. If possible use weight to dose; otherwise, use age • if needed, repeat dose every 4 hours while symptoms persist or as directed by a doctor • do not take more than 5 doses in 24 hours, unless directed by a doctor • use only with enclosed pre-marked measuring cup for accuracy. Do not use any other dosing device

  Age

  Weight

  Dosage

  under 2 yrs

  under 24 lbs

  ask a doctor

  2 - 3 yrs

  24 – 35 lbs

  5 mL*

  4 – 5 yrs

  36 – 47 lbs

  7.5 mL

  6 – 8 yrs

  48 – 59 lbs

  10 mL

  9 – 10 yrs

  60 – 71 lbs

  12.5 mL

  11 yrs

  72 – 95 lbs

  15 mL

  *mL=milliliter

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  Ondansetron | Cardinal Health

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP:

  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use:

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use:

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  Ondansetron | Cardinal Health

  

  ---

  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy

  Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.
  Adults: The recommended adult intravenous dosage of Ondansetron Injection is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection.
  Pediatrics: For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron Injection, is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1), Clinical Pharmacology (12.2, 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection. The drug should be infused intravenously over 15 minutes.

  2.2 Prevention of Postoperative Nausea and Vomiting

  Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.
  Adults: The recommended adult intravenous dosage of Ondansetron Injection is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.
  Pediatrics: For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron Injection.

  2.3 Stability and Handling

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.
  Ondansetron Injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.
  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously. 

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)]. 

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  Ondansetron | Apotex Corp

  

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  Prevention of Nausea and Vomiting Associated with Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron hydrochloride oral solution given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron hydrochloride oral solution should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron hydrochloride tablet or one 4-mg ondansetron orally disintegrating tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ondansetron hydrochloride oral solution given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron hydrochloride tablet or one 4-mg ondansetron orally disintegrating tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ondansetron hydrochloride oral solution should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron hydrochloride oral solution given 3 times a day.  

  For total body irradiation, one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron hydrochloride oral solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.  

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron hydrochloride oral solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.  

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron hydrochloride tablet or one 8-mg ondansetron orally disintegrating tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron hydrochloride oral solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron hydrochloride tablets, ondansetron orally disintegrating tablets, or ondansetron hydrochloride oral solution in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8-mg ondansetron hydrochloride tablets or two 8-mg ondansetron orally disintegrating tablets or 20 mL (4 teaspoonfuls equivalent to 16 mg of ondansetron) of ondansetron hydrochloride oral solution 1 hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron hydrochloride tablets, ondansetron orally disintegrating tablets, or ondansetron hydrochloride oral solution in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  Ondansetron | Bryant Ranch Prepack

  

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  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets:

  Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Silarx Pharmaceuticals, Inc
  

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  Ondansetron | Silarx Pharmaceuticals, Inc

  

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  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy: The recommended adult oral dosage is 24 mg administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy: The recommended adult oral dosage is 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of Ondansetron Oral Solution USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of Ondansetron Oral Solution USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population
  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen: The recommended oral dosage is 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution USP given 3 times a day.
  For total body irradiation, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day

  For single high-dose fraction radiotherapy to the abdomen, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of Ondansetron Oral Solution USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting: The recommended dosage is 20 mL (4 teaspoonfuls equivalent to 16 mg of ondansetron) of Ondansetron Oral Solution USP 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of Ondansetron Oral Solution USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
  

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• Citron Pharma Llc
  

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  Ondansetron | Medsource Pharmaceuticals

  

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  Adults (17 years of age and over)

  For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of tramadol hydrochloride tablets can be improved by initiating therapy with a titration regimen: The total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg q.i.d.). After titration, tramadol hydrochloride tablets 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day.
  For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, tramadol hydrochloride 50 mg to 100 mg can be administered as needed for pain relief every four to six hours, not to exceed 400 mg per day.

  Individualization of Dose

  Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Studies with tramadol in adults have shown that starting at the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability.

  In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis. The recommended dose for adult patients with cirrhosis is 50 mg every 12 hours. In general, dose selection for an elderly patient over 65 years old should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. For elderly patients over 75 years old, total dose should not exceed 300 mg/day.

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• Auromedics Pharma Llc
  

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  Ondansetron | Sanofi-aventis U.s. Llc

  

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  ELOXATIN (oxaliplatin injection) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

  2.1 Dosage

  Administer ELOXATIN in combination with 5-fluorouracil/leucovorin every 2 weeks. For advanced disease, treatment is recommended until disease progression or unacceptable toxicity. For adjuvant use, treatment is recommended for a total of 6 months (12 cycles):

  Day 1: ELOXATIN 85 mg/m2 intravenous infusion in 250–500 mL 5% Dextrose injection, USP and leucovorin 200 mg/m2 intravenous infusion in 5% Dextrose Injection, USP both given over 120 minutes at the same time in separate bags using a Y-line, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2–4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.

  Day 2: Leucovorin 200 mg/m2 intravenous infusion over 120 minutes, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2–4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.

  Figure 1

  The administration of ELOXATIN does not require prehydration. Premedication with antiemetics, including 5-HT3 blockers with or without dexamethasone, is recommended.

  For information on 5-fluorouracil and leucovorin, see the respective package inserts.

  2.2 Dose Modification Recommendations

  Prior to subsequent therapy cycles, patients should be evaluated for clinical toxicities and recommended laboratory tests [see Warnings and Precautions (5.9)]. Prolongation of infusion time for ELOXATIN from 2 hours to 6 hours may mitigate acute toxicities. The infusion times for 5-fluorouracil and leucovorin do not need to be changed.

  Adjuvant Therapy in Patients with Stage III Colon Cancer

  Neuropathy and other toxicities were graded using the NCI CTC scale version 1 [see Warnings and Precautions (5.2)].

  For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of ELOXATIN to 75 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The infusional 5-fluorouracil/leucovorin regimen need not be altered.

  A dose reduction of ELOXATIN to 75 mg/m2 and infusional 5-fluorouracil to 300 mg/m2 bolus and 500 mg/m2 22 hour infusion is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment), or grade 4 neutropenia, or febrile neutropenia, or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥1.5 × 109/L and platelets ≥75 × 109/L.

  Dose Modifications in Therapy in Previously Untreated and Previously Treated Patients with Advanced Colorectal Cancer

  Neuropathy was graded using a study-specific neurotoxicity scale [see Warnings and Precautions (5.2)]. Other toxicities were graded by the NCI CTC, Version 2.0.

  For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of ELOXATIN to 65 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The 5-fluorouracil/leucovorin regimen need not be altered.

  A dose reduction of ELOXATIN to 65 mg/m2 and 5-fluorouracil by 20% (300 mg/m2 bolus and 500 mg/m2 22-hour infusion) is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment), or grade 4 neutropenia, or febrile neutropenia, or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥1.5 × 109/L and platelets ≥75 × 109/L.

  Dose Modifications in Therapy for Patients with Renal Impairment

  In patients with normal renal function or mild to moderate renal impairment, the recommended dose of ELOXATIN is 85 mg/m2. In patients with severe renal impairment, the initial recommended ELOXATIN dose should be reduced to 65 mg/m2 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.3 Preparation of Infusion Solution

  Do not freeze and protect from light the concentrated solution.
  A final dilution must never be performed with a sodium chloride solution or other chloride-containing solutions.
  The solution must be further diluted in an infusion solution of 250-500 mL of 5% Dextrose Injection, USP.
  After dilution with 250-500 mL of 5% Dextrose Injection, USP, the shelf life is 6 hours at room temperature [20-25°C (68-77°F)] or up to 24 hours under refrigeration [2-8°C (36-46°F)].
  After final dilution, protection from light is not required.

  
  

  ELOXATIN is incompatible in solution with alkaline medications or media (such as basic solutions of 5-fluorouracil) and must not be mixed with these or administered simultaneously through the same infusion line. The infusion line should be flushed with 5% Dextrose Injection, USP prior to administration of any concomitant medication.
  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and discarded if present.

  Needles or intravenous administration sets containing aluminum parts that may come in contact with ELOXATIN should not be used for the preparation or mixing of the drug. Aluminum has been reported to cause degradation of platinum compounds.

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  Ondansetron | Sandoz Inc

  

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  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy

  Ondansetron Injection, USP should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Adults

  The recommended adult intravenous dosage of Ondansetron Injection, USP is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection, USP.

  Pediatrics

  For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron Injection, USP is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.2, 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection, USP. The drug should be infused intravenously over 15 minutes.

  2.2 Prevention of Postoperative Nausea and Vomiting

  Ondansetron Injection, USP should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Adults

  The recommended adult intravenous dosage of Ondansetron Injection, USP is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Pediatrics

  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron Injection, USP.

  2.3 Stability and Handling

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron Injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

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  Ondansetron | Cosmetics Institute Technology Co., Ltd.

  

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  Dosage and Administration: Use at least twice a week.

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  Ondansetron | Aurobindo Pharma Limited

  

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  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
  

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use
  

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use
  

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
  

  The recommended adult oral dosage is 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use
  

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ondansetron oral solution given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ondansetron oral solution should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use
  

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen
  

  The recommended oral dosage is 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution given 3 times a day.
  
  For total body irradiation, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
  
  For single high-dose fraction radiotherapy to the abdomen, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
  
  For daily fractionated radiotherapy to the abdomen, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use
  

  There is no experience with the use of ondansetron oral solution in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use
  

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting
  

  The recommended dosage is 20 mL (4 teaspoonfuls equivalent to 16 mg of ondansetron) of ondansetron oral solution 1 hour before induction of anesthesia.

  Pediatric Use
  

  There is no experience with the use of ondansetron oral solution in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use
  

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function
  

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function
  

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Direct Rx
  

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  Ondansetron | Direct Rx

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets

  
  

  Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, remove the tablet from the bottle or PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet.  IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  
  

  The recommended adult oral dosage of ondansetron orally disintegrating tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  
  

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  
  

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  
  

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg  ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  
  

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  
  

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  
  

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  
  

  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  
  

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  
  

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use

  
  

  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  
  

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  
  

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  
  

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Taro Pharmaceuticals U.s.a., Inc.
  

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  Ondansetron | Taro Pharmaceuticals U.s.a., Inc.

  

  ---

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of a single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ondansetron oral solution given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ondansetron oral solution should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution given 3 times a day.

  For total body irradiation, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ondansetron oral solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron oral solution in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as 20 mL (4 teaspoonfuls equivalent to 16 mg of ondansetron) of ondansetron oral solution 1 hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron oral solution in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Remedyrepack Inc.
  

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  Ondansetron | Remedyrepack Inc.

  

  ---

  Do not attempt to push ondansetron disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

   

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

   

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

   

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablets given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

   

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

   

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

   

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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• Aurobindo Pharma Limited
  

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  Ondansetron | Aurobindo Pharma Limited

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets
  
  Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, remove the tablet from the bottle or PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet.  IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.
  
  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
  
  The recommended adult oral dosage of ondansetron orally disintegrating tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.
  
  Pediatric Use
  
  There is no experience with the use of a 24 mg dosage in pediatric patients.
  
  Geriatric Use
  
  The dosage recommendation is the same as for the general population.
  
  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
  
  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
  
  Pediatric Use
  
  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
  
  Geriatric Use
  
  The dosage is the same as for the general population.
  
  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen
  
  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.
  
  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
  
  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
  
  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
  
  Pediatric Use
  
  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.
  
  Geriatric Use
  
  The dosage recommendation is the same as for the general population.
  
  Postoperative Nausea and Vomiting
  
  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.
  
  Pediatric Use
  
  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.
  
  Geriatric Use
  
  The dosage is the same as for the general population.
  
  Dosage Adjustment for Patients With Impaired Renal Function
  
  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
  
  Dosage Adjustment for Patients With Impaired Hepatic Function
  
  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Mylan Pharmaceuticals Inc.
  

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  Ondansetron | Mylan Pharmaceuticals Inc.

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets

  With dry hands, remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated with Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron tablets, ondansetron orally disintegrating tablets or ondansetron oral solution in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets one hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron tablets, ondansetron orally disintegrating tablets or ondansetron oral solution in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first day administration of ondansetron.

  Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Mylan Pharmaceuticals Inc.
  

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  Ondansetron | Mylan Pharmaceuticals Inc.

  

  ---

  Prevention of Nausea and Vomiting Associated with Highly Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy

  The recommended adult oral dosage is one 8 mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated with Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

  The recommended oral dosage is one 8 mg ondansetron tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting

  The recommended dosage is 16 mg given as two 8 mg ondansetron tablets one hour before induction of anesthesia.

  Pediatric Use

  There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients with Impaired Renal Function

  The dosage recommendation is the same as for the general population. There is no experience beyond first day administration of ondansetron.

  Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Qilu Pharmaceutical Co., Ltd.
  

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  Ondansetron | Qilu Pharmaceutical Co., Ltd.

  

  ---

  2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy

  Ondansetron Injection USP should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

  Adults

  The recommended adult intravenous dosage of Ondansetron Injection USP is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection USP.

  Pediatrics

  For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron Injection USP is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1), Clinical Pharmacology (12.2 and 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron Injection USP. The drug should be infused intravenously over 15 minutes.

  2.2 Prevention of Postoperative Nausea and Vomiting

  Ondansetron Injection USP should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Adults

  The recommended adult intravenous dosage of Ondansetron Injection USP is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Pediatrics

  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron Injection USP.

  2.3 Stability and Handling

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron Injection USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

  2.4 Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

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• Proficient Rx Lp
  

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  Ondansetron | Hyland's

  

  ---

  Measure only with the dosing syringe provided Do not use dosing syringe with other products On dosing syringe, mL = milliliter, tsp = teaspoon children under 6 months of age consult a licensed health care professional before using this product children 6 months to under 1 year of age 2.5 mL or ½ teaspoon up to 4 times daily (every 6 hours) children 1 to 3 years of age 5 mL or 1 teaspoon up to 6 times daily (every 4 hours)

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• Remedyrepack Inc.
  

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  Ondansetron | Remedyrepack Inc.

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets: Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy: The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy: The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  
  

  Geriatric Use:

  The dosage is the same as for the general population.
  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen: The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
  Pediatric Use:

  There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.
  Geriatric Use: The dosage recommendation is the same as for the general population.
  Postoperative Nausea and Vomiting: The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.
  Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
  Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

   

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  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets
  
  Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, remove the tablet from the bottle or PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet.  IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.
  
  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
  
  The recommended adult oral dosage of ondansetron orally disintegrating tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m 2. Multiday, single-dose administration of a 24 mg dosage has not been studied.
  
  Pediatric Use
  
  There is no experience with the use of a 24 mg dosage in pediatric patients.
  
  Geriatric Use
  
  The dosage recommendation is the same as for the general population.
  
  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
  
  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
  
  Pediatric Use
  
  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
  
  Geriatric Use
  
  The dosage is the same as for the general population.
  
  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen
  
  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.
  
  For total body irradiation , one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
  
  For single high-dose fraction radiotherapy to the abdomen , one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
  
  For daily fractionated radiotherapy to the abdomen , one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
  
  Pediatric Use
  
  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.
  
  Geriatric Use
  
  The dosage recommendation is the same as for the general population.
  
  Postoperative Nausea and Vomiting
  
  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.
  
  Pediatric Use
  
  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.
  
  Geriatric Use
  
  The dosage is the same as for the general population.
  
  Dosage Adjustment for Patients With Impaired Renal Function
  
  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
  
  Dosage Adjustment for Patients With Impaired Hepatic Function
  
  In patients with severe hepatic impairment (Child-Pugh 2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP:

  Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m 2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use:

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use:

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet USP or one 4-mg ondansetron orally disintegrating tablet USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use:

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen:

  The recommended oral dosage is one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.

  For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting:

  The recommended dosage is 16 mg given as two 8-mg ondansetron tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.

  Pediatric Use:

  There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use:

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function:

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function:

  In patients with severe hepatic impairment (Child-Pugh 2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets 

  Do not attempt to push ondansetron orally disintegrating tablets, USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy 

  The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use 

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use 

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy 

  The recommended adult oral dosage is one 8-mg ondansetron orally disintegrating tablet, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron orally disintegrating tablet, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use 

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron orally disintegrating tablet, USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron orally disintegrating tablet, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use 

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen 

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet, USP given 3 times a day.

  For total body irradiation

  One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen

  One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen

  One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use 

  There is no experience with the use of, ondansetron orally disintegrating tablets, USP, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use 

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting 

  The recommended dosage is 16 mg given as two 8-mg ondansetron orally disintegrating tablets, USP 1 hour before induction of anesthesia.

  Pediatric Use 

  There is no experience with the use of ondansetron orally disintegrating tablets, USP in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use 

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function 

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function 

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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  Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (2.1):

  •Adults and Pediatric patients (6 months to 18 years): Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes. The first dose should be administered 4 and 8 hours after the first dose.

  Prevention of Postoperative Nausea and/or Vomiting (2.2):

  Population

  Age

  Ondansetron
  Injection, USP
  Dosage

  Intravenous
  Infusion Rate

  Adults

  >12 yrs

  4 mg x 1

  over 2 - 5 min

  Pediatrics
  (>40 kg)

  1 mo. – 12 yrs

  4 mg x 1

  over 2 - 5 min

  Pediatrics
  (≤40 kg)

  1 mo. – 12 yrs

  0.1 mg/kg x 1

  over 2 - 5 min

  •In patients with severe hepatic impairment, a total daily dose of 8 mg should not be exceeded. (

  2.4

  )

   

  Ondansetron Injection, USP should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration. 

  Adults 
  The recommended adult intravenous dosage of Ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron. 

  Pediatrics 
  For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Studies (14.1) and Clinical Pharmacology (12.2 and 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron. The drug should be infused intravenously over 15 minutes.

   

  Ondansetron Injection, USP should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.

  Adults
  The recommended adult intravenous dosage of Ondansetron is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

  Pediatrics
  For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron.

   

  After dilution, do not use beyond 24 hours. Although Ondansetron Injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

  Ondansetron Injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

  Note
  Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Precaution
  Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

   

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients [see Clinical Pharmacology (12.3)].

   

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