Ondansetron Solution
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Questions & Answers
Side Effects & Adverse Reactions
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT receptor antagonists. 3
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m . 2
2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, Ondansetron Oral Solution, USP is recommended even where the incidence of postoperative nausea and/or vomiting is low.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in Ondansetron Oral Solution, USP is Ondansetron hydrochloride (HCl), USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: 3
The empirical formula is C H N O•HCl•2H O, representing a molecular weight of 365.9. 181932
Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline.
Each 5 mL of Ondansetron Oral Solution, USP contains 5 mg of ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Ondansetron Oral Solution, USP contains the inactive ingredients citric acid anhydrous, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate and strawberry flavor.
Sources
Ondansetron Solution Manufacturers
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Atlantic Biologicals Corps
![Ondansetron Solution [Atlantic Biologicals Corps]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ondansetron Solution | Atlantic Biologicals Corps
The recommended adult oral dosage 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. Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:
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:
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. Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer 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 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. Pediatric Use:
The dosage is the same as for the general population. Geriatric Use:
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. Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions 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 each fraction of radiotherapy administered each 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 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
, 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. For daily fractionated radiotherapy to the abdomen
There is no experience with the use of Ondansetron Oral Solution, USP 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. Postoperative 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. Geriatric Use:Nausea and Vomiting:
There is no experience with the use of Ondansetron Oral Solution, USP in the prevention of postoperative nausea and vomiting in pediatric patients. Pediatric Use:
The dosage is the same as for the general population. Geriatric Use:
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 Renal 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. Dosage Adjustment for Patients With Impaired Hepatic Function:2
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Atlantic Biologicals Corps
Ondansetron Solution | Atlantic Biologicals Corps
The recommended adult oral dosage 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. Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:
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:
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. Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer 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 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. Pediatric Use:
The dosage is the same as for the general population. Geriatric Use:
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. Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions 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 each fraction of radiotherapy administered each 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 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
, 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. For daily fractionated radiotherapy to the abdomen
There is no experience with the use of Ondansetron Oral Solution, USP 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. Postoperative 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. Geriatric Use:Nausea and Vomiting:
There is no experience with the use of Ondansetron Oral Solution, USP in the prevention of postoperative nausea and vomiting in pediatric patients. Pediatric Use:
The dosage is the same as for the general population. Geriatric Use:
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 Renal 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. Dosage Adjustment for Patients With Impaired Hepatic Function:2
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Amneal Pharmaceuticals Of New York, Llc
Ondansetron Solution | Amneal Pharmaceuticals Of New York, Llc
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, 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.
PostoperativeNausea 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.
![Ondansetron Solution [Atlantic Biologicals Corps]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7a3c9566-1847-4867-b528-0e91fb8bab94&name=b545f174-figure-01.jpg)
![Ondansetron Solution [Amneal Pharmaceuticals Of New York, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=38435346-d505-4bdd-bbc6-a7bcba411033&name=ondansetron-oral-solution-2.jpg)
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