Zofran (ondansetron)
Zofran® is a prescription medication used to treat and prevent nausea and vomiting in people with cancer, those recovering from surgery, and pregnant women with morning sickness. Lawsuits have been filed against the makers of Zofran because many believe fetal exposure to the drug causes serious birth defects, including heart problems and cleft palate.
Loading...Zofran Recall
December 4, 2012
The 32 mg, single intravenous (IV) dose of Zofran would be removed from the market due to being associated with an increased risk of serious cardiac issues. However, no official recall was issued from the manufacturer or FDA. A previous Drug Safety Communication, issued on June 29, 2012, warned that the 32 mg, single IV dose should be avoided due to the risk of a specific type of irregular heart rhythm called QT interval prolongation, which can lead to Torsades de Pointes, an abnormal, potentially fatal heart rhythm. (.pdf)Questions & Answers
Side Effects & Adverse Reactions
Side effects of Zofran include dizziness, stomach aches, oxygen deficiency of tissue (hypoxia), muscle stiffness and spasms, lightheadedness, fatigue, severe skin itching (pruritus), soreness and irritation at the injection site (for the injectable version), anxiety, hiccups, constipation, changes in vision, gynecological problems, and headache. Be cautious when taking this medication and operating dangerous machinery or engaging in other activities that require you to be alert until you are sure of how it affects you. Consumption of alcohol may increase drowsiness and dizziness, and therefore should be limited. Older individuals are more likely to experience these side effects, and should be extra careful when participating in activities that have the potential to be dangerous. (webmd.com) Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT receptor antagonists.
Serious and Fatal Side Effects
Serious complications that have been reported by patients taking this drug include fainting, chest pain, and irregular heartbeat (too fast or too slow). Stevens-Johnson syndrome, a rare, but serious skin and mucous membrane disorder that can cause blisters, fever, and rash, has also developed in patients that took Zofran. (reference.medscape.com) The development of fatal complications such as serotonin syndrome, Stevens-Johnson syndrome, and long QT syndrome (LQTS) have also been reported.Pregnancy Risk & Influence on Fetal Development
The FDA has listed Zofran as a category “B” pregnancy risk. Therefore, there is not enough information on how ondansetron affects a developing fetus or nursing baby, and should be avoided unless deemed necessary by a doctor. In a recent study, surgically removed fetuses that belonged to women who took Zofran during their first trimester of pregnancy were found to contain a significant amount of ondansetron - in fact, every single one that was examined. (ncbi.nlm.nih.gov)Drug Interactions
Taking ondansetron, especially with other medications that increase serotonin, can result in a serious condition called serotonin syndrome (or serotonin toxicity). Signs of toxicity include twitching muscles, fever, severe loss of coordination, dizziness, hallucinations, fast heartbeat, severe vomiting, nausea, diarrhea, and restlessness/agitation. If you are experiencing the following severe adverse reactions after taking Zofran, get immediate medical attention: swelling and itching of the face, throat, and/or tongue, difficulty breathing, rash, and profound dizziness. Serotonin syndrome is most likely to occur when you start or increase your dose of the medication. Taking antidepressants and other drugs that affect serotonin, including St. John's wart, SSRI’s (such as paroxetine, fluoxetine), SNRI’s (including venlafaxine, duloxetine), and certain street drugs like MDMA (ecstasy) increase the risk of developing this condition. Individuals with a personal or family history of long QT syndrome (QT prolongation), other heart rhythm disorders, or heart failure are advised not to take Zofran, as they are more likely to faint or experience sudden death. Those who currently have, or have had liver disease or low levels of potassium or magnesium in their blood also shouldn’t take Ondansetron. The orally disintegrating tablets contain aspartame (that forms phenylalanine), so people with phenylketonuria (PKU) that follow a special diet may not be a good candidate for this drug. (nlm.nih.gov) People who are allergic to Lotronex (alosetron), Kytril (granisetron), ondansetron, Akynzeo (palonosetron), Aloxi (also palonosetron), and Anzemet (dolasetron), and those taking Apokyn (apomorphine) are more likely to experience negative reactions if they take Zofran. Certain seizure medications, such as Epitol, Carbatrol, Tegretol, and Equetro (carbamazepine) and Dilantin (phenytoin), and Clarithromycin, a medication used to treat infection, also do not interact well with this medication. Migraine medications to avoid while taking this drug include Imitrex (sumatriptan), Relpax (eletriptan), Frova (frovatriptan), Maxalt (rizatriptan), Axert (almotriptan), Zomig (zolmitriptan), and Amerge (naratriptan). Those taking it should not be treated with methylene blue, as complications can occur from this combination. Psychiatric drugs (mental health medications) that shouldn’t be taken with Zofran (unless advised by a doctor because the benefits outweigh the risks) are: lithium, SSRI’s (selective serotonin reuptake inhibitors), including Lexapro (escitalopram), tramadol, Luvox (fluvoxamine), Celexa (citalopram), Paxil, Brisdelle, Pexeva (paroxetine), Prozac, Symbyax, Sarafem (fluoxetine), and Zoloft (sertraline). MAOi’s (monoamine oxidase inhibitors) such as Avelox (moxifloxacin), (Emsam, Zelapar, Eldepryl (selegiline), Parnate (tranylcypromine), Nardil (phenelzine), Zyvox (linezolid), and Marplan (isocarboxazid) should also be avoided. Remeron (mirtazapine), another medication used to treat depression, may also interact negatively.Legal Issues
Women that took Zofran while pregnant blame the drug for serious birth defects, including cleft palate and heart defects. These lawsuits claim that GlaxoSmithKline, the manufacturer of Zofran, hid the risks associated with the drug and improperly marketed it as a medication to treat morning sickness in pregnant women. Families are seeking compensation for medical expenses and losses resulting from surgeries and procedures related to these birth defects. Despite the fact that limited information exists on how ondansetron influences fetal development, more than one million pregnant women are treated with the drug annually. Did You Take Zofran?
FDA Safety Alerts
September 2014
Ondansetron (Zuplenz, Zofran ODT), ondansetron hydrochloride (Injection, Tablets, and Oral Solution), and other 5-HT3 receptor antagonists can cause serotonin syndrome, which can be fatal. Symptoms of serotonin syndrome are dizziness, fever, mental health changes, hallucinations, fast heartbeat, nausea, tremors, muscle stiffness, vomiting, diarrhea, seizures, and coma. (fda.gov)June 29, 2012
Following a clinical study suggesting that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes, FDA added published this update to the September 2011 Safety Communication. Zofran manufacturer GlaxoSmithKline also suggested label changes recommending ondansetron continue to be used in children and adults with chemotherapy-induced nausea and vomiting at the lower intravenous dose recommended in the drug label. (fda.gov)September 15, 2011
Patients with certain heart conditions should not take the drug because they are more likely to experience serious complications. People with congenital long QT syndrome and those with low levels of magnesium and potassium in their blood have an increased risk of developing Torsade de Pointes, a potentially fatal heart rhythm disorder. (fda.gov)Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
December 2013
Zofran use can result in the development of toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome. Toxic epidermal necrolysis, also referred to as Lyell’s syndrome, is a rare, potentially fatal skin condition that is caused by an allergic reaction to medication. Stevens-Johnson syndrome is a rare skin disorder that causes blisters, painful rashes, and flu-like symptoms such as sore throat, fever, and coughing, and can also result in death. (fda.gov)November 2012
Taking ondansetron can cause long QT syndrome (LQTS) and Torsades de Pointes - potentially life-threatening heart rhythm conditions that can lead to fainting, seizures, and cardiac arrest. Individuals with congestive heart failure, electrolyte abnormalities, bradyarrhythmias, or those taking other drugs that can cause QT prolongation should undergo ECG monitoring. (fda.gov)September 2010
Ondansetron should not be taken with apomorphine. Using these drugs together can result in loss of consciousness and dangerously low blood pressure (hypotension). (fda.gov)Uses
Zofran is prescribed alone, or in combination with other medications as an antiemetic (to prevent vomiting and nausea) for people with cancer who are undergoing chemotherapy and/or radiation therapy. Ondansetron is also used to prevent nausea and vomiting in patients who have recently had surgery. The medication belongs to the serotonin 5-HT3 receptor antagonist class of drugs, and works by suppressing the neurotransmitter serotonin, a naturally occurring chemical in the body that is thought to play a role in nausea. It is available as an injection (Zofran), in tablet form (Zofran), in a dissolvable, rapidly disintegrating tablet (Zofran ODT and Zuplenz), and in a liquid solution that is taken by mouth (Zofran Oral Solution). Zofran ODT contains ondansetron, and Zofran and Zuplenz contain ondansetron hydrochloride. (nlm.nih.gov)
- Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m
- Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
- 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.
- 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, ZOFRAN Tablets, ZOFRAN ODT Orally Disintegrating Tablets, and ZOFRAN Oral Solution are recommended even where the incidence of postoperative nausea and/or vomiting is low.
History
Zofran was developed by GlaxoSmithKline in London in the mid-1980’s, and was patented in the United States in 1988. Novartis Pharms Corp began manufacturing the injectable version in 1991 and the tablet form in 1992. In 1997, the oral solution became available and, in 1999, a higher strength of the tablet form was released. Generic versions came on the market in 2006 when GlaxoSmithKline lost it’s patent for the drug and SICOR Pharmaceuticals and Teva Pharmaceuticals USA started marketing it. In 2010, the FDA approved Zuplenz, an orally soluble film (OSF) that contains ondansetron, and is manufactured by Strativa Pharmaceuticals, a division of Par Pharmaceutical. In 2014, Galena Biopharma began to market Zuplenz and, by 2015, Zofran was being sold by Novartis. (us.gsk.com)
Other Information
The active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 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:
The empirical formula is C18H19N3O•HCl•2H2O, representing a molecular weight of 365.9.
Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline.
The active ingredient in ZOFRAN ODT Orally Disintegrating Tablets is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula:
The empirical formula is C18H19N3O representing a molecular weight of 293.4.
Zofran Ingredients
4mg Tablets
Each 4-mg Tablet for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron.8mg Tablets
Each 8-mg Tablet for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients lactose, microcrystalline cellulose, pregelatinized starch, hypromellose, magnesium stearate, titanium dioxide, triacetin, and iron oxide yellow (8-mg tablet only).4mg Orally Disintegrating Tablet
Each 4-mg ODT Orally Disintegrating Tablet for oral administration contains 4 mg ondansetron base.8mg Orally Disintegrating Tablet
Each 8-mg ODT Orally Disintegrating Tablet for oral administration contains 8 mg ondansetron base. Each ODT Tablet also contains the inactive ingredients aspartame, gelatin, mannitol, methylparaben sodium, propylparaben sodium, and strawberry flavor.ODT Tablets are a freeze-dried, orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.5mL Oral Solution
Each 5 mL of Oral Solution contains 5 mg of ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. The Oral Solution contains the inactive ingredients citric acid anhydrous, purified water, sodium benzoate, sodium citrate, sorbitol, and strawberry flavor.Sources
Zofran Manufacturers
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Cardinal Health
![Zofran (Ondansetron Hydrochloride) Tablet, Orally Disintegrating [Cardinal Health]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zofran | Cardinal Health
Instructions for Use/Handling ZOFRAN ODT Orally Disintegrating TabletsDo not attempt to push ZOFRAN ODT Tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ZOFRAN ODT 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 ChemotherapyThe recommended adult oral dosage of ZOFRAN 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 UseThere is no experience with the use of a 24 mg dosage in pediatric patients.
Geriatric UseThe dosage recommendation is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer ChemotherapyThe recommended adult oral dosage is one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
PediatricUse: 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 ZOFRAN Tablet or one 4-mg ZOFRAN ODT Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 4-mg ZOFRAN ODT Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ZOFRAN Oral Solution should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Geriatric UseThe 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 AbdomenThe recommended oral dosage is one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution given 3 times a day.
For total body irradiation, one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 UseThere is no experience with the use of ZOFRAN Tablets, ZOFRAN ODT Tablets, or ZOFRAN Oral Solution in the prevention of radiation-induced nausea and vomiting in pediatric patients.
Geriatric UseThe 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 ZOFRAN Tablets or two 8-mg ZOFRAN ODT Tablets or 20 mL (4 teaspoonfuls equivalent to 16 mg of ondansetron) of ZOFRAN Oral Solution 1 hour before induction of anesthesia.
Pediatric UseThere is no experience with the use of ZOFRAN Tablets, ZOFRAN ODT Tablets, or ZOFRAN Oral Solution in the prevention of postoperative nausea and vomiting in pediatric patients.
Geriatric UseThe dosage is the same as for the general population.
Dosage Adjustment for Patients With Impaired Renal FunctionThe 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 FunctionIn 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.
Zofran | Remedyrepack Inc.
Instructions for Use/Handling ZOFRAN ODT Orally Disintegrating Tablets
Do not attempt to push ZOFRAN ODT Tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ZOFRAN ODT 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 ZOFRAN is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin50 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 ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 4-mg ZOFRAN ODT Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 4-mg ZOFRAN ODT Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution given 3 times a day.
For total body irradiation, one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablets, ZOFRAN ODT Tablets, or ZOFRAN 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 ZOFRAN Tablets or two 8-mg ZOFRAN ODT Tablets or 20 mL (4 teaspoonfuls equivalent to 16 mg of ondansetron) of ZOFRAN Oral Solution 1 hour before induction of anesthesia.
Pediatric Use
There is no experience with the use of ZOFRAN Tablets, ZOFRAN ODT Tablets, or ZOFRAN 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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Glaxosmithkline Llc
Zofran | Glaxosmithkline Llc
2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic ChemotherapyZOFRAN Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.
AdultsThe recommended adult intravenous dosage of ZOFRAN 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 ZOFRAN.
PediatricsFor pediatric patients aged 6 months through 18 years, the intravenous dosage of ZOFRAN 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 ZOFRAN. The drug should be infused intravenously over 15 minutes.
2.2 Prevention of Postoperative Nausea and VomitingZOFRAN 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.
AdultsThe recommended adult intravenous dosage of ZOFRAN 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.
PediatricsFor pediatric patients aged 1 month through 12 years, 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 ZOFRAN.
2.3 Stability and HandlingAfter dilution, do not use beyond 24 hours. Although ZOFRAN Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.
ZOFRAN 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 FunctionIn 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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Glaxosmithkline Llc
Zofran | Glaxosmithkline Llc
Instructions for Use/Handling ZOFRAN ODT Orally Disintegrating Tablets:Do not attempt to push ZOFRAN ODT Tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ZOFRAN ODT 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 ZOFRAN 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 ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 aged 12 years and older, the dosage is the same as for adults. For pediatric patients aged 4 through 11 years, the dosage is one 4-mg ZOFRAN Tablet or one 4-mg ZOFRAN ODT Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 4-mg ZOFRAN ODT Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution given 3 times a day.
For total body irradiation, one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 ZOFRAN Tablets, ZOFRAN ODT Tablets, or ZOFRAN 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 ZOFRAN Tablets or two 8-mg ZOFRAN ODT Tablets or 20 mL (4 teaspoonfuls equivalent to 16 mg of ondansetron) of ZOFRAN Oral Solution 1 hour before induction of anesthesia.
Pediatric Use:There is no experience with the use of ZOFRAN Tablets, ZOFRAN ODT Tablets, or ZOFRAN 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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