Monograph Details
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Gastrointestinal Tract
> Nausea
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ZOFRAN |
| Manufacturer |
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GlaxoSmithKline Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Selective 5-HT3 receptor antagonist. |
| Generic Name |
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Ondansetron (as HCl dihydrate) 4mg, 8mg; tabs. |
| Also |
• ZOFRAN INJECTION
• ZOFRAN INJECTION PREMIXED
• ZOFRAN ODT
• ZOFRAN ORAL SOLUTION
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| Indications |
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Prevention of nausea and vomiting associated with highly emetogenic chemotherapy, including cisplatin ≥50mg/m2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy. Prevention of nausea and vomiting associated with radiotherapy in patients receiving total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Prevention of post-op nausea and vomiting. |
| Children |
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Highly emetogenic chemotherapy, radiotherapy, or <4 yrs of age: not recommended (see IV form). 4–11yrs: moderately emetogenic chemotherapy: 4mg every 4 hours for 3 doses beginning 30 minutes before chemotherapy, then 4mg every 8 hours for 1–2 days after chemotherapy completed. Post-op prophylaxis: see IV form. |
| Adults |
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See literature. Highly emetogenic chemotherapy: 24mg once 30 minutes before start of single-day chemotherapy (multi-day, single-dose not studied). Moderately emetogenic chemotherapy: 8mg every 8 hours for 2 doses beginning 30 minutes before chemotherapy, then 8mg every 12 hours for 1–2 days after chemotherapy completed. Total body irradiation: 8mg 1–2 hours before each fraction of radiotherapy administered each day then every 8 hours. Single high-dose fraction radiotherapy to abdomen: 8mg 1–2 hours before radiotherapy, then 8mg every 8 hours after 1st dose for 1–2 days after radiation completed. Daily fractionated radiotherapy to abdomen: 8mg 1–2 hours before radiotherapy, then 8mg every 8 hours after 1st dose for each day of radiotherapy. Post-op prophylaxis: 16mg 1 hour before induction of anesthesia. For all: severe hepatic dysfunction: max 8mg/day. |
| Precautions |
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<4 months of age (monitor closely). May mask progressive ileus and/or gastric distention. Hepatic dysfunction. Pregnancy (Cat.B). Nursing mothers. |
| Adverse Reactions |
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Diarrhea, headache, fever, constipation, abdominal pain, weakness, rash, transient blindness; rare: angina, bronchospasm, anaphylaxis, seizures, ECG changes (including QT prolongation). |
| How Supplied |
Tabs 4mg, 8mg—30
ODT 4mg—30
ODT 8mg—10, 30
Oral soln—50mL
Premixed (32mg/50mL)—6
Single-dose vial (2mg/mL)—5 (2mL/vial)
Multidose vial (2mg/mL)—1 (20mL/vial) |
| Additional Resources |
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• Related Prescribing Note |
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