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Nausea is an uneasy feeling in which a person feels an urge to vomit while vomiting is the natural response to the body to forcefully discharge the stomach contents. Ondansetron is used to prevent nausea and vomiting.
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✅ Description:
Ondansetron belongs to a group of medications called 'anti-emetics primarily used in the prevention of vomiting (being sick) and nausea (feeling sick) that usually occur after cancer chemotherapy, radiation treatment, or surgery.
- Chemotherapy-Induced Nausea and Vomiting: Prevention during initial and repeat courses.
- Post-Operative Nausea and Vomiting: Prevention and Treatment.
- Radiotherapy-Induced Nausea and Vomiting: Prevention.
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✔️ Form:
Zofra ODT is an orally dissolving film designed to be placed on the tongue, dissolving within 20 seconds, and swallowed with saliva.
✔️ Active Ingredient:
Zofra ODT base, a selective 5-HT3 receptor antagonist.
✔️ Molecular Formula:
C18H19N3O, molecular weight of 293.3.
✔️ Mechanism of Action:
Ondansetron blocks the 5-HT3 receptors, preventing the vomiting reflex triggered by chemotherapeutic agents and radiotherapy in the small intestine and central nervous system.
✔️ Post-Operative Use:
The exact mechanism is unknown, but it may share pathways with cytotoxic-induced nausea and vomiting.
✔️ Chemotherapy-Induced Nausea and Vomiting:
- Adults/Pediatrics (6 months - 18 years): Three doses of 0.15 mg/kg (max 16 mg per dose).
- Oral Solution:
- Adults/Geriatric/Children (12+ years): 30 ml (24 mg) or 10 ml (8 mg), depending on emetogenic potential.
- Pediatrics (4-11 years): 5 ml (4 mg) doses.
✔️ Oral Soluble Film:
- Highly Emetogenic Chemotherapy: 24 mg (three 8 mg films) 30 minutes before chemotherapy.
- Moderately Emetogenic Chemotherapy: Doses vary by age and need.
- Radiotherapy and Post-Operative Nausea: Specific doses are provided based on need.
✔️ Radiotherapy-Induced Nausea and Vomiting:
- Adults:
- 8 mg tablet/orodispersible tablet initially, then 8 mg every 8 hours for up to 5 days.
- Oral Solution: 10 ml (8 mg) three times daily.
✔️ Post-Operative Nausea and Vomiting:
- Adults: 16 mg oral dose (or 20 ml oral solution) 1 hour before anesthesia.
- Pediatrics (>40 kg): 4 mg injection.
- Pediatrics (<40 kg): 0.1 mg/kg injection.
✔️ Administration
Oral Soluble Film: Place on the tongue to dissolve in 20 seconds without chewing or swallowing whole.
✔️ Enzyme System:
Zofra ODT does not induce or inhibit hepatic cytochrome P-450 enzymes, though inducers/inhibitors can affect its clearance.
✔️ Contraindications:
Hypersensitivity to the drug or components, and concomitant use with apomorphine.
✔️ Renal Function:
- No dosage adjustment needed
✔️ Elderly:
No dosage adjustment is needed.
✔️ Pediatrics (4 years or younger):
Limited information.
✔️ Hepatic Function:
Severe impairment requires a maximum daily dose of 8 mg.
✔️ Common Side Effcts:
- Headache, constipation, diarrhea, rash, sensation of warmth, hiccups, liver enzyme abnormalities.
✔️ Serious (Rare) Side Effects
Anaphylaxis, bronchospasm, tachycardia, angina, hypokalemia, and shortness of breath.
✔️ Carcinogenicity:
No carcinogenic effects in animal studies.
✔️ Reproduction:
No harm to the fetus in animal studies, but insufficient data for pregnant women.
✔️ Lactation:
Excreted in rat milk; caution in nursing women.
✔️ Hypersensitivity:
Reported in those sensitive to other 5-HT3 antagonists.
✔️ Gastrointestinal:
May mask ileus or gastric distension.
✔️ Use Post-Surgery/Chemotherapy:
Not a replacement for nasogastric suction.
✔️ Storage
Store below 30ºC, in a dry place away from light and moisture.
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