Zofra ODT 4 mg

Description

Indications: Zofra ODT is indicated for the prevention and treatment of:

• Nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
• Post-operative nausea and vomiting.
• Radiotherapy-induced nausea and vomiting.

Use only as per a registered medical professional’s advice.

Description: Zofra ODT is an orally dissolving film that is placed on the tongue where it dissolves within 20 seconds and is swallowed with saliva. No water is required for swallowing. The active ingredient is Ondansetron, a selective serotonin 5-HT3 receptor antagonist. Its empirical formula is C18H19N3O, with a molecular weight of 293.3.

Pharmacology: Ondansetron is a potent 5-HT3 receptor antagonist. Chemotherapy and radiotherapy induce the release of serotonin (5HT) in the small intestine, activating the vomiting reflex through 5-HT3 receptors. Ondansetron blocks this reflex and may also inhibit emesis through central mechanisms involving 5-HT3 receptors in the brain. It works by preventing nausea and vomiting induced by chemotherapy, radiotherapy, and post-operative procedures.

Dosage:

• Chemotherapy-induced nausea and Vomiting (Adults and Pediatric patients 6 months to 18 years):
  • 8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
  • Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused over 15 minutes.
• Radiotherapy-Induced Nausea and Vomiting (Adults):
  • 8 mg tablet/orodispersible tablet: 8 mg orally 1 to 2 hours before radiotherapy, followed by 8 mg every 8 hours for up to 5 days.
• Postoperative Nausea and Vomiting (Adults):
  • 8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets.
• Pediatric (40 kg and above):
  • Injection: 4 mg

Administration:

1. Tear the pouch along the tear mark.
2. Place the Ondansetron film on your tongue. It will dissolve in 20 seconds.
3. Swallow after the film dissolves. You may swallow with or without liquid.

Use only as per a registered medical professional’s advice.

Interaction: Zofra ODT does not induce or inhibit cytochrome P-450 enzymes. No dosage adjustment is required for patients on drugs that induce or inhibit these enzymes.

Contraindications:

• Hypersensitivity to Ondansetron or any of its components.
• Concomitant use with apomorphine.

Side Effects: Common side effects include:

• Headache
• Constipation
• Diarrhea
• Rash (1% of patients) Other rare effects may include:
• Flushing
• Hiccups
• Liver enzyme abnormalities
• Rare anaphylaxis, bronchospasm, tachycardia, and angina.

Pregnancy & Lactation: Ondansetron is excreted in breast milk in animals but caution should be exercised when used by nursing women. There are no adequate studies in pregnant women.

Precautions & Warnings:

• Hypersensitivity reactions may occur in patients with sensitivity to other 5-HT3 antagonists.
• It should not be used as a substitute for nasogastric suction.
• Use with caution in patients post-abdominal surgery or those with chemotherapy-induced nausea, as it may mask ileus or gastric distension.

Special Populations:

• Renal Impairment: No dosage adjustment required.
• Hepatic Impairment: In severe cases, a maximum dose of 8 mg per day is recommended.
• Elderly (65+): No dosage adjustment necessary.

Therapeutic Class: Anti-emetic drugs

Storage Conditions: Store below 30°C in a dry place, protected from light and moisture.

Use only as per a registered medical professional’s advice.