Zofra ODT 8

Indications:

• Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
• Prevention and treatment of post-operative nausea and vomiting.
• Prevention of radiotherapy-induced nausea and vomiting.
• Use only under the guidance of a registered healthcare professional.

Description: Zofra ODT is an oral soluble film that dissolves within 20 seconds on the tongue, without requiring water for dissolution. The active ingredient, Ondansetron, is a selective serotonin 5-HT3 receptor antagonist. It is used primarily for controlling nausea and vomiting due to chemotherapy, radiotherapy, and post-surgical recovery.

Pharmacology: Ondansetron acts by blocking the 5HT3 receptors involved in the initiation of the vomiting reflex triggered by chemotherapy or radiotherapy. This includes both peripheral and central nervous system mechanisms, though its exact mode of action is not fully understood.

Dosage:

• Chemotherapy-induced nausea and vomiting:
  • Adults/Pediatrics (6 months to 18 years): 8 mg orally (up to 16 mg/dose), as 3 doses, administered over several hours.
• Radiotherapy-induced nausea and vomiting:
  • Adults: 8 mg 1–2 hours before treatment; repeat every 8 hours for up to 5 days.
• Postoperative nausea and vomiting:
  • Adults: 8 mg twice, 1 hour before anesthesia induction.
• Administration Instructions:
  1. Open the pouch and place the film on your tongue.
  2. Wait 20 seconds for it to dissolve.
  3. Swallow the dissolved film with or without liquid.
  4. Wash your hands after use.

Interactions: Zofra ODT does not significantly affect the liver’s cytochrome P-450 enzyme system. No dosage adjustments are required for patients using enzyme-inducing or inhibiting drugs.

Contraindications:

• Known hypersensitivity to Ondansetron or any components of the formulation.
• Concomitant use with apomorphine.

Side Effects:

• Common: Headache, constipation, diarrhea.
• Rare: Anaphylaxis, bronchospasm, tachycardia, chest pain, liver enzyme abnormalities, and shortness of breath.
• Generally mild to moderate, and resolved after stopping treatment.

Pregnancy & Lactation:

• No evidence of carcinogenic effects from animal studies.
• Ondansetron is excreted in breast milk. Use with caution in nursing mothers.

Precautions:

• Not suitable for replacing nasogastric suction post-abdominal surgery.
• May mask conditions like ileus or gastric distension.

Storage: Store in a dry place at temperatures not exceeding 30ºC, protected from light and moisture.

Always follow the guidance of a healthcare professional when using this medication.