Zofra 4 mg/5 ml

Description

Indications

Zofra is a selective serotonin subtype 3 (5-HT3) receptor antagonist indicated for:

• Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
• Prevention and treatment of post-operative nausea and vomiting (PONV).
• Prevention of radiotherapy-induced nausea and vomiting.

Always consult a registered healthcare professional before using this medication.

Description

Zofra oral soluble film is an orally dissolving film designed to dissolve on top of the tongue within 20 seconds, making it convenient for administration without water. Its active ingredient, Ondansetron, selectively blocks the serotonin 5-HT3 receptor, which is involved in the nausea and vomiting reflex.

Pharmacology

Ondansetron is a potent 5-HT3 receptor antagonist, blocking serotonin from initiating the vomiting reflex. The action in chemotherapy- and radiotherapy-induced nausea and vomiting likely involves antagonism of 5-HT3 receptors both peripherally (in the gut) and centrally (in the brain).

Dosage

Chemotherapy-Induced Nausea and Vomiting

• Adults/Pediatric (6 months to 18 years):
  • Tablets/Orodispersible Tablets: 8 mg, up to a maximum of 16 mg per dose.
  • Injection: 16 mg, infused intravenously over 15 minutes.

Radiotherapy-Induced Nausea and Vomiting

• Adults:
  • Tablets/Orodispersible Tablets: 8 mg, one hour before radiotherapy and every 8 hours after, up to 5 days.
  • Injection: 16 mg, infused intravenously over 15 minutes.

Postoperative Nausea and Vomiting

• Adults:
  • Tablets/Orodispersible Tablets: 16 mg (two 8 mg tablets) 1 hour before anesthesia.
  • Injection: 4 mg.

Oral Soluble Film Administration

• Chemotherapy: 24 mg (3 x 8 mg films) 30 minutes before chemotherapy.
• Radiotherapy: 8 mg film, 3 times daily.
• Postoperative: 16 mg (2 x 8 mg films) 1 hour before anesthesia.

Always follow your healthcare provider’s instructions for dosage adjustments.

Administration Instructions

1. Tear the pouch carefully along the edge.
2. Place the film on top of the tongue, where it will dissolve within 20 seconds.
3. Do not chew; swallow once dissolved.
4. Wash hands after use.

Interaction

Zofra does not induce or inhibit the cytochrome P-450 enzyme system. Adjustments for other medications affecting these enzymes may be necessary.

Contraindications

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

Side Effects

Common side effects include headache, constipation, and diarrhea. Rare side effects include anaphylaxis, bronchospasm, tachycardia, and liver enzyme abnormalities.

Pregnancy & Lactation

Ondansetron has shown no adverse effects in animal reproduction studies. Caution should be exercised when administered during pregnancy and breastfeeding, as it is excreted in breast milk.

Precautions & Warnings

• Avoid use if there is a history of hypersensitivity to 5-HT3 receptor antagonists.
• Caution in patients post-abdominal surgery or with chemotherapy-induced nausea, as it may mask ileus or gastric distension.

Storage Conditions

Store at temperatures not exceeding 30°C, in a dry place, and protect from light and moisture.