Zofra ODT 8mg Tablet 14pcs

Mode of Action:

Ondansetron blocks the action of serotonin in the brain, preventing nausea and vomiting induced by chemotherapy, radiotherapy, or surgery.

Dosage Recommendations:

Chemotherapy-Induced Nausea and Vomiting

• Adults & Pediatric (6 months to 18 years):
  • 8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to 16 mg per dose.
  • 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to 16 mg per dose.
  • Injection: Three 0.15 mg/kg doses, up to 16 mg per dose, infused intravenously over 15 minutes.

Radiotherapy-Induced Nausea and Vomiting

• Adults:
  • 8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
  • 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to 16 mg per dose.
  • Injection: Three 0.15 mg/kg doses, up to 16 mg per dose, infused intravenously over 15 minutes.

Postoperative Nausea and Vomiting

• Adults:
  • 8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets.
  • 4 mg orodispersible tablet: 16 mg.
  • Injection: 4 mg.
• Pediatrics:
  • >40 kg: Injection: 4 mg.
  • <40 kg: Injection: 0.1 mg/kg.

Oral Solution Dosage:

• Chemotherapy-induced Nausea and Vomiting:
  • Adults/Geriatric/Child (12 years or over): Highly emetogenic cancer chemotherapy: 30 ml (24 mg) once 30 minutes before chemotherapy.
  • Pediatric (4-11 years): 5 ml (4 mg) 30 minutes before chemotherapy. Subsequent doses every 8 hours for 1-2 days after chemotherapy.
• Radiotherapy induced Nausea and Vomiting: 10 ml (8 mg) 1 to 2 hours before radiotherapy.
• Postoperative Nausea and Vomiting: 20 ml (16 mg) 1 hour before anesthesia.

Oral Soluble Film Administration:

1. Tear the pouch carefully.
2. Place the film on your tongue to dissolve within 20 seconds.
3. Do not chew or swallow the film whole.
4. Swallow after the film dissolves with or without liquid.
5. Wash your hands after taking the film.

Quick Suggestions:

• If you vomit within one hour of taking a dose, take another dose.
• Avoid heavy meals; eat small snacks and sip water regularly to prevent dehydration.

Side Effects:

• Common: Constipation, diarrhea, fatigue, headache.
• Rare: Anaphylaxis, bronchospasm, tachycardia, angina, hypokalemia, shortness of breath.

Uses:

Prevention of nausea and vomiting associated with chemotherapy, radiotherapy, surgery, gastroenteritis, and pregnancy.

Use in Special Populations:

• Renal Impairment: No dosage adjustment is needed.
• Hepatic Impairment: Maximal daily dose of 8 mg for severe hepatic impairment.
• Pediatrics: Limited information for children under 4 years of age.
• Elderly: No dosage adjustment is needed.

Precautions & Warnings:

• Hypersensitivity reactions.
• Not a replacement for gastric or intestinal peristalsis.
• May mask ileus or gastric distension.

Storage Conditions:

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