Zofra ODT 4mg Tablet 10pcs

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.