Zofra ODT 4

Presentation:

Each orally disintegrating tablet (ODT) contains 4 mg of Ondansetron BP.

Indications:

Zofra ODT is indicated for the prevention and treatment of nausea and vomiting associated with:

• Chemotherapy
• Radiotherapy
• Post-operative nausea and vomiting (PONV)

Dosage and Administration:

• Chemotherapy-induced nausea and vomiting (CINV):
  • Adults: The recommended oral dose is 8 mg administered 30 minutes to 1 hour before the start of emetogenic chemotherapy, with subsequent doses of 8 mg every 8 hours as needed. For highly emetogenic chemotherapy, a single dose of 24 mg may be administered 30 minutes before the start.
  • Children (6 months to 18 years): The dose is weight-based or body surface area-based. Consult a healthcare professional for specific dosage instructions.
• Radiotherapy-induced nausea and vomiting (RINV):
  • Adults: 8 mg administered 1-2 hours before each fraction of radiotherapy.
• Post-operative nausea and vomiting (PONV):
  • Adults: 16 mg as a single oral dose 1 hour before anesthesia, or 8 mg administered one hour before anesthesia followed by two further doses of 8 mg at eight-hourly intervals.
  • Children (over 2 years): 0.1 mg/kg body weight up to a maximum of 4 mg as a single dose prior to anesthesia.

Zofra ODT tablets should be placed on the tongue, where they will disintegrate rapidly and can be swallowed with or without liquid.

Side Effects:

Common side effects may include:

• Headache
• Constipation
• Diarrhea
• Dizziness
• Fatigue
• Transient elevations in liver enzymes

Less common side effects may include hypersensitivity reactions, blurred vision, and cardiac arrhythmias (rarely).

Precautions:

• Use with caution in patients with hepatic impairment.
• Ondansetron can prolong the QT interval in a dose-dependent manner. Caution should be exercised in patients with pre-existing cardiac conditions or who are taking other medications that prolong the QT interval.
• Monitor for signs of serotonin syndrome, especially if used concomitantly with other serotonergic drugs.
• As Zofra ODT contains aspartame, it should be used with caution in patients with phenylketonuria.
• The safety of Zofra ODT during pregnancy has not been fully established. It should be used during pregnancy only if clearly needed.
• Ondansetron is excreted in breast milk. Caution should be exercised when administered to a nursing woman.

Contraindications:

• Hypersensitivity to ondansetron or any of the excipients.
• Concomitant use of apomorphine.

Storage:

Store below 30°C, protected from light and moisture. Keep out of the reach of children.

Important Note:

This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.