Periset Tablet

Generic Name: Ondansetron Hydrochloride

Strength: Available in 8 mg tablets.

Indications:

• Prevention of Nausea and Vomiting:
  • Chemotherapy-induced nausea and vomiting (CINV).
  • Radiotherapy-induced nausea and vomiting (RINV).
  • Postoperative nausea and vomiting (PONV).

Dosage and Administration:

• Dosage should be determined by a physician based on the emetogenic potential of the treatment.
• Chemotherapy-induced Nausea and Vomiting (CINV):
  • Highly emetogenic chemotherapy: 8 mg orally 1-2 hours before chemotherapy, followed by 8 mg orally 12 hours later.
  • Moderately emetogenic chemotherapy: 8 mg orally 1-2 hours before chemotherapy, followed by 8 mg orally 12 hours later. Subsequent doses may be given for several days.
• Radiotherapy-induced Nausea and Vomiting (RINV): 8 mg orally 1-2 hours before each fraction of radiotherapy.
• Postoperative Nausea and Vomiting (PONV): 16 mg orally one hour before anesthesia or 8 mg orally two hours before anesthesia.
• For children, dosage is based on weight or body surface area as determined by the physician.
• Periset tablets can be taken with or without food.

Contraindications:

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

Side Effects:

• Common: Headache, constipation.
• Less Common: Dizziness, fatigue, diarrhea, abdominal pain, dry mouth.
• Rare: Hypersensitivity reactions (e.g., rash, urticaria, angioedema), transient ECG changes including QT interval prolongation, seizures.

Precautions:

• Use with caution in patients with a history of cardiac problems, especially QT prolongation.
• Monitor ECG in patients with electrolyte abnormalities or those taking other medications that prolong the QT interval.
• Use with caution in patients with hepatic impairment.
• May mask progressive ileus and/or gastric distension following abdominal surgery.
• Serotonin syndrome has been reported with 5-HT3 receptor antagonists, particularly when used concomitantly with other serotonergic drugs.

Use in Pregnancy & Lactation:

• Pregnancy: There are limited data on the use of ondansetron in pregnant women. Use only if the potential benefit outweighs the potential risk to the fetus.
• Lactation: Ondansetron is excreted in breast milk. Caution should be exercised when administering ondansetron to a breastfeeding woman.

Storage:

• Store below 30°C.
• Protect from light and moisture.
• Keep out of reach of children.