Ofran
Generic Name
Ondansetron 8 mg
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
ofran 8 mg tablet | ৳ 11.00 | ৳ 110.00 |
Description
Overview of the medicine
Ofran 8 mg Tablet contains Ondansetron, an anti-emetic medicine used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. It works by blocking the action of serotonin, a natural substance in the body that can cause nausea and vomiting.
Uses & Indications
Dosage
Adults
Chemotherapy-induced nausea and vomiting (CINV): Highly emetogenic: 24 mg orally once daily 30 minutes before chemotherapy, or 8 mg orally twice daily. Moderately emetogenic: 8 mg orally 30 minutes before chemotherapy, then 8 mg every 8-12 hours for 1-2 days. Radiotherapy-induced nausea and vomiting (RINV): 8 mg orally 1-2 hours before radiation, then 8 mg every 8 hours for 1-2 days. Postoperative nausea and vomiting (PONV): 16 mg orally one hour before anesthesia, or 8 mg orally twice daily for up to 5 days.
Elderly
No general dosage adjustment needed, but monitor closely for QT prolongation and hepatic impairment.
Renal_impairment
No dosage adjustment necessary.
How to Take
Take orally with or without food. For CINV, take 30 minutes before chemotherapy. For RINV, take 1-2 hours before radiation. For PONV, take one hour before anesthesia.
Mechanism of Action
Ondansetron is a selective serotonin 5-HT3 receptor antagonist. Serotonin 5-HT3 receptors are present both peripherally, on vagal nerve terminals, and centrally, in the chemoreceptor trigger zone (CTZ) of the area postrema. Blocking these receptors prevents both peripheral and central stimulation of the vomiting reflex.
Pharmacokinetics
Onset
Antiemetic effect within 30 minutes.
Excretion
Approximately 5% excreted unchanged in urine, remaining as metabolites via urine and feces.
Half life
3-5 hours in adults, longer in elderly and hepatic impairment.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations typically reached within 1.5 hours. Oral bioavailability is approximately 60% due to first-pass metabolism.
Metabolism
Extensively metabolized in the liver primarily by CYP1A2, CYP2D6, and CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to ondansetron or any component of the formulation.
- Concomitant use with apomorphine (risk of profound hypotension and loss of consciousness).
- Congenital long QT syndrome.
Drug Interactions
Tramadol
May reduce the analgesic effect of tramadol and increase seizure risk.
Apomorphine
Concomitant use is contraindicated due to risk of severe hypotension and loss of consciousness.
QT-prolonging drugs
Increased risk of QT prolongation and Torsade de Pointes.
CYP3A4 Inducers (e.g., Phenytoin, Carbamazepine, Rifampicin)
May decrease ondansetron plasma concentrations.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe constipation, transient blindness (reported in children), cardiovascular effects (e.g., hypotension, tachycardia, syncope, QT prolongation), and central nervous system effects (e.g., convulsions, sedation). Management is symptomatic and supportive; there is no specific antidote.
Pregnancy & Lactation
Pregnancy Category B. Studies in humans are inconclusive. Use during pregnancy only if clearly needed after careful risk-benefit assessment. Excreted into breast milk in animals; it is unknown whether it is excreted in human milk. Use with caution in breastfeeding mothers.
Side Effects
Contraindications
- Hypersensitivity to ondansetron or any component of the formulation.
- Concomitant use with apomorphine (risk of profound hypotension and loss of consciousness).
- Congenital long QT syndrome.
Drug Interactions
Tramadol
May reduce the analgesic effect of tramadol and increase seizure risk.
Apomorphine
Concomitant use is contraindicated due to risk of severe hypotension and loss of consciousness.
QT-prolonging drugs
Increased risk of QT prolongation and Torsade de Pointes.
CYP3A4 Inducers (e.g., Phenytoin, Carbamazepine, Rifampicin)
May decrease ondansetron plasma concentrations.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe constipation, transient blindness (reported in children), cardiovascular effects (e.g., hypotension, tachycardia, syncope, QT prolongation), and central nervous system effects (e.g., convulsions, sedation). Management is symptomatic and supportive; there is no specific antidote.
Pregnancy & Lactation
Pregnancy Category B. Studies in humans are inconclusive. Use during pregnancy only if clearly needed after careful risk-benefit assessment. Excreted into breast milk in animals; it is unknown whether it is excreted in human milk. Use with caution in breastfeeding mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of ondansetron in preventing and treating chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting.
Lab Monitoring
- ECG monitoring (especially with risk factors for QT prolongation)
- Liver function tests (for patients with hepatic impairment)
Doctor Notes
- Assess patient's cardiac risk factors (e.g., history of QT prolongation, electrolyte imbalances, concomitant QT-prolonging drugs) before prescribing.
- Caution in patients with hepatic impairment; maximum dose 8 mg daily.
Patient Guidelines
- Do not take ondansetron with apomorphine.
- Report any symptoms of irregular heartbeat, shortness of breath, or fainting immediately.
- Inform your doctor about all medications you are taking, especially those that can affect heart rhythm.
- For severe hepatic impairment, daily dose should not exceed 8 mg.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your usual dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Ondansetron may cause dizziness or drowsiness. Avoid driving or operating machinery if you experience these effects.
Lifestyle Advice
- Maintain adequate hydration, especially during chemotherapy or radiation.
- Avoid alcohol if it worsens nausea or vomiting.
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