Osetron
Generic Name
Ondansetron
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
osetron 8 mg tablet | ৳ 10.07 | ৳ 100.70 |
Description
Overview of the medicine
Osetron 8 mg Tablet is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. It works by blocking serotonin, a natural substance in the body that can cause nausea and vomiting.
Uses & Indications
Dosage
Adults
For CINV: 8 mg orally 1-2 hours before chemotherapy, followed by 8 mg every 8-12 hours for up to 5 days. For PONV: 8 mg orally 1 hour before anesthesia.
Elderly
Generally, no dose adjustment is required for the elderly, but caution is advised in patients with impaired hepatic function.
Renal_impairment
No dose adjustment is necessary for patients with renal impairment.
How to Take
Take Osetron tablet orally with or without food, as directed by your doctor. Swallow the tablet whole with a glass of water.
Mechanism of Action
Ondansetron is a selective 5-HT3 receptor antagonist. Serotonin 5-HT3 receptors are present both peripherally, on vagal nerve terminals, and centrally, in the chemoreceptor trigger zone (CTZ). Cancer chemotherapy and radiotherapy may cause release of serotonin from enterochromaffin cells of the small intestine, initiating a vagal afferent discharge via 5-HT3 receptors and hence vomiting.
Pharmacokinetics
Onset
Within 30 minutes (oral).
Excretion
About 5% of the dose is excreted unchanged in the urine, with the remainder excreted as metabolites via urine and feces.
Half life
Approximately 3-6 hours in adults, longer in elderly and patients with severe hepatic impairment.
Absorption
Rapidly and completely absorbed from the GI tract after oral administration, though bioavailability is about 60% due to first-pass metabolism.
Metabolism
Extensively metabolized in the liver by cytochrome P450 enzymes (CYP1A2, CYP2D6, CYP3A4) via hydroxylation followed by glucuronidation or sulfation.
Side Effects
Contraindications
- Hypersensitivity to Ondansetron or any component of the formulation.
- Concomitant use with apomorphine due to risk of profound hypotension and loss of consciousness.
Drug Interactions
Tramadol
May reduce the analgesic effect of tramadol and increase the risk of serotonin syndrome.
Apomorphine
Concomitant use is contraindicated due to severe hypotension and loss of consciousness.
QT-prolonging drugs
Use with caution with other drugs known to prolong the QT interval (e.g., antiarrhythmics, antipsychotics).
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 transient blindness, severe constipation, hypotension, and vasovagal episodes with transient AV block. Serotonin syndrome has also been reported. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category B. Ondansetron should be used during pregnancy only if clearly needed. Studies suggest a possible, small increased risk of oral clefts in infants following ondansetron exposure during the first trimester. It is not known whether ondansetron is excreted in human milk; use with caution in nursing mothers.
Side Effects
Contraindications
- Hypersensitivity to Ondansetron or any component of the formulation.
- Concomitant use with apomorphine due to risk of profound hypotension and loss of consciousness.
Drug Interactions
Tramadol
May reduce the analgesic effect of tramadol and increase the risk of serotonin syndrome.
Apomorphine
Concomitant use is contraindicated due to severe hypotension and loss of consciousness.
QT-prolonging drugs
Use with caution with other drugs known to prolong the QT interval (e.g., antiarrhythmics, antipsychotics).
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 transient blindness, severe constipation, hypotension, and vasovagal episodes with transient AV block. Serotonin syndrome has also been reported. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category B. Ondansetron should be used during pregnancy only if clearly needed. Studies suggest a possible, small increased risk of oral clefts in infants following ondansetron exposure during the first trimester. It is not known whether ondansetron is excreted in human milk; use with caution in nursing mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Patent expired, generic available
WHO Essential Medicine
YesClinical Trials
Ondansetron has undergone extensive clinical trials demonstrating its efficacy and safety for approved indications. Ongoing research may explore new uses or formulations.
Lab Monitoring
- Liver function tests (for long-term use or in patients with hepatic impairment).
- ECG monitoring (for patients at risk of QT prolongation or with pre-existing cardiac conditions).
Doctor Notes
- Assess patient's cardiac history and concomitant medications for potential QT prolongation risk.
- Consider liver function, especially in elderly patients or those with pre-existing hepatic impairment, as dose adjustment may be necessary in severe cases.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Report any unusual or severe side effects to your doctor immediately.
- Do not stop taking the medicine abruptly without consulting your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
Driving Precautions
Ondansetron may cause dizziness or drowsiness. Patients should be advised not to drive or operate machinery if they experience these effects.
Lifestyle Advice
- Stay hydrated by drinking plenty of fluids.
- Avoid heavy or fatty meals if experiencing nausea.
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