Onsat-OSF
Generic Name
Ondansetron
Manufacturer
Popular Pharmaceuticals Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| onsat osf 8 mg oral soluble film | ৳ 18.00 | N/A |
Description
Overview of the medicine
Onsat-OSF 8 mg Oral Soluble Film contains Ondansetron, which is 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
For highly emetogenic chemotherapy: 24 mg orally 30 minutes before chemotherapy. For moderately emetogenic chemotherapy/radiotherapy: 8 mg orally 1-2 hours before therapy, followed by 8 mg every 8-12 hours for 1-2 days. For PONV: 8 mg orally 1 hour before anesthesia, or 8 mg 1 hour before and 8 mg 8 hours after surgery.
Elderly
Generally, no dose adjustment is required. However, for patients >75 years, the initial dose should not exceed 16 mg IV due to QT prolongation risk, but oral doses are usually tolerated well.
Renal_impairment
No dose adjustment is required for patients with renal impairment.
How to Take
Place the oral soluble film on the tongue; it will dissolve rapidly. Do not chew or swallow whole. It can be taken with or without food. Wash hands before handling the film.
Mechanism of Action
Ondansetron is a selective serotonin 5-HT3 receptor antagonist. Chemotherapeutic agents and radiation therapy can cause the release of serotonin from enterochromaffin cells in the small intestine, which then activates 5-HT3 receptors located on vagal afferents to initiate the vomiting reflex. Ondansetron blocks this action both peripherally (in the gut) and centrally (in the chemoreceptor trigger zone in the brain).
Pharmacokinetics
Onset
Within 30 minutes after oral administration.
Excretion
Approximately 5% of the dose is excreted unchanged in urine, with the remainder excreted as metabolites via urine and feces.
Half life
Approximately 3-5 hours in adults, longer in elderly and those with hepatic impairment.
Absorption
Rapidly and completely absorbed from the gastrointestinal tract; however, undergoes some first-pass metabolism, reducing absolute bioavailability to ~60%. Peak plasma concentrations reached within 1.5-2 hours.
Metabolism
Extensively metabolized in the liver by multiple cytochrome P450 enzymes (CYP1A2, CYP2D6, CYP3A4).
Side Effects
Contraindications
- Hypersensitivity to Ondansetron or any component of the formulation.
- Concomitant use with apomorphine due to profound hypotension and loss of consciousness.
Drug Interactions
Tramadol
Ondansetron may reduce the analgesic effect of tramadol.
Apomorphine
Concomitant use is contraindicated due to risk of severe hypotension and loss of consciousness.
SSRIs/SNRIs
Potential for serotonin syndrome, although rare.
QT-prolonging drugs
Use with caution with other drugs known to prolong the QT interval (e.g., amiodarone, sotalol, erythromycin, antipsychotics) as it may increase the risk of arrhythmias.
Phenytoin, Carbamazepine, Rifampicin
These enzyme inducers may reduce ondansetron levels.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include transient visual disturbances, severe constipation, hypotension, and vasovagal episodes with transient AV block. ECG monitoring is recommended in overdose cases, especially for QT prolongation. Treatment is supportive and symptomatic.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. It is unknown whether ondansetron is excreted in human milk; therefore, caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to Ondansetron or any component of the formulation.
- Concomitant use with apomorphine due to profound hypotension and loss of consciousness.
Drug Interactions
Tramadol
Ondansetron may reduce the analgesic effect of tramadol.
Apomorphine
Concomitant use is contraindicated due to risk of severe hypotension and loss of consciousness.
SSRIs/SNRIs
Potential for serotonin syndrome, although rare.
QT-prolonging drugs
Use with caution with other drugs known to prolong the QT interval (e.g., amiodarone, sotalol, erythromycin, antipsychotics) as it may increase the risk of arrhythmias.
Phenytoin, Carbamazepine, Rifampicin
These enzyme inducers may reduce ondansetron levels.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include transient visual disturbances, severe constipation, hypotension, and vasovagal episodes with transient AV block. ECG monitoring is recommended in overdose cases, especially for QT prolongation. Treatment is supportive and symptomatic.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. It is unknown whether ondansetron is excreted in human milk; therefore, caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture, specific to manufacturer.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic
WHO Essential Medicine
YesClinical Trials
Ondansetron has been extensively studied in numerous clinical trials supporting its efficacy and safety for preventing chemotherapy-induced, radiation-induced, and post-operative nausea and vomiting. Specific trials for oral soluble film formulations have also demonstrated bioequivalence and comparable efficacy to traditional oral dosage forms.
Lab Monitoring
- Routine monitoring is generally not required. ECG monitoring is advisable in patients with electrolyte abnormalities, congenital long QT syndrome, congestive heart failure, or on other QT-prolonging medications.
Doctor Notes
- Counsel patients on proper administration technique for oral soluble film.
- Be aware of potential for QT prolongation; caution with concurrent QT-prolonging drugs or cardiac conditions.
- Monitor for constipation, a common side effect, and advise appropriate management.
- Contraindicated with apomorphine due to severe hypotensive risk.
Patient Guidelines
- Do not push the film through the foil. Peel back the foil, then gently remove the film.
- Immediately place the film on top of the tongue where it will dissolve rapidly. Do not swallow the film whole.
- Take the medicine as directed by your doctor, even if you feel well.
- Inform your doctor about all medications, supplements, and herbal products you are taking.
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 go back to your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Ondansetron can cause dizziness or fatigue. Patients should be advised not to drive or operate machinery if they experience these effects.
Lifestyle Advice
- Stay hydrated, especially if experiencing vomiting or diarrhea.
- Eat small, frequent meals rather than large ones to help manage nausea.
- Avoid strong odors, which can trigger nausea.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
Other Medicines in Onsat-OSF Brand
Other medicines available under the same brand name
