Onsat-OSF
Generic Name
Ondansetron
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| onsat osf 4 mg oral soluble film | ৳ 12.00 | N/A |
Description
Overview of the medicine
Ondansetron is a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. This specific formulation is an oral soluble film designed for quick dissolution and absorption.
Uses & Indications
Dosage
Adults
For chemotherapy-induced nausea/vomiting: 8 mg 30 minutes before chemotherapy, then 8 mg 8 hours after the first dose, followed by 8 mg every 12 hours for 1-2 days. For PONV: 4 mg administered 1 hour before induction of anesthesia or immediately post-operatively.
Elderly
No dosage adjustment is generally required for elderly patients with normal hepatic function. For patients >75 years, the initial dose should not exceed 8 mg (for highly emetogenic chemotherapy).
Renal_impairment
No dosage adjustment is required for patients with renal impairment. For severe hepatic impairment, a maximum daily dose of 8 mg is recommended.
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.
Mechanism of Action
Ondansetron works by blocking the action of serotonin (a natural substance) that can cause nausea and vomiting. It selectively antagonizes 5-HT3 receptors located both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone (CTZ) of the brain.
Pharmacokinetics
Onset
Within 30 minutes to 2 hours for oral forms.
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.
Absorption
Rapidly and completely absorbed from the gastrointestinal tract; oral soluble films may have slightly faster absorption.
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 risk of profound hypotension and loss of consciousness).
Drug Interactions
Tramadol
May reduce the analgesic effect of tramadol.
Apomorphine
Concomitant use is contraindicated due to risk of severe hypotension and loss of consciousness.
Phenytoin, Carbamazepine, Rifampicin
May decrease ondansetron plasma concentrations.
Drugs prolonging QT interval (e.g., Amiodarone, Chlorpromazine)
Increased risk of QT prolongation and Torsade de Pointes. Avoid co-administration if possible.
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 episode with transient AV block. Treatment is supportive and symptomatic.
Pregnancy & Lactation
Pregnancy Category B. Use during pregnancy only if clearly needed. Ondansetron is excreted into breast milk; 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 risk of profound hypotension and loss of consciousness).
Drug Interactions
Tramadol
May reduce the analgesic effect of tramadol.
Apomorphine
Concomitant use is contraindicated due to risk of severe hypotension and loss of consciousness.
Phenytoin, Carbamazepine, Rifampicin
May decrease ondansetron plasma concentrations.
Drugs prolonging QT interval (e.g., Amiodarone, Chlorpromazine)
Increased risk of QT prolongation and Torsade de Pointes. Avoid co-administration if possible.
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 episode with transient AV block. Treatment is supportive and symptomatic.
Pregnancy & Lactation
Pregnancy Category B. Use during pregnancy only if clearly needed. Ondansetron is excreted into breast milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, specific to manufacturer's guidelines.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities (e.g., DGDA in Bangladesh)
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Extensively studied in numerous clinical trials demonstrating efficacy in preventing chemotherapy-induced, radiotherapy-induced, and post-operative nausea and vomiting.
Lab Monitoring
- Routine lab monitoring is not typically required. ECG monitoring is advised in patients with risk factors for QT prolongation (e.g., congestive heart failure, bradyarrhythmias, electrolyte abnormalities).
- Monitor potassium and magnesium levels in at-risk patients.
Doctor Notes
- Monitor for QT prolongation in patients with underlying cardiac conditions or those taking other QT-prolonging drugs.
- Caution in patients with hepatic impairment, as ondansetron clearance is reduced.
- Not effective for motion sickness.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not crush or chew the soluble film; allow it to dissolve on the tongue.
- Inform your doctor about all other medications you are taking.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
Ondansetron may cause dizziness or visual disturbances. Patients should be advised not to drive or operate machinery if these effects occur.
Lifestyle Advice
- Avoid driving or operating heavy machinery if you experience dizziness or visual disturbances.
- Stay hydrated, especially if experiencing vomiting.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
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