Onasia
Generic Name
Ondansetron
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| onasia 8 mg injection | ৳ 25.08 | N/A |
Description
Overview of the medicine
Ondansetron is an anti-emetic drug used to prevent nausea and vomiting caused by 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/Vomiting: For highly emetogenic, 24 mg IV single dose over 15 min, 30 min before chemotherapy. For moderately emetogenic, 8 mg IV single dose over 15 min, 30 min before chemotherapy, then 8 mg orally every 12 hours for 1-2 days. Post-operative Nausea/Vomiting: 4 mg IV single dose immediately before anesthesia or shortly after surgery.
Elderly
No dosage adjustment generally required, but consider reduced hepatic function.
Renal_impairment
No dosage adjustment is necessary for patients with renal impairment.
How to Take
Administer intravenously (IV) slowly over 2-5 minutes, or as an infusion over 15 minutes. It should be given by a healthcare professional.
Mechanism of Action
Ondansetron is a selective serotonin 5-HT3 receptor antagonist. It blocks the action of serotonin at 5-HT3 receptors located both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone (CTZ) in the area postrema of the brain. This blockade prevents nausea and vomiting.
Pharmacokinetics
Onset
IV: 30 minutes
Excretion
Primarily via urine (about 5-10% as unchanged drug), some via feces.
Half life
3-5 hours (adults), longer in elderly and hepatic impairment.
Absorption
Rapidly and completely absorbed orally, but bioavailability is about 60% due to first-pass metabolism. IV administration bypasses this.
Metabolism
Extensively metabolized in the liver by cytochrome P450 enzymes (CYP1A2, CYP2D6, CYP3A4) to inactive hydroxylated metabolites.
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).
- Patients with congenital long QT syndrome.
Drug Interactions
Tramadol
May decrease the analgesic effect of tramadol.
Apomorphine
Concomitant use is contraindicated due to severe hypotension and loss of consciousness.
Phenytoin, Carbamazepine, Rifampicin
May decrease ondansetron plasma concentrations.
Drugs that prolong QT interval (e.g., amiodarone, erythromycin)
Increased risk of QT prolongation and Torsades de Pointes.
Storage
Store below 30°C (86°F). Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Overdose symptoms include visual disturbances, severe constipation, hypotension, vasovagal episodes with transient AV block, QT interval prolongation, and Torsades de Pointes. Treatment is symptomatic and supportive, including ECG monitoring.
Pregnancy & Lactation
Pregnancy Category B. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus. It is unknown if 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).
- Patients with congenital long QT syndrome.
Drug Interactions
Tramadol
May decrease the analgesic effect of tramadol.
Apomorphine
Concomitant use is contraindicated due to severe hypotension and loss of consciousness.
Phenytoin, Carbamazepine, Rifampicin
May decrease ondansetron plasma concentrations.
Drugs that prolong QT interval (e.g., amiodarone, erythromycin)
Increased risk of QT prolongation and Torsades de Pointes.
Storage
Store below 30°C (86°F). Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Overdose symptoms include visual disturbances, severe constipation, hypotension, vasovagal episodes with transient AV block, QT interval prolongation, and Torsades de Pointes. Treatment is symptomatic and supportive, including ECG monitoring.
Pregnancy & Lactation
Pregnancy Category B. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus. It is unknown if 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 24 to 36 months from the date of manufacture.
Availability
Hospitals, Pharmacies
Approval Status
FDA approved, DGDA approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Ondansetron has been extensively studied in numerous clinical trials demonstrating its efficacy and safety in preventing chemotherapy-induced nausea and vomiting (CINV), radiation-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). These include several Phase III and IV trials.
Lab Monitoring
- ECG monitoring (especially in patients with cardiac risk factors or on other QT-prolonging drugs).
- Liver function tests (in patients with hepatic impairment).
Doctor Notes
- Monitor ECG in patients with cardiac risk factors (e.g., heart failure, bradyarrhythmias) or those concurrently on other QT-prolonging drugs.
- Consider dose reduction in severe hepatic impairment, as systemic clearance is significantly reduced.
- Caution should be exercised in patients with signs of subacute intestinal obstruction, as ondansetron may mask progressive ileus.
Patient Guidelines
- Inform your doctor about all current medications, including over-the-counter drugs and herbal supplements.
- Report any chest pain, irregular heartbeat, or dizziness immediately to your healthcare provider.
- Do not use this medication if you are pregnant, planning to become pregnant, or breastfeeding without consulting your doctor.
Missed Dose Advice
Since this is an injection usually given by a healthcare professional, missed doses are rare. If administered at home and a dose is missed, contact your doctor immediately for advice.
Driving Precautions
This medicine may cause dizziness or fatigue. Avoid driving or operating heavy machinery until you know how it affects you.
Lifestyle Advice
- Avoid alcohol consumption while taking this medication as it may worsen dizziness. Maintain good hydration.
- Follow your doctor's instructions regarding diet during chemotherapy or radiation therapy.
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