Rupafen
Generic Name
Rupatadine Fumarate + Montelukast Sodium
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rupafen 10 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Rupafen is a fixed-dose combination of rupatadine, a non-sedating antihistamine, and montelukast, a leukotriene receptor antagonist. It is primarily used for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.
Uses & Indications
Dosage
Adults
One tablet (Rupatadine 10 mg + Montelukast 10 mg) once daily.
Elderly
No dose adjustment is generally required in elderly patients with normal renal function.
Renal_impairment
Use with caution in patients with renal impairment. No specific dose adjustment guidelines are available for this combination, consider individual components.
How to Take
Oral administration. Can be taken with or without food.
Mechanism of Action
Rupatadine is a second-generation, non-sedating antihistamine that selectively blocks peripheral H1 receptors. Montelukast is a selective and orally active leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotriene 1 (CysLT1) receptor, thereby blocking the actions of leukotrienes in allergic inflammation.
Pharmacokinetics
Onset
Antihistaminic effects of rupatadine observed within 1 hour; montelukast effects within 1 day.
Excretion
Rupatadine is mainly eliminated via feces. Montelukast and its metabolites are excreted almost exclusively via bile in the feces.
Half life
Rupatadine: approx. 5.9 hours. Montelukast: approx. 2.7-5.5 hours.
Absorption
Rupatadine is rapidly absorbed with a Tmax of 0.75-1.5 hours. Montelukast is also rapidly and well absorbed after oral administration, with a Cmax achieved in 2-4 hours.
Metabolism
Both are extensively metabolized by the liver, primarily via cytochrome P450 (CYP3A4 for rupatadine, CYP3A4, 2C8, 2C9 for montelukast).
Side Effects
Contraindications
- Hypersensitivity to rupatadine, montelukast, or any excipients
- Severe hepatic impairment (for montelukast component)
Drug Interactions
0
Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) may increase rupatadine levels.
1
Alcohol: May increase the sedative effect of rupatadine.
2
Phenobarbital, Phenytoin, Rifampicin: May decrease montelukast levels.
Storage
Store below 30°C, in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptomatic and supportive treatment. Rupatadine overdose symptoms may include somnolence, dry mouth. Montelukast overdose symptoms are generally mild, often involving abdominal pain, somnolence, thirst. Hemodialysis is not effective.
Pregnancy & Lactation
Pregnancy Category B for Montelukast. Limited data on rupatadine in pregnant women. Should only be used during pregnancy or lactation if clearly necessary and potential benefits outweigh potential risks. Consult a doctor.
Side Effects
Contraindications
- Hypersensitivity to rupatadine, montelukast, or any excipients
- Severe hepatic impairment (for montelukast component)
Drug Interactions
0
Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) may increase rupatadine levels.
1
Alcohol: May increase the sedative effect of rupatadine.
2
Phenobarbital, Phenytoin, Rifampicin: May decrease montelukast levels.
Storage
Store below 30°C, in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptomatic and supportive treatment. Rupatadine overdose symptoms may include somnolence, dry mouth. Montelukast overdose symptoms are generally mild, often involving abdominal pain, somnolence, thirst. Hemodialysis is not effective.
Pregnancy & Lactation
Pregnancy Category B for Montelukast. Limited data on rupatadine in pregnant women. Should only be used during pregnancy or lactation if clearly necessary and potential benefits outweigh potential risks. Consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Available in pharmacies and hospitals
Approval Status
DGDA approved
Patent Status
Generic available (original patents expired for individual components)
Clinical Trials
Bioequivalence studies confirm efficacy and safety comparable to individual components.
Lab Monitoring
- No routine laboratory monitoring is typically required.
Doctor Notes
- Advise patients regarding potential drowsiness and driving precautions.
- Evaluate patients for pre-existing psychiatric conditions before prescribing due to montelukast component.
- Consider dosage adjustment in severe hepatic or renal impairment based on individual components' guidelines.
Patient Guidelines
- Take as directed by your doctor.
- Do not exceed the recommended dose.
- Inform your doctor about all other medications you are taking.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with the regular schedule. Do not double the dose.
Driving Precautions
May cause drowsiness or dizziness. Patients should be advised not to drive or operate machinery until they know how they react to this medication.
Lifestyle Advice
- Avoid alcohol consumption while taking this medicine as it may increase drowsiness.
- Maintain a healthy lifestyle to support overall allergic management.
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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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