Rupafen
Generic Name
Rupatadine 10 mg tablet
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 10 mg Tablet contains Rupatadine, a second-generation antihistamine with selective peripheral H1-receptor antagonist activity. It is used for the symptomatic treatment of allergic rhinitis and urticaria.
Uses & Indications
Dosage
Adults
10 mg (one tablet) once daily, with or without food.
Elderly
No specific dose adjustment is required in elderly patients. Use with caution in patients with renal or hepatic impairment.
Renal_impairment
Use with caution in patients with renal impairment. No specific dose adjustment guidelines are available, but consider lower doses or extended intervals. Consult a doctor.
Hepatic_impairment
Use with caution in patients with hepatic impairment. No specific dose adjustment guidelines are available, but consider lower doses or extended intervals. Consult a doctor.
How to Take
Take Rupafen 10 mg Tablet orally with a glass of water, with or without food.
Mechanism of Action
Rupatadine is a long-acting, selective peripheral H1-receptor antagonist. It also has antagonistic activity against platelet-activating factor (PAF) and inhibits the degranulation of mast cells and basophils, thereby reducing the release of inflammatory mediators.
Pharmacokinetics
Onset
Within 1 hour.
Excretion
Approximately 60% via feces and 40% via urine, mainly as metabolites.
Half life
Approximately 5.9 hours.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations reached in approximately 0.75-1.5 hours.
Metabolism
Extensively metabolized, primarily by cytochrome P450 (CYP3A4) to active and inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Rupatadine or any of its excipients.
Drug Interactions
Statins
Rupatadine should be administered with caution with statins due to potential for CYP3A4 interaction.
Grapefruit juice
Can increase systemic exposure to rupatadine (see Drug-Food Interactions).
CNS depressants (e.g., alcohol, sedatives)
May enhance the central nervous system depressant effects (e.g., drowsiness).
Ketoconazole, Erythromycin, Diltiazem, Cimetidine
May increase rupatadine exposure due to CYP3A4 inhibition, potentially increasing the risk of adverse effects. Caution advised.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, symptomatic and supportive treatment should be initiated. No specific antidote for rupatadine is known. Gastric lavage and activated charcoal may be considered. Closely monitor cardiac function and vital signs.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Should be used during pregnancy only if clearly needed. It is unknown whether rupatadine is excreted in human breast milk; a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to Rupatadine or any of its excipients.
Drug Interactions
Statins
Rupatadine should be administered with caution with statins due to potential for CYP3A4 interaction.
Grapefruit juice
Can increase systemic exposure to rupatadine (see Drug-Food Interactions).
CNS depressants (e.g., alcohol, sedatives)
May enhance the central nervous system depressant effects (e.g., drowsiness).
Ketoconazole, Erythromycin, Diltiazem, Cimetidine
May increase rupatadine exposure due to CYP3A4 inhibition, potentially increasing the risk of adverse effects. Caution advised.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, symptomatic and supportive treatment should be initiated. No specific antidote for rupatadine is known. Gastric lavage and activated charcoal may be considered. Closely monitor cardiac function and vital signs.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Should be used during pregnancy only if clearly needed. It is unknown whether rupatadine is excreted in human breast milk; a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years (refer to package for exact expiry)
Availability
Pharmacies nationwide
Approval Status
Approved (DGDA)
Patent Status
Off-patent
Clinical Trials
Rupatadine has undergone extensive clinical trials demonstrating its efficacy and safety in the treatment of allergic rhinitis and urticaria. Studies show rapid onset of action and sustained relief of symptoms.
Lab Monitoring
- No routine lab monitoring is generally required for rupatadine.
Doctor Notes
- Rupatadine is a second-generation antihistamine with additional PAF antagonist activity, which may offer advantages over pure H1-blockers in certain inflammatory conditions. Counsel patients on potential for drowsiness and interactions with CYP3A4 inhibitors and grapefruit juice. Not recommended for children under 12 years of age for tablets.
- Monitor for cardiovascular effects in susceptible patients due to potential QT prolongation, although rare with recommended doses.
Patient Guidelines
- Do not exceed the recommended dose.
- This medicine may cause drowsiness; use caution when driving or operating machinery.
- Inform your doctor about all other medicines you are taking, including herbal supplements and over-the-counter drugs.
- Avoid alcohol consumption while taking this medicine.
- Report any severe or persistent side effects to your doctor.
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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Rupatadine may cause drowsiness, dizziness, or fatigue. Patients should be warned not to drive or operate machinery until they know how they react to this medication.
Lifestyle Advice
- Identify and avoid known allergens that trigger your symptoms.
- Stay hydrated by drinking plenty of water.
- Maintain a healthy lifestyle with regular exercise and a balanced diet.
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