Rupaler
Generic Name
Rupatadine 10 mg tablet
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rupaler 10 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Rupatadine is a non-sedating, long-acting antihistamine with selective peripheral H1-receptor antagonist activity. It also has platelet-activating factor (PAF) antagonist activity. It is used for the symptomatic treatment of allergic rhinitis and urticaria.
Uses & Indications
Dosage
Adults
10 mg once daily, taken with or without food.
Elderly
No specific dose adjustment generally required, but caution is advised in elderly patients, especially those with renal or hepatic impairment.
Renal_impairment
Caution advised. No specific dose adjustment needed for mild to moderate impairment. Not recommended for severe renal impairment as data is limited.
How to Take
For oral administration. Can be taken with or without food.
Mechanism of Action
Rupatadine acts primarily as a selective peripheral H1-receptor antagonist, blocking histamine's effects. It also blocks platelet-activating factor (PAF) receptors, which are involved in allergic inflammation, thereby reducing allergic symptoms.
Pharmacokinetics
Onset
Within 1 hour.
Excretion
Excreted approximately 60% via feces and 40% via urine, mainly as metabolites.
Half life
Approximately 5.9 hours (rupatadine), 26 hours (active metabolite desloratadine).
Absorption
Rapidly absorbed after oral administration. Tmax is approximately 0.75 hours. Bioavailability is low (around 10%).
Metabolism
Extensively metabolized by the liver, primarily via CYP3A4, to active and inactive metabolites, including desloratadine and 3-hydroxydesloratadine.
Side Effects
Contraindications
- Hypersensitivity to rupatadine or any of the excipients.
- Children under 12 years of age (for 10 mg tablets).
Drug Interactions
Grapefruit juice
Can significantly increase rupatadine's systemic exposure. Avoid concomitant intake.
Ketoconazole, Erythromycin
Potentiate rupatadine's systemic exposure due to CYP3A4 inhibition. Avoid concomitant use or use with caution and dose adjustment.
CNS depressants (e.g., alcohol)
May enhance the sedative effects of rupatadine, though clinical studies show minimal potentiation with alcohol at therapeutic doses.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
In case of accidental overdose, symptomatic and supportive treatment should be given. No specific antidote for rupatadine. Seek immediate medical attention.
Pregnancy & Lactation
Pregnancy Category B. Animal studies have not indicated harmful effects. However, human data is limited. Use only if clearly needed and potential benefits outweigh risks. Rupatadine is excreted in breast milk; therefore, it is not recommended during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved by DGDA, Bangladesh
Patent Status
Generic available
Clinical Trials
Rupatadine has undergone extensive clinical trials demonstrating its efficacy and safety in the treatment of allergic rhinitis and urticaria across various patient populations. Post-marketing surveillance also supports its safety profile.
Lab Monitoring
- No specific routine laboratory monitoring is required for rupatadine.
Doctor Notes
- Counsel patients regarding potential drowsiness and advise caution with activities requiring mental alertness.
- Consider alternative antihistamines for patients with severe hepatic or renal impairment due to limited data.
- Advise against concomitant use of grapefruit juice and strong CYP3A4 inhibitors.
Patient Guidelines
- Do not exceed the recommended dose.
- Inform your doctor or pharmacist about all other medications you are taking, including herbal supplements and over-the-counter drugs.
- Avoid driving or operating heavy machinery if you experience drowsiness or dizziness.
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 your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Rupaler may cause drowsiness or dizziness. Patients should be warned about the potential risk and advised not to drive or operate machinery if affected.
Lifestyle Advice
- Identify and avoid known allergens (e.g., pollen, dust mites, pet dander) to reduce allergic symptoms.
- Maintain good indoor air quality and cleanliness.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.