Rumar
Generic Name
Leflunomide
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rumar 10 mg tablet | ৳ 11.00 | ৳ 110.00 |
Description
Overview of the medicine
Rumar 10 mg Tablet contains Leflunomide, an oral disease-modifying antirheumatic drug (DMARD) used to treat active rheumatoid arthritis and psoriatic arthritis. It works by reducing inflammation and preventing joint damage.
Uses & Indications
Dosage
Adults
Initial loading dose (optional): 100 mg once daily for 3 days. Maintenance dose: 10 mg or 20 mg once daily, depending on disease activity and tolerability. For psoriatic arthritis, usually 20 mg once daily.
Elderly
No specific dose adjustment is generally required for elderly patients.
Renal_impairment
Not recommended for patients with severe renal impairment. No dose adjustment for mild to moderate renal impairment, but caution advised.
How to Take
Take orally with or without food. Swallow the tablet whole with a glass of water.
Mechanism of Action
Leflunomide is an isoxazole immunomodulatory agent that inhibits dihydroorotate dehydrogenase (DHODH), an enzyme involved in de novo pyrimidine synthesis. This inhibition leads to a block in lymphocyte proliferation and inflammatory responses.
Pharmacokinetics
Onset
Therapeutic effects typically begin within 4-6 weeks, with maximal effects observed within 4-6 months.
Excretion
The active metabolite is primarily eliminated via bile (feces) and to a lesser extent via urine.
Half life
The active metabolite, A77 1726, has a prolonged half-life of approximately 15-18 days.
Absorption
Well absorbed from the gastrointestinal tract, with bioavailability around 80%. It is a prodrug, rapidly metabolized to its active metabolite, A77 1726.
Metabolism
Leflunomide is rapidly metabolized in the liver and intestine to its primary active metabolite, A77 1726 (teriflunomide).
Side Effects
Contraindications
- Severe hepatic impairment
- Severe immunodeficiency (e.g., AIDS)
- Bone marrow dysplasia or significant anemia, leukopenia, neutropenia, or thrombocytopenia
- Severe uncontrolled infections
- Pregnancy and breastfeeding
- Hypersensitivity to leflunomide or any component of the tablet
Drug Interactions
Warfarin
May increase INR (International Normalized Ratio) in some patients, requiring careful monitoring.
Methotrexate
Increased risk of hepatotoxicity when co-administered with other hepatotoxic DMARDs like methotrexate.
Live vaccines
Avoid administration of live attenuated vaccines during leflunomide treatment.
Cholestyramine or Activated Charcoal
These agents can significantly reduce plasma concentrations of the active metabolite, useful for accelerated elimination in overdose or severe side effects.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In case of overdose, cholestyramine or activated charcoal can be administered to accelerate the elimination of the active metabolite. Close monitoring and supportive measures are necessary.
Pregnancy & Lactation
Leflunomide is contraindicated in pregnancy and in women of childbearing potential who are not using effective contraception. It is also contraindicated during breastfeeding. A washout procedure is required before conception in women and men exposed to leflunomide.
Side Effects
Contraindications
- Severe hepatic impairment
- Severe immunodeficiency (e.g., AIDS)
- Bone marrow dysplasia or significant anemia, leukopenia, neutropenia, or thrombocytopenia
- Severe uncontrolled infections
- Pregnancy and breastfeeding
- Hypersensitivity to leflunomide or any component of the tablet
Drug Interactions
Warfarin
May increase INR (International Normalized Ratio) in some patients, requiring careful monitoring.
Methotrexate
Increased risk of hepatotoxicity when co-administered with other hepatotoxic DMARDs like methotrexate.
Live vaccines
Avoid administration of live attenuated vaccines during leflunomide treatment.
Cholestyramine or Activated Charcoal
These agents can significantly reduce plasma concentrations of the active metabolite, useful for accelerated elimination in overdose or severe side effects.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In case of overdose, cholestyramine or activated charcoal can be administered to accelerate the elimination of the active metabolite. Close monitoring and supportive measures are necessary.
Pregnancy & Lactation
Leflunomide is contraindicated in pregnancy and in women of childbearing potential who are not using effective contraception. It is also contraindicated during breastfeeding. A washout procedure is required before conception in women and men exposed to leflunomide.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date
Availability
Available in pharmacies worldwide
Approval Status
Approved by regulatory authorities (e.g., FDA, EMA)
Patent Status
Off-patent
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of leflunomide in the treatment of active rheumatoid arthritis and psoriatic arthritis, showing significant improvements in disease activity and prevention of joint damage.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) at baseline, monthly for 6 months, then every 6-8 weeks thereafter.
- Complete blood count (CBC) at baseline, monthly for 6 months, then every 6-8 weeks thereafter.
- Blood pressure monitoring at regular intervals.
- Renal function tests periodically.
Doctor Notes
- Emphasize the critical importance of regular liver function tests (LFTs) and complete blood counts (CBCs) throughout the treatment duration.
- Counsel patients thoroughly regarding the teratogenic risk and the necessity of effective contraception and, if applicable, the washout procedure before conception.
- Monitor for signs of infection, interstitial lung disease, and peripheral neuropathy, which require immediate attention.
- Review all concomitant medications to identify potential drug interactions, especially with other hepatotoxic or myelosuppressive agents like methotrexate.
Patient Guidelines
- Adhere strictly to the prescribed dosage and administration schedule.
- Do not stop the medication without consulting your doctor.
- Report any signs of infection, liver problems (e.g., persistent nausea, vomiting, dark urine, yellowing of skin/eyes), or unusual bleeding/bruising immediately.
- Use effective contraception during treatment and for an extended period after stopping the drug (washout procedure may be needed).
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, 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
Leflunomide may cause dizziness or lightheadedness. Patients should exercise caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Avoid or limit alcohol consumption due to increased risk of hepatotoxicity.
- Maintain a balanced diet and regular exercise as advised by your healthcare provider.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
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