TabletsClinical Overview
Leflunomide Tablets (10mg, 20mg) is an oral isoxazole-derivative disease-modifying antirheumatic drug (DMARD) on the WHO Model List of Essential Medicines. It is rapidly converted in the gut wall and liver to its active metabolite teriflunomide (A77 1726), which reversibly inhibits dihydroorotate dehydrogenase (DHODH), the key mitochondrial enzyme in de novo pyrimidine synthesis. Because activated, proliferating autoimmune T- and B-lymphocytes depend on de novo pyrimidine generation (unlike resting cells which use the salvage pathway), leflunomide selectively halts autoimmune lymphocyte proliferation and joint inflammation. Indicated for active Rheumatoid Arthritis and active Psoriatic Arthritis.
Active Pharmaceutical Ingredients
Verified Clinical References
Usage Guidelines
Take orally 10 mg to 20 mg once daily with water, with or without food. Swallow whole. Teriflunomide has an extremely long elimination half-life (~2 weeks) and undergoes enterohepatic recirculation. Cholestyramine washout protocol (8 g three times daily for 11 days) is required to rapidly eliminate the drug in toxicity or pregnancy planning.
General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.
Possible Side Effects
Common: Diarrhea, nausea, abdominal pain, alopecia (hair thinning), hypertension, headache, transaminase elevations. Rare/Severe: Severe hepatotoxicity / acute liver necrosis, severe teratogenicity / fetal death, interstitial lung disease, Stevens-Johnson syndrome, and pancytopenia.
*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.
Precautions & Warnings
Black Box Warning: Severe hepatotoxicity; monitor ALT/AST monthly for the first 6 months and every 6-8 weeks thereafter; contraindicated in pre-existing liver disease. Black Box Warning: Severe embryofetal toxicity / teratogenicity (Category X); strict contraception required. If pregnancy is planned, accelerated drug elimination with cholestyramine is MANDATORY until plasma levels are <0.02 mg/L.
Schedule H (Prescription Required)
This medication is scheduled under statutory drug regulatory frameworks (CDSCO / Drugs & Cosmetics Rules). Dispensing requires a valid medical prescription from a registered medical practitioner. Self-medication or unsupervised dosage adjustment carries significant clinical risks.
Medical Disclaimer: Statutory Clinical Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice, clinical diagnosis, or analgesic treatment guidance. Always consult a registered physician or orthopedic specialist before taking pain relievers, anti-inflammatory medications, or anti-arthritic therapies.