📋 Indications & Clinical Dosage
*Moderate to severe active rheumatoid arthritis, Active psoriatic arthritis:*
Adult: Initially 100 mg once daily for 3 days then reduced to 10-20 mg once daily; if dose not tolerated or ALT level elevations; reduce dose to 10 mg/day. If elevations persist or ALT level is higher further, discontinue. Children: Not recommended.
⛔ Contraindications
Severe immunodeficiency, bone marrow dysfunction, blood dyscrasias, serious infections, hepatic impairment, moderate to severe renal insufficiency, severe hypoproteinaemia, ulcerative stomatitis. Contraception must be used by men and women during and for 2 years after use or until plasma levels fall below 0.02 mg/I.
⚠️ Precautions & Warnings
Anaemia, history of tuberculosis, impaired bone-marrow function, leucopenia, thrombocytopenia, risk of hepatotoxicity; monitor complete blood count & ALT before treatment and every 2 weeks for 6 months, then every 8 weeks; withdraw and washout if elevated and continue to monitor liver enzymes until normal. A washout procedure must be performed if toxicity or severe infection develops, or when switching to another disease-modifying antirheumatic drugs (DMARD) or for a desired preg-nancy.
🔄 Drug Interactions
Other DMARDs, alcohol, hepatotoxic, or haematotoxic drugs, methotrexate, drugs metabolised by CYP2C9 (not NSAIDs), live vaccines, cholestyramine, activated charcoal.
⚠️ Adverse Reactions / Side Effects
Abdominal pain, alopecia, anorexia, asthenia, diarrhoea, dizziness, dry skin, headache, increased blood pressure, leucopenia, nausea, oral mucosal disorders, paraesthesia, pruritus, rash, tenosynovitis, vomiting, anaemia, anxiety, hyperlipidaemia, hypokalaemia, hypophosphataemia, taste disturbance, tendon rupture, thrombocytopenia. Rare: Severe hepatotoxicity, hepatitis, eosinophilia, interstitial lung disease, jaundice, pancytopenia, severe infection, bone-marrow toxicity, hypouricaemia, malignancy, reduced sperm count, renal failure, pancreatitis
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Contraindicated in pregnancy
Lactation / Breastfeeding:
Contraindicated or not recommended
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.