📋 Indications & Clinical Dosage
*Pain and inflammation in Osteoarthritis:*
Adults: 200 mg once daily or in two divided doses; increase to 200 mg twice daily if necessary, max 400 mg daily.
*Pain and inflammation in Rheumatoid arthritis:*
Adults: 200-400 mg daily in two divided doses; max 400 mg daily.
*Dysmenorrhoea:*
Adults: Day 1: 400 mg, then 200 mg if needed; Maintenance: 200 mg twice daily if needed.
*Ankylosing spondylitis:*
Adult: 200 mg daily in 1-2 divided doses, then increased if necessary up to 400 mg daily in 1-2 divided doses, discontinue if no improvement after 2 weeks on max. dose.
*Acute Pain:*
Adults: Day 1: 400 mg, then 200 mg if needed; Maintenance: 200 mg twice daily if needed.
Children: Not recommended.
⛔ Contraindications
Active GI bleeding and ulceration, cerebrovascular disease, inflammatory bowel disease, ischaemic heart disease, mild to severe heart failure, peripheral arterial disease, severe renal or hepatic impairment.
⚠️ Precautions & Warnings
Allergic disorders, cardiac impairment (NSAIDs may impair renal function), coagulation defects, connective-tissue disorders, Crohns disease, history of cardiac failure, hypertension, left ventricular dysfunction, oedema, risk factors for cardiovascular events, ulcerative colitis, renal or hepatic impairment, history of GI disease,
risk of hypovolaemia, elderly (65 years); use lower initial dose. Contraception must be used.
🔄 Drug Interactions
Diuretics, antihypertensives, ACE inhibitors, an-ticoagulants, drug metabolised by CYP2D6 or 2C19, lithium, cyclosporin, tacrolimus, methotrexate (monitor), rifampicin, carbamazepine, barbiturate, fluconazole.
⚠️ Adverse Reactions / Side Effects
Dyspnoea, influenza-like symptoms, cerebral infarction, fatigue, muscle cramps, palpitation, paraesthesia, stomatitis, colitis, Crohns disease, depression, diarrhoea, dizziness, drowsiness, fluid retention, GI bleeding and ulceration, GI disturbances, nausea, nervousness, photosensitivity, raised blood pressure, vomiting, bowel disorders, abdominal pain, haematuria, headache, hearing disturbances, hypersensitivity reactions, insomnia, upper respiratory tract disorder, skin rash.
🤰 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.