API

Celecoxib

Drug classification

Nonsteroidal anti-inflammatory drugs (selective COX-2 inhibitor)

Dosage form

Capsule

API strength per dosage

100 mg

Dose

Adults: 100–200 mg once or twice daily, depending on indication. Pediatrics (≥2 years, juvenile idiopathic arthritis): 50–100 mg twice daily, based on weight. Use lowest effective dose. Caution in hepatic impairment; reduce dose in moderate impairment. Not recommended in severe hepatic or renal impairment.

Mechanism of action

Selectively inhibits cyclooxygenase-2 (COX-2) enzyme, reducing prostaglandin synthesis by blocking the conversion of arachidonic acid to prostaglandin H2, thereby decreasing inflammation and pain without significantly affecting cyclooxygenase-1 (COX-1) activity.

Indications

Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute pain, primary dysmenorrhea, juvenile idiopathic arthritis (in children aged 2 years and older).

Side effects

Gastrointestinal bleeding, abdominal pain, dyspepsia, hypertension, edema, increased risk of cardiovascular events (myocardial infarction, stroke), renal impairment, rash, headache, hypersensitivity reactions.

Pregnancy category

Precautions

History of sulfonamide allergy, cardiovascular disease, cerebrovascular disease, gastrointestinal ulceration or bleeding, renal impairment, hepatic impairment, elderly patients, pregnancy (especially third trimester), lactation, concomitant anticoagulant or antiplatelet therapy, hypertension, fluid retention, asthma, monitoring for serious skin reactions.

Contraindications

Hypersensitivity to celecoxib or sulfonamides, history of asthma, urticaria, or allergic-type reactions to NSAIDs, active peptic ulcer or gastrointestinal bleeding, severe hepatic impairment, advanced renal impairment, pregnancy (third trimester), established cardiovascular disease.