API

Ibuprofen (400mg)

Drug classification

Nonsteroidal anti-inflammatory drugs (propionic acid derivative).

Dosage form

Tablet

API strength per dosage

400 mg

Dose

Adults: 400 mg orally every 4–6 hours as needed; maximum 3200 mg/day. Pediatrics (≥6 months): 5–10 mg/kg orally every 6–8 hours; maximum 40 mg/kg/day. Use lowest effective dose; avoid or adjust in renal, hepatic impairment, and elderly. Not recommended in severe renal impairment.

Mechanism of action

Inhibits cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, blocking arachidonic acid conversion to prostaglandins and thromboxanes, thereby reducing inflammation, pain, and fever through decreased prostaglandin synthesis at peripheral and central sites.

Indications

Pain reliefTreatment of Fever

Side effects

Vomiting Nausea Dizziness Abdominal pain Constipation Flatulence Diarrhea Dyspepsia Headache Fatigue Rash

Pregnancy category

Category C (first and second trimesters), Category D (third trimester)

Precautions

History of peptic ulcer or GI bleeding, asthma, renal impairment, hepatic impairment, cardiovascular disease, hypertension, elderly patients, pregnancy (especially third trimester), breastfeeding, concomitant anticoagulant or antiplatelet therapy, dehydration, avoid with other NSAIDs, monitor for allergic reactions, use lowest effective dose for shortest duration.

Contraindications

Hypersensitivity to ibuprofen or NSAIDs, active peptic ulcer, gastrointestinal bleeding, severe heart failure, severe hepatic or renal impairment, history of asthma with NSAIDs, third trimester of pregnancy.