API

Aceclofenac (100mg) + Paracetamol (325mg)

Drug classification

Nonsteroidal anti-inflammatory drug (NSAID) and analgesic-antipyretic combination.

Dosage form

Film-coated oral tablet containing aceclofenac and paracetamol.

API strength per dosage

Dose

Aceloflam XP (Aceclofenac 100 mg + Paracetamol 325 mg) is typically taken orally twice daily in adults. Use in children is not well established. Caution is advised in renal or hepatic impairment; dose adjustment or avoidance may be necessary. Always use the lowest effective dose for the shortest duration. Consult product literature for full guidance.

Mechanism of action

Aceclofenac inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis and thereby decreasing inflammation and pain. Paracetamol inhibits central prostaglandin synthesis, likely via COX-3 inhibition, resulting in analgesic and antipyretic effects. Together, they provide enhanced pain relief and anti-inflammatory action.

Indications

Pain relief

Side effects

Nausea Vomiting Stomach pain epigastric pain Loss of appetite Heartburn Diarrhea

Pregnancy category

Use in pregnancy only if clearly needed; both aceclofenac and paracetamol should be avoided, especially in the third trimester, unless benefits outweigh risks.

Precautions

Monitor for gastrointestinal bleeding, renal and hepatic impairment, hypersensitivity reactions, cardiovascular risk, avoid in pregnancy and lactation unless necessary, caution in elderly, avoid with other NSAIDs or hepatotoxic drugs, monitor liver and renal function tests, assess for signs of anemia, use lowest effective dose.

Contraindications

Hypersensitivity to aceclofenac, paracetamol, or excipients, active peptic ulcer, gastrointestinal bleeding, severe hepatic or renal impairment, severe heart failure, history of NSAID-induced asthma, pregnancy (third trimester), bleeding disorders.