API

Aceclofenac (100mg) + Paracetamol (325mg)

Drug classification

Aceclofenac: Nonsteroidal anti-inflammatory drug (NSAID); Paracetamol: Analgesic and antipyretic.

Dosage form

Tablet form: Aceclofenac (100mg) + Paracetamol (325mg).

API strength per dosage

Aceclofenac 100 mg, Paracetamol 325 mg per tablet.

Dose

Adults: 1 tablet of Aceclofenac (100mg) + Paracetamol (325mg) every 8 hours. Not recommended for children under 12 years. Caution advised in elderly and patients with renal or hepatic impairment; dose adjustment may be necessary. Consult healthcare provider for specific adjustments.

Mechanism of action

Aceclofenac inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis, thereby alleviating inflammation and pain. Paracetamol acts primarily in the CNS, inhibiting prostaglandin synthesis, possibly through COX-3 inhibition, reducing pain and fever.

Indications

Pain relief

Side effects

Nausea Vomiting Stomach pain epigastric pain Loss of appetite Heartburn Diarrhea

Pregnancy category

Precautions

Avoid in peptic ulcer, severe heart failure, renal or hepatic impairment; caution in asthma, bleeding disorders; monitor elderly closely; not recommended during pregnancy (especially third trimester) and lactation; may interact with anticoagulants, diuretics, lithium, methotrexate; discontinue at first sign of skin rash or any hypersensitivity reaction.

Contraindications

Active peptic ulcer, severe heart failure, severe renal impairment, severe hepatic impairment, hypersensitivity to NSAIDs or paracetamol, third trimester of pregnancy, children under 12 years.