Aceclofenac + Paracetamol information from DrugsUpdate  

Pharmacodynamics

Pharmacokinetics

Aceclofenac is a phenylacetic acid derivative that inhibits synthesis of the inflammatory cytokines interleukin-1b and tumour necrosis factor, and inhibits prostaglandin E2 production. It increases glycosaminoglycans (GAG) synthesis, the principal macromolecule of the extracellular matrix, which aids in repair and regeneration of articular cartilage. Thus, aceclofenac has +ve effects on cartilage anabolism combined with modulating effect of matrix catabolism. Paracetamol has analgesic and antipyretic action with weak anti-inflammatory activity. It produces analgesia by increasing pain threshold and antipyresis by acting on the hypothalamic heat-regulating centre.

Absorption
Aceclofenac: Rapidly absorbed; almost 100% bioavailability; peak plasma levels reached about 1.25-3 hours after oral admin.

Distribution
Aceclofenac: >99.7% bound to plasma proteins; distributes into synovial fluid. Paracetamol: Distributes throughout most fluids of the body.

Metabolism
Aceclofenac: Probably metabolised by CYP2C9; average plasma elimination half-life: 4-4.3 hours. Paracetamol: Mainly metabolised hepatically; plasma elimination half-life: 1-4 hours.

Excretion
Aceclofenac: About two-thirds of the administered dose is removed in the urine, mainly as conjugated hydroxymetabolites. Paracetamol: Most metabolites are removed in the urine within 24 hours.

Aceclofenac + Paracetamol Indications / Aceclofenac + Paracetamol Uses

Information Not Available

Aceclofenac + Paracetamol Adverse Reactions / Aceclofenac + Paracetamol Side Effects

Paracetamol: Nausea, allergic reactions, skin rashes, acute renal tubular necrosis. Aceclofenac: Diarrhoea, headache, vertigo, dizzies, nervousness, tinnitus, depression, drowsiness, insomnia; fever, angioedema, bronchospasm, rashes; blood dyscrasias.

Potentially Fatal: Paracetamol: Very rare, blood dyscrasias (eg, thrombocytopaenia, leucopaenia, neutropaenia, agranulocytosis); liver damage. Aceclofenac: Severe GI bleeding; nephrotoxicity.

Precautions

Information Not Available

Special Precautions

GI disease; renal or hepatic impairment; alcohol-dependent patients; asthma or allergic disorders; haemorrhagic disorders; hypertension; cardiac impairment. Elderly. Caution when driving or operating machinery. Monitor renal and hepatic function and blood counts during long term treatment. Persistently elevated hepatic enzyme levels may require drug withdrawal. Pregnancy, lactation.

Other Drug Interactions

Paracetamol: Reduced absorption of cholestyramine within 1 hour of administration. Accelerated absorption with metoclopramide. Aceclofenac: M0ay increase the plasma concentrations of lithium and digoxin. Increased nephrotoxicity with diuretics. Serum-potassium should be monitored when used with potassium-sparing diuretics. May enhance activity of anticoagulants. May increase plasma methotrexate levels leading to toxicity if administered within 2-4 hours of methotrexate admin. Risk of convulsions with quinolones.

Potentially Fatal: Paracetamol: Increased risk of liver damage in chronic alcoholics. Increased risk of toxicity with high doses or long term admin of barbiturates, carbamazepine, hydantoins, isoniazid, rifampin and sulfinpyrazone.

Other Interactions

Food Interaction

Dosage

Oral
Pain and inflammation
Adult: Each tablet contains aceclofenac 100 mg and paracetamol 500 mg: 1 tablet in the morning and 1 tablet in the evening. Max: 2 tablets/day.

Food(before/after)

Information Not Available

Aceclofenac + Paracetamol and Pregnancy

Contraindicated in pregnancy

Aceclofenac + Paracetamol and Lactation

Information Not Available

Aceclofenac + Paracetamol and Children

Information Not Available

Aceclofenac + Paracetamol and Geriatic

Information Not Available

Aceclofenac + Paracetamol and Other Contraindications

Hypersensitivity. Moderate to severe renal or hepatic impairment; severe heart failure; pregnancy (third trimester).

Storage

Information Not Available

Lab interference

Information Not Available