Indication & 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.

Overdosage

Empty stomach promptly by gastric lavage or induction of emesis. Administer standard supportive measures.

Contraindications

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

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.

Adverse Drug Reactions

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.

Drug Interactions

Paracetamol: Reduced absorption of cholestyramine within 1 hr 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 hr 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.

Lab Interference

Aceclofenac interferes with thyroid function tests.

Mechanism of Action

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 hr 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 hr. Paracetamol: Mainly metabolised hepatically; plasma elimination half-life: 1-4 hr.
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 hr.

CIMS Class

Analgesics (Non-Opioid) & Antipyretics / Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

ATC Classification

M02AA25 - aceclofenac ;
M01AB16 - aceclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products. Used in the treatment of inflammation and rheumatism.
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

Form

Packing (Max Retail Price)

Pacedase film-coated tab