Aceclofenac + paracetamol


Concise Prescribing Info
Indications/Uses
Pain and inflammation.
Dosage/Direction for Use
Adult: PO Per tab contains aceclofenac 100 mg and paracetamol 500 mg: 1 tab in the morning and 1 tab in the evening. Max: 2 tab/day.
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 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.
ATC Classification
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
M02AA25 - aceclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
M01AB16 - aceclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Disclaimer: This information is independently developed by CIMS based on aceclofenac + paracetamol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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