Amoxicillin + clavulanic acid

Generic Medicine Info
Hypersensitivity or history of hypersensitivity reactions (e.g. anaphylaxis, Stevens-Johnson syndrome) to amoxicillin, clavulanic acid, or other β-lactam antibacterials (e.g. penicillin, cephalosporin, carbapenem, monobactam). History of cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanic acid treatment. As extended-release tab: Severe renal impairment (CrCl <30 mL/min) and patients on haemodialysis.
Special Precautions
Patients with infectious mononucleosis; reduced urine output. Atopic individuals. Renal (including haemodialysis patients) and hepatic impairment. Children. Pregnancy and lactation. Patient Counselling This drug may cause dizziness, convulsions, and allergic reactions, if affected, do not drive or operate machinery. Do not switch between different formulations unless instructed by your doctor. Monitoring Parameters Perform culture and sensitivity tests. Monitor CBC with differential, renal function tests, and LFTs periodically especially with prolonged treatment; LFTs at regular intervals in patients with hepatic impairment. Assess for signs of infection at baseline and throughout the treatment; anaphylaxis during 1st dose.
Adverse Reactions
Significant: Diarrhoea, fungal or bacterial superinfection, convulsions (at high doses or in patients with renal impairment), morbilliform rash (in patients with mononucleosis). Rarely, crystalluria (IV), prothrombin time prolongation. Blood and lymphatic system disorders: Haemolytic anaemia, reversible agranulocytosis. Rarely, thrombocytopenia, reversible leucopenia or neutropenia. Gastrointestinal disorders: Nausea, vomiting, indigestion, black hairy tongue. Immune system disorders: Serum sickness-like syndrome, urticaria, hypersensitivity vasculitis. Infections and infestations: Mucocutaneous candidosis. Investigations: Increased AST/ALT. Nervous system disorders: Headache, dizziness, reversible hyperactivity. Renal and urinary disorders: Interstitial nephritis. Reproductive system and breast disorders: Vaginal mycosis. Skin and subcutaneous tissue disorders: Rash, pruritus, Stevens-Johnson syndrome. Rarely, erythema multiforme.
Potentially Fatal: Severe hypersensitivity reactions, including anaphylactoid and severe cutaneous reactions (e.g. acute generalised exanthematous pustulosis); Clostridium difficile-associated diarrhoea or pseudomembranous colitis. Rarely, hepatic dysfunction (e.g. cholestatic jaundice, hepatitis).
Drug Interactions
Reduced pre-dose concentrations of mycophenolate mofetil active metabolite. May reduce the efficacy of combined oral oestrogen/progesterone contraceptives. Amoxicillin: Increased risk of allergic skin reactions with allopurinol. Probenecid increases and prolongs plasma concentrations of amoxicillin. May increase INR in patients maintained with oral anticoagulants (e.g. acenocoumarol, warfarin). May reduce the excretion and increase the risk of methotrexate toxicity.
CIMS Class
ATC Classification
J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
Disclaimer: This information is independently developed by CIMS based on amoxicillin + clavulanic acid 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 © 2023 CIMS. All rights reserved. Powered by
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