Amoxicillin + clavulanic acid


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Upper respiratory tract infections; Ear, nose and/or throat infections; Acute bacterial sinusitis; Genitourinary infections; Cystitis; Pyelonephritis; Skin and soft tissue infections; Infected animal bites; Intra-abdominal infections Individualise dosing based on expected susceptible pathogens, severity and site of infection. Each conventional tab contains amoxicillin (mg)/clavulanic acid (mg): 250/125, 500/125, or 875/125; per 5 mL of oral susp contains amoxicillin (mg) and clavulanic acid (mg): 125/31.25 or 250/62.5: As conventional tab: 250 mg/125 mg tid, or 500 mg/125 mg tid, or 875 mg/125 mg bid. As oral susp: 500 mg/125 mg tid. Treatment duration: Up to 14 days without review. For treatment of acute bacterial sinusitis only: each extended-release tab contains amoxicillin 1,000 mg and clavulanic acid 62.5 mg: 2,000 mg/125 mg 12 hourly for 10 days. Acute otitis media; Lower respiratory tract infections; Acute exacerbations of chronic bronchitis; Community-acquired pneumonia; Bone and joint infections; Osteomyelitis Each conventional tab contains amoxicillin (mg)/clavulanic acid (mg): 500/125 or 875/125; per 5 mL of oral susp contains amoxicillin (mg) and clavulanic acid (mg): 125/31.25 or 250/62.5: As conventional tab: 500 mg/125 mg tid, or 875 mg/125 mg 2 or 3 times daily. As oral susp: 500 mg/125 mg tid. Treatment duration: Up to 14 days without review; osteomyelitis may require longer periods of treatment. For treatment of community-acquired pneumonia only: each extended-release tab contains amoxicillin 1,000 mg and clavulanic acid 62.5 mg: 2,000 mg/125 mg 12 hourly for 7-10 days. IV Upper respiratory tract infections; Ear, nose and/or throat infections; Lower respiratory tract infections; Acute exacerbations of chronic bronchitis; Community-acquired pneumonia; Genitourinary infections; Cystitis; Pyelonephritis; Skin and soft tissue infections; Infected animal bites; Bone and joint infections; Osteomyelitis; Intra-abdominal infections Each vial contains amoxicillin (mg)/clavulanic acid (mg): 500/100 or 1,000/200: 1,000 mg/200 mg 8 hourly via slow inj over 3-4 minutes or infusion over 30-40 minutes, may be increased to 6 hourly in more serious infections. Treatment duration: Up to 14 days without review; osteomyelitis may require longer periods of treatment. Prophylaxis of surgical infections Each vial contains amoxicillin (mg)/clavulanic acid (mg): 500/100 or 1,000/200: In major surgical procedures involving the head and neck, cardiac, gastrointestinal tract, biliary tract, renal, joint replacement, and pelvic cavity: For procedures <1 hour duration: 1,000 mg/200 mg to 2,000 mg/200 mg given at induction of anaesthesia; For procedures >1 hour duration: 1,000 mg/200 mg to 2,000 mg/200 mg given at induction of anaesthesia, then up to 3 more 1,000 mg/500 mg doses in 24 hours.
Contraindications
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 © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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