White AR et al. Augmentin™ (amoxicillin/clavulanate) in the treatment of community-acquired respiratory tract infection: a review of the continuing development of an innovative antimicrobial agent; Journal of Antimicrobial Chemotherapy 2004; 53: S1 i3-i20
Abridged Prescribing Information:Please refer to full Summary of Product Characteristics before prescribing.Trade name: Augmentin 500 mg/125 mg film coated tablets; Augmentin 875 mg/125 mg film-coated tablets; Augmentin SR 1000 mg/62.5 mg prolonged-release tablets. Active Ingredient: Amoxicillin trihydrate. Augmentin 500 mg/125 mg: Each tablet contains 500 mg amoxicillin and 125 mg clavulanic acid; Augmentin 875 mg/125 mg: Each tablet contains 875 mg amoxicillin and 125 mg clavulanic acid; Augmentin SR 1000 mg/62.5 mg prolonged-release tablets: Each tablet contains 1000 mg amoxicillin and 62.5 mg clavulanic acid. Pharmaceutical form: Augmentin 500 mg/125 mg & 875/125 mg: Film coated tablets; Augmentin SR 1000 mg/62.5 mg: Prolonged release tablets. Indications: Augmentin 500 mg/125 mg & 875/125 mg: Acute bacterial sinusitis, acute otitis media, acute exacerbations of chronic bronchitis, community acquired pneumonia, cystitis, pyelonephritis, skin and soft tissue infections, animal bites, severe dental abscess with spreading cellulitis, bone and joint infections; Augmentin SR 1000/ 62.5 mg tablets: are indicated for the treatment of community acquired pneumonia in adults and adolescents aged at least 16 years, caused or thought likely to be caused by penicillin-resistant Streptococcus pneumoniae. Posology and Method of Administration: Oral use. Augmentin 500 mg/125 mg:Adults and children ≥40 kg: One tablet three times a day. Children <25 kg: Children must not be treated with Augmentin tablets. Augmentin 875 mg/125 mg:Adults and children ≥40 kg: standard dose (for all indications) 875 mg/125 mg two times a day; higher dose (particularly for infections such as otitis media, sinusitis, lower respiratory tract infections and urinary tract infections): 875 mg/125 mg three times a day.Children <40 kg: Children may be treated with Augmentin tablets, suspensions or paediatric sachets. Augmentin SR 1000/62.5 mg:Adults and adolescents ≥16yrs: Recommended dose of two tablets twice daily for seven to ten days. Caution in patients with hepatic impairment and monitor hepatic function at regular intervals. In patients with renal impairment dose adjustments are based on the maximum recommended level of amoxicillin. To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption is optimised when taken at the start of a meal. Refer to SPCs for further administration and dosage guidance.Children <16yrs: Not indicated. For all strength/formulations, treatment should not be extended beyond 14 days without review. Contraindications: Hypersensitivity to the active substances, to any penicillins or to any of the excipients; patients with history of hypersensitivity to beta-lactam antbiotics; history of amoxicillin/clavulanic acid associated jaundice/hepatic impairment. Special Warnings and Precautions: Before initiating therapy careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta lactams. Serious and occasionally fatal hypersensitivity reactions have been reported. Where an infection is proven.to be due to an amoxicillin
susceptible organism, a switch to an amoxicillin-only preparation should be considered. Refer to SPCs for full list. Interactions with other medicaments: Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.Concomitant use of probenecid is not recommended If co-administration with oral anticoagulants is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin. Moreover, adjustments in the dose of oral anticoagulants may be necessary. Clinical monitoring should be performed during the combination with mycophenolate mofetil and shortly after antibiotic treatment. Fertility, Pregnancy and Lactation: Use should be avoided in pregnancy unless considered essential by the physician. Amoxicillin/clavulanic acid should only be used during breast-feeding after benefit/risk assessment by the physician. Effect on Ability to Drive or Use Machines: No studies, however undesirable effects such as dizziness may occur. Side Effects: Very common (≥1/10): diarrhoea; Common (≥1/100 to <1/10): mucocutaneous candidosis, nausea, vomiting. Refer to SPCs for full list of undesirable effects. Overdose: Gastrointestinal symptoms may be treated symptomatically. Amoxicillin/clavulanic acid can be removed from the circulation by haemodialysis. Local Presentations: Augmentin 500 mg/125 mg: 21 tablet packs; Augmentin 875 mg/125 mg: 14 tablet packs; Augmentin SR 1000/62.5 mg: 28 tablet packs. Marketing Authorisation Holders: Augmentin 500 mg/125 mg & 875 mg/125 mg: GlaxoSmithKline (Ireland) Ltd; Augmentin SR 1000/62.5 mg: GlaxoSmithKline Bulgaria EOOD. MA Numbers: Augmentin 500 mg/ 125 mg: MA 192/01503; Augmentin 875 mg/125 mg: MA 192/01502; Augmentin SR 1000/62.5 mg: AA 1051/00102. Legal category: POM. Date of revision of text: December 2015. In order to ensure that this product information reflects the most up-to-date clinical and post-marketing surveillance data, please always refer to the latest Summary of Product Characteristics (SPC) which is available from GlaxoSmithKline (Malta) Ltd (Tel: +356 21238131)
REPORTING ADVERSE EVENTS (AEs): Malta: If you become aware of any AEs, medication errors and/or use during pregnancy in association with GSK products, please report the event promptly to: GSK (Malta) Limited, 1, De la Cruz Avenue, Qormi QRM 2458, Malta ( Tel: +356 21238131)
Alternatively, any suspected AEs and medication errors can also be reported via the national Adverse Drug Reactions (ADRs) reporting system: Report forms can be downloaded from www.medicinesauthority.gov.mt/adrportal and posted to the Malta Medicines Authority, Post-licensing Directorate, 203, Level 3, Rue D’Argens, Gżira GŻR 1368, MALTA, or sent by email to postlicensing.medicinesauthority@gov.mt
Job No: MLT_GIB/CAM/0009/15 Date of Preparation: December 2015
