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1981. Augmentin® – The first clavulanate-potentiated
amoxicillin was launched for oral use2

 

LEADERS WALK IN FRONT
1. “The Wright Brothers – First Flight, 1903”, EyeWitness to History, www.eyewitnesstohistory.com (2003) accessed on 28 May 2014. 2. 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.
Mini Abridged Prescribing Information: Please refer to full Summary of Product Characteristics (SPC) before prescribing.
Trade Names: Augmentin ES 600 mg/42.9 mg/5 ml powder for oral suspension; Augmentin-Duo 400 mg/57 mg/ 5 ml Powder for Oral Suspension. Active Ingredients: Amoxicillin (as trihydrate) and potassium clavulanate. Pharmaceutical Form: Powder for oral suspension. Augmentin ES: Each 1 ml of oral suspension contains amoxicillin trihydrate equivalent to 120 mg amoxicillin and potassium clavulanate equivalent to 8.58 mg of clavulanic acid; Augmentin-Duo: Each 1 ml of reconstituted product contains amoxicillin trihydrate equivalent to 80 mg amoxicillin and potassium clavulanate equivalent to 11.4 mg of clavulanic acid. Indications: Augmentin ES/Augmentin Duo: For the treatment of acute otitis media and community acquired pneumonia infections caused or thought likely to be caused by penicillin-resistant Streptococcus pneumoniae. Refer to SPCs for more details and a comprehensive list of sensitive organisms. Posology and Method of Administration: Oral use. Augmentin ES: Children ≥ 40 kg: No experience with Augmentin suspension in adults and children ≥ 40 kg, and therefore no dose recommendation can be given. Children < 40 kg (aged ≥ 3 months): Recommended dose of is 90/6.4 mg/kg/day in two divided doses. There are no clinical data on Augmentin in children under 3 months of age. Augmentin-Duo: Children ≥ 40 kg should be treated with the adult formulations of Augmentin. Children < 40 kg: Recommended doses: 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day given as two divided doses; up to 70 mg/10 mg/kg/ day given as two divided doses may be considered for some infections (such as otitis media, sinusitis and lower respiratory tract infections). There are no clinical data regarding doses higher than 45 mg/6.4 mg per kg per day in children under 2 years. There are no clinical data for patients under 2 months of age. 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. For both products, to minimise potential gastrointestinal intolerance, administer at the start of a meal; absorption is optimised when taken at the start of a meal. Refer to SPCs for further administration and dosage guidance. For both products, treatment should not be extended beyond 14 days without review. Contraindications: Hypersensitivity (and past history of) to the active substances, to any penicillins or to any of the excipients; to beta-lactam agents (e.g. a cephalosporin, carbapenem or monobactam); jaundice/hepatic impairment due to amoxicillin/clavulanic acid. Special Warnings and Precautions: Before initiating therapy careful enquiry of previous hypersensitivity reactions to beta-lactams. Where an infection is proven to be due to an amoxicillin susceptible organism, a switch to an amoxicillin-only preparation should be considered. Convulsions may occur in patients receiving high doses or who have impaired renal function. Concomitant use of allopurinol increase likelihood of allergic skin reactions. Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
 
 
Augmentin ES/Augmentin Duo: Contains aspartame (E951), a source of phenylalanine.The suspension also contains maltodextrin (glucose). 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 unless considered essential by the physician. Effect on Ability to Drive or Use Machines: No studies, however, undesirable effects may occur such as dizziness. Side Effects: Very common (≥1/10): diarrhoea.
Common (≥ 1/100, < 1/10): mucocutaneous candidosis, nausea, abdominal pain, & vomiting. Refer to SPC’s for full list of undesirable effects. Overdose: Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance. Amoxicillin/clavulanic acid can be removed from the circulation by haemodialysis. Local Presentations: Augmentin ES: Supplied in 100 ml glass bottle with a dosing spoon. Augmentin Duo: Supplied in 35 ml & 70 ml bottles. Marketing Authorisation Holders: Augmentin ES: GlaxoSmithKline Bulgaria EOOD; Augmentin Duo: SmithKline Beecham Ltd trading as: GlaxoSmithKline UK. MA Numbers: Augmentin ES: AA 1051/00101; Augmentin Duo: MA 172/00101. Legal category: POM. Date of preparation: 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 & Gibraltar: 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)
Malta: 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
Gibraltar: alternatively, any suspected AEs and medication errors can also be reported via the UK regulatory authority (MHRA): https://yellowcard.mhra.gov.uk/
Date of Preparation: December 2015
Job No: MLT_GIB/CAM/0012/15
 
 
For more information visit our website – www.hcp.gsk.com.mt