Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Amoxicillin; Clavulanic acid
Imbat Limited
J01CR; J01CR02
Amoxicillin; Clavulanic acid
250/125 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor
Authorised
2008-01-11
Health Products Regulatory Authority 03 July 2019 CRN0095H4 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Augmentin 250 mg/125 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Amoxicillin trihydrate equivalent to 250 mg Amoxicillin with potassium clavulanate equivalent to 125 mg of clavulanic acid. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-Coated Tablets _Product imported from the UK_ White to off-white, oval shaped, film-coated tablets engraved Augmentin on one side and plain on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Augmentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1). • Acute bacterial sinusitis (adequately diagnosed) • Cystitis • Pyelonephritis • Cellulitis • Animal bites • Severe dental abscess with spreading cellulitis Consideration should be given to official guidance on the appropriate use of antibacterial agents 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except where doses are stated in terms of an individual component. The dose of Augmentin that is selected to treat an individual infection should take into account: • The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) • The severity and the site of infection • The age, weight and renal function of the patient as shown below. The use of alternative presentations of Augmentin (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4. and 5.1). For adults and children ≥ 40 kg, this formulation of Augmentin provides a total daily dose of 750 mg amoxicillin/375mg clavulanic acid, when administered as recommended below. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that anot Baca dokumen lengkap