Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
AMOXICILLIN CLAVULANIC ACID
Pinewood Laboratories Ltd,
250/125 Milligram
Tablets
2002-02-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pinaclav 250mg/125 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg of amoxicillin as amoxicillin trihydrate and 125 mg of clavulanic acid as potassium clavulanate. Excipients: also includes sucrose, 0.054mg per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets. Yellowish-white or light yellow oblong-formed, biconvex tablet with ‘375’ on one side/engraved line on second side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pinaclav is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): o Acute bacterial sinusitis (adequately diagnosed) o Cystitis o Pyelonephritis o Cellylitis o Animal bites o 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 when doses are stated in terms of an individual component. The dose of Pinaclav that is selected to treat an individual infection should take into account: o The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) o The severity and the site of the infection o The age, weight and renal function of the patient as shown below. The use of alternative presentations of Pinaclav (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). IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed Read the complete document