Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
COLISTIN SULFATE
Forest Laboratories UK Ltd
COLISTIN SULFATE
1,500,000 International Unit
Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-11-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Colomycin Tablets 1,500,000 Units 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1,500,000 units of Colistin Sulphate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet Off-white smooth flat tablets with the Pharmax logo embossed on one surface and a quarter breakline on the other. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of gastrointestinal infections caused by sensitive Gram negative organisms. Also for bowel preparation. Colistin sulphate is not absorbed from the gastro-intestinal tract and must not, therefore, be used for systemic infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To be taken orally. Adults and children over 30kg b.w.: The usual dose is 1.5 to 3.0 million units every 8 hours. Children up to 15kg: The usual dose is 0.25 to 0.50 million units every 8 hours. Children 15 - 30 kg: The usual dose is 0.75 - 1.5 million units every 8 hours. A minimum of five days treatment is recommended. Dosage may be increased when clinical or bacteriological response is slow. For bowel preparation, a 24 hour course at the normal dosage above is given. Treatment should preferably finish 12 hours before surgery. 4.3 CONTRAINDICATIONS Contra-indicated in patients with known sensitivity to colistin. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/09/2012_ _CRN 2120995_ _page number: 1_ Colistin should only be administered with great caution in patients with renal dysfunction or decreased urinary output (as in shock) since the consequent retention of drug will inc read_full_document