Kraj: Irlandia
Język: angielski
Źródło: 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Withdrawn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 Przeczytaj cały dokument