Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colistin sulfate
Forest Laboratories UK Ltd
A07AA10
Colistin sulfate
1500000unit
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010700
COLOMYCIN TABLETS 1,500,000 UNITS COLISTIN SULPHATE PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you notice and side effects, please tell your doctor. IN THIS LEAFLET: 1. WHAT COLOMYCIN TABLETS ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU TAKE COLOMYCIN TABLETS 3. HOW TO TAKE COLOMYCIN TABLETS 4. SIDE EFFECTS 5. HOW TO STORE COLOMYCIN TABLETS 6. FURTHER INFORMATION 1. WHAT COLOMYCIN TABLETS ARE AND WHAT THEY ARE USED FOR Colomycin is an antibiotic. It belongs to a group of antibiotics called polymyxins. Colomycin kills bacteria that cause infections of the gut. It is also used for bowel preparation before surgical operations as it will kill some bacteria that may cause infections after surgery. 2. BEFORE YOU TAKE COLOMYCIN TABLETS DO NOT TAKE COLOMYCIN TABLETS: If you are allergic to Colomycin (also known as colistin, colistin sulphate or colistimethate sodium) or any of the other ingredients of Colomycin Tablets (see Section 6 for ingredients) If you are allergic to another antibiotic called polymyxin B, If you have myasthenia gravis (a disease causing weakened muscles and excessive tiredness) TAKE SPECIAL CARE AND SPEAK TO YOUR DOCTOR BEFORE USING COLOMYCIN TABLETS: If you have porphyria (a rare, often inherited disorder), If you have kidney problems. USE IN CHILDREN: Colomycin tablets are not suitable for children under 15kg in weight, because a suitable dose cannot be given from a 1,500,000 unit tablet. TAKING OR USING OTHER MEDICINES Contact your doctor before taking this medicine: If you are taking other antibiotics If you are taking the oral contraceptive pill as some antibiotics reduce the effectiveness of this pill If you are likely to require an o Прочетете целия документ
COLOMYCIN TABLETS Summary of Product Characteristics Updated 26-Jan-2012 | Forest Laboratories UK Limited (a subsidiary of Actavis PLC) 1. Name of the medicinal product COLOMYCIN TABLETS 2. Qualitative and quantitative composition Colistin Sulphate BP 1.5MU per tablet. 3. Pharmaceutical form Tablet. 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 gastrointestinal tract and must not, therefore, be used for systemic infections. 4.2 Posology and method of administration To be taken orally. Adults (including the elderly) (over 30kg): 1,500,000 to 3,000,000 units every 8 hours. Children (15-30kg): 750,000 to 1,500,000 units every 8 hours. Children (under 15kg): Colomycin tablets are not suitable for children under 15kg, because an appropriate dose cannot be delivered from a 1,500,000 unit tablet presentation. 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 and those with myasthenia gravis. 4.4 Special warnings and precautions for use Colistin is subject to limited and unpredictable absorption from the GI tract in infants under six months. Studies in older children and in adults have demonstrated no systemic absorption of colistin following oral administration. Nevertheless, caution should be employed in the use of the preparation in patients with renal failure, patients receiving curari-form muscle relaxants and patients with porphyria. 4.5 Interaction with other medicinal products and other forms of interaction Neurotoxicity has been reported in association with the concomitant use of either curariform agents or antibiotics with similar neurotoxic effects. T Прочетете целия документ