国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Colestyramine resin
Bristol-Myers Squibb Pharmaceuticals uc
C10AC; C10AC01
Colestyramine resin
4 gram(s)
Powder for oral suspension
Product subject to prescription which may be renewed (B)
Bile acid sequestrants; colestyramine
Marketed
1979-04-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Questran 4g/sachet, Powder for oral suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 4g of colestyramine resin. Excipient with known effect: each sachet contains 3.79g sucrose (421mg of sucrose per gram of powder). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension. A fine, homogeneous, cream to buff-coloured powder for oral suspension. On reconstitution with 150 ml of water or fruit juice a uniform suspension is formed. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. A basic anion exchange resin to complex bile acids and reduce plasma levels of cholesterol. 2. Reduction of plasma cholesterol in hypercholesterolaemia, particularly in those patients who have been diagnosed as Fredrickson’s Type II (high plasma cholesterol with normal or slightly elevated triglycerides). 3. Relief of pruritus associated with partial biliary obstruction and primary biliary cirrhosis. 4. Relief of diarrhoea associated with ileal reaction, Crohn’s disease, vagotomy and diabetic vagal neuropathy. 5. Management of radiation-induced diarrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly)_: 1. Hypercholesterolaemia The usual total daily dose is 12 to 24g (the contents of 3 to 6 sachets) in single or up to 4 divided doses. The maximum daily intake should not exceed 36g (contents of 9 sachets). 2. Management of diarrhoea The usual daily dose is 12 to 24g (the contents of 3 to 6 sachets) in single or up to 4 divided doses. The maximum daily intake should not exceed 36g (contents of 9 sachets). In all patients presenting with diarrhoea induced by bile acid malabsorption, if a response is not seen within 3 days, then alternative therapy should be initiated. 3. Pruritus The usual daily dose is 4 to 8g (contents of 1 to 2 sachets). Doses of more than 24 g a day of colestyramine resin may interfere with normal fat absorption. _Children 6 - 12 years_: The usual 阅读完整的文件