Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
POWDER
**DOSAGE** Adults: 12–16 g which is equivalent to one sachet (4 g) three or four times daily. Children: 4–8 g which is equivalent to one sachet (4 g) one or two times daily. Subsequent adjustment should be made according to clinical response or laboratory results and the benefit/risk ratio. It is recommended that RESINCOLESTIRAMINA be given before meals, dissolved in 1/2 glass of milk or fruit juice. In treatment of hypercholesterolaemia and pruritus, it is preferable to administer the total daily dose in two doses, one before breakfast and one before the evening meal.
ORAL
Medical Information
**INDICATIONS** RESINCOLESTIRAMINA is indicated as adjunctive therapy in hypercholesterolaemia and as an adjunct for the relief of intractable diarrhoea and for the relief of pruritus secondary to biliary stasis.
**CONTRAINDICATIONS** It is contraindicated in patients with complete biliary obstruction and in those individuals who have shown hypersensitivity to any of its components.
C10AC01
colestyramine
Manufacturer Information
ZYFAS PHARMA PTE. LTD.
LABORATORIOS RUBIO SA
Active Ingredients
Documents
Package Inserts
1.4.3 Proposed PI Clean 15.01.2021.pdf
Approved: September 10, 2021