Colesevelam hydrochloride

618.24888

616.43800

1806241-263-5

C28937

C10AC04|C - Cardiovascular system

62.61000

5.97450

There is little evidence that colesevelam causes significant liver injury. Mild elevations in serum aminotransferase and alkaline phosphatase levels have been reported in small numbers of patients on bile acid resins, but the elevations have been mild, transient and without accompanying symptoms. Colesevelam is used in patients with liver disease to treat pruritus, and has little or no effect on serum enzyme or bilirubin levels.

Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA)-reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density-lipoprotein-cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1).

Colesevelam is a nonabsorbed bile acid sequestrant that is used a therapy of hyperlipidemia and for the pruritus of chronic liver disease and biliary obstruction. Colesevelam has not been associated with clinically apparent liver injury.

Antilipemic Agents

Substances used to lower plasma cholesterol levels. (See all compounds classified as Anticholesteremic Agents.)

31104, GT

Human drugs -> Cholestagel -> EMA Drug Category|Lipid modifying agents -> Human pharmacotherapeutic group|Human Drugs -> FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) -> Active Ingredients