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Colesevelam hydrochloride 625 MG Oral Tablet

1 INDICATIONS AND USAGE Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to : reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1) reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1) . improve glycemic control in adults with type 2 diabetes mellitus ( 1.2 ). Limitations of Use (1.3) : Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. Not studied in Fredrickson Type I, III, IV, and V dyslipidemias. 1.1 Primary Hyperlipidemia Colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia). Colesevelam hydrochloride tablets are indicated to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification. 1.2 Type 2 Diabetes Mellitus Colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 1.3 Limitations of Use Colesevelam hydrochloride tablets should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. Colesevelam hydrochloride tablets have not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.

dr.reddys laboratories inc


2 years ago OVAL YELLOW Y625 Colesevelam hydrochloride 625 MG Oral Tablet

OVAL YELLOW Y625

16 HOW SUPPLIED/STORAGE AND HANDLING

COLESEVELAM HYDROCHLORIDE tablets 625 mg, are supplied as an yellowish oval shaped tablets imprinted with 625 on one side and plain on the other side.

COLESEVELAM HYDROCHLORIDE tablets are available as follows: Bottles of 180 NDC 43598-230-18 Store at 20°C to 25°C (68°F to 77°F); [See USP Controlled Room Temperature]. Brief exposure to 40°C (104°F) does not adversely affect the

COLESEVELAM HYDROCHLORIDE tablets. Protect from moisture.

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