Colesevelam hydrochloride 625 MG Oral Tablet
1 INDICATIONS AND USAGE Colesevelam hydrochloride tablets are 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.
glenmark pharmaceuticals inc., usa
OVAL WHITE G 433
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16 HOW SUPPLIED/STORAGE AND HANDLING
COLESEVELAM HYDROCHLORIDE tablets 625 mg are supplied as off-white to pale yellow, capsule shaped, biconvex film-coated tablets imprinted with ‘G433’ on one side and plain on the other side.
COLESEVELAM HYDROCHLORIDE tablets are available as follows: • Bottles of 90 with child-resistant closures, NDC 68462-433-90 • Bottles of 180 with child-resistant closures, NDC 68462-433-18 Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and store in a dry place. Keep tablets in original/pharmacy container.
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