colesevelam hydrochloride tablet coated
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.
amneal pharmaceuticals of new york llc
OVAL WHITE L61
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16 HOW SUPPLIED/STORAGE AND HANDLING
COLESEVELAM HYDROCHLORIDE Tablets, 625 mg are supplied as off-white to pale yellow, film-coated oval tablets, debossed with “L61” on one side and plain on the other side.
COLESEVELAM HYDROCHLORIDE tablets are available as follows: Bottles of 180: NDC 0115-1320-19 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.
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