What is the generic name?

COLESEVELAM HCL

What is the Trade Name for COLESEVELAM HCL?

Colesevelam HCL

What are the Indications for COLESEVELAM HCL?

• 1 INDICATIONS & USAGE Colesevelam hydrochloride tablets 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) ( 1.1 ) Limitations of Use ( 1.3 ): ‚Ä¢Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. ‚Ä¢The effect on cardiovascular morbidity and mortality has not been determined. ‚Ä¢Not studied in type 2 diabetes with a dipeptidyl peptidase 4 inhibitor. ‚Ä¢Not studied in Fredrickson Type I, III, IV, and V dyslipidemias. ‚Ä¢Not studied in children less than 10 years of age or in premenarchal girls. 1.1 Primary Hyperlipidemia Colesevelam hydrochloride tablets is 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 is 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. 1.3 Limitations of Use Colesevelam hydrochloride should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. The effect of colesevelam hydrochloride on cardiovascular morbidity and mortality has not been determined. Colesevelam hydrochloride has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor. Colesevelam hydrochloride has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. Colesevelam hydrochloride has not been studied in children younger than 10 years of age or in premenarchal girls

References: https://open.fda.gov/