Colesevelam hydrochloride 625 MG Oral Tablet Welchol
1 INDICATIONS AND USAGE WELCHOL 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 WELCHOL is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. WELCHOL 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. 1.2 Type 2 Diabetes Mellitus WELCHOL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . 1.3 Limitations of Use WELCHOL should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. WELCHOL has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
Daiichi Sankyo Inc.
OVAL WHITE Sankyo C01
Sankyo C01 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING WELCHOL 625 mg tablets are supplied as off-white, solid tablets imprinted with the word "Sankyo" and "C01" on one side and are available as follows: Bottles of 180 – NDC 65597-701-18 WELCHOL 3.75 gram packets for oral suspension contain a white to pale yellow powder containing yellow granules and are available as follows: Cartons of 30 packets – NDC 65597-902-30 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Brief exposure to 40°C (104°F) does not adversely affect WELCHOL tablets.
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