Colesevelam HCL (Page 5 of 5)
16 HOW SUPPLIED/STORAGE AND HANDLING
NDC: 50090-4371-0 90 TABLET, FILM COATED in a BOTTLE
17 PATIENT COUNSELING INFORMATION
Hypertriglyceridemia and Pancreatitis
Inform patients that colesevelam hydrochloride may increase their serum triglycerides which can lead to hypertriglyceridemia and pancreatitis. Instruct patients to discontinue colesevelam hydrochloride and seek prompt medical attention if the symptoms of acute pancreatitis occur (e.g., severe abdominal pain with or without nausea and vomiting) [see Warnings and Precautions (5.1)].
Inform patients that colesevelam hydrochloride may cause bowel obstruction. Instruct patients to promptly discontinue colesevelam hydrochloride and seek medical attention if severe abdominal pain or severe constipation occurs [see Warnings and Precautions (5.2)].
Drug and Vitamin Interactions
Advise patients that colesevelam hydrochloride has drug interactions and colesevelam hydrochloride may decrease the absorption of fat-soluble vitamins A, D, E, and K. Instruct patients to take oral vitamins at least 4 hours prior to colesevelam hydrochloride. Instruct patients to inform their physician about all the drugs and vitamins that they are prescribed or take over the counter [see Warnings and Precautions (5.3) and Drug Interactions (7)].
Hypertriglyceridemia and Cardiovascular Disease
Inform patients that colesevelam hydrochloride may increase serum triglycerides and that the long-term effect of hypertriglyceridemia on the risk of coronary artery disease is uncertain [see Warnings and Precautions (5.1)].
Administration [see Dosage and Administration (2.2, 2.4 )]
Advise patients to take colesevelam hydrochloride tablets with a meal and liquid. Inform patients that colesevelam hydrochloride tablets can be taken as 6 tablets once daily or 3 tablets twice daily.
Females of Reproductive Potential
Advise females of reproductive potential that colesevelam hydrochloride may reduce the effectiveness of oral contraceptives, and to take oral contraceptives at least 4 hours before taking colesevelam hydrochloride [see Drug Interactions (7.1) and Use in Specific Populations (8.3)].
Alkem Laboratories Ltd.,
Ascend Laboratories, LLC
Parsippany, NJ 07054
Revised: November, 2021
Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Brief exposure to 40°C (104°F) does not adversely affect the product. Protect from moisture.
Colesevelam HCLLabel Image
|COLESEVELAM HCL colesevelam hcl tablet, film coated|
|Labeler — A-S Medication Solutions (830016429)|
|A-S Medication Solutions||830016429||RELABEL (50090-4371), REPACK (50090-4371)|
Revised: 02/2023 A-S Medication Solutions
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