Colesevelam hydrochloride tablets, 625 mg are supplied as white to off-white, oval-shaped, film-coated tablets, printed with “COL” on one side with black ink and are available as follows:
- Bottles of 180 — NDC 69452-158-25
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Brief exposure to 40°C (104°F) does not adversely affect colesevelam hydrochloride tablets.
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)].
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)].
600 Alexander Road,
Princeton, NJ 08540
Made in Canada
Colesevelam Hydrochloride Tablets
| COLESEVELAM HYDROCHLORIDE |
colesevelam hydrochloride tablet, film coated
|Labeler — Bionpharma Inc. (079637826)|
|Registrant — Bionpharma Inc. (079637826)|
|Patheon Whitby, Ontario Canada||205475333||manufacture (69452-158), analysis (69452-158)|
|DPx Fine Chemicals Linz Austria||300398976||api manufacture (69452-158)|
Revised: 12/2020 Bionpharma Inc.
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