COLESEVELAM HYDROCHLORIDE (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

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.

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)].

Gastrointestinal

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)].

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)].

Manufactured for:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

Made in Canada

Rev. 08/2020

FDA-06

PRINCIPAL DISPLAY PANEL — 625 mg, 180 Tablets

BIONPHARMA

NDC 69452-158-25

Colesevelam Hydrochloride Tablets

625 mg

Rx only

180 Tablets

625 mg, 180 Tablets
(click image for full-size original)
COLESEVELAM HYDROCHLORIDE
colesevelam hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-158
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLESEVELAM HYDROCHLORIDE (COLESEVELAM) COLESEVELAM HYDROCHLORIDE 625 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
FERROSOFERRIC OXIDE
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TALC
Product Characteristics
Color white Score no score
Shape OVAL Size 19mm
Flavor Imprint Code COL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-158-25 180 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208670 12/02/2019
Labeler — Bionpharma Inc. (079637826)
Registrant — Bionpharma Inc. (079637826)
Establishment
Name Address ID/FEI Operations
Patheon Whitby, Ontario Canada 205475333 manufacture (69452-158), analysis (69452-158)
Establishment
Name Address ID/FEI Operations
DPx Fine Chemicals Linz Austria 300398976 api manufacture (69452-158)

Revised: 12/2020 Bionpharma Inc.

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