Colesevelam Hydrochloride (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Colesevelam hydrochloride for oral suspension is a white to yellow granular powder containing yellow granules.

NDC: 63629-8860-1: 1 For Suspension Powders in a PACKET

3.75 gram single-dose packet
Cartons of 30 packets – NDC 63629-8860-01

Store at 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture.

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)].
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)]
For Oral Suspension
Instruct patients to empty the entire contents of one packet into a glass or cup and add 1 cup (8 ounces) of water, fruit juice, or diet soft drinks. Stir well and drink. Advise patients to take colesevelam hydrochloride oral suspension with meals. Advise patient to not take colesevelam hydrochloride oral suspension in its dry form.
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)].

cole-logo

Manufactured by: Alkem Laboratories Ltd.,
INDIA.
Distributed by:
Ascend Laboratories, LLC
Parsippany, NJ 07054
Revised: November, 2021 PT 2768-03

Colesevelam Hcl 3.75 g for Oral Susp #30

Label
(click image for full-size original)
COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-8860(NDC:67877-523)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLESEVELAM HYDROCHLORIDE (COLESEVELAM) COLESEVELAM HYDROCHLORIDE 3.75 g
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
MEDIUM-CHAIN TRIGLYCERIDES
SILICON DIOXIDE
MAGNESIUM TRISILICATE
CITRIC ACID MONOHYDRATE
ASPARTAME
DIMETHICONE
LEMON
ORANGE
PROPYLENE GLYCOL ALGINATE
Product Characteristics
Color YELLOW (White to Yellow Granular Powder) Score
Shape Size
Flavor CITRUS (Lemon-Orange Flavor) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-8860-1 30 POWDER, FOR SUSPENSION in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210316 05/09/2019
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-8860), RELABEL (63629-8860)

Revised: 09/2022 Bryant Ranch Prepack

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