Welchol (Page 8 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

WELCHOL (colesevelam hydrochloride) Tablets, 625 mg, are supplied as an off-white, solid tablet imprinted with the word “Sankyo” and “C01” on one side. WELCHOL tablets are available as follows:

Bottles of 30 NDC 54868-4474-1
Bottles of 60 NDC 54868-4474-2
Bottles of 90 NDC 54868-4474-3
Bottles of 180 NDC 54868-4474-0

Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Brief exposure to 40°C (104°F) does not adversely affect the product. Protect from moisture.

WELCHOL (colesevelam hydrochloride) for Oral Suspension is a white to pale yellow powder containing yellow granules. WELCHOL for Oral Suspension is available as follows:

  • 3.75 gram single-dose packet
    Cartons of 30 packets – NDC 54868-6136-0

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

17 PATIENT COUNSELING INFORMATION

Dosing: Patients should be advised to take WELCHOL Tablets with a meal and liquid. WELCHOL can be taken as 6 tablets once daily or 3 tablets twice daily. Patients should be advised to take WELCHOL for Oral Suspension as one 3.75 gram packet once daily or one 1.875 gram packet twice daily. To prepare, empty the entire contents of one packet into a glass or cup. Add ½ to 1 cup (4 to 8 ounces) of water, fruit juice, or diet soft drinks. Stir well and drink. WELCHOL for Oral Suspension should be taken with meals. To avoid esophageal distress, WELCHOL for Oral Suspension should not be taken in its dry form. Always mix WELCHOL for Oral Suspension with water, fruit juice, or diet soft drinks before ingesting [See Dosage and Administration (2)]

Drug interactions: Drugs with a known interaction with colesevelam (e.g., cyclosporine, glyburide, levothyroxine, oral contraceptives) should be administered at least 4 hours prior to WELCHOL. Drugs that have not been tested for interaction with colesevelam, especially those with a narrow therapeutic index (e.g., phenytoin), should also be administered at least 4 hours prior to WELCHOL. Alternatively the physician should monitor blood levels of the coadministered drug. [See Drug Interactions (7)]

Gastrointestinal: WELCHOL can cause constipation. WELCHOL is contraindicated in patients with a history of bowel obstruction. WELCHOL is not recommended in patients who may be at risk of bowel obstruction, including patients with gastroparesis, other gastrointestinal motility disorders, or a history of major gastrointestinal surgery. Patients should be instructed to consume a diet that promotes bowel regularity. Patients should be instructed to promptly discontinue WELCHOL and seek medical attention if severe abdominal pain or severe constipation occurs. Because of the tablet size, WELCHOL Tablets can cause dysphagia or esophageal obstruction and should be used with caution in patients with dysphagia or swallowing disorders. To avoid esophageal distress, WELCHOL for Oral Suspension should not be taken in its dry form. Always mix WELCHOL for Oral Suspension with water, fruit juice, or diet soft drinks before ingesting [See Warnings and Precautions (5.4)]

Hypertriglyceridemia and pancreatitis: Patients should be instructed to discontinue WELCHOL and seek prompt medical attention if the hallmark symptoms of acute pancreatitis occur (e.g., severe abdominal pain with or without nausea and vomiting). [See Warnings and Precautions (5.2)]

17.1 Primary Hyperlipidemia:

Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet.

17.2 Type 2 Diabetes Mellitus:

General: Patients should be advised that it is important to adhere to dietary instructions, a regular exercise program, and regular testing of blood glucose.

Hypertriglyceridemia and cardiovascular disease: Patients receiving a sulfonylurea or insulin should be informed that WELCHOL may increase serum triglyceride concentrations and that the long-term effect of hypertriglyceridemia on the risk of coronary artery disease is uncertain. [See Warnings and Precautions (5.2)]

Marketed by: Daiichi Sankyo, Inc
Parsippany, New Jersey 07054
Active Ingredient: Product of Austria
P1801115



Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

Package Label — Principal Display Panel – Welchol Tablet

Package Label -- Principal Display Panel – 625 mg  Bottle, Welchol Tablet
(click image for full-size original)

Package Label — Principal Display Panel – Welchol for Suspension

Package Label -- Principal Display Panel – 37.5 g  Suspension
(click image for full-size original)
WELCHOL colesevelam hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4474(NDC:65597-701)
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
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
HYPROMELLOSE 2208 (15000 MPA.S)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code Sankyo;C01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4474-0 180 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-4474-1 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:54868-4474-2 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:54868-4474-3 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021176 04/17/2002
WELCHOL colesevelam hydrochloride for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6136(NDC:65597-902)
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
PROPYLENE GLYCOL ALGINATE
ASPARTAME
CITRIC ACID MONOHYDRATE
MAGNESIUM TRISILICATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6136-0 30 FOR SUSPENSION (PACKET) in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022362 07/22/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 02/2012 Physicians Total Care, Inc.

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