WELCHOL- colesevelam hydrochloride tablet, film coated WELCHOL- colesevelam hydrochloride for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

COLESEVELAM HYDROCHLORIDE (UNII: P4SG24WI5Q) (COLESEVELAM - UNII:1XU104G55N)

Available from:

Rebel Distributors Corp

INN (International Name):

COLESEVELAM HYDROCHLORIDE

Composition:

COLESEVELAM HYDROCHLORIDE 625 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

WELCHOL is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin). WELCHOL is indicated as monotherapy or in combination with a statin to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: a. LDL-C remains ≥ 190 mg/dL or b. LDL-C remains ≥ 160 mg/dL and - there is a positive family history of premature cardiovascular disease or - two or more other CVD risk factors are present in the pediatric patient. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate [See Clinical Studies (14.1)] . In patients

Product summary:

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 180 - NDC 21695-781-78 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: Storage : Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

New Drug Application

Summary of Product characteristics

WELCHOL- COLESEVELAM HYDROCHLORIDE TABLET, FILM COATED
WELCHOL- COLESEVELAM HYDROCHLORIDE FOR SUSPENSION
REBEL DISTRIBUTORS CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
WELCHOL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR WELCHOL.
WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED, FOR ORAL
WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION, FOR ORAL
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Indications and Usage (1.1, 1.3) 10/2009
Dosage and Administration (2) 10/2009
Warnings and Precautions (5.6) 10/2009
Adverse Reactions (6.1) 10/2009
Use in Specific Populations (8.4) 10/2009
Clinical Studies (14.1) 10/2009
INDICATIONS AND USAGE
WELCHOL is a bile acid sequestrant indicated as an adjunct to diet and
exercise to
reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults
with primary hyperlipidemia as monotherapy or in
combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA)
reductase inhibitor (statin) (1.1).
reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of
age, with heterozygous familial
hypercholesterolemia as monotherapy or in combination with a statin
after failing an adequate trial of diet therapy
improve glycemic control in adults with type 2 diabetes mellitus
(1.2).
Important Limitations of Use (1.3):
Do not use for glycemic control in type 1 diabetes or for treating
diabetic ketoacidosis.
WELCHOL has not been studied in type 2 diabetes as monotherapy or in
combination with a dipeptidyl peptidase 4
inhibitor and has not been extensively studied in combination with
thiazolidinediones.
WELCHOL has not been studied in Fredrickson Type I, III, IV, and V
dyslipidemias.
WELCHOL has not been studied in children younger than 10 years of age
or in pre-menarchal girls.
DOSAGE AND ADMINISTRATION
WELCHOL Tablets: The recommended dose is 6 tablets once daily or 3
tablets twice daily. WELCHOL Tablets should
be taken with a meal and liquid (2.1, 2.2)
WELCHOL for Oral Suspension: