WELCHOL colesevelam hydrochloride tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Avera McKennan Hospital

INN (International Name):

COLESEVELAM HYDROCHLORIDE

Composition:

COLESEVELAM HYDROCHLORIDE 625 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

WELCHOL- COLESEVELAM HYDROCHLORIDE TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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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)
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 5/2013
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 a 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 in combination with a
dipeptidyl peptidase 4 inhibitor.
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: The recommended dose is 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 (2.1,