WELCHOL- colesevelam hydrochloride tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Carilion Materials Management

INN (इंटरनेशनल नाम):

COLESEVELAM HYDROCHLORIDE

रचना:

COLESEVELAM HYDROCHLORIDE 625 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 a 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 wit

उत्पाद समीक्षा:

Product: 68151-4362 NDC: 68151-4362-1 1 TABLET, FILM COATED in a PACKAGE

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

WELCHOL- COLESEVELAM HYDROCHLORIDE TABLET, FILM COATED
CARILION MATERIALS MANAGEMENT
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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