COLESEVELAM HYDROCHLORIDE tablet, coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

AvKARE

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Colesevelam hydrochloride 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). Colesevelam hydrochloride is indicated as monotherapy or in combination with a statin to reduce LDL-C levels in boys and post-menarchal 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 with coronary heart disease (CHD) or CHD risk equivalents such as diabetes mellitus, LDL-C treatment goals are <100 mg/dL. An LDL-C goal of <70 mg/dL is a therapeutic option on the basis of recent trial evidence. If LDL-C is at goal but the serum triglyceride (TG) value is >200 mg/dL, then non-HDL cholesterol (non-HDL-C) (total cholesterol [TC] minus high density lipoprotein cholesterol [HDL-C]) becomes a secondary target of therapy. The goal for non-HDL-C in persons with high serum TG is set at 30 mg/dL higher than that for LDL-C. - Colesevelam hydrochloride should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. - Colesevelam hydrochloride has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor. - Colesevelam hydrochloride has not been studied in pediatric patients with type 2 diabetes. - Colesevelam hydrochloride has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. - Colesevelam hydrochloride has not been studied in children younger than 10 years of age or in pre-menarchal girls. Colesevelam hydrochloride is contraindicated in patients with - A history of bowel obstruction [see Warnings and Precautions (5.4)] - Serum TG concentrations >500 mg/dL [see Warnings and Precautions (5.2)] - A history of hypertriglyceridemia-induced pancreatitis [see Warnings and Precautions (5.2)] Pregnancy Category B. There are no adequate and well-controlled studies of colesevelam use in pregnant women. Animal reproduction studies in rats and rabbits revealed no evidence of fetal harm. Requirements for vitamins and other nutrients are increased in pregnancy. However, the effect of colesevelam on the absorption of fat-soluble vitamins has not been studied in pregnant women. This drug should be used during pregnancy only if clearly needed. In animal reproduction studies, colesevelam revealed no evidence of fetal harm when administered to rats and rabbits at doses 50 and 17 times the maximum human dose, respectively. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. Colesevelam hydrochloride is not expected to be excreted in human milk because colesevelam hydrochloride is not absorbed systemically from the gastrointestinal tract. The safety and effectiveness of colesevelam hydrochloride as monotherapy or in combination with a statin were evaluated in children, 10 to 17 years of age with heFH [see Clinical Studies (14.1)] . The adverse reaction profile was similar to that of patients treated with placebo. In this limited controlled study, there were no significant effects of growth, sexual maturation, fat-soluble vitamin levels or clotting factors in the adolescent boys or girls relative to placebo [see Adverse Reactions (6.1)] . Due to tablet size, colesevelam hydrochloride for oral suspension is recommended for use in the pediatric population. Dose adjustments are not required when colesevelam hydrochloride is administered to children 10 to 17 years of age. Colesevelam hydrochloride has not been studied in children younger than 10 years of age or in pre-menarchal girls. Primary Hyperlipidemia: Of the 1350 patients enrolled in the hyperlipidemia clinical studies, 349 (26%) were ≥65 years old, and 58 (4%) were ≥75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No special considerations or dosage adjustments are recommended when colesevelam hydrochloride is administered to patients with hepatic impairment. To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email [e-mail]; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

leaflet_short:

Colesevelam hydrochloride tablets, 625 mg, are supplied as off-white to pale yellow film-coated oval tablets, debossed with "L61" on one side and plain on the other side. Colesevelam hydrochloride tablets are available as follows: Storage: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

authorization_status:

Abbreviated New Drug Application

SPC

COLESEVELAM HYDROCHLORIDE- COLESEVELAM HYDROCHLORIDE TABLET, COATED
AVKARE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
COLESEVELAM HYDROCHLORIDE TABLETS
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COLESEVELAM
HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR COLESEVELAM
HYDROCHLORIDE.
COLESEVELAM HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Colesevelam hydrochloride 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 post-menarchal 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.
Important Limitations of Use ( 1.3):
Do not use for glycemic control in type 1 diabetes or for treating
diabetic ketoacidosis.
Colesevelam hydrochloride has not been studied in type 2 diabetes in
combination with a dipeptidyl
peptidase 4 inhibitor.
Colesevelam hydrochloride has not been studied in Fredrickson Type I,
III, IV, and V dyslipidemias.
Colesevelam hydrochloride has not been studied in children younger
than 10 years of age or in pre-
menarchal girls.
DOSAGE AND ADMINISTRATION
Colesevelam Hydrochloride Tablets: The recommended dose is 6 tablets
once daily or 3 tablets twice
daily. Colesevelam hydrochloride tablets should be taken with a meal
and liquid ( 2.1).
DOSAGE FORMS AND STRENGTHS
Tablets: 625 mg ( 3)
CONTRAINDICATIONS
Do not use in patients with a history of bowel obstruction ( 4)
Do not use in patients with serum triglyceride (TG) concentrations
>500 mg/dL ( 4)
Do not use in patients with a history of hypertriglyceridemia-induced
pancreatitis ( 4)
WARNINGS AND PRECAUTIONS
The effect of colesevelam hydrochloride on cardiovascular m