COLESEVELAM tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Zydus Pharmaceuticals USA Inc.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Colesevelam hydrochloride tablets are indicated to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification. Colesevelam hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. - 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 Fredrickson Type I, III, IV, and V dyslipidemias. Colesevelam hydrochloride is contraindicated in patients with: - Serum TG concentrations > 500 mg/dL [see Warnings and Precautions (5.1)] - History of hyp

Sommarju tal-prodott:

Colesevelam Hydrochloride Tablets, 625 mg are cream to light yellow colored with or without matte appearance, modified capsule shaped, biconvex, film-coated tablets, imprinted '619' on one side and plain on other side and are supplied as follows: NDC 68382-619-28 in bottle of 180 tablets NDC 68382-619-10 in bottle of 1000 tablets NDC 68382-619-77 in carton of 100 tablets (10 x 10 unit-dose) Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Brief exposure to 40°C (104°F) does not adversely affect colesevelam hydrochloride tablets.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

COLESEVELAM- COLESEVELAM TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COLESEVELAM
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
COLESEVELAM HYDROCHLORIDE TABLETS.
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 (1.1).
reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of
age, with heterozygous familial
hypercholesterolemia (HeFH), unable to reach LDL-C target levels
despite an adequate trial of diet and
lifestyle modification (1.1).
improve glycemic control in adults with type 2 diabetes mellitus
(1.2).
LIMITATIONS OF USE (1.3)
Do not use for treatment of type 1 diabetes or for diabetic
ketoacidosis.
Not studied in Fredrickson Type I, III, IV, and V.
DOSAGE AND ADMINISTRATION
Obtain lipid parameters, including serum triglyceride (TG) levels
before starting colesevelam
hydrochloride (2.1)
The recommended dosage for adults and for boys and postmenarchal girls
aged 10 to 17 years with
primary hyperlipidemia is 3.75 grams daily. The recommended dosage for
adults with type 2 diabetes
mellitus is 3.75 grams daily. Colesevelam hydrochloride should be
taken as follows (2.2, 2.4):
TABLETS
Take 6 tablets once daily or 3 tablets twice daily with a meal and
liquid.
DOSAGE FORMS AND STRENGTHS
Tablets: 625 mg (3)
CONTRAINDICATIONS
Patients with serum triglyceride levels >500 mg/dL (4).
Patients with a history of hypertriglyceridemia-induced pancreatitis
(4).
Patients with a history of bowel obstruction (4).
WARNINGS AND PRECAUTIONS
_HYPERTRIGLYCERIDEMIA AND PANCREATITIS_ : Colesevelam hydrochloride
can increase TG.
Hypertriglyceridemia can cause acute pancreatitis. Monitor lipids,
including TG. Instruct patien