COLESEVELAM HYDROCHLORIDE powder, for suspension

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Ascend Laboratories, LLC

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Colesevelam hydrochloride for oral suspension is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Colesevelam hydrochloride for oral suspension is 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 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 greater than 500 mg/dL [see Warnings and Precautions (5.1)] - History of hypertriglyceridemia-induced pancreatitis [see Warnings and Precautions (5.1)] - A history of bowel obstruction [see Warnin

Sommarju tal-prodott:

Colesevelam hydrochloride for oral suspension is a white to yellow granular powder containing yellow granules. Colesevelam hydrochloride for oral suspension is available as follows: Cartons of 30 packets – NDC 67877-523-30   Store at 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

COLESEVELAM HYDROCHLORIDE - COLESEVELAM HYDROCHLORIDE POWDER, FOR
SUSPENSION
ASCEND LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COLESEVELAM
HYDROCHLORIDE FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR COLESEVELAM HYDROCHLORIDE FOR ORAL SUSPENSION.
COLESEVELAM HYDROCHLORIDE FOR ORAL SUSPENSION
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).
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 dyslipidemias
DOSAGE AND ADMINISTRATION
• Obtain lipid parameters, including serum triglyceride (TG) levels,
before starting colesevelam
hydrochloride for oral suspension (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. Colesevelam hydrochloride
for oral suspension should be taken
as follows (2.2, 2.4):
For Oral Suspension
Take one packet once daily with a meal. To prepare, empty the entire
contents of one packet into a glass
or cup. Add 1 cup of water, fruit juice, or diet soft drinks. Stir
well and drink.
DOSAGE FORMS AND STRENGTHS
For Oral Suspension: 3.75 gram packet (3)
CONTRAINDICATIONS
Patients with serum triglyceride levels greater than 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