COLESEVELAM HYDROCHLORIDE powder, for suspension

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Glenmark Pharmaceuticals Inc.,USA

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 for oral suspension is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Colesevelam hydrochloride for oral suspension is contraindicated in patients with: Risk Summary Colesevelam hydrochloride is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Limited available data on the use of colesevelam hydrochloride are insufficient to determine a drug

Περίληψη προϊόντος:

Colesevelam hydrochloride for oral suspension contains a citrus flavored off-white to yellow granular powder. Colesevelam hydrochloride for oral suspension is available as follows: NDC 68462-619-60               1 box of 60 single-dose packets    Note to Pharmacists: do not dispense contents separately; dispense as 1 box NDC 68462-620-30 1 box of 30 single-dose packets Note to Pharmacists : do not dispense contents separately; dispense as 1 box Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

COLESEVELAM HYDROCHLORIDE- COLESEVELAM HYDROCHLORIDE POWDER, FOR
SUSPENSION
GLENMARK PHARMACEUTICALS INC.,USA
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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 for oral suspension is a bile acid
sequestrant indicated as an adjunct to diet
and exercise to:
•
•
•
Limitations of Use (1.3):
•
•
DOSAGE AND ADMINISTRATION
•
•
For Oral Suspension
Take one 3.75 grams packet once daily or one 1.875 grams packet twice
daily with a meal. To prepare,
empty the entire contents of one packet into the glass or cup. Add ½
cup to 1 cup of water, fruit juice, or
diet soft drinks. Stir well and drink.
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
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).
Do not use for treatment of type 1 diabetes or for diabetic
ketoacidosis.
Not studied in Fredrickson Type I, III, IV, and V dyslipidemias.
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 or one 1.875 grams packet
twice daily. The recommended
dosage for adults with type 2 diabetes mellitus is 3.75 grams daily or
one 1.875 grams packet twice
daily. Colesevelam hyd