COLESTIPOL HYDROCHLORIDE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

COLESTIPOL HYDROCHLORIDE (UNII: X7D10K905G) (COLESTIPOL - UNII:K50N755924)

Dostopno od:

ANI Pharmaceuticals, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. Generally, colestipol hydrochloride tablets have no clinically significant effect on serum triglycerides, but with their use, triglyceride levels may be raised in some patients. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy (see NCEP guidelines). A minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. Shorter periods may be considere

Povzetek izdelek:

Colestipol hydrochloride tablets USP, 1 gram are yellow, film-coated, elliptical tablets, debossed with “S” on one side and plain on the other. They are supplied as follows: Bottles of 120           NDC 62559-395-12 Each tablet contains 1 gram of micronized colestipol hydrochloride USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

COLESTIPOL HYDROCHLORIDE- COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED
ANI PHARMACEUTICALS, INC.
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COLESTIPOL HYDROCHLORIDE TABLETS USP
DESCRIPTION
The active ingredient in colestipol hydrochloride tablets USP is
micronized colestipol
hydrochloride, which is a lipid lowering agent for oral use.
Colestipol is an insoluble, high
molecular weight basic anion-exchange copolymer of diethylenetriamine
and 1-chloro-2,
3-epoxypropane, with approximately 1 out of 5 amine nitrogens
protonated (chloride
form). It is a light yellow water-insoluble resin which is hygroscopic
and swells when
suspended in water or aqueous fluids.
Each colestipol hydrochloride tablet USP contains one gram of
micronized colestipol
hydrochloride. Colestipol hydrochloride tablets are yellow in color
and are tasteless and
odorless. Inactive ingredients: acetone, cellulose acetate phthalate,
ethanol, magnesium
stearate, microcrystalline cellulose, hypromellose, povidone, silicon
dioxide and triacetin.
CLINICAL PHARMACOLOGY
Cholesterol is the major, and probably the sole precursor of bile
acids. During normal
digestion, bile acids are secreted via the bile from the liver and
gall bladder into the
intestines. Bile acids emulsify the fat and lipid materials present in
food, thus facilitating
absorption. A major portion of the bile acids secreted is reabsorbed
from the intestines
and returned via the portal circulation to the liver, thus completing
the enterohepatic
cycle. Only very small amounts of bile acids are found in normal
serum.
Colestipol hydrochloride binds bile acids in the intestine forming a
complex that is
excreted in the feces. This nonsystemic action results in a partial
removal of the bile
acids from the enterohepatic circulation, preventing their
reabsorption. Since colestipol
hydrochloride is an anion exchange resin, the chloride anions of the
resin can be
replaced by other anions, usually those with a greater affinity for
the resin than the
chloride ion.
Colestipol hydrochloride is hydrophilic, but it is virtually water
insol