COLESTIPOL HYDROCHLORIDE suspension

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Amneal Pharmaceuticals of New York LLC

INN（国际名称）:

COLESTIPOL HYDROCHLORIDE

组成:

COLESTIPOL HYDROCHLORIDE 5 g

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 for oral suspension is indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein (LDL) cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins [LDL] cholesterol) who do not respond adequately to diet. Generally, colestipol hydrochloride for oral suspension has no clinically significant effect on serum triglycerides, but with its 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 considered in patients with severe elevations of LDL-C or with definite CHD. According to the NCEP guidelines, the goal of treatment is to lower LDL-C, and LDL-C is to be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy. The NCEP treatment guidelines are shown below. LDL-Cholesterol mg/dL (mmol/L) Definite Atherosclerotic Disease* Two or More Other Risk Factors** Initiation Level Goal No No ≥ 190 (≥ 4.9) < 160 (< 4.1) No Yes ≥ 160 (≥ 4.1) < 130 (< 3.4) Yes Yes or No ≥ 130 (≥ 3.4) ≤ 100 (≤ 2.6) * Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). ** Other risk factors for coronary heart disease (CHD) include: age (males: ≥ 45 years; females: ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C < 35 mg/dL (0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is ≥ 60 mg/dL (1.6 mmol/L). Colestipol hydrochloride for oral suspension is contraindicated in those individuals who have shown hypersensitivity to any of its components.

產品總結:

Colestipol hydrochloride for oral suspension, USP is available as follows: Carton of 30 foil packets:                                            NDC 0115-5212-18 Carton of 90 foil packets:                                            NDC 0115-5212-29 Bottle of 500 grams with scoop:                                  NDC 0115-5213-02 Each packet or level scoop supplies 5 grams of colestipol hydrochloride, USP for oral suspension. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

授权状态:

Abbreviated New Drug Application

产品特点

COLESTIPOL HYDROCHLORIDE- COLESTIPOL HYDROCHLORIDE SUSPENSION
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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COLESTIPOL HYDROCHLORIDE FOR ORAL SUSPENSION, USP
(5 GRAMS/PACKET AND 5 GRAMS/SCOOPFUL)
RX ONLY
DESCRIPTION
Colestipol hydrochloride for oral suspension, USP contains colestipol
hydrochloride USP,
which is a lipid lowering agent for oral use. Colestipol hydrochloride
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.
Colestipol hydrochloride for oral suspension, USP is tasteless and
odorless. The inactive
ingredient is silicon dioxide. One dose (1 packet or 1 level scoopful)
of colestipol
hydrochloride for oral suspension, USP contains 5 grams of colestipol
hydrochloride,
USP.
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 chloride
ion.
Colestipol hydrochloride is hydrophilic, but it is virtually water
insoluble (99.75%) and it is
not hyd