Colestipol Hydrochloride

Colestipol Hydrochloride

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Questions & Answers

Side Effects & Adverse Reactions

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use.

Micronized 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, micronized 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 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
*
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; female: ≥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).
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)

History

There is currently no drug history available for this drug.

Other Information

The active ingredient in micronized colestipol hydrochloride tablets 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 micronized colestipol hydrochloride tablet contains one gram of micronized colestipol hydrochloride. Micronized colestipol hydrochloride tablets are light yellow in color and are tasteless and odorless. Inactive ingredients: cellulose acetate phthalate, glyceryl triacetate, carnauba wax, hypromellose, magnesium stearate, povidone, silicon dioxide. Micronized colestipol hydrochloride tablets contain no calories.

Colestipol Hydrochloride Manufacturers


  • Physicians Total Care, Inc.
    Colestipol Hydrochloride Tablet [Physicians Total Care, Inc.]
  • Global Pharmaceuticals, Division Of Impax Laboratories Inc.
    Colestipol Hydrochloride Tablet, Film Coated [Global Pharmaceuticals, Division Of Impax Laboratories Inc.]
  • Greenstone Llc
    Colestipol Hydrochloride Tablet [Greenstone Llc]
  • Carilion Materials Management
    Colestipol Hydrochloride Tablet [Carilion Materials Management]

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