Colestipol Suspension
Name: Colestipol Suspension
Colestipol Suspension Description
Colestipol hydrochloride for oral suspension, USP contains colestipol hydrochloride, 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.
Indications and Usage for Colestipol Suspension
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, USP 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, USP 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 Atheroschlerotic 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; 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). | |||
| 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) |
Contraindications
Colestipol hydrochloride for oral suspension is contraindicated in those individuals who have shown hypersensitivity to any of its components.
How is Colestipol Suspension Supplied
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 for oral suspension, USP.
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
PRINCIPAL DISPLAY PANEL - 30 Packet Carton
Impax Generics
NDC 0115-5212-18
Colestipol HCl for Oral
Suspension, USP
5 grams per packet
Rx only
Must be mixed with a liquid.
30 Single Dose Packets (5 grams per packet)
PRINCIPAL DISPLAY PANEL - 500 gram Bottle
Impax Generics
NDC 0115-5213-02
Colestipol HCl for Oral
Suspension, USP
5 grams per scoopful
Rx only
Must be mixed with a liquid.
Net quantity 500 grams granules (17.6 oz)
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| Labeler - Impax Generics (079832487) |