FDA
Colestipol Hydrochloride
The FDA lists this product in 8 strengths and forms.
Indications
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 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 Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease).
Two or More Other Risk Factors 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). 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)
Contraindications
Colestipol Hydrochloride Tablets are contraindicated in those individuals who have shown hypersensitivity to any of their components.
Interactions
Since colestipol hydrochloride is an anion exchange resin, it may have a strong affinity for anions other than the bile acids. In vitro studies have indicated that colestipol hydrochloride binds a number of drugs. Therefore, Colestipol Hydrochloride Tablets may delay or reduce the absorption of concomitant oral medication. The interval between the administration of Colestipol Hydrochloride Tablets and any other medication should be as long as possible.
At a glance
- Brand name
- Colestipol Hydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Riconpharma LLC
- Status
- Prescription
- FDA approval
- 3 Dec 2024
- Application
- ANDA217462-001



