COLESTIPOL HYDROCHLORIDE 5 g/1
COLESTIPOL HYDROCHLORIDE · SUSPENSION · Amneal Pharmaceuticals of New York LLC
COLESTIPOL HYDROCHLORIDE is a suspension containing colestipol hydrochloride at 5 g/1, taken oral. Manufactured by Amneal Pharmaceuticals of New York LLC.
Key Facts
- Brand Name
- COLESTIPOL HYDROCHLORIDE
- Generic Name
- COLESTIPOL HYDROCHLORIDE
- NDC Code (Product)
0115-5212- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- Strength
- 5 g/1
- Dosage Form
- SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077277
- Marketing Start
- 05/02/2006
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS & USAGE 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 …
Dosage & Administration
DOSAGE & ADMINISTRATION For adults, colestipol hydrochloride tablets are recommended in doses of 2 to 16 grams/day given once or in divided doses. The starting dose should be 2 grams once or twice daily. Dosage increases of 2 grams, once or twice daily should occur at 1-or 2-month intervals. Appropriate use of lipid profiles as per NCEP guidelines including LDL-C and triglycerides, is advised so that optimal but not excessive doses are used to obtain the desired therapeutic effect on LDL-C level. If the desired therapeutic effect is not obtained at a dose of 2 to 16 grams/day with good compliance and acceptable side effects, combined therapy or alternate treatment should be considered. Colestipol hydrochloride tablets must be taken one at a time and be promptly swallowed whole, using plenty of water or other appropriate liquid. Do not cut, crush, or chew the tablets. Patients should take other drugs at least one hour before or four hours after colestipol hydrochloride tablets to minimize possible interference with their absorption. (See Drug Interactions.) Before Administration of Colestipol Hydrochloride Tablets Define the type of hyperlipoproteinemia, as described in NCEP guideli…
Contraindications
CONTRAINDICATIONS Colestipol hydrochloride tablets are contraindicated in those individuals who have shown hypersensitivity to any of their components.
Drug Interactions
Drug 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. Patients should take other drugs at least one hour before or four hours after colestipol hydrochloride tablets to avoid impeding their absorption. Repeated doses of colestipol hydrochloride given prior to a single dose of propranolol in human trials have been reported to decrease propranolol absorption. However, in a follow-up study in normal subjects, single-dose administration of colestipol hydrochloride and propranolol and twice-a-day administration for 5 days of both agents did not affect the extent of propranolol absorption, but had a small yet statistically significant effect on its rate of absorption; the time to reach maximum concentration was delayed approximately 30 minutes. Effects on the absorption of ot…
Adverse Reactions
ADVERSE REACTIONS Gastrointestinal The most common adverse reactions are confined to the gastrointestinal tract. To achieve minimal GI disturbance with an optimal LDL-C lowering effect, a gradual increase of dosage starting with 2 grams, once or twice daily is recommended. Constipation is the major single complaint and at times is severe. Most instances of constipation are mild, transient, and controlled with standard treatment. Increased fluid intake and inclusion of additional dietary fiber should be the first step; a stool softener may be added if needed. Some patients require decreased dosage or discontinuation of therapy. Hemorrhoids may be aggravated. Other, less frequent gastrointestinal complaints consist of abdominal discomfort (abdominal pain and cramping), intestinal gas (bloating and flatulence), indigestion and heartburn, diarrhea and loose stools, and nausea and vomiting. Bleeding hemorrhoids and blood in the stool have been infrequently reported. Peptic ulceration, cholecystitis, and cholelithiasis have been rarely reported in patients receiving colestipol hydrochloride granules, and are not necessarily drug related. Difficulty swallowing and transient esophageal obs…
Frequently Asked Questions
What is COLESTIPOL HYDROCHLORIDE used for?
COLESTIPOL HYDROCHLORIDE contains COLESTIPOL HYDROCHLORIDE. It is a suspension taken oral. Consult your doctor for specific uses.
Is COLESTIPOL HYDROCHLORIDE a controlled substance?
COLESTIPOL HYDROCHLORIDE is not classified as a controlled substance by the DEA.
What is the generic name for COLESTIPOL HYDROCHLORIDE?
The generic name for COLESTIPOL HYDROCHLORIDE is COLESTIPOL HYDROCHLORIDE. There are 8 other brand versions of COLESTIPOL HYDROCHLORIDE.
What is the NDC code for COLESTIPOL HYDROCHLORIDE 5 g/1?
The NDC (National Drug Code) for COLESTIPOL HYDROCHLORIDE 5 g/1 is 0115-5212, listed by Amneal Pharmaceuticals of New York LLC.