Drugplain

Colestid 5 g/5g

Colestipol Hydrochloride · GRANULE, FOR SUSPENSION · Pharmacia & Upjohn Company LLC

No Recall History
Plain English

Colestid is a granule, for suspension containing colestipol hydrochloride at 5 g/5g, taken oral. Manufactured by Pharmacia & Upjohn Company LLC.

Key Facts

Brand Name
Colestid
Generic Name
Colestipol Hydrochloride
NDC Code (Product)
0009-0260
Manufacturer
Pharmacia & Upjohn Company LLC
Strength
5 g/5g
Dosage Form
GRANULE, FOR SUSPENSION
Route
ORAL
Marketing Status
Application #
NDA017563
Marketing Start
06/01/1977

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND 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. COLESTID Granules and FLAVORED COLESTID Granules are 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, COLESTID and FLAVORED COLESTID have 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. A…

Dosage & Administration

DOSAGE AND ADMINISTRATION One dose (1 packet or 1 level teaspoon) of COLESTID Granules contains 5 grams of colestipol hydrochloride. One dose (1 packet or 1 level scoopful) of FLAVORED COLESTID Granules is approximately 7.5 grams powder which contains 5 grams of colestipol hydrochloride. The recommended daily adult dose is one to six packets or level scoopfuls given once or in divided doses. Treatment should be started with one dose once or twice daily with an increment of one dose/day at one- or two-month intervals. Appropriate use of lipid profiles as per NCEP guidelines including LDL-cholesterol and triglycerides is advised so that optimal, but not excessive doses are used to obtain the desired therapeutic effect on LDL-cholesterol level. If the desired therapeutic effect is not obtained at one to six doses/day with good compliance and acceptable side effects, combined therapy or alternate treatment should be considered. To avoid accidental inhalation or esophageal distress, COLESTID and FLAVORED COLESTID should not be taken in its dry form. COLESTID and FLAVORED COLESTID should always be mixed with water or other fluids before ingesting. Patients should take other drugs at leas…

Warnings

WARNINGS TO AVOID ACCIDENTAL INHALATION OR ESOPHAGEAL DISTRESS, COLESTID GRANULES AND FLAVORED COLESTID GRANULES SHOULD NOT BE TAKEN IN ITS DRY FORM. ALWAYS MIX COLESTID AND FLAVORED COLESTID WITH WATER OR OTHER FLUIDS BEFORE INGESTING. PHENYLKETONURICS: FLAVORED COLESTID CONTAINS 18.2 MG PHENYLALANINE PER 7.5-GRAM DOSE.

Contraindications

CONTRAINDICATIONS COLESTID Granules and FLAVORED COLESTID Granules are contraindicated in those individuals who have shown hypersensitivity to any of its 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, COLESTID and FLAVORED COLESTID resin may delay or reduce the absorption of concomitant oral medication. The interval between the administration of COLESTID and FLAVORED COLESTID and any other medication should be as long as possible. Patients should take other drugs at least one hour before or four hours after COLESTID and FLAVORED COLESTID 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 effect 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 30 minutes. Effects on the absorption of other beta-block…

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-cholesterol lowering effect, a gradual increase of dosage starting with one dose/day 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. Transient and modest elevations of aspartate aminotrans…

Frequently Asked Questions

What is Colestid used for?

Colestid contains Colestipol Hydrochloride. It is a granule, for suspension taken oral. Consult your doctor for specific uses.

Is Colestid a controlled substance?

Colestid is not classified as a controlled substance by the DEA.

What is the generic name for Colestid?

The generic name for Colestid is Colestipol Hydrochloride. There are 10 other brand versions of Colestipol Hydrochloride.

What is the NDC code for Colestid 5 g/5g?

The NDC (National Drug Code) for Colestid 5 g/5g is 0009-0260, listed by Pharmacia & Upjohn Company LLC.

Product NDC

0009-0260

Package NDC

0009-0260-02

Other Colestid Dosages

Other Colestipol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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