Colestipol (Colestid)
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Colestipol (Colestid)

Colestid®
(micronized colestipol hydrochloride) Tablets

DRUG DESCRIPTION

The active ingredient in COLESTID 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 COLESTID Tablet contains one gram of micronized colestipol hydrochloride. COLESTID (colestipol) 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. COLESTID (colestipol) Tablets contain no calories.

What are the possible side effects of colestipol (Colestid, Colestid Flavored)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • trouble swallowing;
  • severe constipation or stomach pain;
  • black, bloody, or tarry stools; or
  • easy bruising or bleeding, muscle or joint pain, loss of appetite.

Less serious side effects may include:

  • mild or occasional constipation;
  • gas, indigestion,...

Read All Potential Side Effects and See Pictures of Colestid »

What are the precautions when taking colestipol (Colestid)?

Before taking colestipol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: swallowing problems, constipation, hemorrhoids, kidney disease.

Because this drug can interfere with the absorption of certain nutrients (such as folic acid, fat-soluble vitamins including A, D, E, K), your doctor may direct you to take a multivitamin supplement. Consult your doctor for more information.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription...

Read All Potential Precautions of Colestid »

Last reviewed on RxList: 4/9/2009
This monograph has been modified to include the generic and brand name in many instances.

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.

COLESTID (colestipol) 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, COLESTID (colestipol) 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.

Definite Atherosclerotic Disease* Two or More Other Risk Factors** LDL-Cholesterol
mg/dL (mmol/L)
Initiation
Level
Goal
No No ≥ 190 < 160
( ≥ 4.9) ( < 4.1)
No Yes ≥ 160 < 130
( ≥ 4.1) ( < 3.4)
Yes Yes or No ≥ 130 ≤ 100
( ≥ 3.4) ( ≤ 2.6)
* 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).

DOSAGE AND ADMINISTRATION

For adults, COLESTID (colestipol) 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.

COLESTID (colestipol) 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 COLESTID (colestipol) Tablets to minimize possible interference with their absorption. (See DRUG INTERACTIONS.)

Before Administration of COLESTID (colestipol) Tablets

  1. Define the type of hyperlipoproteinemia, as described in NCEP guidelines.
  2. Institute a trial of diet and weight reduction.
  3. Establish baseline serum total and LDL-C and triglyceride levels.

During Administration of COLESTID (colestipol) Tablets

  1. The patient should be carefully monitored clinically, including serum cholesterol and triglyceride levels. Periodic determinations of serum cholesterol levels as outlined in the NCEP guidelines should be done to confirm a favorable initial and long-term response.
  2. Failure of total or LDL-C to fall within the desired range should lead one to first examine dietary and drug compliance. If these are deemed acceptable, combined therapy or alternate treatment should be considered.
  3. Significant rise in triglyceride level should be considered as indication for dose reduction, drug discontinuation, or combined or alternate therapy.

HOW SUPPLIED

COLESTID (colestipol) Tablets are yellow, elliptical, imprinted U, and are supplied as follows:

Bottles of 120 NDC 0009-0450-03

Bottles of 500 NDC 0009-0450-04

Each tablet contains 1 gram of colestipol hydrochloride.

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Distributed by: Pharmacia & Upjohn Company, Division of Pfizer Inc., NY, NY 10017. Revised June 2006.

Last reviewed on RxList: 4/9/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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 obstruction have been rarely reported in patients taking COLESTID (colestipol) Tablets.

Transient and modest elevations of aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT) and alkaline phosphatase were observed on one or more occasions in various patients treated with colestipol hydrochloride.

The following nongastrointestinal adverse reactions have been reported with generally equal frequency in patients receiving COLESTID Tablets, colestipol granules, or placebo in clinical studies:

Cardiovascular

Chest pain, angina, and tachycardia have been infrequently reported.

Hypersensitivity

Rash has been infrequently reported. Urticaria and dermatitis have been rarely noted in patients receiving colestipol hydrochloride granules.

Musculoskeletal

Musculoskeletal pain, aches and pains in the extremities, joint pain and arthritis, and backache have been reported.

Neurologic

Headache, migraine headache, and sinus headache have been reported. Other infrequently reported complaints include dizziness, light-headedness, and insomnia.

Miscellaneous

Anorexia, fatigue, weakness, shortness of breath, and swelling of the hands or feet, have been infrequently reported.

Read the Colestid (colestipol) Side Effects Center for a complete guide to possible side effects »

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 (colestipol) Tablets may delay or reduce the absorption of concomitant oral medication. The interval between the administration of COLESTID (colestipol) 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 COLESTID (colestipol) 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 other beta-blockers have not been determined. Therefore, patients on propranolol should be observed when COLESTID (colestipol) Tablets are either added or deleted from a therapeutic regimen.

Studies in humans show that the absorption of chlorothiazide as reflected in urinary excretion is markedly decreased even when administered one hour before colestipol hydrochloride. The absorption of tetracycline, furosemide, penicillin G, hydrochlorothiazide, and gemfibrozil was significantly decreased when given simultaneously with colestipol hydrochloride; these drugs were not tested to determine the effect of administration one hour before colestipol hydrochloride.

No depressant effect on blood levels in humans was noted when colestipol hydrochloride was administered with any of the following drugs: aspirin, clindamycin, clofibrate, methyldopa, nicotinic acid (niacin), tolbutamide, phenytoin or warfarin. Particular caution should be observed with digitalis preparations since there are conflicting results for the effect of colestipol hydrochloride on the availability of digoxin and digitoxin. The potential for binding of these drugs if given concomitantly is present. Discontinuing colestipol hydrochloride could pose a hazard to health if a potentially toxic drug that is significantly bound to the resin has been titrated to a maintenance level while the patient was taking colestipol hydrochloride.

Bile acid binding resins may also interfere with the absorption of oral phosphate supplements and hydrocortisone.

Last reviewed on RxList: 4/9/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

No information provided.

PRECAUTIONS

Prior to initiating therapy with COLESTID (colestipol) Tablets, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess total cholesterol, HDL-C, and triglycerides (TG). For individuals with TG less than 400 mg/dL ( < 4.5 mmol/L), LDL-C can be estimated using the following equation:

LDL-C = Total cholesterol – [(Triglycerides/5) + HDL-C]

For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases COLESTID (colestipol) Tablets may not be indicated.

Because it sequesters bile acids, colestipol hydrochloride may interfere with normal fat absorption and, thus, may reduce absorption of folic acid and fat soluble vitamins such as A, D, and K.

Chronic use of colestipol hydrochloride may be associated with an increased bleeding tendency due to hypoprothrombinemia from vitamin K deficiency. This will usually respond promptly to parenteral vitamin K1 and recurrences can be prevented by oral administration of vitamin K1.

Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm a favorable initial and adequate long-term response.

COLESTID (colestipol) Tablets may produce or severely worsen pre-existing constipation. The dosage should be increased gradually in patients to minimize the risk of developing fecal impaction. In patients with pre-existing constipation, the starting dose should be 2 grams once or twice a day. Increased fluid and fiber intake should be encouraged to alleviate constipation and a stool softener may occasionally be indicated. If the initial dose is well tolerated, the dose may be increased as needed by a further 2 to 4 grams/day (at monthly intervals) with periodic monitoring of serum lipoproteins. If constipation worsens or the desired therapeutic response is not achieved at 2 to 16 grams/day, combination therapy or alternate therapy should be considered. Particular effort should be made to avoid constipation in patients with symptomatic coronary artery disease. Constipation associated with COLESTID (colestipol) Tablets may aggravate hemorrhoids.

While there have been no reports of hypothyroidism induced in individuals with normal thyroid function, the theoretical possibility exists, particularly in patients with limited thyroid reserve.

Since colestipol hydrochloride is a chloride form of an anion exchange resin, there is a possibility that prolonged use may lead to the development of hyperchloremia acidosis.

Carcinogenesis, Mutagenesis and Impairment of Fertility

In studies conducted in rats in which cholestyramine resin (a bile acid sequestering agent similar to colestipol hydrochloride) was used as a tool to investigate the role of various intestinal factors, such as fat, bile salts, and microbial flora, in the development of intestinal tumors induced by potent carcinogens, the incidence of such tumors was observed to be greater in cholestyramine resin treated rats than in control rats.

The relevance of this laboratory observation from studies in rats with cholestyramine resin to the clinical use of COLESTID (colestipol) Tablets is not known. In the LRC-CPPT study referred to above, the total incidence of fatal and nonfatal neoplasms was similar in both treatment groups. When the many different categories of tumors are examined, various alimentary system cancers were somewhat more prevalent in the cholestyramine group. The small numbers and the multiple categories prevent conclusions from being drawn. Further follow-up of the LRC-CPPT participants by the sponsors of that study is planned for cause-specific mortality and cancer morbidity. When colestipol hydrochloride was administered in the diet to rats for 18 months, there was no evidence of any drug related intestinal tumor formation. In the Ames assay, colestipol hydrochloride was not mutagenic.

Use in Pregnancy

Since colestipol hydrochloride is essentially not absorbed systemically (less than 0.17% of the dose), it is not expected to cause fetal harm when administered during pregnancy in recommended dosages. There are no adequate and well-controlled studies in pregnant women, and the known interference with absorption of fat-soluble vitamins may be detrimental even in the presence of supplementation.

Nursing Mothers

Caution should be exercised when COLESTID (colestipol) Tablets are administered to a nursing mother. The possible lack of proper vitamin absorption described in the “Pregnancy” section may have an effect on nursing infants.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Last reviewed on RxList: 4/9/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Overdosage of COLESTID (colestipol) Tablets has not been reported. Should overdosage occur, however, the chief potential harm would be obstruction of the gastrointestinal tract. The location of such potential obstruction, the degree of obstruction and the presence or absence of normal gut motility would determine treatment.

CONTRAINDICATIONS

COLESTID (colestipol) Tablets are contraindicated in those individuals who have shown hypersensitivity to any of their components.

Last reviewed on RxList: 4/9/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Cholesterol is the major, and probably the sole precursor of bile acids. During normal digestion, bile acids are secreted via the bile from the liver and gall bladder into the intestines. Bile acids emulsify the fat and lipid materials present in food, thus facilitating absorption. A major portion of the bile acids secreted is reabsorbed from the intestines and returned via the portal circulation to the liver, thus completing the enterohepatic cycle. Only very small amounts of bile acids are found in normal serum.

Colestipol hydrochloride binds bile acids in the intestine forming a complex that is excreted in the feces. This nonsystemic action results in a partial removal of the bile acids from the enterohepatic circulation, preventing their reabsorption. Since colestipol hydrochloride is an anion exchange resin, the chloride anions of the resin can be replaced by other anions, usually those with a greater affinity for the resin than the chloride ion.

Colestipol hydrochloride is hydrophilic, but it is virtually water insoluble (99.75%) and it is not hydrolyzed by digestive enzymes. The high molecular weight polymer in colestipol hydrochloride apparently is not absorbed. In humans, less than 0.17% of a single 14Clabeled colestipol hydrochloride dose is excreted in the urine when given following 60 days of dosing of 20 grams of colestipol hydrochloride per day.

The increased fecal loss of bile acids due to colestipol hydrochloride administration leads to an increased oxidation of cholesterol to bile acids. This results in an increase in the number of low-density lipoprotein (LDL) receptors, increased hepatic uptake of LDL and a decrease in beta lipoprotein or LDL serum levels, and a decrease in serum cholesterol levels. Although colestipol hydrochloride produces an increase in the hepatic synthesis of cholesterol in man, serum cholesterol levels fall.

There is evidence to show that this fall in cholesterol is secondary to an increased rate of clearance of cholesterol-rich lipoproteins (beta or low-density lipoproteins) from the plasma. Serum triglyceride levels may increase or remain unchanged in colestipol hydrochloride treated patients.

The decline in serum cholesterol levels with colestipol hydrochloride treatment is usually evident by one month. When colestipol hydrochloride is discontinued, serum cholesterol levels usually return to baseline levels within one month. Periodic determinations of serum cholesterol levels as outlined in the National Cholesterol Education Program (NCEP) guidelines, should be done to confirm a favorable initial and long-term response.1

In a large, placebo-controlled, multiclinic study, the LRC-CPPT2, hypercholesterolemic subjects treated with cholestyramine, a bile-acid sequestrant with a mechanism of action and an effect on serum cholesterol similar to that of colestipol hydrochloride, had reductions in total and LDL-C. Over the 7-year study period the cholestyramine group experienced a 19% reduction (relative to the incidence in the placebo group) in the combined rate of coronary heart disease (CHD) death plus nonfatal myocardial infarction (cumulative incidences of 7% cholestyramine and 8.6% placebo). The subjects included in the study were middle-aged men (aged 35–59) with serum cholesterol levels above 265 mg/dL, LDL-C above 175 mg/dL on a moderate cholesterol-lowering diet, and no history of heart disease. It is not clear to what extent these findings can be extrapolated to other segments of the hypercholesterolemic population not studied.

Treatment with colestipol results in a significant increase in lipoprotein LpAI. Lipoprotein LpAI is one of the two major lipoprotein particles within the high-density lipoprotein (HDL) density range3, and has been shown in cell culture to promote cholesterol efflux or removal from cells4. Although the significance of this finding has not been established in clinical studies, the elevation of the lipoprotein LpAI particle within the HDL fraction is consistent with an antiatherogenic effect of colestipol hydrochloride, even though little change is observed in HDL cholesterol (HDL-C).

In patients with heterozygous familial hypercholesterolemia who have not obtained an optimal response to colestipol hydrochloride alone in maximal doses, the combination of colestipol hydrochloride and nicotinic acid has been shown to further lower serum cholesterol, triglyceride, and LDL-cholesterol (LDL-C) values. Simultaneously, HDL-C values increased significantly. In many such patients it is possible to normalize serum lipid values.5–7

Preliminary evidence suggests that the cholesterol-lowering effects of lovastatin and the bile acid sequestrant, colestipol hydrochloride, are additive.

The effect of intensive lipid-lowering therapy on coronary atherosclerosis has been assessed by arteriography in hyperlipidemic patients. In these randomized, controlled clinical trials, patients were treated for two to four years by either conventional measures (diet, placebo, or in some cases low-dose resin), or with intensive combination therapy using diet and COLESTID (colestipol) Granules plus either nicotinic acid or lovastatin. When compared to conventional measures, intensive lipid-lowering combination therapy significantly reduced the frequency of progression and increased the frequency of regression of coronary atherosclerotic lesions in patients with or at risk for coronary artery disease.8–11

REFERENCES

1. Summary of the Second Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). JAMA 1993; 269(23):3015–3023.

2. Lipid Metabolism-Atherogenesis Branch, National Heart, Lung, and Blood Institute, Bethesda, MD: The Lipid Research Clinics Coronary Primary Prevention Trial Results. I. Reduction in Incidence of Coronary Heart Disease. JAMA 1984; 251:351–364.

3. Parra HJ, et al. Differential electroimmunoassay of human LpA-I lipoprotein particles on ready-to-use plates. Clin. Chem. 1990; 36(8):1431–1435.

4. Barbaras R, et al. Cholesterol efflux from cultured adipose cells is mediated by LpAI particles but not by LpAI:AII particles. Biochem. Biophys. Res. Comm. 1987; 142(1):63–69.

5. Kane JP, et al. Normalization of low-density-lipoprotein levels in heterozygous familial hypercholesterolemia with a combined drug regimen. N Engl. J. Med. 1981; 304:251–258.

6. Illingworth DR, et al. Colestipol plus nicotinic acid in treatment of heterozygous familial hypercholesterolemia. Lancet 1981; 1:296–298.

7. Kuo PT, et al. Familial type II hyperlipoproteinemia with coronary heart disease: Effect of diet-colestipol-nicotinic acid treatment. Chest 1981; 79:286–291.

8. Blankenhorn DH, et al. Beneficial Effects of Combined Colestipol-Niacin Therapy on Coronary Atherosclerosis and Coronary Venous Bypass Grafts. JAMA 1987; 257(23):3233–3240.

9. Cashin-Hemphill L, et al. Beneficial Effects of Colestipol-Niacin on Coronary Atherosclerosis: A 4-Year Follow-up. JAMA 1990; 264:3013–3017.

10. Brown G. et al. Regression of Coronary Artery Disease as a Result of Intensive Lipid-Lowering Therapy in Men with High Levels of Apolipoprotein B. N. Engl. J. Med. 1990; 323:1289–1298.

11. Kane JP, et al. Regression of Coronary Atherosclerosis During Treatment of Familial Hypercholesterolemia with Combined Drug Regimens. JAMA 1990; 264:3007–3012.

Last reviewed on RxList: 4/9/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

COLESTID (colestipol) Tablets may be larger than pills you have taken before. If you have had swallowing problems or choking with food, liquids or other tablets or capsules in the past, you should discuss this with your doctor before taking COLESTID (colestipol) Tablets.

It is important that you take COLESTID (colestipol) Tablets correctly:

  1. Always take one tablet at a time and swallow promptly.
  2. Swallow each tablet whole. Do not cut, crush, or chew the tablets.
  3. COLESTID (colestipol) Tablets must be taken with water or another liquid that you prefer. Swallowing the tablets will be easier if you drink plenty of liquid as you swallow each tablet.

Difficulty swallowing and temporary obstruction of the esophagus (the tube between your mouth and stomach) have been rarely reported in patients taking COLESTID (colestipol) Tablets. If a tablet does get stuck after you swallow it, you may notice pressure or discomfort. If this happens to you, you should contact your doctor. Do not take COLESTID (colestipol) Tablets again without your doctor's advice.

If you are taking other medications, you should take them at least one hour before or four hours after taking COLESTID (colestipol) Tablets.

Last reviewed on RxList: 4/9/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

COLESTID (colestipol) Tablets may be larger than pills you have taken before. If you have had swallowing problems or choking with food, liquids or other tablets or capsules in the past, you should discuss this with your doctor before taking COLESTID (colestipol) Tablets.

It is important that you take COLESTID (colestipol) Tablets correctly:

  1. Always take one tablet at a time and swallow promptly.
  2. Swallow each tablet whole. Do not cut, crush, or chew the tablets.
  3. COLESTID (colestipol) Tablets must be taken with water or another liquid that you prefer. Swallowing the tablets will be easier if you drink plenty of liquid as you swallow each tablet.

Difficulty swallowing and temporary obstruction of the esophagus (the tube between your mouth and stomach) have been rarely reported in patients taking COLESTID (colestipol) Tablets. If a tablet does get stuck after you swallow it, you may notice pressure or discomfort. If this happens to you, you should contact your doctor. Do not take COLESTID (colestipol) Tablets again without your doctor's advice.

If you are taking other medications, you should take them at least one hour before or four hours after taking COLESTID (colestipol) Tablets.

Last reviewed on RxList: 4/9/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Colestid Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

COLESTIPOL TABLET - ORAL

(koe-LES-ti-pol)

COMMON BRAND NAME(S): Colestid

USES: Colestipol is used along with a proper diet to lower cholesterol in the blood. Lowering cholesterol helps decrease the risk for strokes and heart attacks.

In addition to a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

This medication is known as a bile acid-binding resin. It works by removing bile acid from the body. In people with high cholesterol, this causes the liver to make more bile acid by using cholesterol in the blood. This helps to lower the cholesterol levels.

HOW TO USE: Take this medication by mouth as directed by your doctor, usually 1 to 2 times a day. If your dose is more than 1 tablet, take the tablets one at a time. Do not try to swallow more than one tablet at once. Take each tablet with plenty of liquid (such as water, juice). Swallow each tablet whole. Do not crush, chew, or break the tablets. If you have difficulty swallowing the tablet whole, consult your doctor.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. It may take several weeks before you get the full benefit of this drug.

Colestipol may decrease your absorption of other medications. Take your other medications at least 1 hour before or 4 to 6 hours after colestipol. Ask your doctor or pharmacist for more information or if you have any questions.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. It is important to continue taking this medication even if you feel well. Most people with high cholesterol do not feel sick.

Disclaimer

Colestid Consumer (continued)

SIDE EFFECTS: Constipation, stomach/abdominal pain, gas, nausea, and vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a stool softener and/or a laxative.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effect occurs: difficulty swallowing, chest pain/pressure, severe stomach/abdominal pain, unusual bleeding/bruising, rapid breathing, confusion.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Colestid (colestipol) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking colestipol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: swallowing problems, constipation, hemorrhoids, kidney disease.

Because this drug can interfere with the absorption of certain nutrients (such as folic acid, fat-soluble vitamins including A, D, E, K), your doctor may direct you to take a multivitamin supplement. Consult your doctor for more information.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially constipation.

During pregnancy, this medication should be used only when clearly needed. It may affect the absorption of certain nutrients. Discuss the risks and benefits with your doctor.

This medication is unlikely to pass into breast milk. However, it may affect the absorption of certain nutrients. Consult your doctor before breast-feeding.

Disclaimer

Colestid Consumer (continued)

DRUG INTERACTIONS: See also How to Use section.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: "blood thinners" (such as warfarin).

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach/abdominal pain.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as blood cholesterol/triglyceride levels, vitamin levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Colestid Patient Information Including Side Effects

Brand Names: Colestid, Colestid Flavored

Generic Name: colestipol (Pronunciation: koe LES ti pol)

What is colestipol (Colestid)?

Colestipol is a cholesterol-lowering drug.

Colestipol lowers "bad" cholesterol in the blood, which is also called LDL (low-density lipoprotein) cholesterol. Lowering your LDL cholesterol may reduce your risk of hardened arteries, which can lead to heart attacks, stroke, and circulation problems.

Lowering high cholesterol levels is an important part of preventing heart disease and arteriosclerosis (hardening of the arteries).

Colestipol may also be used for other purposes not listed in this medication guide.

Colestid 1 gram

oblong, beige, imprinted with U

Colestipol 1 g-GLO

oval, imprinted with G

Colestipol 1 g-GRE

oval, imprinted with G, 450

What are the possible side effects of colestipol (Colestid)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • trouble swallowing;
  • severe constipation or stomach pain;
  • black, bloody, or tarry stools; or
  • easy bruising or bleeding, muscle or joint pain, loss of appetite.

Less serious side effects may include:

  • mild or occasional constipation;
  • gas, indigestion, heartburn;
  • diarrhea; or
  • hemorrhoids or rectal irritation.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Colestid (colestipol) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about colestipol (Colestid)?

You should not take this medication if you are allergic to colestipol, or if you have a blockage in your intestines.

Before taking colestipol, tell your doctor if have trouble swallowing, constipation or hemorrhoids, a stomach or intestinal disorder, liver disease, a thyroid disorder, a bleeding disorder, a history of major stomach or bowel surgery, or if you have a vitamin A, D, E, or K deficiency.

Before taking colestipol, tell your doctor if you are pregnant or breast-feeding a baby.

Colestipol is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Do not take other medications at the same time you take colestipol. Taking colestipol can make it harder for your body to absorb certain drugs, making them less effective. Take your other medications at least 1 hour before or 4 hours after you take colestipol.

Avoid constipation by drinking 8 to 12 full glasses (8 ounces each) every day while taking this medication. Ask your doctor before using a laxative or stool softener.

Call your doctor at once if you have severe constipation or stomach pain.

To be sure colestipol is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with colestipol. Do not miss any scheduled appointments.

Side Effects Centers

Colestid Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking colestipol (Colestid)?

You should not take this medication if you are allergic to colestipol, or if you have a blockage in your intestines.

Before taking colestipol, tell your doctor if you are allergic to any drugs, or if you have:

  • trouble swallowing;
  • constipation or hemorrhoids;
  • a stomach, intestinal, or digestive disorder;
  • liver disease;
  • a thyroid disorder;
  • a bleeding disorder;
  • a history of major stomach or bowel surgery; or
  • if you have a vitamin A, D, E, or K deficiency.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take colestipol.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Taking colestipol can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not take colestipol without telling your doctor if you are breast-feeding a baby.

Some forms of this medication may contain phenylalanine. Talk to your doctor before using colestipol if you have phenylketonuria (PKU).

How should I take colestipol (Colestid)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Colestipol is usually taken 1 or 2 times per day with meals. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Dissolve the colestipol granules in a small amount of water, broth soup, applesauce, crushed pineapple, or hot or cold cereal. Stir this mixture and drink or eat all of it right away. Swallow the mixture without chewing or holding it in your mouth. Colestipol can damage your teeth if left in contact with them for too long.

If you mix colestipol granules with a liquid, after drinking the mixture add a little more water to the same glass, swirl gently and drink right away. This will assure that you get the entire dose.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with colestipol. Do not miss any scheduled appointments.

It may take 2 weeks to several months of using this medicine before your cholesterol levels improve. For best results, keep using the medication as directed.

Colestipol is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store colestipol at room temperature away from moisture and heat.

Side Effects Centers

Colestid Patient Information including If I Miss a Dose

What happens if I miss a dose (Colestid)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Colestid)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include severe stomach pain or constipation.

What should I avoid while taking colestipol (Colestid)?

Avoid taking other medications at the same time you take colestipol. Taking colestipol can make it harder for your body to absorb certain drugs, making them less effective. Take your other medications at least 1 hour before or 4 hours after you take colestipol.

Avoid constipation by drinking 8 to 12 full glasses (8 ounces each) every day while taking this medication. Ask your doctor before using a laxative or stool softener.

What other drugs will affect colestipol (Colestid)?

Taking colestipol can make it harder for your body to absorb many other medications. Below is just a partial list of these medications. Tell your doctor if you are using:

  • steroid drugs such as hydrocortisone (Cortef, Hydrocortone);
  • heart medication such as digoxin (Lanoxin, Lanoxicaps), propranolol (Inderal), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril), chlorothiazide (Diuril);
  • a diuretic (water pill) such as furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril), or chlorothiazide (Diuril);
  • an antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or
  • other cholesterol-lowering medications such as atorvastatin (Caduet, Lipitor), lovastatin (Altocor, Mevacor, Advicor), ezetimibe (Zetia, Vytorin), fenofibrate (Antara, Lipofen, Lofibra, TriCor, Triglide), gemfibrozil (Lopid), clofibrate (Atromid-S), nicotinic acid (niacin), or ursodiol (Actigall, Urso, Urso Forte).

This list is not complete and there may be other drugs that can interact with colestipol. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about colestipol.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.07. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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