Colestipol hcl for diarrhea

Colestipol

Colestipol is the generic form of the brand-name drug Colestid, which is used to treat high cholesterol.

This prescription medicine is also sometimes given to treat chronic diarrhea after certain intestinal surgeries, and to relieve itching associated with liver disease.

Colestipol is a bile acid sequestrant. It works by promoting the elimination of bile acids in the stool.

The drug is used as treatment along with lifestyle adjustments, such as changes in diet and exercise.

Lowering the levels of cholesterol and other fatty substances in the blood may help prevent heart disease, chest pain, heart attack, and stroke in some people.

The U.S. Food and Drug Administration (FDA) approved colestipol in 1977. It’s manufactured as Colestid by Pfizer, Inc.

Colestipol Warnings

Before taking colestipol, tell your doctor if you have, or have ever had:

  • Any blood disorder (especially bleeding or clotting problems)
  • High blood triglyceride levels
  • Bile blockage or drainage problems
  • Hyperchloremic metabolic acidosis (a type of high blood acid level)
  • Underactive thyroid
  • Heart disease
  • Intestinal diseases
  • Hemorrhoids
  • Severe constipation
  • Problems with swallowing
  • Kidney or liver problems
  • Any vitamin deficiency

Be sure to follow your doctor’s dietary recommendations while taking colestipol. It’s generally best to consume a low-fat, low-cholesterol diet while using this medicine.

You might also need to drink extra fluids and consume more fiber while taking colestipol. Talk to your doctor about any further instructions.

This medicine should be used with extreme caution in children. Safety and effectiveness haven’t been confirmed in children.

Keep all appointments with your doctor and laboratory while taking colestipol. You’ll need frequent blood tests to check your body’s response to the medication.

If a tablet of colestipol gets stuck after you swallow it, and you notice chest pressure or discomfort, call your doctor immediately. Don’t take another tablet unless your doctor tells you otherwise.

It may take several weeks after starting on colestipol before you notice any changes in your cholesterol levels.

Don’t stop taking this drug without first talking to your healthcare provider.

Pregnancy and Colestipol

It’s not known whether colestipol could harm an unborn baby.

Tell your doctor if you’re pregnant or might become pregnant while taking this medicine. You’ll need to discuss the risks and benefits of using colestipol during pregnancy.

It’s also not known whether the drug could pass into breast milk or hurt a breastfeeding baby. Check with your doctor before breastfeeding while taking colestipol.

Review by Cheryl

I suffered with IBS for years in the form of constant diarrhea, and my doctors couldn’t help me. My jobs tended to be very non-understanding about my constant, sometimes prolonged, trips to the bathroom for an ‘imaginary’ medical condition.

My gallbladder then failed, and had to be removed…which made me even sicker. One day, during a doctor’s appointment, I basically refused to leave until the doctor found something that would help me. He flipped and flipped through his prescription book…finally giggled (yes, giggled) and wrote out a prescription for cholestyramine powder, three doses a day. I was in heaven. It stopped my symptoms cold.

It was very difficult to take at work, however, as I had no access to juice and it tasted horrible with water. I went back to the doctor and begged for a pill, which the doctor vehemently swore did not exist. Finally he prescribed me with a Colestid pill. He prescribed this for three doses day as well, but most days I take only one in the morning. One very important thing – I have to wait at least an hour, preferably two, after taking the medication before I eat, or it doesn’t work. Even so, I am thankful every day for my Colestid.

Review by Gillian

I have been taking Colestid in powder form for 26 years now and I know that I couldn’t live without it. My IBS started after the birth of my first child. My weight dropped to six stone and my family were convinced that I had cancer of some form. I had many tests which resulted in the removal of my gallbladder. The symptoms (pain and instant diarrhea after any food) continued and many different drugs were tried. My doctor thought he’d try Colestid (I take the orange flavor kind) and I’ve been taking it ever since!

I have to say that I wasn’t aware it came in tablet form and I will be speaking to my doctor about it. My mother has told me that as a baby I didn’t like or couldn’t take any dairy products and it has since been diagnosed that I am lactose intolerant.

Review by Brigitte

I had terrible IBS and felt homebound because of it. I finally started on Colestid, and it seemed like a miracle. I have been taking it for seven years now. However, I have been experiencing back pain, and had X-rays done, which revealed osteo-arthritis in my spine. I am only 41 and this is not in my family. I researched and found that it is linked to low levels of vitamin K (K2 is especially important). Colestid is great, but I should have taken supplements with it.

Review by Lisa

I was like many of the people on this page, in that I had gallbladder surgery, and would then have bowel movements right after I ate. Sometimes half an hour after, sometimes up to two hours, and it did not matter what I ate. It would be light brown and if there was too much bile there would be yellow juice in the toilet too. I would go to school and teach and I would have to go to the restroom after lunch, it was horrible, sometimes running to the bathroom two or three times.

I spent two years trying to figure out why I was having diarrhea all the time. I searched and searched the internet and finally took all of my information to the doctor, and he put me on Colestid just like I wanted. If I forget a pill I am in trouble. I started with just one in the morning and that was enough. Now just recently I have been taking one in the morning and one in the evening. It does work great.

Review by Monica

I have had my gallbladder removed and have a continuing problem with running to the bathroom when I eat fatty food. Actually I couldn’t even count on it being just fatty food. Finally I talked to a friend who is a doctor and he told me about Colestid. I take two tablets prior to any meals I think might make me sick. Now it is only rarely that I get sick. It has really been a help to me, especially when I am driving and don’t want to risk having to find a bathroom quickly.

Review by David

I have suffered from IBS for over 20 years, and I could not find any medications for relief of severe cramping and diarrhea. I am six foot six and at one point my weight was down to 140lbs, I felt like there was no hope for me. Finally I found a doctor who took a real interest in helping me because I was losing so much weight. Everything I ate made me very sick. I always had cramps and diarrhea.

Then my doctor decided to try Colestid, two 1mg tablets in the morning and two 1mg tablets before bed. It worked like a miracle, I could eat anything I wanted and never got sick. However, the manufacturer does not make the 1mg tabs anymore, so I’m trying the powder form. Just started it so I don’t know how well it’s going to work. I’ll let you know after I take it for at least a week, to let it get in my system and maintain an even level.

Review by Pam

Colestid comes in a pill, which makes it possible to take when you are out. It is a huge pill, but more convenient than the powder. It has the same effect as Questran, though chemically they are a bit different. When I approached my doctor about it, she had to look it up on the internet while I was in her office. Pretty funny and a little unnerving, but I was happy that she was open to my suggestion. It is working very well, and gives me so much confidence and control.

Do you suffer from IBS? Have you tried Colestid? Please contact Sophie to send in your review.

Bile acid malabsorption: colesevelam

Alternative treatment options

After a definitive diagnosis of bile acid malabsorption, people can be treated with bile acid sequestrants that bind with bile acids in the small bowel and prevent the secretory action of bile acids on the colon. There are currently 3 bile acid sequestrants available: colestyramine, colestipol and colesevelam.

Colestyramine and colestipol are anion exchange resins that have a high affinity for bile acids in the gastrointestinal tract, and form complexes with them. An important disadvantage of colestyramine and colestipol is that they are powders that require mixing with water or another liquid and may have an unpleasant taste, which can lead to poor tolerance of and adherence to treatment. Adverse effects include constipation, nausea, borborygmi, flatulence, bloating and abdominal pain. Colesevelam binds to bile acids with higher affinity than colestyramine or colestipol. It is available in tablet form.

The summary of product characteristic for Questran states that colestyramine is licensed for the relief of diarrhoea associated with ileal resection, Crohn’s disease, vagotomy and diabetic vagal neuropathy, and to control radiation-induced diarrhoea. It is also licensed for hypercholesterolemia and the primary prevention of coronary heart disease, and for the relief of pruritus associated with partial biliary obstruction and primary biliary cirrhosis.

Colestipol is not licensed for treating bile acid malabsorption. The summary of product characteristics for Colestid states that it is licensed for treating hypercholesterolaemia, alone or in combination with additional lipid-lowering agents.

DOCTOR’S VIEWS ARCHIVE


Topic: Irritable Bowel Syndrome (IBS), June 2000

Dr. Lee:
A middle aged viewer had ten years diarrhea due to IBS. He has been quite well controlled with Questran and Colestid. Do you have any opinion on these two drugs in the treatment of diarrhea in IBS?

Dr. Marks:
Well, there are no studies of Questran and Colestid in irritable bowel syndrome. However we do know that in most individuals who take these medications they will tend to firm up the stool and improve diarrhea. So it is not surprising if patients get better especially if they have diarrhea.

However the way in which they are working is not clear. Both of these medications bind bile acids, which are chemicals made by the liver and secreted into the intestine. These bile acids may have effects on the way the muscle of the bowel functions. And so it is possible that by binding these bile acids, Questran and Colestid are affecting the muscles of the intestines. So there is at least a theoretical reason as to why these two drugs might work in controlling diarrhea.

Questran and Colestid are certainly reasonably safe with a few precautions. They must be taken at the right time because they also can bind other things like medications a patient is taking. So they are reasonable treatments, but again have not been proven to be effective in patients with irritable bowel syndrome.

The published answers represent the opinions and perspectives of the doctors and pharmacists of MedicineNet.com and are for educational purposes only. They should not be used to replace or substitute for timely consultation with your doctor. Accuracy of information cannot be guaranteed.

Please remember, information can be subject to interpretation and can become obsolete.

Back to Doctors’ Dialogue Index

CONTINUE SCROLLING FOR RELATED SLIDESHOW

Colestid

Generic Name: colestipol hydrochloride
Dosage Form: tablet

Medically reviewed by Drugs.com. Last updated on Jul 1, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Colestid 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 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 Tablets contain no calories.

Colestid – 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 14C-labeled 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 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

Indications and Usage for Colestid

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 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 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.

Contraindications

Colestid Tablets are contraindicated in those individuals who have shown hypersensitivity to any of their components.

Precautions

Prior to initiating therapy with Colestid 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 −

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 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 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 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 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. The use of Colestid tablets in pregnancy or by women of childbearing potential requires that the potential benefits of drug therapy be weighed against possible hazards to the mother or child.

Nursing Mothers

Caution should be exercised when Colestid 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.

Information for Patients

Colestid 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 Tablets.

It is important that you take Colestid 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 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 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 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 Tablets.

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 Tablets may delay or reduce the absorption of concomitant oral medication. The interval between the administration of Colestid 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 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 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.

A study has shown that cholestyramine binds bile acids and reduces mycophenolic acid exposure. As colestipol also binds bile acids, colestipol may reduce mycophenolic acid exposure and potentially reduce efficacy of mycophenolate mofetil.

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 obstruction have been rarely reported in patients taking Colestid 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.

Overdosage

Overdosage of Colestid 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.

Colestid Dosage and Administration

For adults, Colestid 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 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 Tablets to minimize possible interference with their absorption. (See DRUG INTERACTIONS.)

Before Administration of Colestid 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 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 is Colestid Supplied

Colestid Tablets are yellow, elliptical, imprinted U, and are supplied as follows:

Bottles of 120 NDC 0009-0450-03

Each tablet contains 1 gram of micronized colestipol hydrochloride.

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

  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.

Rx only

LAB-0053-5.0
May 2017

PRINCIPAL DISPLAY PANEL – 1 g Tablet Bottle Label

Pfizer

NDC 0009-0450-03

Colestid®
(colestipol hydrochloride)
tablets

1 g

120 Tablets
Rx only

Colestid
colestipol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0009-0450
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLESTIPOL HYDROCHLORIDE (COLESTIPOL) COLESTIPOL HYDROCHLORIDE 1 g
Inactive Ingredients
Ingredient Name Strength
TRIACETIN
CARNAUBA WAX
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape OVAL (elliptical) Size 19mm
Flavor Imprint Code U
Contains
Packaging
# Item Code Package Description
1 NDC:0009-0450-03 120 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020222 07/19/1994

Labeler – Pharmacia and Upjohn Company LLC (618054084)

Pharmacia and Upjohn Company LLC

Medical Disclaimer

More about Colestid (colestipol)

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Pricing & Coupons
  • En Español
  • Generic Availability
  • Drug class: bile acid sequestrants

Consumer resources

  • Colestid
  • … +3 more

Professional resources

  • Colestid (AHFS Monograph)
  • Colestid Oral Suspension (FDA)

Other Formulations

  • Colestid Flavored

Related treatment guides

  • Hyperlipoproteinemia
  • Hyperlipoproteinemia Type IIa, Elevated LDL
  • Hyperlipoproteinemia Type IIb, Elevated LDL VLDL

About the author

Leave a Reply

Your email address will not be published. Required fields are marked *