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Colestipol (Monograph)

Brand name: Colestid
Drug class: Bile Acid Sequestrants
VA class: CV350
CAS number: 37296-80-3

Medically reviewed by Drugs.com on Jul 17, 2023. Written by ASHP.

Introduction

Antilipemic agent; bile acid sequestrant.

Uses for Colestipol

Dyslipidemias

Adjunct to dietary therapy to decrease elevated serum total and LDL-cholesterol concentrations in the management of primary hypercholesterolemia in patients who do not respond adequately to diet.166 167

Generally has no clinically relevant effect on serum triglyceride concentrations,100 167 but may increase triglyceride concentrations in some patients.167 (See Hypertriglyceridemia under Cautions.)

As effective as cholestyramine in lowering serum cholesterol concentrations.d Select bile acid sequestrant based on patient tolerance, including palatability and taste preference, and cost.136 163

AHA/ACC cholesterol management guideline states that lifestyle modification is the foundation of cardiovascular risk reduction.400 If pharmacologic therapy is needed, statins are first-line drugs of choice because of their demonstrated benefits in reducing risk of atherosclerotic cardiovascular disease (ASCVD).400 The addition of a nonstatin drug (e.g., ezetimibe, bile acid sequestrants, PCSK9 inhibitor) may be considered in certain circumstances such as in patients with very severe elevations of LDL-cholesterol concentrations who are not achieving adequate LDL lowering with maximally tolerated statin therapy.400

Colestipol Dosage and Administration

General

Monitoring during Antilipemic Therapy

Administration

Oral Administration

Administer tablets one at a time; promptly swallow whole, using plenty of water or other appropriate liquid.167 The tablets must not be cut, crushed, or chewed.167

To avoid accidental inhalation or esophageal distress, do not administer colestipol hydrochloride for oral suspension in its dry form.166

To minimize excessive swallowing of air, advise patients to avoid rapid ingestion of suspensions of the drug.136 After the mixture is ingested, rinse the glass with a small amount of additional fluid and ingest the remaining liquid to ensure that the entire dose has been taken.166

Reconstitution

Add the prescribed amount of colestipol hydrochloride granules to at least 90 mL of a liquid (e.g., fruit juice, water, milk, soft drink) and stir until completely mixed (colestipol will not dissolve in the liquid).166 Palatability and compliance may be increased if the entire next-day’s dose is mixed in one of these liquids in the evening and then refrigerated.121 Use of a heavy or pulpy fruit juice may minimize complaints about consistency of suspensions of the drug.135 136 166 If a carbonated beverage is used, mix the powder slowly in a large glass to minimize excessive foaming; however, use of a carbonated beverage as a vehicle may be associated with adverse GI effects.166

Alternatively, mix colestipol powder with milk in hot or regular breakfast cereals, a highly fluid soup, or pulpy fruit (e.g., crushed pineapple, pears, peaches, fruit cocktail).166

Dosage

Available as colestipol hydrochloride; expressed in terms of the salt.166 167

One dose (1 packet or 1 level teaspoon) of colestipol hydrochloride granules contains 5 g of colestipol hydrochloride.166 One dose (1 packet or 1 level scoop) of flavored colestipol hydrochloride granules contains 7.5 g of granules, which contains 5 g of colestipol hydrochloride.166

Pediatric Patients

Dyslipidemias† [off-label]
Oral

Pediatric dosage has not been established;100 166 167 however, dosages of 10–20 g or 500 mg/kg daily in 2–4 divided doses have been used.115 116 118 119 Lower dosages (e.g., 125–250 mg/kg daily) have also been used in some children when serum cholesterol concentrations were only 15–20% above normal after dietary management alone.117

Adults

Dyslipidemias
Oral (Tablets)

Initially, 2 g once or twice daily.167 Increase dosage by 2 g once or twice daily at intervals of 1 or 2 months.167 Usual daily dosage range is 2–16 g taken once or in divided doses.167

If the desired therapeutic effect is not achieved with the usual dosage of 2–16 g daily with good compliance and acceptable adverse effects, consider combined therapy or alternative treatment.167

If triglyceride concentrations increase markedly, consider reducing dosage, discontinuing therapy, or using combined or alternative treatment.167

Oral (Granules for oral suspension)

Initially, 5 g (1 packet or 1 level scoop) once or twice daily.100 166 Titrate dose upward as necessary in 5-g increments at 1- or 2-month intervals.135 136 166 Usual daily dosage range is 5–30 g (1–6 packets or level scoops) taken once or in divided doses.100 166

If the desired therapeutic effect is not achieved with the usual dosage of 1–6 doses per day with good compliance and acceptable adverse effects, consider combined therapy or alternative treatment.166

If triglyceride concentrations increase markedly, consider reducing dosage, discontinuing therapy, or using combined or alternative treatment.166

Patients with preexisting constipation receiving granules for oral suspension: Initially, 5 g once daily for 5–7 days; then increase dosage to 5 g twice daily and monitor constipation and serum lipoprotein values, at least twice, 4–6 weeks apart.166 Thereafter, increase dosage as needed by 1 dose per day (at monthly intervals) with periodic monitoring of serum lipoprotein values;166 adjust dosage accordingly to achieve the desired effect while avoiding excessive dosage.135 136 If constipation worsens or the desired effect is not achieved with acceptable adverse effects with the usual dosage of 1–6 doses per day, consider combined therapy or alternative treatment.135 136 166

30 g daily (as granules for oral suspension) has been used in combination with niacin in adults with heterozygous familial hypercholesterolemia.111 112 113 114

Detailed Colestipol dosage information

Cautions for Colestipol

Contraindications

Warnings/Precautions

Warnings

Administration

To avoid accidental inhalation or esophageal distress, do not administer colestipol hydrochloride for oral suspension in its dry form.166 Always mix colestipol hydrochloride granules with water or other fluids before ingesting.166 (See Administration under Dosage and Administration.)

Phenylketonuria

Individuals with phenylketonuria (i.e., homozygous genetic deficiency of phenylalanine hydroxylase) and other individuals who must restrict their intake of phenylalanine should be warned that Flavored Colestid granules for oral suspension contain aspartame (NutraSweet), which is metabolized in the GI tract following oral administration to provide 18.2 mg of phenylalanine per 7.5-g packet.166

General Precautions

Hypertriglyceridemia

Generally has no clinically relevant effect on serum triglyceride concentrations,100 167 but may increase triglyceride concentrations in some patients.167

GI Effects

Mild and, occasionally, severe constipation has occurred.166 167 Exacerbation of preexisting constipation and aggravation of hemorrhoids secondary to constipation may occur.166 167 Encourage increased fluid and fiber intake to alleviate constipation;111 114 121 136 166 167 173 a stool softener can be added if necessary.135 136 166 167 In addition, adjust dosage carefully and titrate slowly to minimize adverse GI effects (e.g., fecal impaction).135 166 167 (See Dosage under Dosage and Administration.) Make particular effort to avoid constipation in patients with symptomatic CHD.166 167 Discontinuation of colestipol therapy may be required in some patients.166 167

Difficulty swallowing and transient esophageal obstruction have been reported rarely.166 167 Patients with a history of swallowing difficulties or choking with food, liquids, or other tablets or capsules should consult a clinician before initiating therapy with colestipol hydrochloride tablets.167 If abdominal pressure or discomfort (secondary to esophageal obstruction) occurs, advise patients to consult a clinician prior to administering the next dose.167

Abdominal discomfort (including pain and cramping), belching, flatulence, indigestion, heartburn, nausea, vomiting, and diarrhea or loose stools also have been reported.166 167 Bleeding hemorrhoids and blood in the stool have been reported infrequently.166 167 Peptic ulceration, cholecystitis, and cholelithiasis have been reported occasionally but are not necessarily drug-related.166 167

Fat-soluble Vitamin Deficiency

May interfere with the absorption of folic acid and fat-soluble vitamins (e.g., vitamins A, D, E, K).166 167 Prolonged use may be associated with an increased bleeding tendency as a result of hypoprothrombinemia secondary to vitamin K deficiency.166 167 (See Specific Drugs under Interactions.)

Hypothyroidism

Theoretical risk for the development of hypothyroidism, especially in patients with limited thyroid reserve.166 167

Hyperchloremic Acidosis

Because colestipol is the chloride form of an anion-exchange resin, there is a possibility that prolonged use may lead to the development of hyperchloremic acidosis.135 166 167

Specific Populations

Pregnancy

Category B.c

Interferes with absorption of fat-soluble vitamins, which may be detrimental even in the presence of supplementation.166 167

Lactation

Use with caution; possible lack of proper vitamin absorption associated with colestipol therapy may have an effect on nursing infants.166 167

Pediatric Use

Safety and efficacy not established.166 167

Common Adverse Effects

Constipation.166 167

Drug Interactions

Effects on GI Absorption of Drugs

May bind to a number of drugs in the GI tract and may delay or reduce their absorption.166 167 Instruct patients to allow as long a time interval as possible between ingestion of other drugs and colestipol.166 167 The manufacturer recommends administering other drugs at least 1 hour before or 4 hours after colestipol.166 167

Consider the possibility that discontinuance of colestipol in patients stabilized on potentially toxic drugs that bind to the resin may lead to toxicity and that administration of colestipol to patients stabilized on other drugs may reduce the effect of these drugs.166 167

Specific Drugs

Drug

Interaction

Comments

Antidiabetic agents (sulfonylureas)

Decreased antilipemic effects of colestipold

β-adrenergic blocking agents (propranolol)

Decreases and/or delays GI absorption of propranolol;133 134 135 166 167 effect on absorption of other β-adrenergic blocking agents not fully determined134 135 166 167

Monitor closely whenever colestipol therapy is initiated or discontinued in patients receiving propranolol;133 135 166 167 adjust propranolol dosage as necessary133 134

Digoxin

Colestipol may bind digoxin in the GI tract and impair its absorption166 167

Diuretics, thiazide (e.g., hydrochlorothiazide, chlorothiazide)

Substantially decreased absorption of diuretic166 167

Decreases absorption of chlorothiazide even when administered 1 hour before colestipol hydrochloride166 167

Fat-soluble vitamins (i.e., vitamins A, D, E, K)

Decreased absorption of fat-soluble vitamins166 167

Consider supplemental administration of vitamins A and D if colestipol is to be given for a prolonged periodd

Bleeding secondary to vitamin K deficiency usually responds promptly to parenteral administration of phytonadione; recurrences can be prevented by oral administration of phytonadione166 167

Furosemide

Substantially decreased absorption of furosemide166 167

Gemfibrozil

Substantially decreased absorption of gemfibrozil166 167

Hydrocortisone

Possible interference with absorption of hydrocortisone166 167

Lovastatin

Possible additive antilipemic effects166 167

Niacin

Additive antilipemic effects166 167

Penicillin G

Substantially decreased absorption of penicillin G166 167

Phosphate supplements, oral

Possible interference with absorption of oral phosphate supplements166 167

Tetracycline

Substantially decreased absorption of tetracycline166 167
Colestipol drug interactions (more detail)

Colestipol Pharmacokinetics

Absorption

Bioavailability

Not absorbed from the GI tract.166 167

Onset

Therapeutic response usually occurs within 1 month.166 167

Elimination

Elimination Route

Binds to bile acids in the intestine and forms a nonabsorbable complex that is excreted in feces.166 167

Stability

Storage

Oral

Tablets

20–25°C.166 167

Granules for Suspension

20–25°C.100

Actions and Spectrum

Advice to Patients

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Colestipol Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For suspension

5 g/packet or calibrated scoop*

Colestid Granules

Pfizer

Colestipol Hydrochloride for Oral Suspension

5 g/7.5 g packet or calibrated scoop

Colestid Flavored Granules

Pfizer

Tablets (micronized)

1 g

Colestid

Pfizer

AHFS DI Essentials™. © Copyright 2024, Selected Revisions July 26, 2021. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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