Class: Bile Acid Sequestrants
VA Class: CV350
CAS Number: 37296-80-3
Brands: Colestid
Introduction
Antilipemic agent; bile acid sequestrant.
Uses for Colestipol Hydrochloride
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 However, because triglyceride concentrations may be increased in some patients,167 do not use alone in the management of hypertriglyceridemia.d
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
Colestipol Hydrochloride Dosage and Administration
General
Patients should be placed on a standard lipid-lowering diet before initiation of colestipol therapy and should remain on this diet during treatment with the drug.166 167
To optimize antilipemic effects while minimizing the risk of adverse GI effects, adjust dosage carefully and titrate slowly.135 136 166
Instruct patients to take other drugs at least 1 hour before or 4 hours after taking colestipol tablets or suspension to minimize possible interference with absorption.166 167 (See Effects on GI Absorption of Drugs under Interactions.)
Monitoring during Antilipemic Therapy
Monitor lipoprotein concentrations periodically to ensure that target LDL-cholesterol goals are achieved and maintained at <100 mg/dL (optional goal: <70 mg/dL) for patients with CHD or CHD risk equivalents; <130 mg/dL (optional goal: <100 mg/dL) for patients with ≥2 risk factors and 10-year risk of 10–20%; <130 mg/dL for patients with ≥2 risk factors and 10-year risk <10%; or <160 mg/dL for patients with 0–1 risk factor.
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†
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
Cautions for Colestipol Hydrochloride
Contraindications
Known hypersensitivity to colestipol or any ingredient in the formulation.166
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
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
Interactions for Colestipol Hydrochloride
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 period.d 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 Hydrochloride 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 SpectrumActions
Binds to bile acids in the intestine and forms a nonabsorbable complex that is excreted in feces.166 167 Partial removal of bile acids from the enterohepatic circulation via this mechanism results in increased conversion of cholesterol to bile acids in the liver.166 167 This causes an increased demand for cholesterol in liver cells, resulting in a compensatory increase in hepatic uptake (and thus systemic clearance) of circulating LDL-cholesterol.166 167
Reduces serum total and LDL-cholesterol concentrations.166 167 Serum triglyceride concentrations may increase or remain unchanged.166 167
Antilipemic effects are additive when used with lovastatin or niacin.166 167
Advice to Patients
Importance of adherence to prescribed directions for use.166 167 (See Oral Administration Under Dosage and Administration.)
Importance of adherence to National Cholesterol Education Program (NCEP)’s dietary recommendations.166 167
Inform patients that colestipol hydrochloride tablets may be larger than typical tablets or capsules.167 (See GI Effects under Cautions.)
Importance of administering other medications at least 1 hour before or 4 hours after colestipol.166 167
For phenylketonurics, importance to inform them that Flavored Colestid granules for oral suspension contains aspartame.166
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.166 167
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.166 167
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | For suspension | 5 g/packet or calibrated scoop* | Colestid Granules | Pfizer |
Colestipol Hydrochloride for Oral Suspension | Global | |||
5 g/7.5 g packet or calibrated scoop | Colestid Flavored Granules (with aspartame) | Pfizer | ||
Tablets (micronized) | 1 g | Colestid (with povidone) | Pfizer |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Colestid 1GM Tablets (PFIZER U.S.): 120/$106 or 360/$302.98
Colestid 5GM Granules (PFIZER U.S.): 500/$150.99 or 1500/$435.98
Colestid 5GM Packet (PFIZER U.S.): 30/$85.99 or 90/$239.96
Colestid 5GM Packet (PFIZER U.S.): 90/$213.33 or 270/$640
Colestid Flavored 5GM Granules (PFIZER U.S.): 450/$129.99 or 1350/$375.96
Colestid Flavored 5GM/7.5GM Packet (PFIZER U.S.): 60/$165.99 or 180/$496
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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