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.

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).

Chronic use of colestipol hydrochloride may be associated with an increased bleeding tendency due to hypoprothrombinemia from vitamin K deficiency.

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. Particular effort should be made to avoid constipation in patients with symptomatic coronary artery disease. Constipation associated with COLESTID Tablets may aggravate hemorrhoids.

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.

Before Administration of COLESTID Tablets

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

During administration of COLESTID Tablets

• 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
• 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
• Significant rise in triglyceride level should be considered as indication for dose reduction, drug discontinuation, or combined or alternate therapy

Use with chlorothiazide decreases chlorothiazide.

Absorption of tetracycline, furosemide, penicillin G, hydrochlorothiazide, and gemfibrozil is significantly decreased when given simultaneously with colestipol hydrochloride.

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

Colestipol may reduce mycophenolic acid exposure and potentially reduce efficacy of mycophenolate mofetil.

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.

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.

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• Use in patients under the age of 18. GoToSource 

• Enteral feeding-induced diarrhea. GoToSource

• Pruritus of cholestasis. GoToSource  

• Familial hypercholesterolemia and for the treatment of generalized atherosclerosis. GoToSource

• Management of diabetes. GoToSource

• Clostridium difficile-associated disease. GoToSource

• Hyperthyroidism. GoToSource

• Unremitting nephrotic syndrome. GoToSource

• Pseudomembranous colitis. GoToSource

Severe constipation, intestinal obstruction and increased plasma triglycerides. GoToSource

Hepatotoxicity (liver damage). GoToSource

Osteomalacia (softening of the bones), hemorrhagic diathesis (unusual bleeding susceptibility) and hyperchloremic metabolic acidosis. GoToSource

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