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COLESTID® GRANULES (colestipol HCl for oral suspension) Warnings and Precautions

WARNINGS

TO AVOID ACCIDENTAL INHALATION OR ESOPHAGEAL DISTRESS, COLESTID GRANULES AND FLAVORED COLESTID GRANULES SHOULD NOT BE TAKEN IN ITS DRY FORM. ALWAYS MIX COLESTID AND FLAVORED COLESTID WITH WATER OR OTHER FLUIDS BEFORE INGESTING.

PHENYLKETONURICS: FLAVORED COLESTID CONTAINS 18.2 MG PHENYLALANINE PER 7.5-GRAM DOSE.


PRECAUTIONS

Prior to initiating therapy with COLESTID Granules and FLAVORED COLESTID Granules, 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 and FLAVORED COLESTID 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 and FLAVORED COLESTID 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 1 packet or 1 scoop once daily for 5–7 days, increasing to twice daily with monitoring of constipation and of serum lipoproteins, at least twice, 4–6 weeks apart. 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 one dose/day (at monthly intervals) with periodic monitoring of serum lipoproteins. If constipation worsens or the desired therapeutic response is not achieved at one to six doses/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 and FLAVORED COLESTID 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 hyperchloremic 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 colestipol hydrochloride is not known. In the LRC-CPPT study referred to above, the total incidence of fatal and non-fatal 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 or FLAVORED COLESTID 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 Mother

Caution should be exercised when COLESTID or FLAVORED COLESTID is 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.

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 and FLAVORED COLESTID resin may delay or reduce the absorption of concomitant oral medication. The interval between the administration of COLESTID and FLAVORED COLESTID 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 and FLAVORED COLESTID 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 effect 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 30 minutes. Effects on the absorption of other beta-blockers have not been determined. Therefore, patients on propranolol should be observed when COLESTID or FLAVORED COLESTID is 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.

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