Olestar Powder for Suspension

To familiarize the patient with Cholestyramine Resin Light Powder and to minimize gastrointestinal side effects, it is desirable to begin all therapy with one dose daily. Dosage is then increased within a day or two to the desired level for effective control. Motivation of the patient to continue the prescribed regimen in spite of gastrointestinal problems is important. Physician encouragement and supervision are essential for successful management. The recommended adult dose is 4 grams of cholestyramine resin, one to six times daily. Dosages may be adjusted as required to meet the patient's needs. A pediatric dosage schedule has not been established.

Since Olestar is an anion-exchange resin, it may have strong affinity for anions other than the bile acids. Drug that are affected by co-administration of bile acid sequestrants vary widely in pharmacologic effect and mechanisms, magnitude of doses, and chemical characteristics. Therefore, it is not possible to predict a priori whether or not co-administration with cholestyramine will interfere with absorption. It should be assumed that concomitantly administered drugs have the potential interacting with cholestyramine unless clinical studies have shown otherwise.

Olestar may delay or reduce the absorption of concomitant oral medication such as thyroid and thyroxine preparations, warfarin, chlorothiazide (acidic), phenylbutazone, phenobarbital, tetracycline, penicillin G, and digitalis. The discontinuance of cholestyramine could pose a hazard to health if a potentially toxic drug such as digitalis has been titrated to maintenance level while the patient was taking cholestyramine. The concomitant drug should be re-titrated to avoid over-dosage when cholestyramine is discontinued. Also, Olestar may interfere with the pharmacokinetics of drugs (e.g., estrogens) that undergo enterohepatic recirculation.

Drug Interaction studies have been conducted with cholestyramine and various HMG-CoA reductase inhibitors. Although cholestyramine has been shown to reduce the bioavailability of HMG-CoA reductase inhibitors, the clinical cholesterol-lowering effects of an HMG-CoA reductase inhibitor and cholestyramine have been shown to be additive.

Cholestyramine resin is contraindicated in patients with complete biliary obstruction where bile is not excreted into the intestine and in those individuals who have shown hypersensitivity to any of its components.

The most frequent adverse effect of Olestar is constipation. When used as a cholesterol lowering agent predisposing factors for most complaints of constipation are high dose and increased age (more than 60 years old). Most instances of constipation are mild, transient, and controlled with conventional therapy. Some patients require a temporary decrease in dosage or discontinuation of therapy. Less frequent adverse reactions: Abdominal discomfort, flatulence, nausea, vomiting, diarrhea, heartburn, anorexia, dyspepsia and steatorrhea, bleeding tendencies due to hypoprothrombinemia (Vitamin K deficiency) as well as Vitamin A (night blindness has been reported rarely) and D deficiencies, hyperchloremic acidosis in children, osteoporosis, rash and irritation of the skin, tongue and perinatal area.

Pregnancy: Since cholestyramine resin is not absorbed systemically, it is not expected to cause fetal harm when administered during pregnancy in recommended dosages. There are, however, 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.

Nursing Mothers: Caution should be exercised when cholestyramine resin 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. Use in pregnancy or lactation requires that the potential benefits of drug therapy be weighed against the possible hazards to the mother and the child.

Use in Children: The effects of long term drug administration, as well as its effect in maintaining lowered cholesterol levels in pediatric patients, are unknown. A pediatric dosage schedule has not been established.

Geriatrics: Appropriate studies on the relationship of age to the effects of cholestyramine have not been performed in the geriatric population. However, patients over 60 years of age may be more likely to experience gastrointestinal side effects.

Store at room temperature between 15°C and 30°C. Protect from moisture.