Cholestyramine for oral suspension, USP powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low-density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine for oral suspension, USP powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. See package insert for complete information.

The recommended starting adult dose for cholestyramine for oral suspension, USP powder is 1 pouch or 1 level scoopful (8.780 grams of cholestyramine for oral suspension, USP powder contains 4 grams of anhydrous cholestyramine resin) once or twice a day. The recommended maintenance dose for cholestyramine for oral suspension, USP powder is 2 to 4 pouches or scoopfuls daily (8 to 16 grams anhydrous cholestyramine resin) divided into two doses. It is recommended that increases in dose be gradual with periodic assessment of lipid/lipoprotein levels at intervals of not less than 4 weeks. The maximum recommended daily dose is 6 pouches or scoopfuls of cholestyramine for oral suspension, USP powder (24 grams of anhydrous cholestyramine resin). See package insert for complete information.

The most common adverse reaction 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 and/or pain, flatulence, nausea, vomiting, diarrhea, eructation, anorexia, steatorrhea, bleeding tendencies due to hypoprothrombinemia (Vitamin K deficiency) as well as Vitamin A (one case of night blindness reported) and D deficiencies, hyperchloremic acidosis in children, osteoporosis, rash and irritation of the skin, tongue, and perianal area. Rare reports of intestinal obstruction, including two deaths, have been reported in pediatric patients. See package insert for complete information.

Cholestyramine for oral suspension, USP powder is contraindicated in patients with complete biliary obstruction where bile is not secreted into the intestine and in those individuals who have shown hypersensitivity to any of its components.

Chronic use of cholestyramine resin may be associated with increased bleeding tendency due to hypoprothrombinemia associated with Vitamin K deficiency. This will usually respond promptly to parenteral Vitamin K and recurrences can be prevented by oral administration of Vitamin K1. Reduction of serum or red cell folate has been reported over long-term administration of cholestyramine resin. Supplementation with folic acid should be considered in these cases. See package insert for complete information.