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Drug Catalog - Product Detail

CHOLESTYRAMINE REGULAR CAN PWD 4GM 378GM

NDC Mfr Size Str Form
49884-0465-66 PAR PHARMACEUTICAL 378 4GM/DOSE POWDER
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PACKAGE FILES

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Generic Name
CHOLESTYRAMINE
Substance Name
CHOLESTYRAMINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA077204
Description
DESCRIPTION Cholestyramine for Oral Suspension USP, the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in Cholestyramine is not absorbed from the digestive tract. Four grams of anhydrous cholestyramine resin is contained in 9 grams of Cholestyramine for Oral Suspension USP. Four grams of anhydrous cholestyramine resin is contained in 5 grams of Cholestyramine for Oral Suspension USP, Light. It is represented by the following structural formula: Cholestyramine for Oral Suspension USP contains the following inactive ingredients: acacia, citric acid, D&C Yellow No. 10, FD&C Yellow No. 6, flavor (natural and artificial Orange), polysorbate 80, propylene glycol alginate and sucrose. Cholestyramine for Oral Suspension USP, Light contains the following inactive ingredients: aspartame, citric acid, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Red No. 40, flavor (natural and artificial Orange), maltodextrin, propylene glycol alginate and xanthan gum. structure
How Supplied
HOW SUPPLIED Cholestyramine for Oral Suspension USP is a yellow colored orange flavored powder available in cans containing 378 grams and in cartons of sixty 9 gram packets. Four grams of anhydrous cholestyramine resin are contained in 9 grams of Cholestyramine for Oral Suspension USP. The 378 g can includes a 15 cc scoop. The scoop is not interchangeable with scoops from other products. NDC 49884-465-66 Can, 378 g NDC 49884-465-65 Carton of 60, 9 g packets *Cholestyramine for Oral Suspension USP, Light is a cream to pale yellow colored orange flavored powder available in cans containing 210 grams and in cartons of sixty 5 gram packets. Four grams of anhydrous cholestyramine resin are contained in 5 grams of Cholestyramine for Oral Suspension USP, Light. The 210 g can includes a 9 cc scoop. The scoop is not interchangeable with scoops from other products. NDC 49884-466-67 Can, 210 g NDC 49884-466-65 Carton of 60, 5 g packets Storage Store between 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Excursions permitted to 15º to 30ºC (59º to 86ºF).
Indications & Usage
INDICATIONS AND USAGE 1) Cholestyramine for Oral Suspension USP 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 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. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with Cholestyramine, 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 – [(TG/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 Cholestyramine may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of Cholestyramine therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of Cholestyramine or adding other lipid-lowering agents in combination with Cholestyramine should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. *Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). **Other risk factors for coronary heart disease (CHD) include: age (males ≥45 years; females ≥55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (<0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is ≥60 mg/dL (≥1.6 mmol/L). LDL-Cholesterol mg/dL (mmol/L) Definite Atherosclerotic Disease* Two or More Other Risk Factors** Initiation Level Goal NO NO ≥190 (≥4.9) <160 (<4.1) NO YES ≥160 (≥4.1) <130 (<3.4) YES YES or NO ≥130 (≥3.4) ≤100 (≤2.6) Cholestyramine monotherapy has been demonstrated to retard the rate of progression 2,3 and increase the rate of regression 3 of coronary atherosclerosis. 2) Cholestyramine for oral suspension is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine for oral suspension has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.
Dosage and Administration
DOSAGE AND ADMINISTRATION The recommended starting adult dose for all cholestyramine for oral suspension powdered products (Cholestyramine for Oral Suspension USP and Cholestyramine for Oral Suspension USP, Light) is one packet or one level scoopful once or twice a day. The recommended maintenance dose for all cholestyramine for oral suspension powdered products is 2 to 4 packets or scoopfuls daily (8-16 grams anhydrous cholestyramine resin) divided into two doses. Four grams of anhydrous cholestyramine resin is contained in each measured dose of Cholestyramine as follows: Cholestyramine for Oral Suspension USP 9 grams Cholestyramine for Oral Suspension USP, Light 5 grams 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 six packets or scoopfuls of cholestyramine for oral suspension (24 grams of anhydrous cholestyramine resin). The suggested time of administration is at mealtime but may be modified to avoid interference with absorption of other medications. Although the recommended dosing schedule is twice daily, cholestyramine for oral suspension may be administered in 1 to 6 doses per day. Cholestyramine should not be taken in its dry form. Always mix Cholestyramine with water or other fluids before ingesting. See Preparation Instructions. Concomitant Therapy Preliminary evidence suggests that the lipid-lowering effects of Cholestyramine on total and LDL-cholesterol are enhanced when combined with a HMG-CoA reductase inhibitor, e.g., pravastatin, lovastatin, simvastatin, and fluvastatin. Additive effects on LDL-cholesterol are also seen with combined nicotinic acid/Cholestyramine therapy. See the Drug Interactions subsection of the PRECAUTIONS section for recommendations on administering concomitant therapy. PREPARATION The color of Cholestyramine may vary somewhat from batch to batch but this variation does not affect the performance of the product. Place the contents of one single-dose packet or one level scoopful of Cholestyramine in a glass or cup. Add an amount of water or other non-carbonated beverage of your choice depending on the product being used: Product Formula Amount of Water or other Non-Carbonated Liquid Cholestyramine for Oral Suspension USP 2-6 ounces per dose Cholestyramine for Oral Suspension USP, Light 2-6 ounces per dose Stir to a uniform consistency and drink. Cholestyramine may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.