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Questran

Questran

INDICATIONS

1) QUESTRAN (Cholestyramine for Oral Suspension USP), is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholes-terolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. QUESTRAN (cholestyramine) may be useful to lower LDL cholesterol in patients who also have hyper-triglyceridemia, 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 QUESTRAN (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 QUESTRAN (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 QUESTRAN (cholestyramine) therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of QUESTRAN (cholestyramine) or adding other lipid-lowering agents in combination with QUESTRAN (cholestyramine) should be considered.

Since the goal of treatment is to lower LDL-C, the NCEP4 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.

LDL-Cholesterol mg/dL (mmol/L)

Definite Atherosclerotic Disease* Two or More Other Risk Factors** Initiation Level Goal
NO NO ≥ 190 < 160
( ≥ 4.9) ( < 4.1)
NO YES ≥ 160 < 130
( ≥ 4.1) ( < 3.4)
YES YES or NO ≥ 130 ≤ 100
( ≥ 3.4) ( ≤ 2.6)
*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).

QUESTRAN (cholestyramine) monotherapy has been demonstrated to retard the rate of progression2, 3 and increase the rate of regression3 of coronary atherosclerosis.

2) QUESTRAN (cholestyramine) is indicated for the relief of pruritus associated with partial biliary obstruction. QUESTRAN (cholestyramine) 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

The recommended starting adult dose for all QUESTRAN (cholestyramine) powdered products (QUESTRAN (cholestyramine) Powder and QUESTRAN (cholestyramine) LIGHT) is one packet or one level scoopful once or twice a day. The recommended maintenance dose for all QUESTRAN (cholestyramine) 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 QUESTRAN (cholestyramine) as follows:

QUESTRAN Powder 9 grams
QUESTRAN 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 QUESTRAN (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, QUESTRAN (cholestyramine) may be administered in 1-6 doses per day.

QUESTRAN (cholestyramine) should not be taken in its dry form. Always mix QUESTRAN (cholestyramine) with water or other fluids before ingesting. See Preparation Instructions.

Concomitant Therapy

Preliminary evidence suggests that the lipid-lowering effects of QUESTRAN (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 /QUESTRAN therapy. See the DRUG INTERACTIONS subsection of the PRECAUTIONS section for recommendations on administering concomitant therapy.

Preparation

The color of QUESTRAN (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 QUESTRAN (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
QUESTRAN Powder 2-6 ounces per dose
QUESTRAN LIGHT 2-6 ounces per dose

Stir to a uniform consistency and drink.

QUESTRAN (cholestyramine) may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.

HOW SUPPLIED

QUESTRAN® Powder (Cholestyramine for Oral Suspension USP) is available in cans containing 378 grams and in cartons of sixty 9 gram packets. Four grams of anhydrous cholestyra-mine resin are contained in 9 grams of QUESTRAN (cholestyramine) Powder. The 378 g can includes a 15 cc scoop. The scoop is not interchangeable with scoops from other products.

NDC-49884-936-66 Can, 378 g
NDC-49884-936-65 Carton of 60, 9 g packets

QUESTRAN® LIGHT (Cholestyramine for Oral Suspension USP) is 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 QUESTRAN (cholestyramine) LIGHT. The 210 g can includes a 9 cc scoop. The scoop is not interchangeable with scoops from other products.

NDC-49884-937-67 Can, 210 g
NDC-49884-937-65 Carton of 60, 5 g packets

Storage

Store between 20°-25°C (68°-77°F).[See USP Controlled Room Temperature].Excursions permitted to 15°-30°C (59°-86°F).

REFERENCES

2. Brensike JF, Levy RI, Kelsey SF, et al.Effects of therapy with cholestyramine on progression of coronary arteriosclerosis: results of the NHLBI type II coronary intervention study. Circulation 1984;69:313-24.

3. Watts, GF, Lewis B, Brunt JNH Lewis ES, et al.Effects on coronary artery disease of lipid-lowering diet, or diet plus cholestyramine. In the St. Thomas Atherosclerosis Regression Study (STARS). Lancet 1992;339:563-69.

4.National Cholesterol Education Program. Second Report of the Expert Panel Detection. Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). Circulation 1994 Mar; 89(3):1333-445.

® Registered trademark of Par Pharmaceutical, Inc., Distributed by: PAR PHARMACEUTICAL COMPANIES, INC., Spring Valley, NY 10977. Revised:05/06. FDA revision date: 8/22/1997

Last reviewed on RxList: 6/2/2008
This monograph has been modified to include the generic and brand name in many instances.

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