QUESTRAN (Page 3 of 4)

OVERDOSAGE

Overdosage with QUESTRAN has been reported in a patient taking 150% of the maximum recommended daily dosage for a period of several weeks. No ill effects were reported. Should an overdosage occur, the chief potential harm would be obstruction of the gastrointestinal tract. The location of such potential obstruction, the degree of obstruction, and the presence or absence of normal gut motility would determine treatment.

DOSAGE AND ADMINISTRATION

The recommended starting adult dose for all QUESTRAN powdered products (QUESTRAN Powder and QUESTRAN Light) is one packet or one level scoopful once or twice a day. The recommended maintenance dose for all QUESTRAN 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 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 may be administered in 1–6 doses per day.

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

Concomitant Therapy

Preliminary evidence suggests that the lipid-lowering effects of QUESTRAN 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 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 in a glass or cup. Add an amount of water or other noncarbonated 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 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 cholestyramine resin are contained in 9 grams of QUESTRAN 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), Light 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 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 20º-25ºC (68º-77ºF). [See USP Controlled Room Temperature]. Excursions permitted to 15º-30ºC (59º-86ºF).

CLINICAL STUDIES

In a large, placebo-controlled, multi-clinic study, LRC-CPPT 1, hypercholesterolemic subjects treated with QUESTRAN had mean reductions in total and low-density lipoprotein cholesterol (LDL-C) which exceeded those for diet and placebo treatment by 7.2% and 10.4%, respectively. Over the seven-year study period the QUESTRAN group experienced a 19% reduction (relative to the incidence in the placebo group) in the combined rate of coronary heart disease death plus non-fatal myocardial infarction (cumulative incidences of 7% QUESTRAN and 8.6% placebo). The subjects included in the study were men aged 35 — 59 with serum cholesterol levels above 265 mg/dL and no previous history of heart disease. It is not clear to what extent these findings can be extrapolated to females and other segments of the hypercholesterolemic population. (See also PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility.)

Two controlled clinical trials have examined the effects of QUESTRAN monotherapy upon coronary atherosclerotic lesions using coronary arteriography. In the NHLBI Type II Coronary Intervention Trial 2, 116 patients (80% male) with coronary artery disease (CAD) documented by arteriography were randomized to QUESTRAN or placebo for five years of treatment. Final study arteriography revealed progression of coronary artery disease in 49% of placebo patients compared to 32% of the QUESTRAN group (p<0.05).

In the St. Thomas Atherosclerosis Regression Study (STARS) 3, 90 hypercholesterolemic men with CAD were randomized to three blinded treatments: usual care, lipid-lowering diet, and lipid-lowering diet plus QUESTRAN. After 36 months, follow-up coronary arteriography revealed progression of disease in 46% of usual care patients, 15% of patients on lipid-lowering diet and 12% of those receiving diet plus QUESTRAN (p<0.02). The mean absolute width of coronary segments decreased in the usual care group, increased slightly (0.003mm) in the diet group and increased by 0.103mm in the diet plus QUESTRAN group (p<0.05). Thus in these randomized controlled clinical trials using coronary arteriography, QUESTRAN monotherapy has been demonstrated to slow progression 2,3 and promote regression3 of atherosclerotic lesions in the coronary arteries of patients with coronary artery disease.

The effect of intensive lipid-lowering therapy on coronary atherosclerosis has been assessed by arteriography in hyperlipidemic patients. In these randomized, controlled clinical trials, patients were treated for two to four years by either conventional measures (diet, placebo, or in some cases low dose resin), or intensive combination therapy using diet plus colestipol (an anion exchange resin with a mechanism of action and an effect on serum lipids similar to that of QUESTRAN and QUESTRAN LIGHT) plus either nicotinic acid or lovastatin. When compared to conventional measures, intensive lipid-lowering combination therapy significantly reduced the frequency of progression and increased the frequency of regression of coronary atherosclerotic lesions in patients with or at risk for coronary artery disease.

REFERENCES

  • •The Lipid Research Clinics Coronary Primary Prevention Trial Results: (I) Reduction in Incidence of Coronary Heart Disease; (II) The Relationship of Reduction in Incidence of Coronary Heart Disease to Cholesterol Lowering. JAMA 1984; 251:351-374.
  • •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.
  • •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.
  • •National Cholesterol Education Program. Second Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). Circulation 1994 Mar; 89(3):1333-445.
  • •The Lipid Research Clinics Investigators. The Lipid Research Clinics Coronary Primary Prevention Trial: Results of 6 Years of Post-Trial Follow-up. Arch Intern Med 1992; 152:1399-1410.
  • •Behrman RE et al (eds): Nelson, Textbook of Pediatrics, ed 15. Philadelphia, PA, WB Saunders Company, 1996.
  • •Takemoto CK et al (eds): Pediatric Dosage Handbook, ed 3. Cleveland/Akron, OH, Lexi-Comp, Inc., 1996-1997.

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