CHOLESTYRAMINE (Page 3 of 4)

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 PRECAUTIONS, Drug Interactions 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 noncarbonated 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.

HOW SUPPLIED

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 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 60429-355-37 Can, 378 g

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 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 60429-356-21 Can, 210 g

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 Cholestyramine 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 Cholestyramine 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% Cholestyramine 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 Cholestyramine 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 Cholestyramine 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 Cholestyramine 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 Cholestyramine. 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 Cholestyramine (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 Cholestyramine group (p<0.05). Thus in these randomized controlled clinical trials using coronary arteriography, Cholestyramine 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 Cholestyramine for Oral Suspension USP and Cholestyramine for Oral Suspension USP, 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

  1. 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.
  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 on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). Circulation 1994 Mar; 89(3):1333-445.
  5. 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.
  6. Behrman RE et al (eds): Nelson, Textbook of Pediatrics, ed 15. Philadelphia, PA, WB Saunders Company, 1996.
  7. Takemoto CK et al (eds): Pediatric Dosage Handbook, ed 3. Cleveland/Akron, OH, Lexi-Comp, Inc., 1996-1997.

Manufactured by: Catalent Pharma Solutions , Winchester, KY 40391

Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977

Marketed/Packaged by: GSMS Inc. Camarillo, CA 93012

Revised: 05/06 OS466-65-1-02

PRINCIPAL DISPLAY PANEL- 4GM/9GM 378 GRAM CAN

Label Graphic- 378 G -- 4G/9G
(click image for full-size original)

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