Overdosage of cholestyramine resin 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.
The recommended starting adult dose for Cholestyramine for Oral Suspension, USP powder is 1 pouch or 1 level scoopful (9 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). 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, USP powder may be administered in 1 to 6 doses per day.
Cholestyramine for Oral Suspension, USP powder should not be taken in its dry form. Always mix the dry powder with water or other fluids before ingesting. See Preparation Instructions.
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 PRECAUTIONS, Drug Interactions for recommendations on administering concomitant therapy.
The color of Cholestyramine for Oral Suspension, USP powder 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 pouch or one level scoopful of Cholestyramine for Oral Suspension, USP powder in a glass or cup. Add at least 2 to 6 ounces of water or the beverage of your choice. Stir to a uniform consistency.
Cholestyramine for Oral Suspension, USP powder may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.
Cholestyramine for Oral Suspension, USP powder orange flavor is available in cartons of sixty 9 gram pouches and in cans containing 378 grams. Nine grams of Cholestyramine for Oral Suspension, USP powder contain 4 grams of anhydrous cholestyramine resin.
- NDC # 0245-0536-60 Carton of 60 pouches
- NDC # 0245-0536-37 Can, 378 g (containing a scoop that is not interchangeable with scoops from other products)
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Always replace plastic lid after using.
KEEP OUT OF THE REACH OF CHILDREN.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC. at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
UPSHER-SMITH LABORATORIES, LLC.
Maple Grove, MN 55369
©2017 Upsher-Smith Laboratories, LLC.
Cholestyramine for Oral Suspension, USP
4 grams cholestyramine resin, USP per scoopful*
CONTENTS: 378 g (168 g CHOLESTYRAMINE RESIN, USP)
42 MEASURED DOSES Rx only
| CHOLESTYRAMINE |
cholestyramine powder, for suspension
|Labeler — Upsher-Smith Laboratories, Inc. (079111820)|
Revised: 08/2020 Upsher-Smith Laboratories, Inc.
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