Cholestyramine (Page 3 of 3)

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

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.

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 PRECAUTIONS, Drug Interactions for recommendations on administering concomitant therapy.

Preparation

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.

HOW SUPPLIED

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.

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.

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.

Manufactured for

UPSHER-SMITH LABORATORIES, LLC.

Maple Grove, MN 55369

©2017 Upsher-Smith Laboratories, LLC.

OE1308

Rev. 12/17

MF0536REV12/17

PRINCIPAL DISPLAY PANEL

NDC 0245-0536-37

Cholestyramine for Oral Suspension, USP

POWDER

Orange Flavor

4 grams cholestyramine resin, USP per scoopful*

CONTENTS: 378 g (168 g CHOLESTYRAMINE RESIN, USP)

42 MEASURED DOSES Rx only

UPSHER-SMITH

Can-Label
(click image for full-size original)
CHOLESTYRAMINE
cholestyramine powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-0536
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHOLESTYRAMINE (CHOLESTYRAMINE) CHOLESTYRAMINE 4 g in 9 g
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
FRUCTOSE
AMMONIUM GLYCYRRHIZATE
ORANGE
PECTIN
PROPYLENE GLYCOL ALGINATE
SORBITOL
SUCROSE
XANTHAN GUM
Product Characteristics
Color YELLOW (yellowish/orange) Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0245-0536-37 378 g in 1 CAN None
2 NDC:0245-0536-60 60 POUCH in 1 CARTON contains a POUCH
2 9 g in 1 POUCH This package is contained within the CARTON (0245-0536-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074557 08/15/1996 09/30/2023
Labeler — Upsher-Smith Laboratories, Inc. (079111820)

Revised: 08/2020 Upsher-Smith Laboratories, Inc.

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