Cholestyramine (Page 3 of 3)

OVERDOSAGE

Overdosage with Cholestyramine 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 cholestyramine for oral suspension powdered products (Cholestyramine for Oral Suspension USP and Cholestyramine for Oral Suspension USP, Light) is one packet or one level scoopful once or twice a day. The recommended maintenance dose for all cholestyramine for oral suspension 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 Cholestyramine as follows:

Cholestyramine for Oral Suspension USP

9 grams

Cholestyramine for Oral Suspension USP, 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 cholestyramine for oral suspension (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 may be administered in 1 to 6 doses per day.

Cholestyramine should not be taken in its dry form. Always mix Cholestyramine 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 the Drug Interactions subsection of the PRECAUTIONS 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 non-carbonated 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, Light is a cream to pale yellow colored orange flavored powder available in cans containing 210 grams. The 210 g can includes a 9 cc scoop. The scoop is not interchangeable with scoops from other products.

NDC: 72162-1505-2: 210g in a CAN.

Storage
Store between 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Excursions permitted to 15º to 30ºC (59º to 86ºF).

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

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.

Rx Only
Dist. by:
Par Pharmaceutical
Chestnut Ridge, NY 10977 U.S.A.


Mfg. by:
Par Formulations Private Limited,
9/215, Pudupakkam, Kelambakkam — 603 103.
Made in India


*Product of France
from Active Pharmaceutical
Ingredient made in France


Mfg. Lic. No.: TN00002121
OS466-01-74-04
Revised: 02/2022

Cholestyramine 4gm Powder For Susp, #210

Label
(click image for full-size original)
CHOLESTYRAMINE
cholestyramine powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72162-1505(NDC:49884-466)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHOLESTYRAMINE (CHOLESTYRAMINE) CHOLESTYRAMINE 4 g in 5 g
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C RED NO. 40
MALTODEXTRIN
PROPYLENE GLYCOL ALGINATE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72162-1505-2 210 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077203 09/15/2005
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (72162-1505), RELABEL (72162-1505)

Revised: 03/2024 Bryant Ranch Prepack

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