CHOLEYSTYRAMINE LIGHT powder, for suspension

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

CHOLESTYRAMINE (UNII: 4B33BGI082) (CHOLESTYRAMINE - UNII:4B33BGI082)

থেকে পাওয়া:

Ascend Laboratories, LLC

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

1) Cholestyramine for Oral Suspension USP Light powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine for Oral Suspension USP Light powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the over

পণ্য সারাংশ:

Cholestyramine for Oral Suspension USP Light powder orange flavor is available in cartons of sixty 5.718 gram pouches and in jars containing 240.156 grams. Each 5.718 gram dose of Cholestyramine for Oral Suspension USP Light powder contains 4 grams of anhydrous cholestyramine resin. Pouch : Pale yellow to yellow powder filled in sealed paper foil pouch. 67877-422-60 Carton of 60 pouches 67877-422-57 5.718 gram pouch Jar : Pale yellow to yellow powder filled in sealed white HDPE jar. 67877-422-24 240.156 gram (Jar Pack) (containing a scoop that is not interchangeable with scoops from other products) Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. 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. Watte, 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 Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC 339 Jefferson Road, Parsippany, NJ 07054 Revised: November 2021 PT9076-02

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

CHOLEYSTYRAMINE LIGHT - CHOLEYSTYRAMINE LIGHT POWDER, FOR SUSPENSION
ASCEND LABORATORIES, LLC
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CHOLESTYRAMINE FOR ORAL SUSPENSION USP, LIGHT
RX ONLY
DESCRIPTION
Cholestyramine for Oral Suspension USP Light powder, the chloride salt
of a basic anion
exchange resin, a cholesterol-lowering agent, is intended for oral
administration.
Cholestyramine resin is quite hydrophilic, but insoluble in water.
Cholestyramine resin is
not absorbed from the digestive tract. Each 5.718 grams of
Cholestyramine for Oral
Suspension USP Light powder contain 4 grams of cholestyramine resin.
It is represented
by the following structural formula: REPRESENTATION OF STRUCTURE OF MAIN POLYMERIC GROUPS
INACTIVE INGREDIENTS: mannitol, fructose, sorbitol, aspartame, citric
acid, lake pigment
6010 D&C yellow #10 aluminum lake and FD&C yellow #6/sunset yellow FCF
AI 15% -
18%, orange flavour, propylene glycol alginate, xanthan gum, pectin,
silicon
dioxide.
CLINICAL PHARMACOLOGY
Cholesterol is probably the sole precursor of bile acids. During
normal digestion, bile
acids are secreted into the intestines. A major portion of the bile
acids is absorbed from
the intestinal tract and returned to the liver via the enterohepatic
circulation. Only very
small amounts of bile acids are found in normal serum.
Cholestyramine resin adsorbs and combines with the bile acids in the
intestine to form
an insoluble complex which is excreted in the feces. This results in a
partial removal of
bile acids from the enterohepatic circulation by preventing their
absorption.
The increased fecal loss of bile acids due to cholestyramine resin
administration leads to
an increased oxidation of cholesterol to bile acids, a decrease in
beta lipoprotein or low
density lipoprotein plasma levels and a decrease in serum cholesterol
levels. Although in
man, cholestyramine resin produces an increase in hepatic synthesis of
cholesterol,
plasma cholesterol levels fall.
In patients with partial biliary obstruction, the reduction of serum
bile acid levels by
cholestyramine resin