CHOLESTYRAMINE powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Lifesciences Limited

INN (International Name):

CHOLESTYRAMINE

Composition:

CHOLESTYRAMINE 4 g in 5.5 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 overweight. Prior to initiating therapy with cholestyramine for oral suspension USP light powder secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess Total cholesterol, HDL-C, and triglycerides (TG). For individuals with TG less than 400 mg/dL (< 4.5 mmol/L), LDL-C can be estimated using the following equation:- LDL-C = Total cholesterol – [(TG/5) + HDL-C] For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine for oral suspension USP light powder may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine for oral suspension USP light powder therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine for oral suspension USP light powder or adding other lipid-lowering agents in combination with cholestyramine for oral suspension USP light powder should be considered. Since the goal of treatment is to lower LDL-C, the NCEP4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. * Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). * * Other risk factors for coronary heart disease (CHD) include: age (males ≥ 45 years; females ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C < 35 mg/dL (< 0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is ≥ 60 mg/dL (≥ 1.6 mmol/L). Cholestyramine for oral suspension USP light powder monotherapy has been demonstrated to retard the rate of progression2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) Cholestyramine for oral suspension USP light powder is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine for oral suspension USP light powder has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease. Cholestyramine for oral suspension USP light powder is contraindicated in patients with complete biliary obstruction where bile is not secreted into the intestine and in those individuals who have shown hypersensitivity to any of its components.

Product summary:

Cholestyramine for Oral Suspension USP Light Powder is available in HDPE container containing 231 grams and in cartons of sixty 5.5 gram pouches. Four grams of anhydrous cholestyramine resin are contained in 5.5 grams of cholestyramine for oral suspension USP light powder. The 231 grams HDPE container includes a 10 cc scoop. The scoop is not interchangeable with scoops from other products. NDC 70771-1070-1           Can, 231 grams NDC 70771-1070-2           Carton of 60, 5.5 grams pouches Store between 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHOLESTYRAMINE- CHOLESTYRAMINE POWDER, FOR SUSPENSION
ZYDUS LIFESCIENCES LIMITED
----------
CHOLESTYRAMINE FOR ORAL SUSPENSION USP, LIGHT
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. The
cholestyramine resin
in cholestyramine for oral suspension USP light powder is not absorbed
from the
digestive tract. Four grams of anhydrous cholestyramine resin is
contained in 5.5 grams
of cholestyramine for oral suspension USP light powder. It is
represented by the
following structural formula:
Cholestyramine for oral suspension USP light powder contains the
following inactive
ingredients: aspartame, citric acid, colloidal silicon dioxide, D&C
Yellow # 10 aluminum
lake, FD&C Yellow # 6 aluminum lake, flavor (natural and artificial
Orange, natural and
artificial Vanilla), mannitol, propylene glycol alginate and xanthan
gum.
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 for oral suspension USP light powder 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 for oral
suspension USP light
powder 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 for oral
suspension USP light
powder produces an increase