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Prevalite (Cholestyramine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

1) Prevalite® 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. Prevalite® 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 resin, 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 (Total-C), high-density lipoprotein 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 resin 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 resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin 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 is <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).

LDL- Cholesterol
mg/dL (mmol/L)
Definite
Atherosclerotic
Disease*
Two or More
Other Risk
Factors**
Initiation
Level
Goal
NO NO ≥190
(≥4.9)
<160
(<4.1)
NO YES ≥160
(≥4.1)
<130
(<3.4)
YES YES or NO ≥130
(≥3.4)
≤100
(≤2.6)

Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression2,3 and increase the rate of regression3 of coronary atherosclerosis.

2) Prevalite® is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin 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.

DOSAGE AND ADMINISTRATION

The recommended starting adult dose for Prevalite® is one packet or one level scoopful (5.5 grams of Prevalite® contain 4 grams of anhydrous cholestyramine resin) once or twice a day. The recommended maintenance dose for Prevalite® is 2 to 4 packets 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 six packets or scoopfuls of Prevalite® (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, Prevalite® may be administered in 1 to 6 doses per day.

Prevalite ® should not be taken in its dry form. Always mix Prevalite ® 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 Prevalite® 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 Prevalite® in a glass or cup. Add at least 2 to 3 ounces of water or the beverage of your choice. Stir to a uniform consistency.

Prevalite® may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.

HOW SUPPLIED

Prevalite® (Cholestyramine for Oral Suspension, USP) available in cartons of forty-two and sixty single-dose packets and in cans containing 231 grams. 5.5 grams of Prevalite® contain 4 grams of anhydrous cholestyramine resin.

  •  NDC 0245-0036-42    Cartons of 42, 5.5 g packets
  •  NDC 0245-0036-60    Cartons of 60, 5.5 g packets
  •  NDC 0245-0036-23    Cans, 231 g (42 doses)

Store at controlled room temperature, 15-30°C (59-86°F).

Rx only.

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