Prevalite 4 g/5.5g

cholestyramine · POWDER, FOR SUSPENSION · Upsher-Smith Laboratories, LLC

No Recall History

Plain English

Prevalite is a powder, for suspension containing cholestyramine at 4 g/5.5g, taken oral. Manufactured by Upsher-Smith Laboratories, LLC.

Key Facts

Brand Name: Prevalite
Generic Name: cholestyramine
NDC Code (Product): 0245-0036
Manufacturer: Upsher-Smith Laboratories, LLC
Strength: 4 g/5.5g
Dosage Form: POWDER, FOR SUSPENSION
Route: ORAL
Marketing Status
Application #: ANDA073263
Drug Class: Bile Acid Sequestrant [EPC]
Marketing Start: 02/01/1996

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea1,245 reports

off label use950 reports

drug ineffective790 reports

fatigue698 reports

nausea599 reports

arthralgia516 reports

headache440 reports

weight decreased422 reports

abdominal pain390 reports

pain376 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 1) Prevalite ® (cholestyramine for oral suspension, USP) 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. Prevalite ® (cholestyramine for oral suspension, USP) 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 resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes …

Dosage & Administration

DOSAGE AND ADMINISTRATION The recommended starting adult dose for Prevalite ® (cholestyramine for oral suspension, USP) powder is one packet or one level scoopful (5.5 grams of Prevalite ® [cholestyramine for oral suspension, USP] powder contain 4 grams of anhydrous cholestyramine resin) once or twice a day. The recommended maintenance dose for Prevalite ® (cholestyramine for oral suspension, USP) powder 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 ® (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, Prevalite ® (cholestyramine for oral suspension, USP) powder may be administered in 1 to 6 doses per day. Prevalite ® (cholestyramine for oral suspension, USP) powder should not …

Warnings

WARNING PHENYLKETONURICS: PREVALITE ® CONTAINS 14.1 mg PHENYLALANINE PER 5.5 GRAM DOSE.

Contraindications

CONTRAINDICATIONS Prevalite ® 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.

Drug Interactions

Drug Interactions Cholestyramine resin may delay or reduce the absorption of concomitant oral medication such as phenylbutazone, warfarin, thiazide diuretics (acidic) or propranolol (basic), as well as tetracycline, penicillin G, phenobarbital, thyroid and thyroxine preparations, estrogens and progestins and digitalis. Interference with the absorption of oral phosphate supplements has been observed with another positively-charged bile acid sequestrant. Cholestyramine resin may interfere with the pharmacokinetics of drugs that undergo enterohepatic circulation. The discontinuance of cholestyramine resin could pose a hazard to health if a potentially toxic drug such as digitalis has been titrated to a maintenance level while the patient was taking cholestyramine resin. Because cholestyramine binds bile acids, cholestyramine resin may interfere with normal fat digestion and absorption and thus may prevent absorption of fat soluble vitamins such as A, D, E and K. When cholestyramine resin is given for long periods of time, concomitant supplementation with water-miscible (or parenteral) forms of fat-soluble vitamins should be considered. SINCE CHOLESTYRAMINE RESIN MAY BIND OTHER DRUGS G…

Adverse Reactions

ADVERSE REACTIONS The most common adverse reaction is constipation. When used as a cholesterol-lowering agent, predisposing factors for most complaints of constipation are high dose and increased age (more than 60 years old). Most instances of constipation are mild, transient and controlled with conventional therapy. Some patients require a temporary decrease in dosage or discontinuation of therapy. Less Frequent Adverse Reactions: Abdominal discomfort and/or pain, flatulence, nausea, vomiting, diarrhea, eructation, anorexia, steatorrhea, bleeding tendencies due to hypoprothrombinemia (Vitamin K deficiency) as well as Vitamin A (one case of night blindness reported) and D deficiencies, hyperchloremic acidosis in children, osteoporosis, rash and irritation of the skin, tongue and perianal area. Rare reports of intestinal obstruction, including two deaths, have been reported in pediatric patients. Occasional calcified material has been observed in the biliary tree, including calcification of the gallbladder, in patients to whom cholestyramine resin has been given. However, this may be a manifestation of the liver disease and not drug related. One patient experienced biliary colic on …

Frequently Asked Questions

What is Prevalite used for?

Prevalite contains cholestyramine. It is a powder, for suspension taken oral. Consult your doctor for specific uses.

Is Prevalite a controlled substance?

Prevalite is not classified as a controlled substance by the DEA.

What is the generic name for Prevalite?

The generic name for Prevalite is cholestyramine. There are 12 other brand versions of cholestyramine.

What is the NDC code for Prevalite 4 g/5.5g?

The NDC (National Drug Code) for Prevalite 4 g/5.5g is 0245-0036, listed by Upsher-Smith Laboratories, LLC.

Product NDC

0245-0036

Package NDC

0245-0036-23

Other Cholestyramine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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