QUESTRAN 4 g/5g

Cholestyramine · POWDER, FOR SUSPENSION · Endo USA, Inc.

No Recall History

Plain English

QUESTRAN is a powder, for suspension containing cholestyramine at 4 g/5g, taken oral. Manufactured by Endo USA, Inc..

Key Facts

Brand Name: QUESTRAN
Generic Name: Cholestyramine
NDC Code (Product): 49884-937
Manufacturer: Endo USA, Inc.
Strength: 4 g/5g
Dosage Form: POWDER, FOR SUSPENSION
Route: ORAL
Marketing Status
Application #: ANDA077203
Drug Class: Bile Acid Sequestrant [EPC]
Marketing Start: 07/24/2003

Recall History

No Recall History

Side Effects Reported to FDA

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

diarrhoea1,525 reports

off label use1,032 reports

drug ineffective880 reports

fatigue824 reports

nausea738 reports

arthralgia589 reports

headache516 reports

abdominal pain512 reports

vomiting475 reports

dyspnoea472 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 1) QUESTRAN (Cholestyramine for Oral Suspension USP), 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. QUESTRAN 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 QUESTRAN secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive …

Dosage & Administration

DOSAGE AND ADMINISTRATION The recommended starting adult dose for all QUESTRAN powdered products (QUESTRAN Powder and QUESTRAN LIGHT) is one packet or one level scoopful once or twice a day. The recommended maintenance dose for all QUESTRAN powdered products is 2 to 4 packets or scoopfuls daily (8 to 16 grams anhydrous cholestyramine resin) divided into two doses. Four grams of anhydrous cholestyramine resin is contained in each measured dose of QUESTRAN as follows: QUESTRAN Powder 9 grams QUESTRAN 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 QUESTRAN (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, QUESTRAN may be administered in 1 to 6 doses per day. QUESTRAN should not be taken in its dry form. Always mix QUESTRAN with water or other fluids before ingesting. See Preparation Instructions. Concomitant Therapy Preliminary e…

Warnings

WARNINGS PHENYLKETONURICS: QUESTRAN LIGHT CONTAINS 14.0 mg PHENYLALANINE PER 5 gram DOSE.

Contraindications

CONTRAINDICATIONS QUESTRAN 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 QUESTRAN (Cholestyramine for Oral Suspension USP) 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. QUESTRAN may interfere with the pharmacokinetics of drugs that undergo enterohepatic circulation. The discontinuance of QUESTRAN 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 QUESTRAN. Because cholestyramine binds bile acids, QUESTRAN 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 QUESTRAN is given for long periods of time, concomitant supplementation with water-miscible (or parenteral) forms of fat-soluble vitamins should be considered. SINCE QUESTRAN MAY BIND OTHER DRUGS GIVEN CONCURRENTLY, IT IS RECOMMENDED THAT…

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, and 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 QUESTRAN has been given. However, this may be a manifestation of the liver disease and not drug related. One patient experienced biliary colic on each of …

Frequently Asked Questions

What is QUESTRAN used for?

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

Is QUESTRAN a controlled substance?

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

What is the generic name for QUESTRAN?

The generic name for QUESTRAN is Cholestyramine. There are 11 other brand versions of Cholestyramine.

What is the NDC code for QUESTRAN 4 g/5g?

The NDC (National Drug Code) for QUESTRAN 4 g/5g is 49884-937, listed by Endo USA, Inc..

Product NDC

49884-937

Package NDC

49884-937-67

Other Cholestyramine Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)