OLESTYR Oral suspension (2022)

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Name of the medicinal product

OLESTYR Cholestyramine Resin for Oral Suspension, Light Powder, 4g/5g dose, Oral Regular Powder, 4g/9g dose, Oral, USP

Description

<b>OLESTYR Light Powder</b> is available in cartons of 3 and 30 sachets (each sachet contains one dose of cholestyramine resin). Each 5 gram-dose contains 4 grams of cholestyramine resin (dried basis). ...

Indications and clinical use

OLESTYR (cholestyramine resin) is indicated in adults: As adjunctive therapy to diet and exercise for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated ...

Contraindications

OLESTYR is contraindicated in patients: who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete ...

Warnings and precautions

Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Before instituting therapy with OLESTYR, an attempt should be made to control serum cholesterol by appropriate dietary regimen, weight reduction, ...

Adverse reactions

8.1 Adverse Reaction Overview The most frequent adverse effect of cholestyramine resin is constipation (see 8.5 Post-Market Adverse Reactions). When used as a cholesterol lowering agent, predisposing factors ...

Drug interactions

9.2 Drug Interactions Overview Since cholestyramine resin is an anion-exchange resin, it may have strong affinity for anions other than the bile acids. Drug that are affected by co-administration of bile ...

Dosage and administration

4.1 Dosing Considerations To familiarize the patient with OLESTYR and to minimize gastrointestinal side effects, it is desirable to begin all therapy with one dose daily. Dosage is then increased within ...

Overdosage

One case of overdosage with cholestyramine resin has been reported in a patient taking 150% of the maximum recommended daily dosage for several weeks. No ill effects were observed. Should overdosage occur, ...

Storage and stability

Store at room temperature (15-30°C). Protect from moisture. Keep out of reach and sight of children.

Special handling instructions

Bring unused and expired prescription drugs to your local pharmacist for proper disposal. No further special handling instructions are required for this product.

Dosage forms, composition and packaging

<b>Table 1. Dosage Forms, Strengths, Composition and Packaging:</b> Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral Cholestyramine resin for oral suspension / ...

Pharmaceutical information

Drug Substance Proper name: Cholestyramine Resin Chemical name: Styrene-divinylbenzene copolymer with quaternary ammonium functional groups Structural formula: Physicochemical properties: The drug is ...

Clinical trials

The clinical trial data on which the original indication was authorized is not available.

Microbiology

No microbiological information is required for this drug product.

Toxicology

16 NON-CLINICAL TOXICOLOGY General Toxicology Oral chronic toxicity studies lasting for one year were conducted in rats and in dogs. Dosages of cholestyramine greatly in excess of those used in man exhibited ...

Marketing authorization holder

Pharmascience Inc., 6111 Royalmount Avenue, Suite 100, Montréal, QC, Canada, H4P 2T4

Submission control number

256040

Date of approval

Mar 15, 2012

Date of revision

Feb 9, 2022

Serious warnings and precautions box

OLESTYR should not be taken in its dry form. Always mix OLESTYR with water or other fluids before ingesting. Patients should be advised never to take OLESTYR in its dry form as it may cause the patient ...

Clinical pharmacology

10.1 Mechanism of Action Cholestyramine is a quaternary ammonium anion exchange resin with a polystyrene polymer skeleton. As the chloride salt, it binds bile acids both in vitro and in vivo, exchanging ...