OLESTYR Oral suspension Ref.[49692] Active ingredients: Colestyramine

Source: Health Products and Food Branch (CA) Revision Year: 2022

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 low-density lipoproteins). Such reduction of serum cholesterol may reduce the risks of atherosclerotic coronary artery disease and myocardial infarction.
For lowering elevated cholesterol in patients with combined hypercholesterolemia and hypertriglyceridemia.OLESTYR is not indicated where hypertriglyceridemia is the abnormality of most concern.
As a symptomatic control of bile acid induced diarrhea due to short bowel syndrome.
For the relief of pruritus associated with partial biliary obstruction.

1.1 Pediatrics

Pediatrics (birth to 18 year of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of OLESTYR in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use (see 4.2 Special Populations and Conditions; 7.1.3 Pediatrics).

1.2 Geriatrics

Geriatrics (over 65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness (see 7.1.4 Geriatrics; 8.1 Adverse Reaction Overview).

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 a day or two to the desired level for effective control.
Motivation of the patient to continue the prescribed regimen despite gastrointestinal problems is important. Physician encouragement and supervision are essential for successful management.
The colour of cholestyramine resin may vary somewhat from batch to batch, but this variation does not affect the performance of the product.

4.2 Recommended Dose and Dosage Adjustment

Adults

The recommended dose is 4 grams of cholestyramine resin, one to six times daily. Dosages may be adjusted as required to meet the patient’s needs.

Special Populations and Conditions

Pediatrics: Health Canada has not authorized an indication for pediatric use (see 1.2 Pediatrics; 7.1.3 Pediatrics).

Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness (see 7.1.4 Geriatrics).

4.3 Reconstitution

Place the contents of one sachet of OLESTYR on the surface of 120 mL – 180 mL of water, or non-carbonated beverage such as milk or fruit juice. After 1-2 minutes mix thoroughly by stirring.
OLESTYR may also be mixed in highly fluid soups or pulpy fruits with high moisture content such as applesauce or crushed pineapple.

4.4 Administration

OLESTYR is administered orally and should not be taken in its dry form; always mix the powder with water or other fluids before ingestion (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX).

4.5 Missed Dose

If a dose is missed, patients are advised to take the dose as soon as remembered, unless it is almost time for the next dose. Patients are advised not to take extra medicine to make up the missed dose.

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, the chief potential harm would be obstruction of the gastrointestinal tract. The location of such potential obstruction, the degree of obstruction, and the presence or absence of normal gut motility would determine treatment.

For management of a suspected drug overdose, contact your regional poison control centre.

Storage and stability

Store at room temperature (15-30°C). Protect from moisture.

Keep out of reach and sight of children.

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