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OLESTYR is a brand name for Cholestyramine Resin, supplied as a powder for suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's HC label. Tap a section to expand.
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.
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. 3 Pediatrics). 4 Geriatrics). 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 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).
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.
5 Post-Market Adverse Reactions). 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. [*] The percentage of complaints that are associated with these predisposing factors is unknown. 2 Clinical Trial Adverse Reactions The clinical trial data on which the original indication was authorized is not available.
5 Post-Market Adverse Reactions The following table presents a listing of post-market adverse reactions with their frequency of occurrence in patients treated with cholestyramine. OLESTYR (cholestyramine resin) Page 11 of 27 Adverse Reactions Categorized by System Organ Class Very Common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Blood and lymphatic system disorders Bleeding tendencies due to hypoprothrombinaemia (Vitamin K deficiency) Vitamin A and vitamin D deficiencies Night blindness Gastrointestinal disorders Constipation Abdominal discomfort Flatulence Nausea Vomiting Diarrhea Heartburn Dyspepsia Steatorrhea Intestinal obstruction Metabolism and nutrition disorders Anorexia Musculoskeletal and connective tissue disorders Osteoporosis Skin and subcutaneous tissue disorders Rash and irritation of skin, tongue and perianal area The frequency of the following post-market adverse reactions is unknown.
OLESTYR (cholestyramine resin) Page 12 of 27 Gastrointestinal: gastrointestinal-rectal bleeding, black stools, hemorrhoidal bleeding, bleeding from known duodenal ulcer, dysphagia, hiccups, ulcer attack, sour taste, pancreatitis, rectal pain, diverticulitis, eructation Hematologic: decreased or increased prothrombin time, ecchymosis, anemia, dental bleeding Hypersensitivity: asthma, wheezing, shortness of breath Monitoring and Laboratory Tests: liver function abnormalities Musculoskeletal: backache, muscle and joint pain, arthritis Neurologic: headache, anxiety, vertigo, dizziness, fatigue, tinnitus, syncope, drowsiness, femoral nerve pain, paresthesia Ophthalmologic: uveitis Renal: hematuria, dysuria, burnt odour of urine, diuresis Other: weight loss, weight gain, increased libido, swollen glands, edema, dental caries.
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, and the treatment of any underlying disorder such as hypothyroidism, diabetes mellitus, nephrotic syndrome, Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral Cholestyramine resin for oral suspension / 4g per 5g dose (light powder, orange flavour) Aspartame (each 5g contains 50 mg phenylalanine), Citric Acid Anhydrous, Colloidal Silicon Dioxide, FD&C Yellow #6, Natural Orange Flavour, Propylene Glycol Alginate oral Cholestyramine resin for oral suspension / 4g per 5g dose (light powder, lemon-lime flavour) Aspartame (each 5g contains 50 mg phenylalanine), Citric Acid Anhydrous, Colloidal Silicon Dioxide, D&C Yellow #10, Natural Lemon-Lime Flavour, Propylene Glycol Alginate oral Cholestyramine resin for oral suspension / 4g per 9g dose (regular powder, orange flavour) Citric Acid Anhydrous, Colloidal Silicon Dioxide, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6, Orange Flavour, Propylene Glycol Alginate, Sucrose OLESTYR (cholestyramine resin) Page 8 of 27 dysproteinemias and obstructive liver disease which might be the cause of hypercholesterolemia.
In addition, the current medications of the patient should be reviewed for their potential to increase serum LDL-C or total cholesterol. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine therapy.
The therapy should be continued to sustain cholesterol reduction. Carcinogenesis and Mutagenesis Please see section 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity / Genotoxicity. Driving and Operating Machinery OLESTYR has not been shown to impair the patient’s ability to drive or use machines .
Endocrine and Metabolism There is a possibility that prolonged use of cholestyramine resin, since it is a chloride form of anion exchange resin, may produce hyperchloremic acidosis. This would especially be true in younger and smaller patients where the relative dosage may be higher.
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 listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
with complete biliary obstruction where bile is not excreted into the intestine . OLESTYR (cholestyramine resin) Page 5 of 27
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Because cholestyramine binds bile acids, it may interfere with normal fat digestion and absorption and thus may prevent absorption of fat-soluble vitamins such as A, D and K. When OLESTYR is given for long periods of time, concomitant supplementation of water-miscible parenteral forms of vitamins A and D should be considered.
Chronic use of OLESTYR may be associated with increased bleeding tendency due to hypoprothrombinemia associated with vitamin K deficiency. This will usually respond promptly to parenteral vitamin K1 and recurrences can be prevented by oral administration of vitamin K1.
Reduction of serum or red cell folate has been reported over long-term administration of cholestyramine resin. Supplementation with folic acid should be considered in these cases . Gastrointestinal Cholestyramine resin may produce or worsen pre-existing constipation.
Dosage should be reduced or discontinued in such cases. Fecal impaction and aggravation of hemorrhoids may occur. Every effort should be made to avert severe constipation and its inherent prob lems in those patients with clinically symptomatic coronary artery disease.
Cholestyramine potentially may cause steatorrhea or accentuate pre -existing steatorrhea, and this may require reduction and adjustment of dosage. OLESTYR (cholestyramine resin) Page 9 of 27 Hepatic/Biliary/Pancreatic Occasional calcified material has been observed in the biliary tree, including calcification of the gallbladder, in patients to whom cholestyramine resin has been given.
This may be a manifestation of the liver disease and not drug related. Monitoring and Laboratory Tests Serum cholesterol levels should be determined frequently during the first few months of therapy and periodically thereafter. Serum triglyceride levels should be measured periodically to detect whether significant changes have occurred.
Reproductive Health:
Female and Male Potential Fertility The effect of OLESTYR on human fertility is unknown (see 16 Reproductive and Developmental Toxicology). Teratogenic Risk There is non-clinical evidence suggesting that cholestyramine is not embryotoxic or teratogenic (see 16 Reproductive and Developmental Toxicology).
1 Pregnant Women). 1 Pregnant Women Since cholestyramine is not absorbed systemically, it is not expected to cause fetal harm when administered during pregnancy in recommended dosages. There are, however, no adequate and well controlled studies in pregnant women.
Use in pregnancy or lactation requires that the potential benefits of drug therapy be weighed against the possible hazards to the mother and child. The known interference with absorption of fat-soluble vitamins may be detrimental even in the presence of supplementation.
2 Breast-feeding Caution should be exercised when OLESTYR is administered to a nursing mother. The possible lack of proper vitamin absorption (see 7 Endocrine and Metabolism) may have an effect on nursing infants. Use in pregnancy or lactation requires that the potential benefits of drug therapy be weighed against the possible hazards to the mother and child.
3 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.
The effects of long-term drug administration, as well as its effect in maintaining lowered cholesterol levels in pediatric patients, are unknown. A pediatric dosage schedule has not been established. 4 Geriatrics Appropriate studies on the relationship of age to the effects of cholestyramine have […]