Rosiglitazone is an active pharmaceutical ingredient in the Thiazolidinediones group (A10BG). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised March 22, 2025[1]
AND CLINICAL USE ......................................................................................... 3 CONTRAINDICATIONS ............................................................................................................
4 WARNINGS AND PRECAUTIONS ............................................................................................. 4 ADVERSE REACTIONS ...........................................................................................................
10 DRUG INTERACTIONS ........................................................................................................... 17 DOSAGE AND ADMINISTRATION .........................................................................................
19 OVERDOSAGE ........................................................................................................................ 21 ACTION AND CLINICAL PHARMACOLOGY .........................................................................
Drug interactions
Known interactions involving Rosiglitazone. Select one for details. This list is informational and not a complete interaction checker.
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[1]Health Canada (DPD) · 02403366 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
21 STORAGE AND STABILITY .................................................................................................... 27 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................................ 27 PART II: SCIENTIFIC INFORMATION ....................................................................................
28 PHARMACEUTICAL INFORMATION ..................................................................................... 28 CLINICAL TRIALS ..................................................................................................................
42 REFERENCES .......................................................................................................................... 45 PART III: CONSUMER INFORMATION ..................................................................................
48 Page 3 of 51 PrROSIGLITAZONE rosiglitazone (as rosiglitazone maleate) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Non- Medicinal Ingredients Oral Tablet / 2 mg, 4 mg and 8 mg Lactose Monohydrate For a complete listing see Dosage Forms, Composition and Packaging Section.
INDICATIONS AND CLINICAL USE ROSIGLITAZONE (rosiglitazone maleate) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus for whom all other oral antidiabetic agents, in monotherapy or in combination, do not result in adequate glycemic control or are inappropriate due to contraindications or intolerance.
(See WARNINGS AND PRECAUTIONS, Serious Warnings and Precautions Box and Cardiovascular). Prior to prescribing ROSIGLITAZONE, physicians must: Document the eligibility of patients to meet the above criteria; Counsel each patient on the risks and benefits of ROSIGLITAZONE, including the cardiovascular risks; and Obtain the patient’s written informed consent to take the drug.
In combination therapy, ROSIGLITAZONE is only indicated with metformin OR a sulfonylurea. Caloric restriction, weight loss, and exercise improve insulin sensitivity and are essential for the proper treatment of a diabetic patient. These measures are important not only in the primary treatment of type 2 diabetes, but also in maintaining the efficacy of drug therapy.
, infection) should be investigated and treated. Geriatrics (≥ 65 years of age) Evidence from clinical studies and experience suggest that use in the geriatric population may be associated with differences in safety See WARNINGS & PRECAUTIONS, Cardiovascular.
Pediatrics (< 18 years of age) Page 4 of 51 The safety and effectiveness of rosiglitazone have not been established in patients younger than 18 years of age. Furthermore, thiazoledinediones promote the maturation of preadipocytes and have been associated with weight gain.
Therefore, ROSIGLITAZONE is not indicated in patients younger than 18 years of age. See WARNINGS AND PRECAUTIONS, Special Populations. CONTRAINDICATIONS ROSIGLITAZONE is contraindicated in: Patients with New York Heart Association (NYHA) Class I to IV heart failure.
Patients with known hypersensitivity to this product or any of its ingredients. Patients with serious hepatic impairment (see WARNINGS AND PRECAUTIONS). Pregnancy. Insulin is recommended during pregnancy to control blood glucose levels.
Oral antidiabetic agents should not be given (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women). WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Rosiglitazone maleate, like other thiazolidinediones, can cause or exacerbate fluid retention and congestive heart failure (See Cardiovascular below).
Rosiglitazone maleate may be associated with an increased risk of cardiac ischemia. Rosiglitazone maleate is not recommended in patients with a history of ischemic heart disease, particularly those with myocardial ischemic symptoms.
(See Cardiovascular below). Rosiglitazone maleate should be used only when all other oral antidiabetic agents, in monotherapy or in combination, do not result in adequate glycemic control or are inappropriate due to contraindications or intolerance (See Cardiovascular below).
General Rosiglitazone maleate is active only in the presence of insulin due to its mechanism of action. Therefore, rosiglitazone maleate should not be used in the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.
For safety reasons, the use of rosiglitazone maleate in combination with insulin is not indicated (see CLINICAL TRIALS). The use of rosiglitazone maleate in combination with metformin AND a sulfonylurea […]