Rosiglit


Composition:
Each tablet contains:
Rosiglitazone maleate                  5.3 mg
Equivalent to Rosiglitazone          4 mg

Pharmacological Properties :
Rosiglitazone is a member of thiazolidinedione class of antidiabetic agents.
It improves glycemic control by enhancing insulin sensitivity. Rosiglitazone is a highly selective and potent agonist for the peroxisome proliferator–activated receptor–gamma (PPAR). In humans PPAR receptors are found in key target tissues for insulin action.
Activation of PPAR receptors regulates the transcription of insulin responsive genes involved in the control of glucose production, transport and utilization. Insulin resistance is a common feature characterizing the pathogenesis of type II diabetes. The antidiabetic activity of Rosiglitazone has been demonstrated in animal models of type II diabetes in which hyperglycemia and/or impaired glucose tolerance is a consequence of insulin resistance in target tissues.
C max and the area under the curve (AUC) of Rosiglitazone increase in a dose proportional manner over the therapeutic dose. Peak plasma concentrations are observed about one hour after dosing. Rosiglitazone is approximately 99.8% bound to plasma proteins primarily albumin. 64% and 23%of the dose are eliminated in the urine and in feaces respectively.

Indications:
Rosiglit tablet is indicated as monotherapy as an adjunct to diet and exercise to improve glycemic control in patients with type II diabetes mellitus. Management of type II diabetes should include diet control, weight loss and exercise, they are essential for the proper treatment of the diabetic patients because they improve insulin sensitivity and in maintaining the efficacy of drug therapy.

Contraindications:
Rosiglit is contraindicated in:
•    Patients with known hypersensitivity to this product or to any of its components
•    Patients with type I diabetes or for the treatment of diabetic ketoacidosis.

Precautions:
•    Rosiglit should be used with caution in patients with edema.
•    Across all controlled clinical studies, decreases in hemoglobin and hematocrit were observed after Rosiglit treatment.
•    Rosiglit may result in resumption of ovulation in premenopausal, anovulatory women with insulin resistance.
•    This drug is of value in selected cases of diabetes mellitus and should not be used except under strict medical supervision.

Pregnancy:
Rosiglit should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

Lactation:
Rosgilit should not be administered to a nursing women.

Side Effects:

Mild to moderate edema and anemia have been observed.

Dosage and Administration:

One tablet once daily or twice daily.
The dose may be increased to 8 mg once daily or twice daily.

Package: