Description

This is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus who are not adequately controlled on Metformin alone. Management of type 2 diabetes mellitus should include diet control. Caloric restriction, weight loss, and exercise are essential for the proper treatment of the diabetic patient because they help improve insulin sensitivity. This is important not only in the primary treatment of type 2 diabetes but also in maintaining the efficacy of drug therapy.

Combination of Rosiglitazone and Metformin tablets are contraindicated in patients with: Renal disease or renal dysfunction which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia Congestive heart failure requiring pharmacologic treatment. Known hypersensitivity to Rosiglitazone maleate or Metformin hydrochloride. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Combination of Rosiglitazone and Metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.

The incidence and types of adverse events reported in clinical trials of Rosiglitazone as monotherapy are upper respiratory tract infection, headache, back pain, hyperglycemia, fatigue, sinusitis, diarrhea, and hypoglycemia. Adverse reactions reported in greater than 5% of the Metformin patients, and that were more common in Metformin- than placebo-treated patients are diarrhea, nausea, vomiting, flatulence, asthenia, indigestion, abdominal discomfort, headache.

Pregnancy Category C. Because current information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital anomalies as well as increased neonatal morbidity and mortality, most experts recommend that insulin monotherapy be used during pregnancy to maintain blood glucose levels as close to normal as possible. Combination of Rosiglitazone and Metformin should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women with combination of Rosiglitazone and Metformin or its individual components. It is not known whether Rosiglitazone and/or Metformin are excreted in human milk. Because many drugs are excreted in human milk, a combination of Rosiglitazone and Metformin should not be administered to a nursing woman.

When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a temporary loss of glycemic control may occur. At such times, it may be necessary to withhold combination of Rosiglitazone and Metformin and temporarily administer insulin. Combination of Rosiglitazone and Metformin may be reinstituted after the acute episode is resolved. Combination of Rosiglitazone and Metformin should be used with caution in patients with edema.

Pediatric Use: Safety and effectiveness of combination of Rosiglitazone and Metformin in pdiatric patients have not been established. Geriatric Use: Because aging is associated with reduced renal function, combination of Rosi litazone and Metformin should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function. Generally, elderly patients should not be titrated to the maximum dose of combination of Rosiglitazone and Metformin.

Combination Oral hypoglycemic preparations