Combination of Glimepiride and Rosiglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of Rosiglitazone and sulfonylurea as separate tablet or who are not adequately controlled on a sulfonylurea alone or for those patients who have initially responded to Rosiglitazone alone and require additional glycemic control.
Combination Oral hypoglycemic preparations
Glimepiride plus Rosiglitazone should be given once daily with the first meal of the day. The dosage of antidiabetic therapy with Glimepiride plus Rosiglitazone should be individualized on the basis of effectiveness and tolerability. No exact dosage relationship exists between Glimepiride plus Rosiglitazone and other antidiabetic agents. For patients inadequately controlled on sulfonylurea monotherapy or who have initially responded to Rosiglitazone alone and require additional glycemic control, the usual starting dose of Glimepiride plus Rosiglitazone is 1 mg/4 mg or 2 mg/4 mg once daily. When switching from combination therapy of Glimepiride plus Rosiglitazone as separate tablets, the usual starting dose of Glimepiride plus Rosiglitazone is the dose of Glimepiride and Rosiglitazone already being taken. The maximum recommended daily dose of Glimepiride plus Rosiglitazone is 4 mg of Glimepiride and 8 mg of Rosiglitazone. Sufficient time should be given to assess adequacy of therapeutic response. Fasting glucose should be used to determine the therapeutic response to Glimepiride plus Rosiglitazone. For patients previously treated with sulfonylurea monotherapy switched to Glimepiride plus Rosiglitazone, it may take 2 weeks to see a reduction in blood glucose and 2 to 3 months to see the full effect of the Rosiglitazone component. If additional glycemic control is needed, the dose of the Glimepiride component may be increased. The dose of the Rosiglitazone component should not exceed 8 mg. As with other sulfonylurea-containing antidiabetic agents, no transition period is necessary when transferring patients to Glimepiride plus Rosiglitazone. Patients should be observed carefully (1 to 2 weeks) for hypoglycemia when being transferred from longer half life sulfonylureas (e.g., chlorpropamide) to Glimepiride plus Rosiglitazone due to potential overlapping of drug effect. For patients previously treated with thiazolidinedione monotherapy switched to Glimepiride plus Rosiglitazone dose titration is recommended if patients are not adequately controlled after 1 to 2 weeks. If additional glycemic control is needed, the daily dose of Glimepiride plus Rosiglitazone may be increased by increasing the Glimepiride component in no more than 2 mg increments at 1 to 2 week intervals up to the maximum recommended total daily dose of 4 mg Glimepiride/8 mg Rosiglitazone. If hypoglycemia occurs during up-titration of the dose or while maintained on therapy, a dosage reduction of the sulfonylurea component of Glimepiride plus Rosiglitazone may be considered.
Combination of Glimepiride and Rosiglitazone is contraindicated in patients with known hypersensitivity to Glimepiride or Rosiglitazone or any of the components of combination of Glimepiride or Rosiglitazone. Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
Glimepiride: Hypoglycemia: The incidence of hypoglycemia with Glimepiride is documented. In patients treated with Glimepiride, adverse events, other than hypoglycemia, considered to be possibly or probably related to study drug that occurred in more than 1% of patients included dizziness, asthenia, headache, and nausea. Dermatologic Reactions: Allergic skin reactions, e.g., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occur in less than 1% of treated patients. These may be transient and may disappear despite continued use of Glimepiride. Rosiglitazone: The most common adverse experiences with Rosiglitazone monotherapy were upper respiratory tract infection, injury, and headache. Overall, the types of adverse experiences reported when Rosiglitazone was used in combination with a sulfonylurea were similar to those during monotherapy with Rosiglitazone. Events of anemia and edema tended to be reported more frequently at higher doses, and were generally mild to moderate in severity and usually did not require discontinuation of treatment with Rosiglitazone. Angioedema and urticaria have been reported rarely with Rosiglitazone treatment.
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 Glimepiride or Rosiglitazone should not be used during pregnancy. Nursing mothers: No studies have been conducted with combination of Glimepiride or Rosiglitazone. It is not known whether Glimepiride and/or Rosiglitazone is excreted in human milk. Because many drugs are excreted in human milk, combination of Glimepiride or Rosiglitazone should not be administered to a nursing woman.
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