The management of antidiabetic therapy should be individualized. All patients should start rosiglitazone maleate tablets at the lowest recommended dose. Further increases in the dose of rosiglitazone maleate tablets should be accompanied by careful monitoring for adverse events related to fluid retention [see Boxed Warning and Warnings and Precautions (5.1) ].
Rosiglitazone maleate tablets may be administered at a starting dose of 4 mg either as a single daily dose or in 2 divided doses. For patients who respond inadequately following 8 to 12 weeks of treatment, as determined by reduction in fasting plasma glucose (FPG), the dose may be increased to 8 mg daily as monotherapy or in combination with metformin, sulfonylurea, or sulfonylurea plus metformin. Reductions in glycemic parameters by dose and regimen are described under Clinical Studies (14.1) . Rosiglitazone maleate tablets may be taken with or without food.
The total daily dose of rosiglitazone maleate tablets should not exceed 8 mg.
2.1 Monotherapy
The usual starting dose of rosiglitazone maleate tablets is 4 mg administered either as a single dose once daily or in divided doses twice daily. In clinical trials, the 4-mg twice-daily regimen resulted in the greatest reduction in FPG and hemoglobin A1c (HbA1c).
2.2 Combination With Sulfonylurea or Metformin
When rosiglitazone maleate tablets is added to existing therapy, the current dose(s) of the agent(s) can be continued upon initiation of therapy with rosiglitazone maleate tablets.
Sulfonylurea
When used in combination with sulfonylurea, the usual starting dose of Rosiglitazone maleate is 4 mg administered as either a single dose once daily or in divided doses twice daily. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased.
Metformin
The usual starting dose of Rosiglitazone Maleate in combination with metformin is 4 mg administered as either a single dose once daily or in divided doses twice daily. It is unlikely that the dose of metformin will require adjustment due to hypoglycemia during combination therapy with Rosiglitazone Maleate.
2.3 Combination With Sulfonylurea Plus Metformin
The usual starting dose of rosiglitazone maleate tablets in combination with a sulfonylurea plus metformin is 4 mg administered as either a single dose once daily or divided doses twice daily. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased.
2.4 Specific Patient Populations
Renal Impairment
No dosage adjustment is necessary when Rosiglitazone maleate is used as monotherapy in patients with renal impairment. Since metformin is contraindicated in such patients, concomitant administration of metformin and Rosiglitazone maleate is also contraindicated in patients with renal impairment.
Hepatic Impairment
Liver enzymes should be measured prior to initiating treatment with rosiglitazone maleate. Therapy with rosiglitazone maleateshould not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT >2.5X upper limit of normal at start of therapy). After initiation of rosiglitazone maleate, liver enzymes should be monitored periodically per the clinical judgment of the healthcare professional. [See Warnings and Precautions (5.6) and Clinical Pharmacology (12.3) .]
Pediatric
Data are insufficient to recommend pediatric use of rosiglitazone maleate [see Use in Specific Populations (8.4 )].
2.1 Monotherapy
The usual starting dose of rosiglitazone maleate tablets is 4 mg administered either as a single dose once daily or in divided doses twice daily. In clinical trials, the 4-mg twice-daily regimen resulted in the greatest reduction in FPG and hemoglobin A1c (HbA1c).
2.2 Combination With Sulfonylurea or Metformin
When rosiglitazone maleate tablets is added to existing therapy, the current dose(s) of the agent(s) can be continued upon initiation of therapy with rosiglitazone maleate tablets.
Sulfonylurea
When used in combination with sulfonylurea, the usual starting dose of Rosiglitazone maleate is 4 mg administered as either a single dose once daily or in divided doses twice daily. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased.
Metformin
The usual starting dose of Rosiglitazone Maleate in combination with metformin is 4 mg administered as either a single dose once daily or in divided doses twice daily. It is unlikely that the dose of metformin will require adjustment due to hypoglycemia during combination therapy with Rosiglitazone Maleate.
Sulfonylurea
When used in combination with sulfonylurea, the usual starting dose of Rosiglitazone maleate is 4 mg administered as either a single dose once daily or in divided doses twice daily. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased.
Metformin
The usual starting dose of Rosiglitazone Maleate in combination with metformin is 4 mg administered as either a single dose once daily or in divided doses twice daily. It is unlikely that the dose of metformin will require adjustment due to hypoglycemia during combination therapy with Rosiglitazone Maleate.
2.3 Combination With Sulfonylurea Plus Metformin
The usual starting dose of rosiglitazone maleate tablets in combination with a sulfonylurea plus metformin is 4 mg administered as either a single dose once daily or divided doses twice daily. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased.
2.4 Specific Patient Populations
Renal Impairment
No dosage adjustment is necessary when Rosiglitazone maleate is used as monotherapy in patients with renal impairment. Since metformin is contraindicated in such patients, concomitant administration of metformin and Rosiglitazone maleate is also contraindicated in patients with renal impairment.
Hepatic Impairment
Liver enzymes should be measured prior to initiating treatment with rosiglitazone maleate. Therapy with rosiglitazone maleateshould not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT >2.5X upper limit of normal at start of therapy). After initiation of rosiglitazone maleate, liver enzymes should be monitored periodically per the clinical judgment of the healthcare professional. [See Warnings and Precautions (5.6) and Clinical Pharmacology (12.3) .]
Pediatric
Data are insufficient to recommend pediatric use of rosiglitazone maleate [see Use in Specific Populations (8.4 )].
Renal Impairment
No dosage adjustment is necessary when Rosiglitazone maleate is used as monotherapy in patients with renal impairment. Since metformin is contraindicated in such patients, concomitant administration of metformin and Rosiglitazone maleate is also contraindicated in patients with renal impairment.
Hepatic Impairment
Liver enzymes should be measured prior to initiating treatment with rosiglitazone maleate. Therapy with rosiglitazone maleateshould not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT >2.5X upper limit of normal at start of therapy). After initiation of rosiglitazone maleate, liver enzymes should be monitored periodically per the clinical judgment of the healthcare professional. [See Warnings and Precautions (5.6) and Clinical Pharmacology (12.3) .]
Pediatric
Data are insufficient to recommend pediatric use of rosiglitazone maleate [see Use in Specific Populations (8.4 )].
