Rosiglitazone Maleate
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FDA Labeling Changes
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Uses
Rogislitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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Due to its mechanism of action, Rosiglitazone maleate is active only in the presence of endogenous insulin. Therefore, Rosiglitazone maleate should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
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The coadministration of Rosiglitazone maleate and insulin is not recommended.
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The use of Rosiglitazone maleate with nitrates is not recommended.
Rogislitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1.2 Important Limitations of Use-
Due to its mechanism of action, Rosiglitazone maleate is active only in the presence of endogenous insulin. Therefore, Rosiglitazone maleate should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
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The coadministration of Rosiglitazone maleate and insulin is not recommended.
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The use of Rosiglitazone maleate with nitrates is not recommended.
History
There is currently no drug history available for this drug.
Other Information
Rosiglitazone maleate is an oral antidiabetic agent which acts primarily by increasing iinsulin sensitivity. Rosiglitazone maleate improves glycemic control while reducing circulating insulin levels.
Rosiglitazone maleate is not chemically or functionally related to the sulfonylureas, the biguanides, or the alpha-glucosidase inhibitors.
Chemically, rosiglitazone maleate is (±)-5-[[4-[2-(methyl-2-pyridinylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedione, (Z)-2-butenedioate (1:1) with a molecular weight of 473.52 (357.44 free base). The molecule has a single chiral center and is present as a racemate. Due to rapid interconversion, the enantiomers are functionally indistinguishable. The structural formula of rosiglitazone maleate is:
Structural Formula
The molecular formula is C18H19N3O3S•C4H4O4. Rosiglitazone maleate is a white to off-white solid with a melting point range of 122° to 123°C. The pKa values of rosiglitazone maleate are 6.8 and 6.1. It is readily soluble in ethanol and a buffered aqueous solution with pH of 2.3; solubility decreases with increasing pH in the physiological range. Each film-coated tablet contains rosiglitazone maleate equivalent to rosiglitazone, 2 mg, 4 mg or 8 mg, for oral administration.
Inactive ingredients are: Lactose monohydrate, lechithinm, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, sodium starch glycolate type A, talc, titanium dioxide. The 4 mg tablet also contains FD&C yellow No, 6 aluminum lake and yellow iron oxide.
Sources
Rosiglitazone Maleate Manufacturers
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West-ward Pharmaceutical Corp
![Rosiglitazone Maleate Tablet [West-ward Pharmaceutical Corp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Rosiglitazone Maleate | West-ward Pharmaceutical Corp
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 MonotherapyThe 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 MetforminWhen 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.
SulfonylureaWhen 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.
MetforminThe 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 MetforminThe 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 ImpairmentNo 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 ImpairmentLiver 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) .]
PediatricData are insufficient to recommend pediatric use of rosiglitazone maleate [see Use in Specific Populations (8.4 )].
2.1 MonotherapyThe 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 MetforminWhen 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.
SulfonylureaWhen 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.
MetforminThe 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.
SulfonylureaWhen 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.
MetforminThe 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 MetforminThe 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 ImpairmentNo 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 ImpairmentLiver 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) .]
PediatricData are insufficient to recommend pediatric use of rosiglitazone maleate [see Use in Specific Populations (8.4 )].
Renal ImpairmentNo 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 ImpairmentLiver 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) .]
PediatricData are insufficient to recommend pediatric use of rosiglitazone maleate [see Use in Specific Populations (8.4 )].
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