GLIMEPIRIDE - glimepiride tablet
Aurobindo Pharma Limited
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use glimepiride tablets safely and effectively. See full prescribing information for glimepiride tablets, USP.
Glimepiride Tablets, USP Initial U.S. Approval: 1995 INDICATIONS AND USAGEDOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSTablets (scored): 1 mg, 2 mg, and 4 mg (3). CONTRAINDICATIONSWARNINGS AND PRECAUTIONS
ADVERSE REACTIONSCommon adverse reactions in clinical trials (≥5% and more common than with placebo) include hypoglycemia, headache, nausea, and dizziness (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION. Revised: 02/2013 |
Glimepiride N=745 % | Placebo N=294 % |
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* Glimepiride doses ranged from 1 to 16 mg administered daily † Insufficient information to determine whether any of the accidental injury events were associated with hypoglycemia |
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Headache | 8.2 | 7.8 |
Accidental Injury†
| 5.8 | 3.4 |
Flu Syndrome | 5.4 | 4.4 |
Nausea | 5 | 3.4 |
Dizziness | 5 | 2.4 |
Metformin | Glimepiride | |
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* Intent-to-treat population using last-observation-carried-forward for missing data (glimepiride, n=127; metformin, n=126) + adjusted for baseline HbA1C and Tanner Stage ** Difference is glimepiride – metformin with positive differences favoring metformin |
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Treatment-Naïve Patients*
| N=69 | N=72 |
HbA1C (%)
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Baseline (mean) | 8.2 | 8.3 |
Change from baseline (adjusted LS mean)+
| -1.2 | -1 |
Adjusted Treatment Difference** (95%CI) | 0.2 (-0.3; 0.6) |
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Previously Treated Patients*
| N=57 | N=55 |
HbA1C (%)
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Baseline (mean) | 9 | 8.7 |
Change from baseline (adjusted LS mean)+
| -0.2 | 0.2 |
Adjusted Treatment Difference** (95%CI) | 0.4 (-0.4; 1.2) |
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Body Weight (kg)*
| N=126 | N=129 |
Baseline (mean) | 67.3 | 66.5 |
Change from baseline (adjusted LS mean)+
| 0.7 | 2 |
Adjusted Treatment Difference** (95% CI) | 1.3 (0.3; 2.3) |
Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. In addition, 1 mg contains ferric oxide red, 2 mg contains ferric oxide yellow and FD&C blue No. 2, and 4 mg contains FD&C blue No. 2.
Placebo (N=74) | Glimepiride | |||
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1 mg (N=78) | 4 mg (N=76) | 8 mg (N=76) |
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a Intent-to-treat population using last observation on study b Least squares mean adjusted for baseline value * p<0.001 |
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HbA1C (%)
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| n=59 | n=65 | n=65 | n=68 |
Baseline (mean) | 8 | 7.9 | 7.9 | 8 |
Change from Baseline (adjusted meanb) | 1.5 | 0.3 | -0.3 | -0.4 |
Difference from Placebo (adjusted meanb) 95% confidence interval | | -1.2* (-1.5, -0.8) | -1.8* (-2.1, -1.4) | -1.8* (-2.2, -1.5) |
Mean Baseline Weight (kg)
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| n=67 | n=76 | n=75 | n=73 |
Baseline (mean) | 85.7 | 84.3 | 86.1 | 85.5 |
Change from Baseline (adjusted meanb) | -2.3 | -0.2 | 0.5 | 1 |
Difference from Placebo (adjusted meanb) 95% confidence interval | | 2* (1.4, 2.7) | 2.8* (2.1, 3.5) | 3.2* (2.5, 4) |
Placebo (N=126) | Glimepiride (N=123) |
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a Intent-to-treat population using last observation on study b Least squares mean adjusted for baseline value * p<0.0001 |
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HbA1C (%)
| n=97 | n=106 |
Baseline (mean) | 9.1 | 9.3 |
Change from Baseline (adjusted meanb) | -1.1* | -2.2* |
Difference from Placebo (adjusted meanb) 95% confidence interval | -1.1* (-1.5, -0.8) |
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Body Weight (kg)
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| n=122 | n=119 |
Baseline (mean) | 86.5 | 87.1 |
Change from Baseline (adjusted meanb) | -0.9 | 1.8 |
Difference from Placebo (adjusted meanb) 95% confidence interval | 2.7 (1.9, 3.6) |
GLIMEPIRIDE
glimepiride tablet |
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GLIMEPIRIDE
glimepiride tablet |
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GLIMEPIRIDE
glimepiride tablet |
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Labeler - Aurobindo Pharma Limited (650082092) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Aurobindo Pharma Limited | 650381903 | ANALYSIS(65862-579, 65862-580, 65862-581), MANUFACTURE(65862-579, 65862-580, 65862-581) |