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Overdosage & Contraindications
CONTRAINDICATIONS
GLUCOVANCE (Glyburide and Metformin HCl Tablets) is contraindicated in patients with: 1. Renal disease or renal dysfunction (e. g., as suggested by serum creatinine levels 1.5 mg/ dL [males], 1.4 mg/ dL [females], or abnormal creatinine clearance) which may also result from con-ditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS). Text Continues Below
2. Congestive heart failure requiring pharmacologic treatment. 3. Known hypersensitivity to metformin hydrochloride or glyburide. 4. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. GLUCOVANCE 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. (See also PRECAUTIONS.) Table 3. GLUCOVANCE as Second-Line Therapy: Summary of Trial Data at 16 Weeks
Glyburide Metformin GLUCOVANCE GLUCOVANCE 5 mg 500 mg 2.5 mg/ 500 mg 5 mg/ 500 mg tablets tablets tablets tablets
Mean Final Dose 20 mg 1840 mg 8.8 mg/ 1760 mg 17 mg/ 1740 mg
Hemoglobin A 1c N= 158 N= 142 N= 154 N= 159
Baseline Mean (%) 9.63 9.51 9.43 9.44
Final Mean 9.61 9.82 7.92 7.91
Difference from Glyburide -1.69 a -1.70 a
Difference from Metformin -1.90 a -1.91 a
Fasting Plasma Glucose N= 163 N= 152 N= 160 N= 160
Baseline Mean (mg/ dL) 218.4 213.4 212.2 210.2
Final Mean 221.0 233.8 169.6 161.1
Difference from Glyburide -51.3 a -59.9 a
Difference from Metformin -64.2 a -72.7 a
Body Weight Mean Change from Baseline +0.43 kg -2.76 kg +0.75 kg +0.47 kg Final HbA 1c Distribution (%) N= 158 N= 142 N= 154 N= 159
<7% 2.5% 2.8% 24.7% 22.6%
7% and <8% 9.5% 11.3% 33.1% 37.1%
8% 88% 85.9% 42.2% 40.3% Table 2. Placebo-and Active-Controlled Trial of GLUCOVANCE as Initial Therapy:
Summary of Trial Data at 20 Weeks Page: 1 | 2 | 3 | Next >>
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