glimepiride 4 mg oral tablet
1 INDICATIONS AND USAGE Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1) ] . Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. Glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ). Limitations of Use: Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ( 1 ).
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16 HOW SUPPLIED/STORAGE AND HANDLING
GLIMEPIRIDE Tablets USP are available in the following strengths and package sizes: 1 mg (Light pink colored, flat capsule shaped uncoated tablets having break line on both faces and GM and 1 on engraved on either side of breakline on one face.) Bottles of 100 (NDC 42571-100-01) Bottles of 500 (NDC 42571-100-05) 2 mg (Light green colored, flat capsule shaped uncoated matt finished tablets having break line on both faces and GM and 2 engraved on either side of breakline on one face.) Bottles of 100 (NDC 42571-101-01) Bottles of 500 (NDC 42571-101-05) 3 mg (Pale yellow colored, flat capsule shaped uncoated tablets having breakline on both faces and GM and 3 engraved on either side of breakline on one face.) Bottles of 100 (NDC 42571-102-01) Bottles of 500 (NDC 42571-102-05) 4 mg (Light blue colored, flat capsule shaped uncoated matt finished tablets having break line on both faces and GM and 4 engraved on either side of breakline on one face.) Bottles of 100 (NDC 42571-103-01) Bottles of 500 (NDC 42571-103-05) 6 mg (Brick red colored, flat capsule shaped uncoated tablets having breakline on both faces and GM and 6 engraved on either side of breakline on one face.) Bottles of 100 (NDC 42571-104-01) Bottles of 500 (NDC 42571-104-05) 8 mg (white to off white, flat capsule shaped uncoated tablets having breakline on both faces and GM and 8 engraved on either side of breakline on one face.) Bottles of 100 (NDC 42571-105-01) Bottles of 500 (NDC 42571-105-05) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers with safety closures.
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