| EMPACOZA TRIO tablets for oral use contain: empagliflozin, linagliptin, and metformin HCl.
Each extended release film-coated tablet of EMPACOZA TRIO consists of an extended-release metformin hydrochloride core tablet that is coated with the immediate-release drug substances: empagliflozin and linagliptin.
EMPACOZA TRIO tablets for oral administration are available in four strengths containing:
· 10 mg empagliflozin (micronized), 5 mg linagliptin (micronized) and 1,000 mg metformin HCl
· 25 mg empagliflozin (micronized), 5 mg linagliptin (micronized) and 1,000 mg metformin HCl
INDICATIONS AND USAGE:
EMPACOZA TRIOis a combination of empagliflozin, linagliptin, and metformin hydrochloride (HCl) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease
HOW SUPPLIED/STORAGE AND HANDLING
EMPACOZA TRIO tablets are available as follows:
Tablet Strength
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Package Size
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| 10 mg Empagliflozin (micronized)
5 mg Linagliptin (micronized)
1,000 mg Metformin HCl Extended release
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Carton box containing (AL/AL) strips each strip of 10 extended release film coated tablets and inner leaflet
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| 25 mg Empagliflozin (micronized)
5 mg Linagliptin (micronized)
1,000 mg Metformin HCl Extended release |
Carton box containing (AL/AL) strips each strip of 10 extended release film coated tablets and inner leaflet |
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