Rx Item-Glyxambi empagliflozin/linagliptin 25Mg/5Mg Tab 30 By Boehringer

GLYXAMBI- empagliflozin and linagliptin tablet, film coated
Boehringer Ingelheim Pharmaceuticals, Inc.

1??INDICATIONS AND USAGE

GLYXAMBI is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.

? Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see Clinical Studies (14.2)]. However, the effectiveness of GLYXAMBI on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established.



Limitations of Use
GLYXAMBI is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis [see Warnings and Precautions (5.3)].

GLYXAMBI has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using GLYXAMBI [see Warnings and Precautions (5.1)].

2??DOSAGE AND ADMINISTRATION

2.1?Recommended Dosage
The recommended dose of GLYXAMBI is 10 mg empagliflozin/5 mg linagliptin once daily in the morning, taken with or without food. In patients tolerating GLYXAMBI, the dose may be increased to 25 mg empagliflozin/5 mg linagliptin once daily.

In patients with volume depletion, correcting this condition prior to initiation of GLYXAMBI is recommended [see Warnings and Precautions (5.2), Use in Specific Populations (8.5), and Patient Counseling Information (17)].

No studies have been performed specifically examining the safety and efficacy of GLYXAMBI in patients previously treated with other oral antihyperglycemic agents and switched to GLYXAMBI. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.

2.2?Patients with Renal Impairment
Assessment of renal function is recommended prior to initiation of GLYXAMBI and periodically thereafter.

GLYXAMBI should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m2.

No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73 m2.

GLYXAMBI should be discontinued if eGFR is less than 45 mL/min/1.73 m2 [see Warnings and Precautions (5.2, 5.4), and Use in Specific Populations (8.6)].

3??DOSAGE FORMS AND STRENGTHS

GLYXAMBI is a combination of empagliflozin and linagliptin. GLYXAMBI is available in the following dosage forms and strengths:

10 mg empagliflozin/5 mg linagliptin tablets are pale yellow, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol; the other side is debossed with "10/5?.
25 mg empagliflozin/5 mg linagliptin tablets are pale pink, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol; the other side is debossed with "25/5?.

RX ITEM-Glyxambi 25Mg/5Mg Tab 30 By Boeh
Glyxambi empagliflozin/linagliptin 25Mg/5Mg Tab 30 By Boehringer item No.:RX377205 NDC No.00597-164-30 0059716430 597016430 UPC No.:305970164302 NDC No. 00597-0164-30 UPC/GTIN No. 3-05970-16430-2 MPN

Glyxambi 25Mg/5Mg Tab 30 By Boehringer I
BRAND: GLYXAMBI NDC: 00597-0164-30,597016430 UPC: 3-05970-16430-2,305970164302 Boehringer Ingelheim

EMPAGLIFLOZIN/LINAGLIPTIN
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