Linagliptin 5 MG Oral Tablet Tradjenta
1 INDICATIONS AND USAGE TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . TRADJENTA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ) Limitations of Use Not recommended in patients with type 1 diabetes mellitus as it would not be effective ( 1 ) Has not been studied in patients with a history of pancreatitis ( 1 ) Limitations of Use TRADJENTA is not recommended in patients with type 1 diabetes mellitus as it would not be effective. TRADJENTA 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 TRADJENTA [see Warnings and Precautions (5.1) ].
Boehringer Ingelheim Pharmaceuticals, Inc.
ROUND RED D5
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16 HOW SUPPLIED/STORAGE AND HANDLING TRADJENTA tablets are available as light red, round, biconvex, bevel-edged, film-coated tablets containing 5 mg of
LINAGLIPTIN. TRADJENTA tablets are debossed with "D5" on one side and the Boehringer Ingelheim symbol on the other side. They are supplied as follows: Bottles of 30 (NDC 0597-0140-30) Bottles of 90 (NDC 0597-0140-90) Cartons containing 10 blister cards of 10 tablets each (10 × 10) (NDC 0597-0140-61), institutional pack. If repackaging is required, dispense in a tight container as defined in USP. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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