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Monotherapy and Combination Therapy
TRADJENTA tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].
Important Limitations of Use
DOSAGE AND ADMINISTRATION
The recommended dose of TRADJENTA is 5 mg once daily.
TRADJENTA tablets can be taken with or without food.
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When TRADJENTA is used in combination with an insulin secretagogue (e.g., Sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia [see WARNINGS AND PRECAUTIONS].
Dosage Forms and Strengths
TRADJENTA (linagliptin) 5 mg tablets are light red, round, biconvex, bevel-edged, film-coated tablets with "D5" debossed on one side and the Boehringer Ingelheim logo debossed on the other side.
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 logo on the other side.
They are supplied as follows:
Bottles of 30 (NDC 0597-0140-30)
Bottles of 90 (NDC 0597-0140-90)
Bottles of 1000 (NDC 0597-0140-10)
Cartons containing 10 blister cards of 10 tablets each (10x10) (NDC 0597-0140-61)
If repackaging is required, dispense in a tight container as defined in USP.
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Store in a safe place out of reach of children.
Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company Indianapolis, IN 46285 USA.
Last reviewed on RxList: 8/29/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Tradjenta Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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