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Tradjenta

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Tradjenta

Tradjenta

INDICATIONS

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

TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

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].

DOSAGE AND ADMINISTRATION

Recommended Dosing

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].

HOW SUPPLIED

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.

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 logo 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 x 10) (NDC 0597-0140-61)

If repackaging is required, dispense in a tight container as defined in USP.

Storage

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. Revised: May 2014

Last reviewed on RxList: 6/9/2014
This monograph has been modified to include the generic and brand name in many instances.

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