ean) 8.2 8.1
Change from baseline (adjusted mean) -0.7 -0.1
Difference from placebo (adjusted mean) (95% CI) -0.6 (-0.7, -0.5)
Patients n (%) achieving A1C <7% 243 (31.2) 24 (9.2)
FPG (mg/dL)
Number of patients n = 739 n = 248
Baseline (mean) 159.2 162.6
Change from baseline (adjusted mean) -4.6 8.1
Difference from placebo (adjusted mean) (95% CI) -12.7 (-18.1, -7.3)
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 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)
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.
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling.
17.1 Instructions
Inform patients of the potential risks and benefits of TRADJENTA and of alternative modes of therapy. Also inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and A1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change.
Instruct patients to take TRADJENTA only as prescribed. If a dose is missed, advise patients not to double their next dose.
Instruct patients to read the Patient Information before starting TRADJENTA therapy and to reread it each time the prescription is renewed. Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.
17.2 Laboratory Tests
Inform patients that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and A1C levels, with a goal of decreasing these levels toward the normal range. A1C monitoring is especially useful for eva luating long-term glycemic control.
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
Licensed from:
Boehringer Ingelheim International GmbH, Ingelheim, Germany
Copyright 2011 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED
IT5253AD2911
10007261/01
IT5437AD2911
10007237/01
PATIENT INFORMATION
TRADJENTA™ (TRAD gen ta)
(linagliptin)
Tablets
Read this Patient Information before you start taking TRADJENTA and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is TRADJENTA?
TRADJENTA is a prescription medicine used along with diet and exercise to lower blood sugar in adults wi |
