TRADJENTA- linagliptin tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

LINAGLIPTIN (UNII: 3X29ZEJ4R2) (LINAGLIPTIN - UNII:3X29ZEJ4R2)

Dostupné s:

Boehringer Ingelheim Pharmaceuticals, Inc.

INN (Mezinárodní Name):

linagliptin

Složení:

linagliptin 5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 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)]. TRADJENTA is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in TRADJENTA, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred [see Warnings and Precautions (5.3) and Adverse Reactions (6)]. Risk Summary The limited data with TRADJENTA use in pregnant women are not sufficient to inform of drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated

Přehled produktů:

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].

Stav Autorizace:

New Drug Application

Informace pro uživatele

Boehringer Ingelheim Pharmaceuticals, Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: June 2023
MEDICATION GUIDE
TRADJENTA® (TRAD gen ta)
(linagliptin tablets)
for oral use
What is the most important information I should know about TRADJENTA?
TRADJENTA can cause serious side effects, including:
•
Inflammation of the pancreas (pancreatitis) which may be severe and
lead to death. Certain
medical problems make you more likely to get pancreatitis.
Before you start taking TRADJENTA, tell your healthcare provider if
you have ever had:
•
inflammation of your pancreas (pancreatitis)
•
a history of alcoholism
•
stones in your gallbladder
(gallstones)
•
high blood triglyceride levels
Stop taking TRADJENTA and call your healthcare provider right away if
you have pain in your
stomach area (abdomen) that is severe and will not go away. The pain
may be felt going from your
abdomen to your back. The pain may happen with or without vomiting.
These may be symptoms of
pancreatitis.
What is TRADJENTA?
•
TRADJENTA is a prescription medicine used along with diet and exercise
to lower blood sugar
in adults with type 2 diabetes mellitus.
•
TRADJENTA is not for people with type 1 diabetes mellitus.
•
If you have had pancreatitis in the past, it is not known if you have
a higher chance of getting
pancreatitis while you take TRADJENTA.
•
It is not known if TRADJENTA is safe and effective in children.
Who should not take TRADJENTA?
Do not take TRADJENTA if you:
•
are allergic to linagliptin or any of the ingredients in TRADJENTA.
See the end of this
Medication Guide for a complete list of ingredients in TRADJENTA.
Symptoms of a serious allergic reaction to TRADJENTA may include:
•
skin rash, itching, flaking or peeling
•
raised red patches on your skin (hives)
•
swelling of your face, lips, tongue and throat that may cause
difficulty in breathing or
swallowing
•
difficulty with swallowing or breathing
If you have any of these symptoms, stop taking TRADJ

Charakteristika produktu

TRADJENTA- LINAGLIPTIN TABLET, FILM COATED
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRADJENTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRADJENTA.
TRADJENTA (LINAGLIPTIN TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
The recommended dosage of TRADJENTA is 5 mg orally once daily (2.1)
TRADJENTA can be taken with or without food (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg (3)
CONTRAINDICATIONS
Hypersensitivity to linagliptin or any of the excipients in TRADJENTA
(4, 5.3)
WARNINGS AND PRECAUTIONS
_Pancreatitis:_ There have been reports of acute pancreatitis,
including fatal pancreatitis. If pancreatitis is
suspected, promptly discontinue TRADJENTA. (5.1)
_Hypoglycemia:_ Consider lowering the dosage of insulin secretagogue
or insulin to reduce the risk of
hypoglycemia when initiating TRADJENTA (5.2)
_Hypersensitivity reactions:_ Serious hypersensitivity reactions
(e.g., anaphylaxis, angioedema, and
exfoliative skin conditions) have occurred with TRADJENTA. If
hypersensitivity reactions occur,
discontinue TRADJENTA, treat promptly, and monitor until signs and
symptoms resolve. (5.3)
_Arthralgia:_ Severe and disabling arthralgia has been reported in
patients taking TRADJENTA. Consider as
a possible cause for severe joint pain and discontinue drug if
appropriate. (5.4)
_Bullous pemphigoid:_ There have been reports of bullous pemphigoid
requiring hospitalization. Tell
patients to report development of blisters or erosions. If bullous
pemphigoid is suspected, discontinue
TRADJENTA. (5.5)
_H