JENTADUETO- linagliptin and metformin hydrochloride tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

LINAGLIPTIN (UNII: 3X29ZEJ4R2) (LINAGLIPTIN - UNII:3X29ZEJ4R2), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Disponível em:

Boehringer Ingelheim Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

linagliptin

Composição:

linagliptin 2.5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO 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 JENTADUETO [see Warnings and Precautions (5.2)]. JENTADUETO is contraindicated in patients with: - severe renal impairment (eGFR below 30 mL/min/1.73 m2 ) [see Warnings and Precautions (5.1)]. - acute or chronic metabolic acidosis, including diabetic ketoacidosis [see Warnings and Precautions (5.1)]. - hypersensitivity to linagliptin, metformin, or any of the excipients in JENTADUETO, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred with linagliptin [see Warnings and Precautions (5.4) and Adverse Reactions (6.1

Resumo do produto:

JENTADUETO (linagliptin and metformin HCl) tablets 2.5 mg/500 mg are light yellow, oval, biconvex tablets debossed with "D2/500" on one side and the Boehringer Ingelheim symbol on the other side, and are supplied as follows: Bottles of 60 (NDC 0597-0146-60) Bottles of 180 (NDC 0597-0146-18) JENTADUETO (linagliptin and metformin HCl) tablets 2.5 mg/850 mg are light orange, oval, biconvex tablets debossed with "D2/850" on one side and the Boehringer Ingelheim symbol on the other side, and are supplied as follows: Bottles of 60 (NDC 0597-0147-60) Bottles of 180 (NDC 0597-0147-18) JENTADUETO (linagliptin and metformin HCl) tablets 2.5 mg/1,000 mg are light pink, oval, biconvex tablets debossed with "D2/1000" on one side and the Boehringer Ingelheim symbol on the other side, and are supplied as follows: Bottles of 60 (NDC 0597-0148-60) Bottles of 180 (NDC 0597-0148-18) 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]. Protect from exposure to high humidity.

Status de autorização:

New Drug Application

Folheto informativo - Bula

Boehringer Ingelheim Pharmaceuticals, Inc.
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MEDICATION GUIDE
JENTADUETO® (JEN TA DOO E TOE)
(LINAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS)
FOR ORAL USE
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: April
2022
What is the most important information I should know about JENTADUETO?
JENTADUETO can cause serious side effects, including:
1.
Lactic acidosis. Metformin hydrochloride, one of the medicines in
JENTADUETO, can cause a rare
but serious condition called lactic acidosis (a build-up of lactic
acid in the blood) that can cause death.
Lactic acidosis is a medical emergency and must be treated in a
hospital.
Stop taking JENTADUETO and call your healthcare provider right away or
go to the nearest hospital
emergency room if you get any of the following symptoms of lactic
acidosis:
•
feel very weak and tired
•
have unusual (not normal) muscle pain
•
have trouble breathing
•
have unexplained stomach or intestinal problems with
nausea and vomiting, or diarrhea
•
have unusual sleepiness or sleep
longer than usual
•
feel cold, especially in your arms
and legs
•
feel dizzy or lightheaded
•
have a slow or irregular heartbeat
You have a higher chance of getting lactic acidosis with JENTADUETO if
you:
•
have severe kidney problems.
•
have liver problems.
•
drink a lot of alcohol (very often or short-term "binge" drinking).
•
get dehydrated (lose a large amount of body fluids). This can happen
if you are sick with a fever,
vomiting, or diarrhea. Dehydration can also happen when you sweat a
lot with activity or exercise
and do not drink enough fluids.
•
have certain x-ray tests with injectable dyes or contrast agents.
•
have surgery or other procedures for which you need to restrict the
amount of food and liquid you eat
and drink.
•
have congestive heart failure.
•
have a heart attack, severe infection, or stroke.
•
are 65 years of age or older.
Tell your healthcare provider if you have any of the problems in the
list above. Tell your h

Características técnicas

JENTADUETO- LINAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM
COATED
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JENTADUETO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR JENTADUETO.
JENTADUETO® (LINAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS), FOR
ORAL USE
INITIAL U.S. APPROVAL: 2012
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
POSTMARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE
RESULTED IN DEATH,
HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS. SYMPTOMS
INCLUDED
MALAISE, MYALGIAS, RESPIRATORY DISTRESS, SOMNOLENCE, AND ABDOMINAL
PAIN.
LABORATORY ABNORMALITIES INCLUDED ELEVATED BLOOD LACTATE LEVELS, ANION
GAP ACIDOSIS,
INCREASED LACTATE/PYRUVATE RATIO; AND METFORMIN PLASMA LEVELS
GENERALLY >5 MCG/ML.
(5.1)
RISK FACTORS INCLUDE RENAL IMPAIRMENT, CONCOMITANT USE OF CERTAIN
DRUGS, AGE ≥65
YEARS OLD, RADIOLOGICAL STUDIES WITH CONTRAST, SURGERY AND OTHER
PROCEDURES, HYPOXIC
STATES, EXCESSIVE ALCOHOL INTAKE, AND HEPATIC IMPAIRMENT. STEPS TO
REDUCE THE RISK
OF AND MANAGE METFORMIN-ASSOCIATED LACTIC ACIDOSIS IN THESE HIGH RISK
GROUPS ARE
PROVIDED IN THE FULL PRESCRIBING INFORMATION. (5.1)
IF LACTIC ACIDOSIS IS SUSPECTED, DISCONTINUE JENTADUETO AND INSTITUTE
GENERAL
SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS
RECOMMENDED.
(5.1)
RECENT MAJOR CHANGES
Indications and Usage (1)
4/2022
INDICATIONS AND USAGE
JENTADUETO is a combination of linagliptin, a dipeptidyl peptidase-4
(DPP-4) inhibitor and metformin
hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and
exercise to improve glycemic control
in adults with type 2 diabetes mellitus (1)
Limitations of Use
Not for treatment of type 1 diabetes (1)
Has not been studied in patients with a history of pancreatitis (1)
DOSAGE AND ADMINISTRATION
Individualize the starting dose of JENTADUETO based on the patient's
current regimen (2.1)
The maximum re