JENTADUETO XR- linagliptin and metformin hydrochloride tablet, film coated, extended release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Boehringer Ingelheim Pharmaceuticals, Inc.

INN (International ime):

linagliptin

Sastav:

linagliptin 2.5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus. JENTADUETO XR 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 XR [see Warnings and Precautions (5.2)]. JENTADUETO XR 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 XR, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred with linagliptin [see Warnings and Precautions (5.4) and Adve

Proizvod sažetak:

JENTADUETO XR (linagliptin and metformin HCl extended-release) tablets 5 mg/1,000 mg, white, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim symbol and "D5" on the top line and "1000 M" on the bottom line, are supplied as follows: Bottles of 30 (NDC 0597-0275-33) Bottles of 90 (NDC 0597-0275-81) JENTADUETO XR (linagliptin and metformin HCl extended-release) tablets 2.5 mg/1,000 mg, yellow, oval-shaped coated tablets with one side printed in black ink with the Boehringer Ingelheim symbol and "D2" on the top line and "1000 M" on the bottom line, are supplied as follows: Bottles of 60 (NDC 0597-0270-73) Bottles of 180 (NDC 0597-0270-94) 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 autorizacije:

New Drug Application

Uputa o lijeku

Boehringer Ingelheim Pharmaceuticals, Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: June
2023
MEDICATION GUIDE
JENTADUETO® XR (JEN ta doo e toe XR)
(linagliptin and metformin hydrochloride extended-release tablets)
for oral use
What is the most important information I should know about JENTADUETO
XR?
JENTADUETO XR can cause serious side effects, including:
1. Lactic acidosis. Metformin hydrochloride (HCl), one of the
medicines in JENTADUETO
XR, 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 XR 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 XR
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 t

Svojstava lijeka

JENTADUETO XR- LINAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM
COATED,
EXTENDED RELEASE
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JENTADUETO XR SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR JENTADUETO XR.
JENTADUETO XR (LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
EXTENDED-RELEASE 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 XR AND
INSTITUTE GENERAL
SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS
RECOMMENDED.
(5.1)
INDICATIONS AND USAGE
JENTADUETO XR 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 recommended in patients with type 1 diabetes mellitus (1)
Has not been studied in patients with a history of pancreatitis (1)
DOSAGE AND ADMINISTRATION
Individualize the starting dosage of JENTADUETO XR based on the
patient's current regim