JANUMET XR- sitagliptin and metformin hydrochloride tablet, film coated, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

SITAGLIPTIN PHOSPHATE (UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Tilgjengelig fra:

A-S Medication Solutions

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

JANUMET® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JANUMET XR should not be used in patients with type 1 diabetes mellitus. JANUMET XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET XR. [See Warnings and Precautions (5.2).] JANUMET 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. - History of a serious hypersensitivity reaction to JANUMET XR, sitagliptin, or metformin such as anaphylaxis or angioedema. [See Warnings and Precautions (5.7); Adverse Reactions (6.2). ] Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to JANUMET XR durin

Produkt oppsummering:

Product: 50090-4411 NDC: 50090-4411-0 90 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 50090-4411-1 180 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

Autorisasjon status:

New Drug Application

Informasjon til brukeren

A-S Medication Solutions
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 12/2020
Medication Guide
JANUMET® XR (JAN-you-met XR)
(sitagliptin and metformin hydrochloride extended-release)
tablets, for oral use
Read this Medication Guide carefully before you start taking JANUMET
XR and each time you get a
refill. There may be new information. This information does not take
the place of talking with your
doctor about your medical condition or your treatment. If you have any
questions about JANUMET XR,
ask your doctor or pharmacist.
What is the most important information I should know about JANUMET XR?
JANUMET XR can cause serious side effects, including:
1.
Lactic Acidosis. Metformin, one of the medicines in JANUMET XR, can
cause a rare but serious
condition called lactic acidosis (a buildup of an acid in the blood)
that can cause death. Lactic
acidosis is a medical emergency and must be treated in the hospital.
Stop taking JANUMET XR and call your doctor right away if you have any
of the following symptoms,
which could be signs of lactic acidosis:
•
you feel cold in your hands or feet
•
you feel dizzy or lightheaded
•
you have a slow or irregular heartbeat
•
you feel very weak or tired
•
you have unusual (not normal) muscle pain
•
you have trouble breathing
•
you feel sleepy or drowsy
•
you have stomach pains, nausea or vomiting
Most people who have had lactic acidosis with metformin have other
things that, combined with the
metformin, led to the lactic acidosis. Tell your doctor if you have
any of the following, because you have
a higher chance for getting lactic acidosis with JANUMET XR if you:
•
have severe kidney problems or your kidneys are affected by certain
x-ray tests that use injectable
dye
•
have liver problems
•
drink alcohol very often, or drink a lot of alcohol in 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

Preparatomtale

JANUMET XR- SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED RELEASE
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JANUMET XR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR JANUMET XR.
JANUMET XR (SITAGLIPTIN 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 HIGHRISK GROUPS ARE PROVIDED IN THE FULL PRESCRIBING
INFORMATION. (5.1)
IF LACTIC ACIDOSIS IS SUSPECTED, DISCONTINUE JANUMET XR AND INSTITUTE
GENERAL SUPPORTIVE MEASURES IN
A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS RECOMMENDED. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1)
12/2020
Dosage and Administration (2.1)
12/2020
Contraindications (4)
12/2020
Warnings and Precautions (5.4, 5.6)
12/2020
Warnings and Precautions (5.12) Removal
12/2020
INDICATIONS AND USAGE
JANUMET XR is a combination of sitagliptin, 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 the treatment of type 1 diabetes. (1)
Has not been st