QTERNMET XR- dapagliflozin saxagliptin and metformin hydrochloride tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

DAPAGLIFLOZIN (UNII: 1ULL0QJ8UC) (DAPAGLIFLOZIN - UNII:1ULL0QJ8UC), SAXAGLIPTIN HYDROCHLORIDE (UNII: Z8J84YIX6L) (SAXAGLIPTIN ANHYDROUS - UNII:8I7IO46IVQ), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Предлага се от:

AstraZeneca Pharmaceuticals LP

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

QTERNMET XR (dapagliflozin, saxagliptin, and metformin hydrochloride) extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use QTERNMET XR is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. QTERNMET XR initiation is intended only for patients currently taking metformin. QTERNMET XR is contraindicated in patients with: Risk Summary Based on animal data showing adverse renal effects, from dapagliflozin, QTERNMET XR is not recommended during the second and third trimesters of pregnancy. The limited available data with QTERNMET XR or components (dapagliflozin and saxagliptin) in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk (see Data ). There are risks to the moth

Каталог на резюме:

How Supplied QTERNMET XR (dapagliflozin, saxagliptin, and metformin HCl) extended-release tablets are available in packages as listed: 2.5 mg dapagliflozin /2.5 mg saxagliptin /1000 mg metformin HCl Light brown to brown biconvex, oval “3001” debossed on one side Bottles of 60 0310‑6925‑60 5 mg dapagliflozin /2.5 mg saxagliptin /1000 mg metformin HCl Green biconvex, oval “3002” debossed on one side Bottles of 60 0310‑6950‑60 5 mg dapagliflozin /5 mg saxagliptin /1000 mg metformin HCl Pink biconvex, oval “3003” debossed on one side Bottles of 30 0310‑6975‑30 10 mg dapagliflozin /5 mg saxagliptin /1000 mg metformin HCl Gray biconvex, oval “3004” debossed on one side Bottles of 30 0310‑6990-30 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Статус Оторизация:

New Drug Application

Листовка

AstraZeneca Pharmaceuticals LP
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MEDICATION GUIDE
QTERNMET® XR (CUE-turnmet)
(dapagliflozin, saxagliptin, and metformin hydrochloride)
extended-release tablets, for oral use
What is the most important information I should know about QTERNMET
XR?
Serious side effects can happen to people taking QTERNMET XR,
including:
•
Lactic Acidosis. Metformin, one of the medicines in QTERNMET XR, can
cause a rare but serious
condition called lactic acidosis (a build-up of an acid in the blood)
that can cause death. Lactic acidosis
is a medical emergency and must be treated in the hospital.
Call your healthcare provider 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 unusual sleepiness or sleep longer than usual
∘
you have stomach pains, nausea, or vomiting
Most people who have had lactic acidosis with metformin have other
things that, combined with the
metformin use, led to the lactic acidosis. Tell your healthcare
provider if you have any of the
following, because you have a higher chance for getting lactic
acidosis with QTERNMET 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 can also happen when you sweat a
lot with activity or
exercise and do not drink enough fluids
∘
have surgery
∘
have a heart attack, severe infection, or stroke.
The best way to keep from having a problem with lactic acidosis from
metformin is to tell your
healthcare provider if you have any of the problems in the list above.
Your healthcare

Данни за продукта

QTERNMET XR- DAPAGLIFLOZIN SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
TABLET, FILM COATED
ASTRAZENECA PHARMACEUTICALS LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QTERNMET XR SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR QTERNMET XR.
QTERNMET XR (DAPAGLIFLOZIN, SAXAGLIPTIN, AND METFORMIN HYDROCHLORIDE)
EXTENDED-RELEASE TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 2019
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.5, 5.6) 01/2020
Warnings and Precautions (5.13, 5.14) Removed 01/2020
INDICATIONS AND USAGE
QTERNMET XR is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a
dipeptidyl peptidase-4 (DPP-4) inhibitor and a
biguanide combination product indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type
2 diabetes mellitus. (1)
Limitations of Use
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
•
•
•
®
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 QTERNMET XR AND INSTITUTE
GENERAL SUPPORTIVE
MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS RECOMMENDED.
(5.1)
Is not