INVOKAMET XR canagliflozin and metformin hydrochloride tablet film coated extended release

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

canagliflozin (UNII: 0SAC974Z85) (canagliflozin anhydrous - UNII:6S49DGR869)

متاح من:

Janssen Pharmaceuticals, Inc.

INN (الاسم الدولي):

canagliflozin

تركيب:

canagliflozin anhydrous 50 mg

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الوضع إذن:

New Drug Application

خصائص المنتج

INVOKAMET XR- CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
JANSSEN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INVOKAMET XR SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR INVOKAMET XR.
INVOKAMET XR (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
EXTENDED-RELEASE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL – 2016
WARNING: LACTIC ACIDOSIS AND LOWER LIMB AMPUTATION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LACTIC ACIDOSIS
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 INVOKAMET XR AND
INSTITUTE GENERAL SUPPORTIVE MEASURES
IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS RECOMMENDED. (5.1)
RISK OF LOWER LIMB AMPUTATION
IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE ESTABLISHED CARDIOVASCULAR
DISEASE (CVD) OR AT RISK FOR CVD,
CANAGLIFLOZIN, A COMPONENT OF INVOKAMET XR, HAS BEEN ASSOCIATED WITH
LOWER LIMB AMPUTATIONS,
MOST FREQUENTLY OF THE TOE AND MIDFOOT; SOME ALSO INVOLVED THE LEG.
(5.2)
BEFORE INITIATING, CONSIDER FACTORS THAT MAY INCREASE THE RISK OF
AMPUTATION. MONITOR PATIENTS
RECEIVING INVOKAMET XR FOR INFECTIONS OR ULCERS OF THE LOWER LIMBS,
AND DISCONTINUE IF THESE OCCUR.
(5.2)
RECENT MA