DEPAKOTE ER

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

DIVALPROEX SODIUM

제공처:

ABBOTT INDONESIA - Indonesia

INN (International Name):

DIVALPROEX SODIUM

복용량:

250 MG

약제 형태:

TABLET SALUT SELAPUT PELEPASAN LAMBAT

패키지 단위:

DUS, 1 BOTOL @ 100 TABLET SALUT SELAPUT PELEPASAN LAMBAT

Manufactured by:

ABBOTT INDONESIA - Indonesia

승인 날짜:

2019-12-27

제품 특성 요약

Page 1 of 45
DEPAKOTE ER
cc
DEPAKOTE ER
DIVALPROEX SODIUM EXTENDED – RELEASE TABLETS
WARNING: LIFE THREATENING ADVERSE REACTIONS
HEPATOTOXICITY
_GENERAL POPULATION: _HEPATIC FAILURE RESULTING IN FATALITIES HAS
OCCURRED IN PATIENTS RECEIVING VALPROATE
AND ITS DERIVATIVES. THESE INCIDENTS USUALLY HAVE OCCURRED DURING THE
FIRST SIX MONTHS OF TREATMENT.
SERIOUS
OR
FATAL
HEPATOTOXICITY
MAY
BE
PRECEDED
BY
NON-SPECIFIC
SYMPTOMS
SUCH
AS
MALAISE,
WEAKNESS, LETHARGY, FACIAL EDEMA, ANOREXIA, AND VOMITING. IN PATIENTS
WITH EPILEPSY, A LOSS OF SEIZURE
CONTROL MAY ALSO OCCUR. PATIENTS SHOULD BE MONITORED CLOSELY FOR
APPEARANCE OF THESE SYMPTOMS.
SERUM LIVER TESTS SHOULD BE PERFORMED PRIOR TO THERAPY AND AT FREQUENT
INTERVALS THEREAFTER, ESPECIALLY
DURING THE FIRST SIX MONTHS _[SEE WARNINGS AND PRECAUTIONS (5.1)]_.
CHILDREN UNDER THE AGE OF TWO YEARS ARE AT A CONSIDERABLY INCREASED
RISK OF DEVELOPING FATAL
HEPATOTOXICITY,
ESPECIALLY
THOSE
ON
MULTIPLE
ANTICONVULSANTS,
THOSE
WITH
CONGENITAL
METABOLIC
DISORDERS, THOSE WITH SEVERE SEIZURE DISORDERS ACCOMPANIED BY MENTAL
RETARDATION, AND THOSE WITH
ORGANIC BRAIN DISEASE. WHEN DEPAKOTE ER IS USED IN THIS PATIENT GROUP,
IT SHOULD BE USED WITH EXTREME
CAUTION AND AS A SOLE AGENT. THE BENEFITS OF THERAPY SHOULD BE WEIGHED
AGAINST THE RISKS. THE
INCIDENCE OF FATAL HEPATOTOXICITY DECREASES CONSIDERABLY IN
PROGRESSIVELY OLDER PATIENT GROUPS.
_PATIENTS WITH MITOCHONDRIAL DISEASE: _THERE IS AN INCREASED RISK OF
VALPROATE-INDUCED ACUTE LIVER FAILURE
AND
RESULTANT
DEATHS
IN
PATIENTS
WITH
HEREDITARY
NEUROMETABOLIC
SYNDROMES
CAUSED
BY
DNA
MUTATIONS OF THE MITOCHONDRIAL DNA POLYMERASE Γ (POLG) GENE (E.G.
ALPERS HUTTENLOCHER SYNDROME).
DEPAKOTE ER IS CONTRAINDICATED IN PATIENTS KNOWN TO HAVE MITOCHONDRIAL
DISORDERS CAUSED BY POLG
MUTATIONS AND CHILDREN UNDER TWO YEARS OF AGE WHO ARE CLINICALLY
SUSPECTED OF HAVING A MITOCHONDRIAL
DISORDER _[SEE CONTRAINDICATIONS (4)]_. IN PATIENTS OVER TWO YEARS OF
AGE WHO ARE CLINICALLY SUSPECTED OF
HAVING
A
HEREDITARY
MITOCHONDRIAL
DISEASE,
DEPAKOTE
ER
SHOULD