DEPACON- valproate sodium injection

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI)

Доступно од:

AbbVie Inc.

INN (Међународно име):

VALPROATE SODIUM

Састав:

VALPROIC ACID 100 mg in 1 mL

Пут администрације:

INTRAVENOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Depacon is indicated as an intravenous alternative in patients for whom oral administration of valproate products is temporarily not feasible in the following conditions: Depacon is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Depacon is also indicated for use as sole and adjunctive therapy in the treatment of patients with simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. See Warnings and Precautions (5.1) for statement regarding fatal hepatic dysfunction. Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tu

Резиме производа:

Depacon (valproate sodium injection), equivalent to 100 mg of valproic acid per mL, is a clear, colorless solution in 5 mL single-dose vials, available in trays of 10 vials (NDC 0074-1564-10). Recommended storage: Store vials at controlled room temperature 15-30°C (59-86°F). No preservatives have been added. Unused portion of container should be discarded.

Статус ауторизације:

New Drug Application

Карактеристике производа

DEPACON- VALPROATE SODIUM INJECTION
ABBVIE INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEPACON SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DEPACON.
DEPACON (VALPROATE SODIUM), FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 1996
WARNING: LIFE THREATENING ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HEPATOTOXICITY, INCLUDING FATALITIES, USUALLY DURING THE FIRST 6
MONTHS OF TREATMENT. CHILDREN UNDER THE
AGE OF TWO YEARS AND PATIENTS WITH MITOCHONDRIAL DISORDERS ARE AT
HIGHER RISK. MONITOR PATIENTS CLOSELY,
AND PERFORM SERUM LIVER TESTING PRIOR TO THERAPY AND AT FREQUENT
INTERVALS THEREAFTER (5.1)
FETAL RISK, PARTICULARLY NEURAL TUBE DEFECTS, OTHER MAJOR
MALFORMATIONS, AND DECREASED IQ (5.2, 5.3, 5.4)
PANCREATITIS, INCLUDING FATAL HEMORRHAGIC CASES (5.5)
RECENT MAJOR CHANGES
Boxed Warning, Fetal Risk
2/2019
Indications and Usage, Important Limitations (1.2)
2/2019
Contraindications (4)
2/2019
Warnings and Precautions, Use in Women of Childbearing Potential (5.4)
2/2019
INDICATIONS AND USAGE
Depacon is indicated as an intravenous alternative in patients in whom
oral administration of valproate products is
temporarily not feasible in the following conditions:
Monotherapy and adjunctive therapy of complex partial seizures and
simple and complex absence seizures; adjunctive
therapy in patients with multiple seizure types that include absence
seizures (1)
DOSAGE AND ADMINISTRATION
Depacon is intended for intravenous use only.
Epile psy
Complex Partial Seizures in Adults and Children 10 years of age or
older: Initial dose is 10 to 15 mg/kg/day,
increasing at 1 week intervals by 5 to10 mg/kg/day to achieve optimal
clinical response. Maximum recommended
dose is 60 mg/kg/day (2.1).
Simple and Complex Absence Seizures: Initial dose is 10 to 15
mg/kg/day, increasing at 1 week intervals by 5 to 10
mg/kg/day to achieve optimal clinical response. Maximum recommended
dose is 60 mg/kg/day (2.1).
DOSAGE F