VALPROATE SODIUM injection, solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Fresenius Kabi USA, LLC

INN (Mezinárodní Name):

VALPROATE SODIUM

Složení:

VALPROIC ACID 100 mg in 1 mL

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Valproate sodium injection is indicated as an intravenous alternative in patients for whom oral administration of valproate products is temporarily not feasible in the following conditions: Valproate sodium injection 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. Valproate sodium injection 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 fet

Přehled produktů:

Valproate Sodium Injection is a clear, colorless solution supplied as: Available in packages of 10. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preservative Free. Unused portion of container should be discarded. The container closure is not made with natural rubber latex.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

VALPROATE SODIUM - VALPROATE SODIUM INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALPROATE SODIUM
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
VALPROATE SODIUM
INJECTION.
VALPROATE SODIUM INJECTION, FOR INTRAVENOUS INJECTION ONLY
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
6/2020
Indications and Usage, Important Limitations (1.2)
6/2020
Contraindications (4)
6/2020
Warnings and Precautions, Use in Women of Childbearing Potential (5.4)
6/2020
INDICATIONS AND USAGE
Valproate sodium injection 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
Valproate sodium injection is intended for intravenous use only.
Epilepsy
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 to 10 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