VALPROATE SODIUM injection

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Hikma Pharmaceuticals USA Inc.

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 fetus

Přehled produktů:

Valproate Sodium Injection, USP, 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 0143-9637-10). Recommended storage: Store vials at 20° to 25°C (68° to 77°F) with excursions between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature]. No preservatives have been added. Unused portion of container should be discarded.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

VALPROATE SODIUM- VALPROATE SODIUM INJECTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALPROATE SODIUM
INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR VALPROATE
SODIUM INJECTION, USP.
VALPROATE SODIUM INJECTION, USP 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)
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 5 to 10 mg/kg/day to achieve optimal clinical response.
Maximum recommended dose is
60 mg/kg/day (2.1).
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg per mL in a 5 mL single dose vial (3)
CONTRAINDICATIONS
Hepatic d