DEPAKENE valproic acid capsule liquid filled

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

VALPROIC ACID (UNII: 614OI1Z5WI) (VALPROIC ACID - UNII:614OI1Z5WI)

Verfügbar ab:

REMEDYREPACK INC.

INN (Internationale Bezeichnung):

VALPROIC ACID

Zusammensetzung:

VALPROIC ACID 250 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

New Drug Application

Fachinformation

DEPAKENE- VALPROIC ACID CAPSULE, LIQUID FILLED
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEPAKENE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DEPAKENE.
DEPAKENE (VALPROIC ACID), CAPSULES, USP, FOR ORAL USE
DEPAKENE (VALPROIC ACID) ORAL SOLUTION, USP
INITIAL U.S. APPROVAL: 1978
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
Depakene is an anti-epileptic drug indicated for:
Monotherapy and adjunctive therapy of complex partial seizures; sole
and adjunctive therapy of simple and complex
absence seizures; adjunctive therapy in patients with multiple seizure
types that include absence seizures (1)
DOSAGE AND ADMINISTRATION
Depakene is intended for oral administration. (2.1)
Simple and Complex Absence Seizures: Start at 10 to 15 mg/kg/day,
increasing at 1 week intervals by 5 to 10
mg/kg/week until seizure control or limiting side effects (2.1)
Safety of doses above 60 mg/kg/day is not established (2.1, 2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 250 mg valproic acid (3)
Syrup: Equivalent of 250 mg valproic acid per 5 mL as the sodium salt
(3)
CONTRAINDICATIONS
Hepatic disease or significant hepatic dysfunction (4, 5.1)
Known mitochondrial disorders caused by mutations in mitochondrial DNA
polymerase γ (POLG) (4, 5.1)
Suspected POLG-related disorder in children under two years of age (4,
5.1)
Known hypersensitivity to the drug (4, 5.12)
Urea cycle disorders (4, 5.6)
WARNINGS AND PR