VALPROIC- valproic acid capsule, liquid filled

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

VALPROIC ACID

Sammensetning:

VALPROIC ACID 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Valproic Acid 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. Valproic Acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which 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 Precaution (5.1) for statement regarding fatal hepatic dysfunction. Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the ma

Produkt oppsummering:

Valproic Acid Capsules, USP 250 mg. Each off-white colored soft gelatin Capsule is imprinted with VALPROIC 250. Store capsules at controlled room temperature 15-30°C (59-86°F), see USP. Dispense in a tight, light-resistant container.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

VALPROIC- VALPROIC ACID CAPSULE, LIQUID FILLED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALPROIC ACID SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VALPROIC ACID. VALPROIC ACID CAPSULES, USP
INITIAL U.S. APPROVAL: 1978
WARNINGS: LIFE THREATENING ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
• Hepatotoxicity, including fatalities, usually during first 6
months of treatment. Children under the age of two years
are a considerable higher risk of fatal hepatotoxicity. Monitor
patients closely, and perform liver function test 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 06/2013
Indications and Usage, Important Limitations (1.2) 06/2013
Warnings and Precautions, Birth Defects (5.2) 06/2013
Warnings and Precautions, Decreased IQ (5.3) 06/2013
Warnings and Precautions, Use in Women of Childbearing Potential (5.4)
06/2013
INDICATIONS AND USAGE
Valproic Acid 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
Valproic Acid 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)
CONTRAINDICATIONS
Hepatic disease or significant hepatic dysfunction (4, 5.1)
Known hypersensitivity to the drug (4, 5.12)
Urea cycle disorder