VALPROIC ACID capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

valproic acid (UNII: 614OI1Z5WI) (valproic acid - UNII:614OI1Z5WI)

Предлага се от:

Upsher-Smith Laboratories, Inc

INN (Международно Name):

valproic acid

Композиция:

valproic acid 250 mg

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

VALPROIC ACID- VALPROIC ACID CAPSULE
UPSHER-SMITH LABORATORIES, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALPROIC ACID CAPSULES, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALPROIC ACID
CAPSULES, USP.
VALPROIC ACID CAPSULES, USP FOR ORAL USE
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 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, Hepatotoxicity 05/2013
Boxed Warning, Fetal Risk 05/2013
Indications and Usage, Important Limitations (1.2) 05/2013
Contraindications, Known or Suspected Mitochondrial Disorders (4)
05/2013
Warnings and Precautions, Hepatotoxicity (5.1) 05/2013
Warnings and Precautions, Birth Defects (5.2) 05/2013
Warnings and Precautions, Decreased IQ (5.3) 05/2013
Warnings and Precautions, Use in Women of Childbearing Potential (5.4)
05/2013
Warnings and Precautions, Brain Atrophy (5.7) 05/2013
INDICATIONS AND USAGE
Valproic Acid Capsules, USP are 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 capsules are 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