País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
VALPROIC ACID (UNII: 614OI1Z5WI) (VALPROIC ACID - UNII:614OI1Z5WI)
Pliva Inc.
VALPROIC ACID
VALPROIC ACID 250 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
VALPROIC ACID - VALPROIC ACID CAPSULE, LIQUID FILLED PLIVA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VALPROIC ACID CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALPROIC ACID CAPSULES. VALPROIC ACID CAPSULES, USP FOR ORAL USE 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 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 Warnings and Precautions, Birth Defects (5.2) 01/2015 Warnings and Precautions, Bleeding and Other Hematopeietic Disorders (5.8) 01/2015 Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reaction (5.12) 01/2015 INDICATIONS AND USAGE Valproic Acid Capsules 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 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 mitochondrial disorders caused by mut Leer el documento completo