Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
VALPROIC ACID (UNII: 614OI1Z5WI) (VALPROIC ACID - UNII:614OI1Z5WI)
Caraco Pharmaceutical Laboratories, Ltd.
VALPROIC ACID
VALPROIC ACID 250 mg in 5 mL
ORAL
PRESCRIPTION DRUG
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 Precautions (5.1) for statement regarding fatal hepatic dysfunction. Valproic acid should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions (5.1)] . Valproic acid is contraindicated in patients with known hypersensitivity to the drug [see Warnings and Precautions (5.
Valproic acid is available as a red Oral Solution containing the equivalent of 250 mg valproic acid per 5 mL as the sodium salt in bottles of 16 ounces (NDC 57664-124-34). Store at 20 to 25°C (68 to 77°F). [See USP for Controlled Room Temperature].
Abbreviated New Drug Application
VALPROIC ACID - VALPROIC ACID SOLUTION CARACO PHARMACEUTICAL LABORATORIES, LTD. ---------- 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 ORAL SOLUTION, 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 and other major malformations (5.2, 5.3) Pancreatitis, including fatal hemorrhagic cases (5.4) RECENT MAJOR CHANGES Warnings and Precautions, Use in Women of Childbearing Potential (5.2) 10/2011 Warnings and Precautions, Birth Defects (5.3) 10/2011 INDICATIONS AND USAGE Valproic acid is an anti-epileptic drug indicated for: (1) 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) (2) 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) (2) DOSAGE FORMS AND STRENGTHS Oral Solution: 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 hypersensitivity to the drug (4, 5.11) Urea cycle disorders (4, 5.5) (4) WARNINGS AND PRECAUTIONS Hepatotoxicity; monitor liver function tests (5.1) Women of Childbearing Potential; Прочитать полный документ