VALPROIC ACID - valproic acid solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Caraco Pharmaceutical Laboratories, Ltd.

INN (Internationale Bezeichnung):

VALPROIC ACID

Zusammensetzung:

VALPROIC ACID 250 mg in 5 mL

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

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].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

VALPROIC ACID - VALPROIC ACID SOLUTION
CARACO PHARMACEUTICAL LABORATORIES, LTD.
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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 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;