国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
VALPROIC ACID (UNII: 614OI1Z5WI) (VALPROIC ACID - UNII:614OI1Z5WI)
Cardinal Health
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 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 man
Valproic Acid Oral Solution USP is available as a red, cherry flavored solution containing the equivalent of 250 mg valproic acid per 5 mL as the sodium salt in 5 mL unit dose containers, available overbagged with 5 cups per bag, NDC 55154-9430-5.. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Repackaged By: Cardinal Health Zanesville, OH 43701 L37248870715
Abbreviated New Drug Application
VALPROIC ACID- VALPROIC ACID SOLUTION Cardinal Health ---------- MEDICATION GUIDE VALPROIC ACID ORAL SOLUTION USP Read this Medication Guide before you start taking valproic acid and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about valproic acid? Do not stop taking valproic acid without first talking to your healthcare provider. Stopping valproic acid suddenly can cause serious problems. Valproic acid can cause serious side effects, including: • Serious liver damage that can cause death, especially in children younger than 2 years old. The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment. Call your healthcare provider right away if you get any of the following symptoms: • nausea or vomiting that does not go away • loss of appetite • pain on the right side of your stomach (abdomen) • dark urine • swelling of your face • yellowing of your skin or the whites of your eyes In some cases, liver damage may continue despite stopping the drug. • Valproic acid may harm your unborn baby. • If you take valproic acid during pregnancy for any medical condition, your baby is at risk for serious birth defects. The most common birth defects with valproic acid affect the brain and spinal cord and are called spina bifida or neural tube defects. These defects occur in 1 to 2 out of every 100 babies born to mothers who use this medicine during pregnancy. These defects can begin in the first month, even before you know you are pregnant. Other birth defects can happen. • Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors. • Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect. • If you take valproic acid dur 阅读完整的文件
VALPROIC ACID- VALPROIC ACID SOLUTION CARDINAL HEALTH ---------- 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 ORAL SOLUTION USP. VALPROIC ACID ORAL SOLUTION, USP INITIAL U.S. APPROVAL: 2000 WARNINGS: LIFE THREATENING ADVERSE REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ • • • RECENT MAJOR CHANGES Boxed Warning, Hepatotoxicity 10/2013 Boxed Warning, Fetal Risk 10/2013 Indications and Usage, Important Limitations (1.2) 10/2013 Contraindications, Known or Suspected Mitochondrial Disorders (4) 10/2013 Warnings and Precautions, Hepatotoxicity (5.1) 10/2013 Warnings and Precautions, Birth Defects (5.2) 10/2013 Warnings and Precautions, Decreased IQ (5.3) 10/2013 Warnings and Precautions, Use in Women of Childbearing Potential (5.4) 10/2013 Warnings and Precautions, Brain Atrophy (5.7) 10/2013 INDICATIONS AND USAGE Valproic acid is an anti-epileptic drug indicated for: • DOSAGE AND ADMINISTRATION Valproic acid is intended for oral administration. (2.1) • • DOSAGE FORMS AND STRENGTHS Valproic acid oral solution USP: Equivalent of 250 mg valproic acid per 5 mL as the sodium salt CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • 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) 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) Simple and Complex Absence Se 阅读完整的文件