Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
VALPROIC ACID (UNII: 614OI1Z5WI) (VALPROIC ACID - UNII:614OI1Z5WI)
Akorn
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, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who
Valproic Acid Oral Solution, USP is available as a raspberry flavored, reddish clear oral solution containing the equivalent of 250 mg valproic acid per 5 mL as the sodium salt in bottles of 16 ounces, 5 mL unit dose, and in 10 mL unit dose in trays of ten cups. Store at controlled room temperature 15 to 30°C (59 to 86°F).
Abbreviated New Drug Application
VALPROIC ACID- VALPROIC ACID SOLUTION Akorn ---------- MEDICATION GUIDE Valproic Acid Oral Solution, USP (val • pro • ic acid) Revised 06/2022 Read this Medication Guide before you start taking Valproic Acid Oral Solution, USP 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 Oral Solution, USP? Do not stop taking Valproic Acid Oral Solution, USP without first talking to your healthcare provider. Stopping Valproic Acid Oral Solution, USP suddenly can cause serious problems. Valproic Acid Oral Solution, USP can cause serious side effects, including: 1. 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 thefollowing 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. 1. Valproic Acid Oral Solution, USP may harm your unborn baby. 2. If you take Valproic Acid Oral Solution, USP during pregnancy for any medical condition, your baby is at risk for serious birth defects that 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 that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out (urethra) on the bottom of the penis can also happen. Decreased hearing or hearing loss can also happen. Læs hele dokumentet
VALPROIC ACID- VALPROIC ACID SOLUTION AKORN ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VALPROIC ACID ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALPROIC ACID ORAL SOLUTION. VALPROIC ACID ORAL SOLUTION, USP INITIAL U.S. APPROVAL: 1978 WARNINGS: LIFE THREATENING ADVERSE REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • INDICATIONS AND USAGE Valproic acid is an antiepileptic drug indicated for: (1) • DOSAGE AND ADMINISTRATION Valproic acid is intended for oral administration. (2.1) (2) • • DOSAGE FORMS AND STRENGTHS Oral Solution: Equivalent of 250 mg valproic acid per 5 mL as the sodium salt (3) (3) CONTRAINDICATIONS • • • • • • WARNINGS AND PRECAUTIONS • • • • • HEPATOTOXICITY, INCLUDING FATALITIES, USUALLY DURING THE 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 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) Hepatic disease or significant hepatic dysfunction (4, 5.1) Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG) (4, 5.1) Suspected POLG-related disorder in children under two years of age (4, 5.1) Known hypersensitivity to the drug (4, 5.12) Urea Læs hele dokumentet