Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
VALPROIC ACID (UNII: 614OI1Z5WI) (VALPROIC ACID - UNII:614OI1Z5WI)
Contract Pharmacy Services-PA
VALPROIC ACID
VALPROIC ACID 250 mg
ORAL
PRESCRIPTION DRUG
Valproic Acid Capsules are 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 Capsules are 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 unle
Each white, oblong soft-gelatin capsule is imprinted PA2120, contains 250 mg valproic acid in the following: NDC 67046-807-07 blisterpacks of 7 NDC 67046-807-14 blisterpacks of 14 NDC 67046-807-15 blisterpacks of 15 NDC 67046-807-20 blisterpacks of 20 NDC 67046-807-21 blisterpacks of 21 NDC 67046-807-28 blisterpacks of 28 NDC 67046-807-30 blisterpacks of 30 NDC 67046-807-60 blisterpacks of 60 The softgels should be protected from moisture and humidity and stored between 59 to 77°F (15 to 25°C) as per the container label. Dispense in a tight, light-resistant container as defined in the USP/NF.
Abbreviated New Drug Application
VALPROIC ACID- VALPROIC ACID CAPSULE, LIQUID FILLED Contract Pharmacy Services-PA ---------- MEDICATION GUIDE Valproic Acid Capsules Read this Medication Guide before you start taking Valproic Acid Capsules 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 Capsules? Do not stop taking Valproic Acid Capsules without first talking to your healthcare provider. Stopping Valproic Acid suddenly can cause serious problems. Valproic Acid Capsules 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 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 Capsules may harm your unborn baby. • If you take Valproic Acid Capsules 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. • Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors. • Taking fo Przeczytaj cały dokument
VALPROIC ACID- VALPROIC ACID CAPSULE, LIQUID FILLED CONTRACT PHARMACY SERVICES-PA ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 807 VALPROIC ACID 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) 1/2015 Warnings and Precautions, Bleeding and Other Hematopeietic Disorders ( 5.8) 1/2015 Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reaction ( 5.12) 1/2015 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 Przeczytaj cały dokument