Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)
NCS HealthCare of KY, Inc dba Vangard Labs
DIVALPROEX SODIUM
VALPROIC ACID 125 mg
ORAL
PRESCRIPTION DRUG
Divalproex sodium is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. The efficacy of divalproex sodium was established in 3 week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)] . The safety and effectiveness of divalproex sodium for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient. Divalproex sodium delayed-release tablets are indicated as monothe
Divalproex Sodium Delayed-release Tablets, USP equivalent to 125 mg of valproic acid, are white to off-white having mottled spots, oval shaped, enteric-coated tablets with the logo of "ZA08" on one side and plain on other side.and are supplied as follows: NDC 0615-7848-39 in blistercards of 30 tablets NDC 0615-7848-30 in unit-dose boxes of 30 tablets Divalproex Sodium Delayed-release Tablets, USP equivalent to 250 mg of valproic acid, are white to off-white having mottled spots, oval shape, convex, enteric-coated tablets imprinted with the logo of "ZA07" on one side and plain on other side. Divalproex Sodium Delayed-release Tablets, USP equivalent to 500 mg of valproic acid, are white to off-white having mottled spots, oval shape, beveled edge, convex enteric-coated tablets imprinted with the logo of "ZA06" on one side and plain on other side. Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in light-resistant container.
Abbreviated New Drug Application
DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE NCS HealthCare of KY, Inc dba Vangard Labs ---------- MEDICATION GUIDE Divalproex Sodium (dye val PRO ex sew dee uhm) Delayed-release Tablets, USP Read this Medication Guide before you start taking divalproex sodium 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 divalproex sodium? Do not stop divalproex sodium without first talking to your healthcare provider. Stopping divalproex sodium suddenly can cause serious problems. Divalproex sodium 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. 2. Divalproex sodium may harm your unborn baby. • If you take divalproex sodium during pregnancy for any medical condition, your baby is at risk for serious birth defects. The most common birth defects with divalproex sodium 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 duri Citiți documentul complet
DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DIVALPROEX SODIUM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIVALPROEX SODIUM. DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP FOR ORAL USE INITIAL U.S. APPROVAL: 1983 WARNINGS: LIFE THREATENING ADVERSE REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ 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) RECENT MAJOR CHANGES Boxed Warning, Hepatotoxicity 07/2013 Boxed Warning, Fetal Risk 06/2013 Indications and Usage, Important Limitations (1.4) 06/2013 Contraindications, Known or Suspected Mitochondrial Disorders (4) 07/2013 Contraindications, Prophylaxis of Migraines in Pregnancy (4) 06/2013 Warnings and Precautions, Hepatotoxicity (5.1) 07/2013 Warnings and Precautions, Birth Defects (5.2) 06/2013 Warnings and Precautions, Decreased IQ (5.3) 06/2013 Warnings and Precautions, Use in Women of Childbearing Potential (5.4) 06/2013 INDICATIONS AND USAGE Divalproex sodium delayed-release tablets are anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder (1.1) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2) Prophylaxis of migraine headaches (1.3) DOSAGE AND ADMINISTRATION Divalproex sodium delayed-release tablets are administered orally in divided doses Divalproex sodium d Citiți documentul complet