Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)
Aphena Pharma Solutions - Tennessee, LLC
DIVALPROEX SODIUM
VALPROIC ACID 500 mg
ORAL
PRESCRIPTION DRUG
Depakote ER is a valproate and is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. 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. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). The efficacy of Depakote ER is based in part on studies of Depakote (divalproex sodium delayed release tablets) in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see Clinical Studies (14.1)] . The effectiveness of valproate for long-term
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Depakote ER 250 mg is available as white ovaloid tablets with the “a” logo and the code (HF). Each Depakote ER tablet contains divalproex sodium equivalent to 250 mg of valproic acid in the following package sizes: Bottles of 60....……………………………………………(NDC 0074-3826-60). Bottles of 100……………………………………………..(NDC 0074-3826-13). Bottles of 500……………………………………………..(NDC 0074-3826-53). Unit Dose Packages of 100..................…………………..(NDC 0074-3826-11). Depakote ER 500 mg is available as gray ovaloid tablets with the “a” logo and the code HC. Each Depakote ER tablet contains divalproex sodium equivalent to 500 mg of valproic acid in the following packaging sizes: Bottles of 100...................................................................(NDC 0074-7126-13). Bottles of 500...................................................................(NDC 0074-7126-53). Unit Dose Packages of 100...............................................(NDC 0074-7126-11). Recommended Storage Store tablets at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
New Drug Application
DEPAKOTE ER- DIVALPROEX SODIUM TABLET, EXTENDED RELEASE Aphena Pharma Solutions - Tennessee, LLC ---------- MEDICATION GUIDE DEPAKOTE ER (dep-a-kOte) (divalproex sodium) Extended Release Tablets DEPAKOTE (dep-a-kOte) (divalproex sodium) Tablets DEPAKOTE (dep-a-kOte) (divalproex sodium coated particles in capsules) Sprinkle Capsules DEPAKENE (dep-a-keen) (valproic acid) Capsules and Oral Solution Read this Medication Guide before you start taking Depakote or Depakene 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 Depakote and Depakene? Do not stop taking Depakote or Depakene without first talking to your healthcare provider. Stopping Depakote or Depakene suddenly can cause serious problems. Depakote and Depakene 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. Depakote or Depakene may harm your unborn baby. • If you take Depakote or Depakene during pregnancy for any medical condition, your baby is at risk for serious birth defects. The most common birth defects with Depakote or Depakene 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. Ot Прочитайте повний документ
DEPAKOTE ER- DIVALPROEX SODIUM TABLET, EXTENDED RELEASE APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DEPAKOTE ER SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEPAKOTE ER. DEPAKOTE ER (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE FOR ORAL USE INITIAL U.S. APPROVAL: 2000 WARNING: 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 Boxed Warning, Hepatotoxicity 05/2013 Boxed Warning, Fetal Risk 05/2013 Indications and Usage, Important Limitations (1.4) 05/2013 Contraindications, Known or Suspected Mitochondrial Disorders (4) 05/2013 Contraindications, Prophylaxis of Migraines in Pregnancy (4) 05/2013 Warnings and Precautions, Hepatotoxicity (5.1) 05/2013 Warnings and Precautions, Birth Defects (5.2) 05/2013 Warnings and Precautions, Decreased IQ (5.3) 05/2013 Warnings and Precautions, Use in Women of Childbearing Potential (5.4) 05/2013 Warnings and Precautions, Brain Atrophy (5.7) 05/2013 Warning and Precautions, Medication Residue in the Stool (5.19) 02/2013 INDICATIONS AND USAGE Depakote ER is an anti-epileptic drug indicated for: Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (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 Прочитайте повний документ