Country: United States
Language: English
Source: NLM (National Library of Medicine)
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)
Major Pharmaceuticals
DIVALPROEX SODIUM
VALPROIC ACID 250 mg
ORAL
PRESCRIPTION DRUG
Divalproex sodium extended-release tablet 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 divalproex sodium extended-release tablets is based in part on studies of 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
Divalproex sodium extended-release tablets USP, 250 mg are available as white to off white, round shaped, beveled edge, biconvex coated tablets debossed “R” on one side and “533” on other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to 250 mg of valproic acid and are supplied in: Carton of 80 tablets (10 tablets each blister pack x 8) NDC 0904-6363-45 Recommended Storage Store tablets at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, EXTENDED RELEASE Major Pharmaceuticals ---------- MEDICATION GUIDE Divalproex Sodium Extended-Release Tablets USP, 250 mg (dye val’ proe ex soe’ dee um) Read this Medication Guide before you start taking divalproex sodium extended-release tablets 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 extended-release tablets? Do not stop taking divalproex sodium extended-release tabletswithout first talking to your healthcare provider. Stopping divalproex sodium extended-release tablets suddenly can cause serious problems. Divalproex sodium extended-release tabletscan 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: 1. nausea or vomiting that does not go away 2. loss of appetite 3. pain on the right side of your stomach (abdomen) 4. dark urine 5. swelling of your face 6. yellowing of your skin or the whites of your eyes In some cases, liver damage may continue despite stopping the drug. 2. Divalproex sodium extended-release tablets may harm your unborn baby. 1. If you take divalproex sodium extended-release tablets 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 urin Read the complete document
DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, EXTENDED RELEASE MAJOR PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DIVALPROEX SODIUM EXTENDED- RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2000 WARNING: LIFE THREATENING ADVERSE REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ 4. 5. 6. INDICATIONS AND USAGE Divalproex sodium extended-release tablet is indicated for: 4. 5. 6. DOSAGE AND ADMINISTRATION 6. 7. 8. 9. 10. DOSAGE FORMS AND STRENGTHS 250 mg Tablets (3) (3) CONTRAINDICATIONS 8. 9. 10. 11. 12. 13. 14. WARNINGS AND PRECAUTIONS 10. 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) 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 (1.3) Divalproex sodium extended-release tablets are intended for once-a-day oral administration. Divalproex sodium extended-release tablets should be swallowed whole and should not be crushed or chewed (2.1, 2.2). Mania: - Initial dose is 25 mg/kg/day, increasing as rapidly as possible to achieve therapeutic response or desired plasma level (2.1). The maximum recommended dosage is 60 mg/kg/day (2.1, 2.2) Complex Partial Seiz Read the complete document