国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
Divalproex sodium extended-release tablets, USP are valproate and are 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 Studie
Divalproex Sodium Extended-release Tablets USP, 250 mg are available as white to off-white, capsule-shaped, biconvex, film-coated tablets imprinted with "ZA47" on one side and the other side plain and are supplied as follows: NDC 68001-105-00 in bottle of 100 tablets NDC 68001-105-03 in bottle of 500 tablets Divalproex Sodium Extended-release Tablets USP, 500 mg are available as white to off-white, capsule-shaped, biconvex, film-coated tablets imprinted with "ZA48" on one side and the other side plain and are supplied as follows: NDC 68001-106-00 in bottle of 100 tablets NDC 68001-106-03 in bottle of 500 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Maalox ® is the registered trademark of Novartis Consumer Health. Trisogel ® is the registered trademark of Eli Lilly Corporation. Titralac ® is the registered trademark of 3M Pharmaceuticals.
Abbreviated New Drug Application
DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE REMEDYREPACK INC. ---------- MEDICATION GUIDE Divalproex Sodium (dye val PRO ex sew dee uhm) Extended-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 taking 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. 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 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 n 完全なドキュメントを読む
DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE REMEDYREPACK INC. ---------- 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._ 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 1. Boxed Warning, Fetal Risk 2/2019 2. Indications and Usage, Important Limitations (1.4) 2/2019 3. Contraindications (4) 2/2019 Warnings and Precautions, Use in Women of Childbearing Potential (5.4) 2/2019 INDICATIONS AND USAGE Divalproex sodium extended-release tablets, USP are 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 ( 1.3) DOSAGE AND ADMINISTRATION 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 lev 完全なドキュメントを読む