Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)
Physicians Total Care, Inc.
DIVALPROEX SODIUM
DIVALPROEX SODIUM 500 mg
ORAL
PRESCRIPTION DRUG
Divalproex sodium extended-release tablets 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 Studies (14.1)] . The safety
Divalproex sodium extended-release tablets 500 mg are white, oval, biconvex, film coated tablets printed "A511" in black ink on one side and plain on the other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to 500 mg of valproic acid in the following packaging sizes: Recommended Storage Store tablets at 20- 25°C (68- 77°F) [see USP Controlled Room Temperature]. Manufactured by Anchen Pharmaceuticals (Taiwan), Inc. Zhongli City, Taoyuan County 320, Taiwan Manufactured for Anchen Pharmaceuticals, Inc. Irvine, CA 92618 Revised: 07/09 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
DIVALPROEX SODIUM - DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE PHYSICIANS TOTAL CARE, 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 ADMINISTRATION 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 ARE AT CONSIDERABLY HIGHER RISK OF FATAL HEPATOTOXICITY. MONITOR PATIENTS CLOSELY, AND PERFORM LIVER FUNCTION TESTS PRIOR TO THERAPY AND AT FREQUENT INTERVALS THEREAFTER (5.1) TERATOGENICITY, INCLUDING NEURAL TUBE DEFECTS (5.2) PANCREATITIS, INCLUDING FATAL HEMORRHAGIC CASES (5.3) RECENT MAJOR CHANGES Warnings and Precautions (5.5, 5.9, 5.11, 5.13, 5.14, 5.15 3/2008 Pediatric Use (8.4) 3/2008 INDICATIONS AND USAGE Divalproex sodium extended-release tablets 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. 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 Seizures: Start at 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/d Læs hele dokumentet