Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)
Contract Pharmacy Services-PA
DIVALPROEX SODIUM
VALPROIC ACID 500 mg
ORAL
PRESCRIPTION DRUG
Divalproex sodium extended-release tablets are a 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 Studies (
Divalproex Sodium Extended-Release Tablets are available containing divalproex sodium, USP equivalent to 500 mg of valproic acid. The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with M 473 on one side of the tablet and blank on the other side. They are available as follows: NDC 67046-122-30 blisters of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription. * Maalox® is a registered trademark of Novartis. † TitralacTM is a trademark of 3M.
Abbreviated New Drug Application
DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE CONTRACT PHARMACY SERVICES-PA ---------- 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 FOR ORAL ADM INISTRATIO N. DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS 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 2 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 one week intervals by 5 to 10 mg/kg/d Lue koko asiakirja