DIVALPROEX SODIUM tablet, film coated, extended release

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)

Disponibbli minn:

Physicians Total Care, Inc.

INN (Isem Internazzjonali):

DIVALPROEX SODIUM

Kompożizzjoni:

DIVALPROEX SODIUM 500 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

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