DEPAKOTE- divalproex sodium tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

DIVALPROEX SODIUM

Composition:

DIVALPROEX SODIUM 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Depakote ER 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 Depakote ER is based in part on studies of Depakote (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 effectiveness of valproate for long-term

Product summary:

Depakote ER 250 mg is available as white ovaloid tablets with the corporate Abbott “A” logo , and the Abbo-Code (HF). Each Depakote ER tablet contains divalproex sodium equivalent to 250 mg of valproic acid in the following package sizes: Depakote ER 500 mg is available as gray ovaloid tablets with the corporate Abbott “A” logo, and the Abbo-Code HC. Each Depakote ER tablet contains divalproex sodium equivalent to 500 mg of valproic acid in the following packaging sizes: Recommended Storage Store tablets at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

DEPAKOTE - DIVALPROEX SODIUM TABLET, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEPAKOTE ER SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DEPAKOTE ER.
DEPAKOTE ER (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE 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 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) 4/2009
Warnings and Precautions (5.2) 11/2009
INDICATIONS AND USAGE
Depakote ER is 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
Depakote ER is intended for once-a-day oral administration. Depakote
ER 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/day to achieve
optimal clinical response; if response is not satisfactory, check
valproate plasma level; see full prescribing information
for conversion to monotherapy(2.2). The maximum recommended