DIVALPROEX SODIUM ER- divalproex sodium tablet, film coated, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

WOCKHARDT LIMITED

INN (International namn):

DIVALPROEX SODIUM

Sammansättning:

VALPROIC ACID 250 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Divalproex sodium extended-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium extended-release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older with multiple seizure types that include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. Divalproex sodium extended-release tablets are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium extend

Produktsammanfattning:

Divalproex sodium extended-release 250 mg tablets are available as white, oval shaped film coated biconvex beveled edge tablets, debossed with W on one side and 724 on other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to 250 mg of valproic acid in the following packaging sizes: Bottles of 30          (NDC 64679-724-01) Bottles of 100        (NDC 64679-724-02) Bottles of 500        (NDC 64679-724-03) Unit Dose Pack  of 100 (10 x 10)     (NDC 64679-724-04) Divalproex sodium extended-release 500 mg tablets are available as dark grey colored, oval shaped film coated biconvex tablets, debossed with W725 on one side and plain on other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to 500 mg of valproic acid in the following packaging sizes: Bottles of 30          (NDC 64679-725-01) Bottles of 100        (NDC 64679-725-02) Bottles of 500        (NDC 64679-725-03) Unit Dose Pack of 100 (10x10)       (NDC 64679-725-04) Recommended Storage Store at 200 -250 C (680 -770 F) [see USP Controlled Room Temperature

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

DIVALPROEX SODIUM ER- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
WOCKHARDT LIMITED
----------
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 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:
(1)
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/day to achieve
optim