EPIVAL ER TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VALPROIC ACID (DIVALPROEX SODIUM)

Available from:

ABBOTT LABORATORIES, LIMITED

ATC code:

N03AG01

INN (International Name):

VALPROIC ACID

Dosage:

500MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

VALPROIC ACID (DIVALPROEX SODIUM) 500MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTICONVULSANTS

Product summary:

Active ingredient group (AIG) number: 0112996003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2008-06-06

Summary of Product characteristics

PRODUCT MONOGRAPH
for
EPIVAL®
(Divalproex Sodium Enteric-Coated Tablets)
125, 250, 500 mg
EPIVAL® ER
(Divalproex Sodium Extended Release Tablets)
500 mg
EPIJECT® I.V.
(valproic acid injection,
present as the sodium salt)
100 mg/mL Fliptop Vials
_Anticonvulsant_
Abbott Laboratories, Limited
DATE OF PREPARATION:
8401 Trans Canada Highway
November 30, 1983
Saint-Laurent (Qc) Canada H4S 1Z1
DATE OF PREVIOUS REVISION:
July 23, 2004
Control #102231/102232
DATE OF REVISION:
March 3, 2006
- 2 -
PRODUCT MONOGRAPH
NAME OF DRUG
EPIVAL®
(Divalproex Sodium Enteric-Coated Tablets)
125, 250, 500 mg
EPIVAL® ER
(Divalproex Sodium Extended Release Tablets)
500 mg
EPIJECT® I.V.
(valproic acid injection,
present as the sodium salt)
100 mg/mL Fliptop Vials
THERAPEUTIC CLASSIFICATION
Anticonvulsant
ACTIONS AND CLINICAL PHARMACOLOGY
EPIVAL® (divalproex sodium) has anticonvulsant properties, and is
chemically related to valproic
acid. EPIVAL® dissociates to the valproate ion in the
gastrointestinal tract. Although its mechanism
of action has not yet been established, it has been suggested that its
activity in epilepsy is related
to increased brain concentrations of gamma-aminobutyric acid (GABA).
The effect on the neuronal
membrane is unknown.
PHARMACOKINETICS
_EPIVAL® (divalproex sodium) Enteric-Coated Tablets_
Absorption/Bioavailability
Peak serum levels of valproic acid occur in 3 to 4 hours. A slight
delay in absorption occurs when
the drug is administered with meals but this does not affect the total
absorption.
Valproic acid is rapidly distributed throughout the body and the drug
is strongly bound (90%) to
human plasma proteins. Increases in doses may result in decreases in
the extent of protein binding
and variable changes in valproic acid clearance and elimination.
- 3 -
The plasma protein binding of valproate is concentration dependent and
the free fraction increases
from approximately 10% at 40 mcg/mL to 18.5% at 130 mcg/mL. Protein
binding of valproate is
reduced in the elderly, in patients with chronic hepatic disea