TOPIRAMATE tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)

Fáanlegur frá:

St Marys Medical Park Pharmacy

INN (Alþjóðlegt nafn):

TOPIRAMATE

Samsetning:

TOPIRAMATE 25 mg

Gerð lyfseðils:

PRESCRIPTION DRUG

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

TOPIRAMATE - TOPIRAMATE TABLET
ST MARYS MEDICAL PARK PHARMACY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPIRAMATE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR TOPIRAMATE TABLETS
TOPIRAMATE TABLETS
RX ONLY
INITIAL U.S. APPROVAL - 1996
RECENT MAJOR CHANGES
Warnings and Precautions (5.3) [04/2009]
Warnings and Precautions (5.8) [12/2009]
INDICATIONS AND USAGE
Topiramate is an antiepileptic (AED) agent indicated for:
Monotherapy epilepsy: Initial monotherapy in patients ≥10 years of
age with partial onset or primary generalized tonic-
clonic seizures (1.1).
Adjunctive therapy epilepsy: Adjunctive therapy for adults and
pediatric patients (2 to 16 years of age) with partial
onset seizures or primary generalized tonic-clonic seizures, and in
patients ≥2 years of age with seizures associated
with Lennox-Gastaut syndrome (LGS) (1.2).
DOSAGE AND ADMINISTRATION
See DOSAGE AND ADMINISTRATION, Epilepsy: Adjunctive Therapy Use for
additional details (2.1).
Initial Dose
T itration
Recommended Dose
Epilepsy monotherapy:
adults and
pediatric patients
≥10 years (2.1)
50 mg/day
in two
divided
dose s
The dosage should be increased weekly by
increments of 50 mg for the first 4 weeks
then 100 mg for weeks 5 to 6.
400 mg/day in
two divided
dose s
Epilepsy adjunctive
therapy: adults
with partial onset
seizures or LGS (2.1)
25 to 50
mg/day
The dosage should be increased weekly to an
effective dose by increments of 25 to 50 mg.
200-400
mg/day in two
divided doses
Epilepsy adjunctive
therapy: adults
with primary
generalized tonic-clonic
seizures (2.1)
25 to 50
mg/day
The dosage should be increased weekly to an
effective dose by increments of 25 to 50 mg.
400 mg/day in
two divided
dose s
Epilepsy adjunctive
therapy: pediatric
patients with
partial onset
seizures, primary
generalized tonic-clonic
seizures or LGS (2.1)
25 mg/day
(or less,
based on a
range of 1 to 3 mg/kg/day)
nightly for
the first
week
The dosage should be increased at 1-