TOPIRAMATE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

REMEDYREPACK INC.

INN (Διεθνής Όνομα):

TOPIRAMATE

Σύνθεση:

TOPIRAMATE 100 mg

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

TOPIRAMATE- TOPIRAMATE TABLET
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPIRAMATE TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPIRAMATE TABLETS,
USPTOPIRAMATE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions, Visual Field Defects ( 5.2) 01/2014
INDICATIONS AND USAGE
Topiramate is indicated for:
Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 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: Monotherapy and Adjunctive
Therapy Use for additional details ( 2.1).
Initial Dose
Titration
Recommended Dose
Epilepsy monotherapy: children 2 to
<10 years ( 2.1)
25 mg/day
administered nightly
for the first week
The dosage should be
titrated over 5 to 7 weeks
Daily doses in two
divided doses based
on weight (Table 2)
Epilepsy monotherapy: adults and
pediatric patients ≥10 years ( 2.1)
50 mg/day in two
divided doses.
The dosage should be increased
weekly by increment of 50 mg for
the first 4 weeks then 100 mg for
weeks 5 to 6.
400 mg/day in two
divided doses
Epilepsy adjunctive therapy: adults
with partial onset seizures or LGS ( 2.1)
25 to 50 mg/day
The dosage should be incrased
weekly to an effective dose by
increments of 25 to 50 mg.
200 to 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 doses
Epilepsy adjunctive therapy: pediatric
patients with partial onset
sei