TOPIRAMATE tablet, film coated TOPIRAMATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DirectRX

INN (International Name):

TOPIRAMATE

Composition:

TOPIRAMATE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 1.1 Monotherapy Epilepsy Topiramate tablets, USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies ( 14.1)]. 1.2 Adjunctive Therapy Epilepsy Topiramate tablets, USP are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies ( 14.2)]. Topiramate tablets, USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a prev

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOPIRAMATE- TOPIRAMATE TABLET
DirectRX
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Revised: 5/2023
Document Id: fc5dd4b0-0e34-858e-e053-6394a90a2714
34391-3
Set id: 2082548c-371c-4c98-98a6-effe0a9bd2a4
Version: 6
Effective Time: 20230523
DirectRX

Summary of Product characteristics

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
TOPIRAMATE- TOPIRAMATE TABLET
DIRECTRX
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TOPIRAMATE
INDICATIONS & USAGE SECTION
1.1 Monotherapy Epilepsy
Topiramate tablets, USP are indicated as initial monotherapy in
patients 2 years of age
and older with partial onset or primary generalized tonic-clonic
seizures. Safety and
effectiveness in patients who were converted to monotherapy from a
previous
regimen of other anticonvulsant drugs have not been established in
controlled trials
[see Clinical Studies ( 14.1)].
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets, USP are indicated as adjunctive therapy for adults
and pediatric
patients ages 2 to 16 years with partial onset seizures or primary
generalized tonic-
clonic seizures, and in patients 2 years of age and older with
seizures associated with
Lennox-Gastaut syndrome [see Clinical Studies ( 14.2)].
DOSAGE & ADMINISTRATION SECTION
2.1 Epilepsy
It is not necessary to monitor topiramate plasma concentrations to
optimize
topiramate therapy.
On occasion, the addition of topiramate tablets to phenytoin may
require an
adjustment of the dose of phenytoin to achieve optimal clinical
outcome. Addition or
withdrawal of phenytoin and/or carbamazepine during adjunctive therapy
with
topiramate tablets may require adjustment of the dose of topiramate
tablets.
Because of the bitter taste, tablets should not be broken.
Topiramate tablets can be taken without regard to meals.
Monotherapy Use
Adults and Pediatric Patients 10 Years and Older
The recommended dose for topiramate tablets monotherapy in adults and
pediatric
patients 10 years of age and older is 400 mg/day in two divided doses.
Approximately
58% of patients randomized to 400 mg/day achieved this maximal dose in
the
monotherapy controlled trial; the mean dose achieved in the trial was
275 mg/day.
The dose should be achieved by titration according to the following
schedule (Table
1):
TABLE 1: MONOTHERAPY TITRATION SCHEDULE FOR ADULTS AND
PEDIATRIC PATIENTS 10 YEARS AND OLDER
MORNING DOSE
EVENING DOSE
Week 1
25 mg