TOPIRAMATE- topiramate tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

H.J. Harkins Company, Inc.

INN (Међународно име):

TOPIRAMATE

Састав:

TOPIRAMATE 25 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. 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)]. Topiramate tablets 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)]. None. Pregnancy Category C. Topiramate may cause serious adverse fetal effects, based on clinical and nonclinical data.   Topiramate treatment is associated with metabolic acidosis [see Warnings and Precau

Резиме производа:

Topiramate Tablets 25 mg are white to off white, round, biconvex, film coated tablets debossed with ‘1031’ on one side and ‘25’ on other side. Topiramate Tablets 25 mg are supplied as follows: Package                                                                                                                 NDC Number Topiramate Tablets 50 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘1032’ on one side and ‘50’ on other side. Topiramate Tablets 50 mg are supplied as follows: Package                                                                                                                 NDC Number Topiramate tablets should be stored in tightly-closed containers at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. PROTECT FROM MOISTURE.

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

TOPIRAMATE - TOPIRAMATE TABLET
H.J. Harkins Company, Inc.
----------
MEDICATION GUIDE
Topiramate tablets
Rx Only
Read this Medication Guide before you start taking topiramate tablets
and each time you get a refill.
There may be new information. This information does not take the place
of talking to your healthcare
provider about your medical condition or treatment. If you have any
questions about topiramate tablets,
talk to your healthcare provider or pharmacist.
What is the most important information I should know about topiramate
tablets?
• Topiramate tablets may cause eye problems. Serious eye problems
include:
•
any sudden decrease in vision with or without eye pain and redness,
•
a blockage of fluid in the eye causing increased pressure in the eye
(secondary angle closure
glaucoma).
•
These eye problems can lead to permanent loss of vision if not
treated. You should call your
healthcare provider right away if you have any new eye symptoms.
• Topiramate tablets may cause decreased sweating and increased body
temperature (fever). People,
especially children, should be watched for signs of decreased sweating
and fever, especially in hot
temperatures. Some people may need to be hospitalized for this
condition.
• Like other antiepileptic drugs, topiramate tablets may cause
suicidal thoughts or actions in a very small
number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse, or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
Do not stop topiramate tablets without first talking to a healthcare
provider.
•
Stopping topiramate tablets suddenly can ca

Карактеристике производа

TOPIRAMATE - TOPIRAMATE TABLET
H.J. HARKINS COMPANY, INC.
----------
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- or 2