TOPIRAMATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Blenheim Pharmacal, Inc.

INN (International Name):

TOPIRAMATE

Composition:

TOPIRAMATE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topiramate Tablets USP 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 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 (14.1) ] None. [see Warnings and Precautions (5.6)] Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero

Product summary:

Topiramate Tablets USP are available as circular, biconvex, film coated, tablets in the following strengths and colors: 50 mg yellow (engraved “G” on one side; “50” on the other 100 mg yellow (engraved “G” on one side; “100” on the other) They are supplied as follows: 50 mg Tablets-bottles of 60 count with desiccant (NDC 10544-847-30) 50 mg Tablets-bottles of 1000 count with desiccant (NDC 10544-847-60) 50 mg Tablets-bottles of 1000 count with desiccant (NDC 10544-847-90) 100 mg tablets – bottles of 60 count with desiccant (NDC 10544-489-30) 100 mg tablets – bottles of 1000 count with desiccant (NDC 10544-489-60) Topiramate Tablets USP should be stored in tightly-closed containers at 20-25oC (68-77°F) [See USP Controlled Room Temperature]. Protect from moisture

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
Blenheim Pharmacal, Inc.
----------
MEDICATION GUIDE
Topiramate ( TOE-pee-rah-mate) Tablets USP
Read this Medication Guide before you start taking topiramate 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 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 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 without first talking to a healthcare provider.
•
Stopping topiramate suddenly can cause serious pro

Summary of Product characteristics

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
BLENHEIM PHARMACAL, 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 USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Topiramate Tablets USP are an antiepileptic (AED) agent indicated for:
(1)
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) (2)
Initial Dose
T itration
Recommended Dose
Epile psy
monotherapy: (2)
adults and pediatric
patients ≥10 years
(2.1) (2)
50 mg/day in two divided
doses (2)
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 doses (2)
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 doses
Epilepsy adjunctive
therapy: pediatric
patients with partial
onset seizures,
primary generalized
tonic-clonic seizures
or LGS (2.1) (2)
25 mg/day (or less, based
on a range of 1 to 3
mg/kg/day) nightly for the
first week (2)
The dosage should be
increased at 1- or 2-week
intervals by increments of 1
to 3 mg/k