TOPIRAMATE - 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:

Citron Pharma LLC

INN (International Name):

TOPIRAMATE

Composition:

TOPIRAMATE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topiramate tablets 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)] . 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)] . Topiramate tablets are indicated for adults for the prophylaxis of migraine headache [see Clinical Studies (14.3)]. The usefulness of topiramate tablets in the acute treatment of migraine headache has not been studied. Additional pediatric use information for patients ages 12 to 17 years is approved for Janssen Pharmaceuticals, Inc.’s TOPAMAX (t

Product summary:

Topiramate Tablets USP, 25 mg are white, circular, biconvex, film-coated tablets debossed with “E” on one side and “22” on the other side.         Bottles of 60               NDC 57237-134-60 Topiramate Tablets USP, 50 mg are light yellow colored, circular, biconvex, film-coated tablets debossed with “E” on one side and “33” on the other side.         Bottles of 60               NDC 57237-135-60 Topiramate Tablets USP, 100 mg are dark yellow colored, circular, biconvex, beveled edge, film-coated tablets debossed with “E” on one side and “23” on the other side.         Bottles of 60               NDC 57237-136-60 Topiramate Tablets USP, 200 mg are pink colored, circular, biconvex, beveled edge, film-coated tablets debossed with “E” on one side and “24” on the other side.         Bottles of 60               NDC 57237-137-60 Store topiramate tablets in tightly-closed containers at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOPIRAMATE - TOPIRAMATE TABLET, FILM COATED
Citron Pharma LLC
----------
MEDICATION GUIDE
Topiramate Tablets USP
(toe pir' a mate)
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, including
any new problems with your vision.
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. Call your healthcare provider
right away if you have a high fever, a fever that does not go away, or
decreased sweating.
Topiramate tablets can increase the level of acid in your blood
(metabolic acidosis). If left untreated,
metabolic acidosis can cause brittle or soft bones (osteoporosis,
osteomalacia, osteopenia), kidney stones,
can slow the rate of growth in children, and may possibly harm your
baby if you are pregnant. Metabolic
acidosis can happen with or without symptoms.
Sometimes people with metabolic acidosis will:
•
feel tired
•
not feel hungry (loss of appetite)
•
feel changes in heartbeat
•
have trouble thinking clearly
Your healthcare provider should do a blood test to measure the level
of acid in your blood before a

Summary of Product characteristics

TOPIRAMATE - TOPIRAMATE TABLET, FILM COATED
CITRON PHARMA LLC
----------
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, 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 tablets are 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).
Migraine: Treatment for adults for prophylaxis of migraine headache
(1.3)
DOSAGE AND ADMINISTRATION
See DOSAGE AND ADMINISTRATION, Epilepsy: Monotherapy and Adjunctive
Therapy Use for additional details (2.1).
Initial Dose
T itration
Recommended
Dose
Epilepsy
monothe rapy:
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
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 mg 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 mg to 50
mg.
400 mg/day in