TOPIRAMATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT Rx USA 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)]. None. Pregnancy Category D. [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 have an increased risk for cleft lip and/or cleft palate (oral clefts). When multiple species of pregnant animals received topiramate

Product summary:

Topiramate Tablets, USP 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, USP 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, USP 100 mg are light yellow colored, round, biconvex, film coated tablets debossed with ‘1033’ on one side and ‘100’ on other side. Topiramate Tablets 100 mg are supplied as follows: Package                                                                                                                 NDC Number Topiramate Tablets, USP 200 mg are peach colored, round, biconvex, film coated tablets debossed with ‘1034’ on one side and ‘200’ on other side. Topiramate Tablets 200 mg are supplied as follows: Package                                                                                                                 NDC Number Storage and Handling 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOPIRAMATE - TOPIRAMATE TABLET
STAT Rx USA LLC
----------
MEDICATION GUIDE
Topiramate Tablets, USP
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.
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 and
during your treatment with topiramate tablets. If you are pregnant,
you should talk to your healthcare
provider about whether you have metabolic acidosis.
• Like other antiepileptic drugs,

Summary of Product characteristics

TOPIRAMATE - TOPIRAMATE TABLET
STAT RX USA 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, USP
RX ONLY
INITIAL U.S. APPROVAL - 1996
RECENT MAJOR CHANGES
Indications and Usage (1.1) 07/2011
Dosage and Administration (2.1) 07/2011
Metabolic Acidosis (5.3) 07/2011
Hypothermia with Concomitant Valproic Acid (VPA) Use (5.11) 07/2011
INDICATIONS AND USAGE
Topiramate is an antiepileptic (AED) agent 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
T itration
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 5-7 weeks
Daily doses
in two divided doses
based on weight (Table
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
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)
nightl