TOPIRAMATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

TOPIRAMATE

Composition:

TOPIRAMATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. 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)]. None. Pregnancy Category D  [see Warnings and Precautions (5.7)] 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

Product summary:

Topiramate tablets, USP are available containing 25 mg, 50 mg, 100 mg or 200 mg of topiramate USP. The 25 mg tablets are white, film coated, round, biconvex tablets debossed with IG on one side and 278 on other. They are available as follows: NDC 60429-769-60 bottles of 60 tablets NDC 60429-769-10 bottles of 1000 tablets The 50 mg tablets are yellow, film coated, round, biconvex tablets debossed with IG on one side and 279 on other. They are available as follows: NDC 60429-770-60 bottles of 60 tablets NDC 60429-770-10 bottles of 1000 tablets The 100 mg tablets are light yellow, film coated, round, biconvex tablets debossed with IG on one side and 280 on other. They are available as follows: NDC 60429-771-60 bottles of 60 tablets NDC 60429-771-10 bottles of 1000 tablets The 200 mg tablets are pink, film coated, round, biconvex tablets debossed with IG on one side and 281 on other. They are available as follows: NDC 60429-772-60 bottles of 60 tablets NDC 60429-772-10 bottles of 1000 tablets Topiramate tablets-Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOPIRAMATE- TOPIRAMATE TABLET
Aphena Pharma Solutions - Tennessee, 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 bloo

Summary of Product characteristics

TOPIRAMATE- TOPIRAMATE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
[TOPIRAMATE TABLETS, USP] SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR[TOPIRAMATE TABLETS,
USP] INITIAL U.S. APPROVAL:[1996]
RECENT MAJOR CHANGES
Warnings and Precautions, Visual Field Defects (5.2) 01/2014
INDICATIONS AND USAGE
Topiramate is indicated for:
•
•
DOSAGE AND ADMINISTRATION
SEE DOSAGE AND ADMINISTRATION, EPILEPSY: MONOTHERAPY AND ADJUNCTIVE
THERAPY USE FOR ADDITIONAL
DETAILS (2)
Initial Dose
(2)
T itration
(2)
Recommended Dose
(2)
Epilepsymonotherapy:children 2 to <10 years (2.1)
(2)
25 mg/day administered nightly for the first week
(2)
The dosage should be titrated over 5 to 7
weeks
(2)
Daily doses in two
divided doses based on weight (Table 2)
(2)
Epilepsy monotherapy: adults and
pediatric patients ≥10 years (2.1)
(2)
50 mg/day in two divided doses
(2)
The dosage should be increased weekly by
increment of 50 mg
for the first 4 weeks then 100 mg
for weeks 5 to 6.
(2)
400 mg/day in two
divided doses
(2)
Epilepsy adjunctive therapy: adults with
partial onset
seizures or LGS (2.1)
(2)
25 to 50 mg/day
(2)
The dosage should be increased
weekly to an effective dose by
increments of 25 to 50 mg.
(2)
200 to 400 mg/day in two
divided doses
(2)
Epilepsy adjunctive therapy: adults
with primary
generalized tonic-clonic seizures (2.1)
(2)
25 to 50 mg/day
(2)
The dosage should be increased
weekly to an effective dose
by increments of 25 to 50 mg.
(2)
400 mg/day in
two divided doses
(2)
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/kg/day (administered in two divided doses).
Dose titration should be guided by clinical
outcome .
(2)
5 to 9 mg/kg/day in