TOPIRAMATE- topiramate tablet tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

INN (International Name):

TOPIRAMATE

Composition:

TOPIRAMATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1 Monotherapy Epilepsy 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)]. 1.2 Adjunctive Therapy Epilepsy 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. 8.1 Pregnancy 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

Product summary:

16.1 How Supplied 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 16.2 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 TABLET
DIRECT RX
----------
MEDICATION GUIDE
MEDICATION GUIDE
Topiramate (toe-PIR-a-mate) Tablets, USP
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.
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

Summary of Product characteristics

TOPIRAMATE- TOPIRAMATE TABLET TABLET
DIRECT RX
----------
TOPIRAMATE- TOPIRAMATE TABLET
INDICATIONS AND USAGE
1.1 Monotherapy Epilepsy
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)].
1.2 Adjunctive Therapy Epilepsy
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)].
DOSAGE AND ADMINISTRATION
2.1 Epilepsy
It is not necessary to monitor topiramate plasma concentrations to
optimize topiramate tablets therapy.
On occasion, the addition of topiramate tablets to phenytoin may
require an adjustment of the dose of
phenytoin to achieve optimal clinical outcome. Addition or withdrawal
of phenytoin and/or
carbamazepine during adjunctive therapy with topiramate tablets may
require adjustment of the dose of
topiramate tablets.
Because of the bitter taste, tablets should not be broken.
Topiramate tablets can be taken without regard to meals.
Monotherapy Use
Adults and Pediatric Patients 10 Years and Older
The recommended dose for topiramate monotherapy in adults and
pediatric patients 10 years of age and
older is 400 mg/day in two divided doses. Approximately 58% of
patients randomized to 400 mg/day
achieved this maximal dose in the monotherapy controlled trial; the
mean dose achieved in the trial was
275 mg/day. The dose should be achieved by titration according to the
following schedule(Table 1):
TABLE 1: MONOTHERAPY TITRATION SCHEDULE FOR ADULTS AND PEDIATRIC
PATIENTS 10 YEARS AND OLDER
Morning Dose
Evening Dose
Week 1
25 mg
25 mg
Week 2
50 mg
50 mg
Week 3
75 mg
75