TOPAMAX- topiramate tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

topiramate (UNII: 0H73WJJ391) (topiramate - UNII:0H73WJJ391)

Available from:

Rebel Distributors Corp

INN (International Name):

topiramate

Composition:

topiramate 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TOPAMAX® (topiramate) Tablets and TOPAMAX® (topiramate capsules) Sprinkle Capsules 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)] . TOPAMAX® (topiramate) Tablets and TOPAMAX® (topiramate capsules) Sprinkle Capsules 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)] . TOPAMAX® (topiramate) Tablets and TOPAMAX® (topiramate capsules) Sprin

Product summary:

TOPAMAX® Tablets TOPAMAX® (topiramate) Tablets are available as debossed, coated, round tablets in the following strengths and colors: 25 mg cream tablet (debossed "OMN" on one side; "25" on the other) and are available in bottles of 15 and 60 count 50 mg light yellow tablet (debossed "OMN" on one side; "50" on the other) and are available in bottles of 15 count 100 mg yellow tablet (debossed "OMN" on one side; "100" on the other) and are available in bottles of 15 count Storage and Handling TOPAMAX® (topiramate) Tablets should be stored in tightly-closed containers at controlled room temperature (59° to 86°F, 15° to 30°C). Protect from moisture.

Authorization status:

New Drug Application

Patient Information leaflet

TOPAMAX- TOPIRAMATE TABLET, COATED
Rebel Distributors Corp
----------
MEDICATION GUIDE
TOPAMAX® (Toe-pa-max)
(topiramate)
Tablets and Sprinkle Capsules
Read this Medication Guide before you start taking TOPAMAX® 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 TOPAMAX®, talk to your
healthcare provider or pharmacist.
What is the most important information I should know about TOPAMAX®?
•
TOPAMAX® 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.
•
TOPAMAX® 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, TOPAMAX® 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 TOPAMAX® without first talking to a healthcare provider.
•
Stopping TOPAMAX® suddenly can cause serious problems.
•
Suicida

Summary of Product characteristics

TOPAMAX- TOPIRAMATE TABLET, COATED
REBEL DISTRIBUTORS CORP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPAMAX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TOPAMAX
TOPAMAX (TOPIRAMATE) TABLETS
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
• Warnings and Precautions (5.8)
[12/2009]
INDICATIONS AND USAGE
TOPAMAX is an antiepileptic (AED) agent indicated for:
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).
Migraine: Treatment for adults for prophylaxis of migraine headache
(1.3).
DOSAGE AND ADMINISTRATION
See DOSAGE AND ADMINISTRATION, Epilepsy: Adjunctive Therapy Use for
additional details (2.1).
Initial Dose
T itration
Recommended Dose
Epilepsy monotherapy: adults
and pediatric patients ≥10
years (2.1)
50 mg/day in two divided
dose s
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 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)
nightly for the first week
The dosage should be
inc