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:

Ranbaxy Pharmaceuticals Inc

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. Teratogenic Effects 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 animal

Product summary:

Topiramate tablets are available in the following strengths and colors: 25 mg - white, round, film-coated tablets, debossed with “ RX8 ” on one side and plain on the other side. They are supplied as follows: Bottles of 30 NDC 63304-778-30 Bottles of 1000 NDC 63304-778-10 100 mg - yellow colored, round, beveled edge, film-coated tablets, debossed with “ RX779 ” on one side and plain on the other side. They are supplied as follows: Bottles of 30 NDC 63304-779-30 Bottles of 1000 NDC 63304-779-10 200 mg - reddish-brown colored, round, beveled edge, film-coated tablets, debossed with “ RX780 ” on one side and plain on the other side. They are supplied as follows: Bottles of 30 NDC 63304-780-30 Bottles of 1000 NDC 63304-780-10 Storage and Handling Topiramate tablets should be stored in tightly-closed containers at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Protect from moisture. Bottle contains desiccant.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
Ranbaxy Pharmaceuticals Inc
----------
MEDICATION GUIDE
TOPIRAMATE TABLETS
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, 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 and
du

Summary of Product characteristics

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
RANBAXY PHARMACEUTICALS INC
----------
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.
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions, Visual Field Defects (5.2) 01/2014
Warnings and Precautions, Metabolic Acidosis (5.4) 03/2014
Warnings and Precautions, Cognitive/Neuropsychiatric Adverse Reactions
(5.6) 03/2014
Warnings and Precautions, Monitoring: Laboratory Tests (5.16) 03/2014
INDICATIONS AND USAGE
Topiramate tablets are an antiepileptic (AED) agent indicated for: (1)
•
•
DOSAGE AND ADMINISTRATION
See DOSAGE AND ADMINISTRATION, Epilepsy: Monotherapy and Adjunctive
Therapy Use for additional details (2.1)
(2)
Initial Dose (2)
Titration (2)
Recommended Dose
(2)
Epilepsy monotherapy: 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 increments 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