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:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

TOPIRAMATE

Composition:

TOPIRAMATE 25 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 as debossed, film-coated, circular tablets in the following strengths and colors: 25 mg white (coded “S” on one side; “707” on the other) 50 mg yellow (coded “S” on one side; “710” on the other) 100 mg yellow (coded “S” on one side; “711” on the other) 200 mg brown (coded “S” on one side; “712” on the other) They are supplied as follows: 25 mg tablets    Bottles of 30’s with Child Resistant Cap…………...NDC 62756-707-83 Bottles of 60’s with Child Resistant Cap…………...NDC 62756-707-86 Bottles of 100’s with Child Resistant Cap …............NDC 62756-707-88 Bottles of 100’s with Non Child Resistant Cap ……NDC 62756-707-08 Bottles of 500’s with Non Child Resistant Cap ……NDC 62756-707-13 Bottles of 1000’s with Non Child Resistant Cap …..NDC 62756-707-18 50 mg tablets    Bottles of 30’s with Child Resistant Cap…..............NDC 62756-710-83 Bottles of 60’s with Child Resistant Cap…………..NDC 62756-710-86 Bottles of 100’s with Child Resistant Cap …...........NDC 62756-710-88 Bottles of 100’s with Non Child Resistant Cap …...NDC 62756-710-08 Bottles of 500’s with Non Child Resistant Cap …...NDC 62756-710-13 Bottles of 1000’s with Non Child Resistant Cap ….NDC 62756-710-18 100 mg tablets Bottles of 30’s with Child Resistant Cap…..............NDC 62756-711-83 Bottles of 60’s with Child Resistant Cap…………...NDC 62756-711-86 Bottles of 100’s with Child Resistant Cap …............NDC 62756-711-88 Bottles of 100’s with Non Child Resistant Cap ……NDC 62756-711-08 Bottles of 500’s with Non Child Resistant Cap …....NDC 62756-711-13 Bottles of 1000’s with Non Child Resistant Cap …..NDC 62756-711-18 200 mg tablets Bottles of 30’s with Child Resistant Cap…...............NDC 62756-712-83 Bottles of 60’s with Child Resistant Cap…………...NDC 62756-712-86 Bottles of 100’s with Child Resistant Cap …............NDC 62756-712-88 Bottles of 100’s with Non Child Resistant Cap …....NDC 62756-712-08 Bottles of 500’s with Non Child Resistant Cap …....NDC 62756-712-13 Bottles of 1000’s with Non Child Resistant Cap …..NDC 62756-712-18 Storage and Handling Store topiramate tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOPIRAMATE - TOPIRAMATE TABLET, FILM COATED
Sun Pharmaceutical Industries, Inc.
----------
MEDICATION GUIDE
Topiramate Tablets, USP
(toe-PEER-uh-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

Summary of Product characteristics

TOPIRAMATE - TOPIRAMATE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, 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, USP.
TOPIRAMATE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions, Visual Field Defects (5.2) 01/2014
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 ITRATIO N
RECO MMENDED
DO SE
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 to 7 weeks
Daily doses in
two divided
doses based on
weight (Table 2)
Epilepsy monotherapy: adults and
pediatric patients ≥10 years (2.1)
50 mg/day in two
divided doses
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
doses
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 to 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
doses
Epilepsy adjuncti