TOPIRAMATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

TOPIRAMATE

Composition:

TOPIRAMATE 50 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 tablets 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 rec

Product summary:

Topiramate tablets USP Topiramate tablets USP are available in the following strengths and colors: 25 mg, White colored, circular, biconvex film-coated tablets, debossed with "122" on one side and "C" on the other side and are available in 50 mg, Light orange colored, circular, biconvex, film-coated tablets, debossed with "123" on one side and "C" on the other side and are available in 100 mg, Orange colored, circular, biconvex, film-coated tablets, debossed with "124" on one side and "Cipla" on the other side and are available in 200 mg, Pink colored, capsule shaped, biconvex, film-coated tablets, debossed with "125" on one side and "Cipla" on other side and are available in PHARMACIST: Dispense in a tight container as defined in the USP. Use child-resistant closure (as required). Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOPIRAMATE- TOPIRAMATE TABLET
Lake Erie Medical DBA Quality Care Products LLC
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MEDICATIONGUIDE
TOPIRAMATETABLETS, 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.
WhatisthemostimportantinformationIshouldknowabouttopiramate tablets?
Topiramate tablets maycauseeyeproblems. 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 may 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
during your t

Summary of Product characteristics

TOPIRAMATE- TOPIRAMATE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS 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.
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 tablets USP 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
INITIAL DOSE
TITRATION
RECOMMENDED
DOSE
Epilepsy monotherapy:
children 2to<10years (2.1)
25mg/day
administered nightly
for the first week
The dosage should
betitratedover5–7 weeks
Daily doses in two
divided doses based
on weight(Table2)
Epilepsy monotherapy:
adults and pediatric patients≥10years(2.1)50mg/day in two
divided doses
The dosage should be
increased weekly by
increments of 50mg for the
first 4 weeks
then100mgfor weeks 5to6.
400 mg/day in two
divided doses
Epilepsy adjunctive therapy :adults with
partial onset seizures or LGS(2.1)
25to50mg/day
The dosage should be
increased weekly to an
effective dose by
incrementsof25to50mg.
200–400 mg/day in
two divided doses
Epilepsy adjunctive therapy: adults with
primary generalized tonic- clonic
seizures(2.1)
25to50mg/day
The dosage should be
increased weekly to an
effective dose by
incrementsof25to50mg.
400 mg/day in two
divided doses
Epilepsy adjunctive therapy: pediatric
Patients wit