TOPIRAMATE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Blenheim Pharmacal, Inc.

INN (International Name):

TOPIRAMATE

Sammensætning:

TOPIRAMATE 25 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Topiramate Tablets USP are indicated as initial monotherapy in patients 10 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. Teratogenic Effects Pregnancy Category D [See Warnings and Precautions (5.6). ] 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 pre

Produkt oversigt:

Topiramate tablets, USP are available containing 25 mg, 50 mg, 100 mg or 200 mg of topiramate USP. The 25 mg tablets are white, round, biconvex tablets debossed with "IG" on one side and "278" on other. They are available as follows: NDC 10544-628-90 bottles of 90 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

TOPIRAMATE- TOPIRAMATE TABLET
Blenheim Pharmacal, Inc.
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MEDICATION GUIDE
TOPIRAMATE (toe-PEER-uh-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,
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
during

Produktets egenskaber

TOPIRAMATE- TOPIRAMATE TABLET
BLENHEIM PHARMACAL, INC.
----------
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.
OPIRAMATE TABLETS USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions, Visual Field Defects (5.1) 07/2013
INDICATIONS AND USAGE
Topiramate Tablets USP are an antiepileptic (AED) agent indicated for:
•
•
DOSAGE AND ADMINISTRATION
See DOSAGE AND ADMINISTRATION, Epilepsy: Monotherapy and 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 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 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 increased at 1 or 2
week intervals by increments of 1 to 3
mg/kg/day (administered in two divided
doses). Dose titration should be guided by
clinical outcome.
5 to 9 mg/kg/day in
two divided doses
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
Monotherapy epilepsy: Initial monotherapy in patients ≥ 10 years of
age with partial onset or primary general