TOPIRAMATE- topiramate tablet, film coated

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Lake Erie Medical DBA Quality Care Products LLC

INN (Isem Internazzjonali):

TOPIRAMATE

Kompożizzjoni:

TOPIRAMATE 50 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Topiramate tablets, USP and topiramate Capsules (Sprinkle) 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) ]. Topiramate tablets, USP and topiramate Capsules (Sprinkle) 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 (5.6)] Topiramate can cause fetal harm when administered to a pregn

Sommarju tal-prodott:

Topiramate Tablets, USP Topiramate Tablets USP, 25 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with 'ZD 16' on one side and plain on the other side and are supplied as follows: Topiramate Tablets USP, 50 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with 'ZD 15' on one side and plain on the other side and are supplied as follows: Bottles of 30 55700-0210-30 Topiramate Tablets, USP 100 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with 'ZD 14' on one side and plain on the other side and are supplied as follows: Topiramate Tablets USP, 200 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with 'ZD 13' on one side and plain on the other side and are supplied as follows: Topiramate Capsules (Sprinkle) Topiramate Capsules (Sprinkle), 15 mg are white to off-white pellets filled in size ‘2’ empty hard gelatin capsules with white opaque cap imprinted with 'ZA63' and white opaque body imprinted with '15 mg' in black ink and are supplied as follows: Topiramate Capsules (Sprinkle), 25 mg are white to off-white pellets filled in size ‘1’ empty hard gelatin capsules with white opaque cap imprinted with 'ZA64' and white opaque body imprinted with '25 mg' in black ink Storage and Handling Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
Topiramate Tablets, USP
Topiramate Capsules (Sprinkle)
Read this Medication Guide before you start taking topiramate 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, talk to your healthcare
provider or pharmacist.
What is the most important information I should know about Topiramate?
•
Topiramate 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.
•
Topiramate 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, topiramate 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 topiramate without first talking to a healthcare provider.
•
Stopping topiramate suddenly can cause

Karatteristiċi tal-prodott

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPIRAMATE SAFELYAND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TOPIRAMATE.TOPIRAMATE TABLETS,
USPTOPIRAMATE CAPSULES (SPRINKLE) "INITIAL U.S.
APPROVAL:". 1996
INDICATIONS AND USAGE
Topiramate is an antiepileptic (AED) agent indicated for: (1)
• Monotherapy epilepsy: Initial monotherapy in patients ≥ 10 years
of age with partial onset or primary generalized tonic-
clonic sizures. (1.1) (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) (1)
DOSAGE AND ADMINISTRATION
See DOSAGE AND ADMINISTRATION, Epilepsy: Adjunctive Therapy Use for
additional details (2.1) (2)
Initial Dose (2)
Titration (2)
Recommended Dose (2)
Epilepsy monotherapy: (2)
50 mg/day in two (2)
The dosage should (2)
400 mg/day in two (2)
adults and pediatric (2)
divided doses (2)
be increased weekly (2)
divided doses (2)
patients ≥ 10 years (2.1) (2)
by increments of 50 (2)
mg for the first 4 (2)
weeks then 100mg (2)
for weeks 5 to 6. (2)
Epilepsy adjunctive (2)
25 to 50 mg/day (2)
The dosage should (2)
200 to 400 mg/day in (2)
therapy: adults with (2)
be increased weekly (2)
two divided doses (2)
partial onset seizures or (2)
to an effective dose (2)
LGS (2.1) (2)
by increments of 25 (2)
to 50 mg. (2)
Epilepsy adjunctive (2)
25 to 50 mg/day (2)
The dosage should (2)
400 mg/day in two (2)
therapy: adults with (2)
be increased weekly (2)
divided doses (2)
primary generalized (2)
to an effective dose (2)
tonic-clonic seizures. (2)
by increments of 25 (2)
(2.1) (2)
to 50 mg. (2)
Epilepsy adjunctive (2)
25 mg/day (or less, (2) The doseage should (2)
5 to 9 mg/kg/day in (2)
therapy: pediatric (2)
based on a