TOPIRAMATE tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

State of Florida DOH Central Pharmacy

INN (Nome Internazionale):

TOPIRAMATE

Composizione:

TOPIRAMATE 25 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Topiramate tablets, USP and topiramate capsules (sprinkle) 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 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 (5.7)]   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

Dettagli prodotto:

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. 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. 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. 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. They are supplied by State of Florida DOH Central Pharmacy 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. 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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

TOPIRAMATE - TOPIRAMATE TABLET, FILM COATED
State of Florida DOH Central Pharmacy
----------
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, including
any new problems with your vision.
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. Call your
healthcare provider right away if
you have a high fever, a fever that does not go away, or decreased
sweating.
Topiramate 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 your treatment with t

Scheda tecnica

TOPIRAMATE - TOPIRAMATE TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPIRAMATE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TOPIRAMATE.
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
TITRATION
RECOMMENDED DOSE
Epile psy
monothe rapy:
children 2 to < 10
years (2.1)
25 mg/day
administe re d
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
monothe rapy:
adults and
pediatric patients
≥ 10 years (2.1)
50 mg/day
in two
divide d
dose s
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
dose s
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
Epile psy
adjunctive
therapy: adults
with primary
ge ne ralize d
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
dose s
Epilepsy adjunctive
therapy: pediatric
patients with
partial o