TOPAMAX- topiramate tablet, coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

topiramate (UNII: 0H73WJJ391) (topiramate - UNII:0H73WJJ391)

Dostępny od:

Physicians Total Care, Inc.

INN (International Nazwa):

topiramate

Skład:

topiramate 25 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

TOPAMAX® (topiramate) Tablets and TOPAMAX® (topiramate capsules) Sprinkle Capsules 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)] . TOPAMAX® Tablets and TOPAMAX® Sprinkle Capsules 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)] . TOPAMAX® Tablets and TOPAMAX® Sprinkle Capsules are indicated for adults for the prophylaxis of migraine headache [see Clinical Studies (14.3)] . The usefulness of TOPAMAX® in the acute treatment of migraine headache has not been studied. None. Pregnanc

Podsumowanie produktu:

TOPAMAX® Tablets TOPAMAX® (topiramate) Tablets are available as debossed, coated, round tablets in the following strengths and colors: 25 mg cream tablet (debossed "OMN" on one side; "25" on the other) and are available in 50 mg light yellow tablet (debossed "OMN" on one side; "50" on the other) and are available in 100 mg yellow tablet (debossed "OMN" on one side; "100" on the other) and are available in 200 mg salmon tablet (debossed "OMN" on one side; "200" on the other) and are available in Storage and Handling TOPAMAX® Tablets should be stored in tightly-closed containers at controlled room temperature (59° to 86°F, 15° to 30°C). Protect from moisture. TOPAMAX® Sprinkle Capsules should be stored in tightly-closed containers at or below 25°C (77°F). Protect from moisture.

Status autoryzacji:

New Drug Application

Ulotka dla pacjenta

TOPAMAX - TOPIRAMATE TABLET, COATED
Physicians Total Care, Inc.
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MEDICATION GUIDE
TOPAMAX® (TOE-PA-MAX)
(topiramate)
Tablets and Sprinkle Capsules
Read this Medication Guide before you start taking TOPAMAX® 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 TOPAMAX®, talk to your
healthcare provider or pharmacist.
What is the most important information I should know about TOPAMAX®?
TOPAMAX® 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.
TOPAMAX® 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 fever or decreased sweating.
TOPAMAX® 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 TOPAMAX®. If you are pregnant, you should
talk to your healthcare
provider about w

Charakterystyka produktu

TOPAMAX - TOPIRAMATE TABLET, COATED
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPAMAX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TOPAMAX
TOPAMAX (TOPIRAMATE) TABLETS FOR ORAL USE
TOPAMAX (TOPIRAMATE CAPSULES) SPRINKLE CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL – 1996
RECENT MAJOR CHANGES
• Indications and Usage (1.1)
07/2011
• Dosage and Administration (2.1)
07/2011
• Metabolic Acidosis (5.3)
07/2011
• Hypothermia with Concomitant Valproic Acid (VPA) Use (5.11)
07/2011
INDICATIONS AND USAGE
TOPAMAX 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)
Migraine: Treatment for adults for prophylaxis of migraine headache
(1.3)
DOSAGE AND ADMINISTRATION
See DOSAGE AND ADMINISTRATION, Epilepsy: Monotherapy and Adjunctive
Therapy Use for additional details (2.1)
INITIAL DOSE
T ITRATIO N
RECOMMENDED DOSE
Epilepsy monotherapy:
children 2 to <10 years
(2.1)
25 mg/day
administered nightly for
the first week
The dosage should be
titrated over 5–7 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.
200–400 mg/day in two
divided doses
Epilepsy adjunctive