TOPIRAMATE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Proficient Rx LP

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Topiramate tablets USP Topiramate tablets USP are available in the following strengths and colors:                                                                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 Bottles of 30's (NDC 63187-696-30) Bottles of 60's (NDC 63187-696-60) Bottles of 90's (NDC 63187-696-90) 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.

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

TOPIRAMATE- topiramate tablet
Proficient Rx LP
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Medication Guide
TOPIRAMATE 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 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 treatment with to

Charakterystyka produktu

TOPIRAMATE- TOPIRAMATE TABLET
PROFICIENT RX LP
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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
•
INDICATIONS AND USAGE
Topiramate tablets USP is an antiepileptic (AED) agent indicated for:
•
•
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 with partial
onset seizures, primary generalized tonic-
clonic seizures or LGS(186ERROR!
HYPERLINK REFERENCE NOT VALID.
25mg/day(or less,
based on a range
of1to3mg/kg/day)
nightly for the first
week
The dosage should
beincreasedat1-or
2-weekintervalsby
incrementsof1to3
mg/kg/day(administered
in two divided doses).Dose
titration should be guided
by clinical outcome.
5to9mg/kg/day in
two divided doses
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, 100 mg, and 200 mg (3)
CONTRAINDICATIONS
None (4)
WA