TOPIRAMATE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

NuCare Pharmaceuticals, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Topiramate tablets USP are available in the following strengths and colors: 25 mg, White colored, circular, biconvex film-coated tablets, debossed with "122" on one side and "C" on the other side and are available in Bottles of 30 NDC 68071-1971-3 Bottles of 60 NDC 68071-1971-6 Bottles of 90 NDC 68071-1971-9 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 dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

TOPIRAMATE- TOPIRAMATE TABLET
NuCare Pharmaceuticals, Inc.
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17 PATIENT COUNSELING
INFORMATION
Advise the patient to read the FDA-approved patient labeling
(Medication Guide).
Eye Disorders
Instruct patient taking topiramate tablets should be told to seek
immediate medical attention if they
experience blurred vision, visual disturbances, or periorbital pain
[see Warnings and Precautions
Oligohidrosis and Hyperthermia
Closely monitor topiramate tablets-treated pateints, especially
pediatric patients, for evidence of
decreased sweating and increased body temperature, especially in hot
weather. Counsel patient to contact
their healthcare professionals immediately if they develop a high or
persistent fever, or decreased
sweating [see Warnings and Precautions ( 5.3)] .
Metabolic Acidosis
Warn patients about the potential significant risk for metabolic
acidosis that may be asymptomatic and
may be associated with adverse effects on kidneys (e.g., kidney
stones, nephrocalcinosis), bones (e.g.,
osteoporosis, osteomalacia, and/or rickets in children), and growth
(e.g., growth delay/retardation) in
pediatric patients, and on the fetus [see Warnings and Precautions (
5.4) and Use in Specific Populations (
8.1)] .
Suicidal Behavior and Ideation
Counsel patients, their caregivers, and families that AEDs, including
topiramate tablets, may increase the
risk of suicidal thoughts and behavior, and advise of the need to be
alert for the emergence or worsening
of the signs and symptoms of depression, any unusual changes in mood
or behavior or the emergence of
suicidal thoughts, or behavior or thoughts about self-harm. Instruct
patients to immediately report
behaviors of concern to their healthcare providers [see Warnings and
Precautions
Interference with Cognitive and Motor Performance
Warn patients about the potential for somnolence, dizziness,
confusion, difficulty concentrating, or visual
effects, and advise patients not to drive or operate machinery until
they have gained sufficient experience
on topiramate tablets to g

Lastnosti izdelka

TOPIRAMATE- TOPIRAMATE TABLET
NUCARE PHARMACEUTICALS, 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.
TOPIRAMATE TABLETS USP, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions, Visual Field Defects ( 5.2) 01/2014
INDICATIONS AND USAGE
Topiramate tablets USP 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 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
on