TOPIRAMATE tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

PD-Rx Pharmaceuticals, Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. Topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334. Information about the North American Drug Pregnancy

Ringkasan produk:

Topiramate tablets, USP are available as debossed, film-coated, circular tablets in the following strengths and colors: 25 mg white (coded “S” on one side; “707” on the other) They are supplied as follows: 25 mg tablets  Bottles of 30........................…NDC 43063-998-30 Bottles of 60...........................NDC 43063-998-60 Store topiramate tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

PD-Rx Pharmaceuticals, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
MEDICATION GUIDE
Topiramate Tablets, USP
(toe pir' a mate)
for oral use
What
is
the
most
important
information
I
should
know
about
topiramate
tablet?
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 tablet 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. If a high fever, a fever that
does not go away, or decreased sweating develops, call your healthcare
provider right away.
Topiramate tablet 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 topiramate tablets. If you are pregnant,
you should talk to your healthcare
provider
about
whether
you
have
metabolic
acidosis.
Like other antiepileptic drugs, topiramate tablet may cause suicidal
thoughts or actions in a very small
number
of
peopl

Ciri produk

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPIRAMATE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TOPIRAMATE TABLETS.
TOPIRAMATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions (5.1, 5.4, 5.7, 5.9, 5.10, 5.13) 10/2022
INDICATIONS AND USAGE
Topiramate is indicated for: (1)
Epilepsy: initial monotherapy for the treatment of partial-onset or
primary generalized tonic-clonic
seizures in patients 2 years of age and older (1.1); adjunctive
therapy for the treatment of partial-onset
seizures, primary generalized tonic-clonic seizures, or seizures
associated with Lennox- Gastaut
syndrome in patients 2 years of age and older (1.2)
Preventive treatment of migraine in patients 12 years of age and older
(1.3)
DOSAGE AND ADMINISTRATION
Topiramate initial dose, titration, and recommended maintenance dose
varies by indication and age
group. See Full Prescribing Information for recommended dosage, and
dosing considerations in patients
with renal impairment, geriatric patients, and patients undergoing
hemodialysis (2.1, 2.2, 2.3, 2.4, 2.5, 2.6)
(2)
DOSAGE FORMS AND STRENGTHS
• Tablets: 25 mg, 50 mg, 100 mg, and 200 mg (3) (3)
CONTRAINDICATIONS
None (4) (4)
WARNINGS AND PRECAUTIONS
Acute myopia and secondary angle closure glaucoma: can lead to
permanent visual loss; discontinue
topiramate as soon as possible (5.1)
Visual field defects: consider discontinuation of topiramate (5.2)
Oligohidrosis and hyperthermia: monitor decreased sweating and
increased body temperature,
especially in pediatric patients (5.3)
Metabolic acidosis: baseline and periodic measurement of serum
bicarbonate is recommended;
consider dose reduction or discontinuation of topiramate if clinically
appropriate (5.4)
Suicidal behavior and ideation: antiepileptic drugs increase the risk
of suicidal behavior or ideation (5.5)
Cognitive/neuropsychiatric