TOPIRAMATE capsule, coated pellets

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Teva Pharmaceuticals USA, Inc.

INN (שם בינלאומי):

TOPIRAMATE

הרכב:

TOPIRAMATE 15 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Topiramate capsules (sprinkle) 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 capsules (sprinkle) 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 capsules (sprinkle) 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 abo

leaflet_short:

Topiramate capsules (sprinkle) are available as follows: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

מצב אישור:

Abbreviated New Drug Application

עלון מידע

Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Topiramate (toe pir′ a
mate) Capsules
(Sprinkle)
for oral use
What is the most
important information I
should know about
topiramate capsules
(sprinkle)?
Topiramate capsules
(sprinkle) 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 capsules
(sprinkle) 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 capsules
(sprinkle) 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 capsules
(sprinkle). If you are
pregnant, you should talk
to your healthcare
provider about whether
you have metabolic
acidosis.
Like other antiepileptic
drugs, topiramate
capsules (sprinkle) may
cause

מאפייני מוצר

TOPIRAMATE- TOPIRAMATE CAPSULE, COATED PELLETS
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPIRAMATE CAPSULES
(SPRINKLE) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR TOPIRAMATE
CAPSULES (SPRINKLE).
TOPIRAMATE CAPSULES (SPRINKLE), 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 capsules (sprinkle) are indicated for:
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 capsules (sprinkle) 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)
DOSAGE FORMS AND STRENGTHS
Capsules (Sprinkle): 15 mg and 25 mg (3)
CONTRAINDICATIONS
None (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 suic