TOPAMAX- topiramate tablet, coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

REMEDYREPACK INC.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

TOPAMAX ® is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. TOPAMAX ® is 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. TOPAMAX ® is 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 TOPAMAX ® 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 Registry can be found at h

Produktsammanfattning:

TOPAMAX ® Tablets TOPAMAX ® (topiramate) Tablets are available as debossed, coated, round tablets in the following strengths and colors: TOPAMAX ® Sprinkle Capsules TOPAMAX ® (topiramate capsules) Sprinkle Capsules contain small, white to off-white spheres. The gelatin capsules are white and clear and are marked as follows: TOPAMAX ® Tablets 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 TOPAMAX ® Sprinkle Capsules should be stored in tightly-closed containers at or below 25°C (77°F). Protect from moisture.

Bemyndigande status:

New Drug Application

Bipacksedel

REMEDYREPACK INC.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised:12/2018
MEDICATION GUIDE
TOPAMAX ® (TOE-PA-MAX)
(topiramate)
TABLETS, for oral use
TOPAMAX ®
(TOE-PA-MAX)
(topiramate capsules)
SPRINKLE CAPSULES, for oral use
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, including
any new problems with your vision.
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. If a high
fever, a fever that does not go away, or
decreased sweating develops, call your healthcare provider right away.
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
whether you have metabolic acidosis.
Like other antiepileptic drugs, TOPAMAX may cause suicidal thoughts or
actions in a very small number

Produktens egenskaper

TOPAMAX- TOPIRAMATE TABLET, COATED
REMEDYREPACK INC.
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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
INDICATIONS AND USAGE
TOPAMAX
is 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
TOPAMAX
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
Tablets: 25 mg, 50 mg, 100 mg, and 200 mg ( 3)
Sprinkle Capsules: 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 TOPAMAX
as
soon as possible ( 5.1)
Visual field defects: consider discontinuation of TOPAMAX
( 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 TOPAMAX
if clinically appropriate ( 5.4)
Suicidal behavior and ideation: antiepileptic drugs increase the risk
of suicidal behavior or ideation ( 5.5)
Cognitive/neuropsychiatric adverse reactions: use caution when
ope