TOPIRAMATE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Direct_Rx

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

1.1 Monotherapy Epilepsy 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. 1.2 Adjunctive Therapy Epilepsy 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. 1.3 Migraine Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older. None. 8.1 Pregnancy 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

Produktsammanfattning:

16.1 How Supplied 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) 50 mg yellow (coded “S” on one side; “710” on the other) 100 mg yellow (coded “S” on one side; “711” on the other) 200 mg brown (coded “S” on one side; “712” on the other) They are supplied as follows: 25 mg tablets Bottles of 30’s with Child Resistant Cap…………... Bottles of 60’s with Child Resistant Cap…………... Bottles of 100’s with Child Resistant Cap …............ Bottles of 100’s with Non Child Resistant Cap … Bottles of 500’s with Non Child Resistant Cap …… Bottles of 1000’s with Non Child Resistant Cap ….. 50 mg tablets Bottles of 30’s with Child Resistant Cap….............. Bottles of 60’s with Child Resistant Cap………….. Bottles of 100’s with Child Resistant Cap …........... Bottles of 100’s with Non Child Resistant Cap …... Bottles of 500’s with Non Child Resistant Cap …... Bottles of 1000’s with Non Child Resistant Cap …. 100 mg tablets Bottles of 30’s with Child Resistant Cap….............. Bottles of 60’s with Child Resistant Cap………….. Bottles of 100’s with Child Resistant Cap …............ Bottles of 100’s with Non Child Resistant Cap …… Bottles of 500’s with Non Child Resistant Cap ….... Bottles of 1000’s with Non Child Resistant Cap ….. 200 mg tablets Bottles of 30’s with Child Resistant Cap…............... Bottles of 60’s with Child Resistant Cap…………... Bottles of 100’s with Child Resistant Cap …............ Bottles of 100’s with Non Child Resistant Cap ….... Bottles of 500’s with Non Child Resistant Cap ….... Bottles of 1000’s with Non Child Resistant Cap ….. 16.2 Storage and Handling 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.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Direct_Rx
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Topiramate Tablets, USP
(toe-PEER-uh-mate)
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 people, about 1 in 500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse, or worry you:
• t

Produktens egenskaper

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
DIRECT_RX
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TOPIRAMATE
1.1 Monotherapy Epilepsy
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.
1.2 Adjunctive Therapy Epilepsy
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.
1.3 Migraine
Topiramate tablets
are indicated for the preventive treatment of migraine in patients 12
years of age and
older.
2.1 Dosing in Monotherapy Epilepsy
Adults and Pediatric Patients 10 Years of Age and Older
The recommended dose for topiramate monotherapy in adults and
pediatric patients 10
years of age and older is 400 mg/day in two divided doses. The dose
should be achieved
by titration according to the following schedule (Table 1):
Table 1: Monotherapy Titration Schedule for Adults and Pediatric
Patients 10 years and
older
Morning Dose
Evening Dose
Week 1
25 mg
25 mg
Week 2
50 mg
50 mg
Week 3
75 mg
75 mg
Week 4
100 mg
100 mg
Week 5
150 mg
150 mg
Week 6
200 mg
200 mg
Pediatric Patients 2 to 9 Years of Age
Dosing in patients 2 to 9 years of age is based on weight. During the
titration period, the
initial dose of topiramate is 25 mg/day nightly for the first week.
Based upon tolerability,
the dosage can be increased to 50 mg/day (25 mg twice daily) in the
second week.
Dosage can be increased by 25 to 50 mg/day each subsequent week as
tolerated.
Titration to the minimum maintenance dose should be attempted over 5
to 7 weeks of
the total titration period. Based upon tolerability and clinical
response, additional titration
to a higher dose (up to the maximum maintenance dose) can be attempted
at 25 to 50
mg/day weekly increments. The total daily dose should not exceed the
maximum
maintenance dose for each range of body weight (Table 2).
Table 2: Monotherapy Target Total Daily M