TOPIRAMATE tablet, film coated TOPIRAMATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct_Rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1 Monotherapy Epilepsy Topiramate tablets and topiramate capsules 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 and topiramate capsules are indicated as adjunctive therapy for 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 and topiramate capsules 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 saf

Product summary:

16.1 How Supplied Topiramate Tablets, USP Topiramate Tablets USP, 25 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 16" on one side and plain on the other side and are supplied as follows: in bottle of 60 tablets in bottle of 90 tablets in bottle of 100 tablets in bottle of 500 tablets Topiramate Tablets USP, 50 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 15" on one side and plain on the other side and are supplied as follows: in bottle of 60 tablets in bottle of 90 tablets in bottle of 100 tablets in bottle of 500 tablets Topiramate Tablets USP, 100 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 14" on one side and plain on the other side and are supplied as follows: in bottle of 60 tablets in bottle of 90 tablets in bottle of 100 tablets in bottle of 500 tablets Topiramate Tablets USP, 200 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 13" on one side and plain on the other side and are supplied as follows: in bottle of 60 tablets in bottle of 90 tablets in bottle of 100 tablets in bottle of 500 tablets Topiramate Capsules, USP Topiramate Capsules USP, 15 mg are white to off-white pellets filled in size '2' empty hard gelatin capsules with white opaque cap imprinted with "ZA63" and white opaque body imprinted with "15 mg" in black ink and are supplied as follows: in bottle of 60 capsules in bottle of 90 capsules in bottle of 100 capsules in bottle of 500 capsules capsules Topiramate Capsules USP, 25 mg are white to off-white pellets filled in size '1' empty hard gelatin capsules with white opaque cap imprinted with "ZA64" and white opaque body imprinted with "25 mg" in black ink and are supplied as follows: in bottle of 28 capsules in bottle of 60 capsules in bottle of 90 capsules in bottle of 100 capsules in bottle of 500 capsules in bottle of 1000 capsules 16.2 Storage and Handling Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
TOPIRAMATE- TOPIRAMATE TABLET
Direct_Rx
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MEDICATION GUIDE
Topiramate (toe-PIR-a-mate) Tablets, USP
Topiramate (toe-PIR-a-mate) Capsules, USP
What is the most important information I should know about Topiramate?
Topiramate 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 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 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. If you are pregnant, you should
talk to your healthcare provider
about whether you have metabolic acidosis.
Like other antiepileptic drugs, topiramate 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,

Summary of Product characteristics

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
TOPIRAMATE- TOPIRAMATE TABLET
DIRECT_RX
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TOPIRAMATE
1.1 Monotherapy Epilepsy
Topiramate tablets and topiramate capsules 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 and topiramate capsules are indicated as adjunctive
therapy for 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 and topiramate capsules 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
Header$
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 mg/day to 50 mg/day each subsequent week
as
tolerated. Titration to the minimum maintenance dose should be
attempted over 5 weeks
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 mg/day to 50 mg/day weekly increments. The total daily
d