TOPIRAMATE tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Proficient Rx LP

INN (Միջազգային անվանումը):

TOPIRAMATE

Կազմը:

TOPIRAMATE 100 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Topiramate tablets, USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies (14.1)] . Topiramate tablets, USP are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies (14.2)] . Additional pediatric use information for patients ages 12 to 17 years is approved for Janssen Pharmaceuticals, Inc.’s TOPAMAX (topiramate) Tablets and Sprinkle Capsules. However, due to Janssen Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. None. Pregnancy Category D. [

Ապրանքի ամփոփագիր:

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: 100 mg tablets Bottles of 30’s with Child Resistant Cap….............. NDC 63187-801-30 Bottles of 60’s with Child Resistant Cap…………...NDC 63187-801-60 Bottles of 90’s with Child Resistant Cap ….......... ..NDC 63187-801-90 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.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
Proficient Rx LP
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MEDICATION GUIDE
Topiramate Tablets, USP
(toe-PEER-uh-mate)
Read this Medication Guide before you start taking topiramate tablets
and each time you get a refill.
There may be new information. This information does not take the place
of talking to your healthcare
provider about your medical condition or treatment. If you have any
questions about topiramate tablets,
talk to your healthcare provider or pharmacist.
What is the most important information I should know about topiramate
tablets?
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 tablets 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. Call your healthcare
provider right away if you have a high fever, a fever that does not go
away, or decreased sweating.
Topiramate tablets 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 a

Ապրանքի հատկությունները

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
PROFICIENT RX LP
----------
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
•
INDICATIONS AND USAGE
Topiramate is indicated for:
•
•
DOSAGE AND ADMINISTRATION
See DOSAGE AND ADMINISTRATION, Epilepsy: Monotherapy and Adjunctive
Therapy Use for additional details (2.1)
INITIAL DOSE
T ITRATIO N
RECOMMENDED DOSE
Epilepsy monotherapy:
children 2 to <10 years (2.1)
25 mg/day administered
nightly for the first week
The dosage should be titrated
over 5 to 7 weeks
Daily doses in two divided
doses based on weight (Table
2)
Epilepsy monotherapy: adults
and pediatric patients ≥10
years (2.1)
50 mg/day in two divided
doses
The dosage should be
increased weekly by
increments of 50 mg for the
first 4 weeks then 100 mg for
weeks 5 to 6.
400 mg/day in two divided
doses
Epilepsy adjunctive therapy:
adults with partial onset
seizures or LGS (2.1)
25 to 50 mg/day
The dosage should be
increased weekly to an
effective dose by increments
of 25 to 50 mg.
200 to 400 mg/day in two
divided doses
Epilepsy adjunctive therapy:
adults with primary
generalized tonic clonic
seizures (2.1)
25 to 50 mg/day
The dosage should be
increased weekly to an
effective dose by increments
of 25 to 50 mg.
400 mg/day in two divided
doses
Epilepsy adjunctive therapy:
pediatric patients with partial
onset seizures, primary
generalized tonic-clonic
seizures or LGS (2.1)
25 mg/day (or less, based on
a range of 1 to 3 mg/kg/day)
nightly for the first week
The dosage should be
increased at 1- or 2-week
intervals by increments of 1 to
3 mg/kg/day (administered in
two divided doses). Dose
titration should be guided by
clinical outcome.
5 to 9 mg/kg/day in two divided
dose s
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
None (4) (4)
WARNINGS AND PRECAUTIONS
•
Warnings and Precauti