TOPIRAMATE tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Northwind Pharmaceuticals, LLC

DCI (Denominação Comum Internacional):

TOPIRAMATE

Composição:

TOPIRAMATE 100 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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. 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. Topiramate tablets 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 about the North American Drug Pregnancy

Resumo do produto:

Topiramate Tablets, USP are available as circular, biconvex, film-coated tablets in the following strengths and colors: 100 mg yellow tablets with ‘G’ engraved on one side and ‘100’ on the other side. Topiramate tablets should be stored in tightly-closed containers at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
Northwind Pharmaceuticals, LLC
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MEDICATION GUIDE
Topiramate (TOE-pee-rah-mate)
Tablets
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. If a high fever, a fever that
does not go away, or decreased sweating develops, call your healthcare
provider right away.
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:
1.
● feel tired
1.
●feel changes in heartbeat
1.
● not feel hungry (loss of appetite)
1.
●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 tablets may cause suicidal
thoughts or actions in a very small
number of people, about 1 in 500.
Call a healthcare provider right away

Características técnicas

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
NORTHWIND PHARMACEUTICALS, LLC
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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
1. Warnings and Precautions ( 5.1, 5.4, 5.7, 5.9, 5.10, 5.13) 10/2022
INDICATIONS AND USAGE
Topiramate tablets 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 tablets 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)
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 suicidal behavior or ideation ( 5.5)
Cognitive/n