TOPAMAX- topiramate tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

DIRECT RX

INN (Tarptautinis Pavadinimas):

TOPIRAMATE

Sudėtis:

TOPIRAMATE 50 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

9.1 Controlled Substance Topiramate is not a controlled substance. 9.2 Abuse The abuse and dependence potential of topiramate has not been evaluated in human studies. 9.3 Dependence Topiramate has not been systematically studied in animals or humans for its potential for tolerance or physical dependence. 8.1 Pregnancy Pregnancy Category D [See Warnings and Precautions (5.7)] Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts). When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring. Topiramate should be used during pregnancy only if the potential benefit outweighs the potential risk. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

TOPAMAX- TOPIRAMATE TABLET
DIRECT RX
----------
MEDICATION GUIDE
Topiramate Tablets USP
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 and
during your treatment with topiramate. If you are pregnant, you should
t

Prekės savybės

TOPAMAX- TOPIRAMATE TABLET
DIRECT RX
----------
TOPIRAMATE
MEDICATION GUIDE
Topiramate Tablets USP
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 and
during your treatment with topiramate. If you are pregnant, y