Adults and adolescents 12 years of age and older for the prophylaxis of migraine headache. The usefulness of TOPAMAX® in the acute treatment of migraine headache has not been studied.
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.
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.
INDICATIONS
TOPAMAX® is a prescription medicine used:
Important Safety Information
What is the most important information I should know about TOPAMAX®?
TOPAMAX® may cause eye problems. Serious eye problems include:
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.
TOPAMAX® 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.
TOPAMAX® 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:
Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with TOPAMAX®. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.
Like other antiepileptic drugs, TOPAMAX® 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:
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TOPAMAX® may lower bone mineral density. TOPAMAX® may decrease the density of bones when used over a long period.
TOPAMAX® may have negative effects on growth in children. TOPAMAX® may slow height increases and weight gain in children and adolescents when used over a long period
Do not stop TOPAMAX® without first talking to a healthcare provider.
How can I watch for early symptoms of suicidal thoughts and actions?
TOPAMAX® can harm your unborn baby.
Before taking TOPAMAX®, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TOPAMAX® and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:
Ask your healthcare provider if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.
How should I take TOPAMAX®?
What should I avoid while taking TOPAMAX®?
Even when taking TOPAMAX® or other antiepileptic medicines, some people with epilepsy will continue to have unpredictable seizures. Therefore, use caution and talk to your doctor before beginning any activities where loss of consciousness could result in serious danger to you or those around you (including swimming, driving a car, climbing in high places, etc.).
What are the possible side effects of TOPAMAX®?
TOPAMAX® may cause serious side effects including:
See “What is the most important information I should know about TOPAMAX®?”
Call your healthcare provider right away if you have any of the symptoms above.
The most common side effects of TOPAMAX® include:
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|
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the possible side effects of TOPAMAX®.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or by visiting http://www.fda.gov/medwatch.
You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please click here to read the full Prescribing Information and Medication Guide for TOPAMAX®.
cp-17014v7
INDICATIONS
TOPAMAX® is a prescription medicine used:
Important Safety Information
What is the most important information I should know about TOPAMAX®?
TOPAMAX® may cause eye problems. Serious eye problems include:
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.
TOPAMAX® 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.
TOPAMAX® 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:
Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with TOPAMAX®. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.
Like other antiepileptic drugs, TOPAMAX® 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:
|
|
TOPAMAX® may lower bone mineral density. TOPAMAX® may decrease the density of bones when used over a long period.
TOPAMAX® may have negative effects on growth in children. TOPAMAX® may slow height increases and weight gain in children and adolescents when used over a long period
Do not stop TOPAMAX® without first talking to a healthcare provider.
How can I watch for early symptoms of suicidal thoughts and actions?
TOPAMAX® can harm your unborn baby.
Before taking TOPAMAX®, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TOPAMAX® and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:
Ask your healthcare provider if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.
How should I take TOPAMAX®?
What should I avoid while taking TOPAMAX®?
Even when taking TOPAMAX® or other antiepileptic medicines, some people with epilepsy will continue to have unpredictable seizures. Therefore, use caution and talk to your doctor before beginning any activities where loss of consciousness could result in serious danger to you or those around you (including swimming, driving a car, climbing in high places, etc.).
What are the possible side effects of TOPAMAX®?
TOPAMAX® may cause serious side effects including:
See “What is the most important information I should know about TOPAMAX®?”
Call your healthcare provider right away if you have any of the symptoms above.
The most common side effects of TOPAMAX® include:
|
|
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the possible side effects of TOPAMAX®.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or by visiting http://www.fda.gov/medwatch.
You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please click here to read the full Prescribing Information and Medication Guide for TOPAMAX®.
cp-17014v7