Topamax

Topamax is a prescription medication used to treat certain types of seizures in adults and children. It is also used to prevent migraines in patients 12 years of age and older. Topamax belongs to a group of drugs called anticonvulsants, which decrease abnormal brain activity.

This medication comes in tablet form. Swallow tablets whole. Topamax is also available in sprinkle capsules.

Common side effects of Topamax include tingling of the limbs, decrease in appetite, and nausea. Topamax can cause vision changes, dizziness, and drowsiness. Do not drive or operate machinery until you know how Topamax will affect you.

Topamax is a prescription medicine used:

• to treat certain types of seizures (partial onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older
• with other medicines to treat certain types of seizures (partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older
• to prevent migraine headaches in adults and in adolescents ages 12 years of age and older

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Janssen Pharmaceuticals, Inc.

Topamax  may cause serious side effects including:

See "Drug Precautions".

• Metabolic acidosis. Metabolic acidosis can cause:
  • tiredness
  • loss of appetite
  • irregular heartbeat
  • impaired consciousness
• High blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. This has happened when Topamax is taken with a medicine called valproic acid (Depakene and Depakote).
• Low body temperature. Taking Topamax when you are also taking valproic acid can cause a drop in body temperature to less than 95°F, feeling tired, confusion, or coma.
• Kidney stones. Drink plenty of fluids when taking Topamax to decrease your chances of getting kidney stones.
• Effects on thinking and alertness. Topamax may affect how you think and cause confusion, problems with concentration, attention, memory, or speech. Topamax may cause depression or mood problems, tiredness, and sleepiness.
• Dizziness or loss of muscle coordination.

Call your healthcare provider right away if you have any of the symptoms above.

The most common side effects of Topamax include:

• tingling of the arms and legs (paresthesia)
• not feeling hungry
• nausea
• a change in the way foods taste
• diarrhea
• weight loss
• nervousness
• upper respiratory tract infection

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. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medicines for epilepsy (phenytoin, carbamazepine, and valproic acid)
• birth control medicines taken by mouth (oral contraceptives)
• metformin
• lithium
• other carbonic anydrase inhibitors (zonisamide, acetazolamide, dichlorphenamide)
• CNS depressants (medicines that impair your thinking, concentration or muscle coordination). For example:
  • medicines for anxiety 
  • medicines for insomnia
  • pain medicines
  • alcohol

This is not a complete list of possible drug interactions with Topamax. Talk to your doctor or pharmacist for more information.

Topamax 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.

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. Call your healthcare provider right away if you have a fever or decreased sweating.

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:

• 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 Topamax. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.

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:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

Do not stop Topamax without first talking to a healthcare provider.

• Stopping Topamax suddenly can cause serious problems.
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Watch for early symptoms of suicidal thoughts and actions.

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Topamax can harm your unborn baby (see "Pregnant Section").

• Do not drink alcohol while taking Topamax. Topamax and alcohol can affect each other causing side effects such as sleepiness and dizziness.
• Do not drive a car or operate heavy machinery until you know how Topamax affects you. Topamax can slow your thinking and motor skills, and may affect vision.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Topamax there are no specific foods that you must exclude from your diet when receiving Topamax.

Before taking Topamax, tell your healthcare provider about all your medical conditions, including if you:

• have or have had depression, mood problems, or suicidal thoughts or behavior
• have kidney problems, have kidney stones, or are getting kidney dialysis
• have a history of metabolic acidosis (too much acid in the blood)
• have liver problems
• have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density)
• have lung or breathing problems
• have eye problems, especially glaucoma
• have diarrhea
• have a growth problem
• are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet
• are having surgery
• are pregnant or plan to become pregnant
• are breastfeeding. Topamax passes into breast milk. It is not known if the Topamax that passes into breast milk can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Topamax.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Topamax and other medicines may affect each other causing side effects.

Especially tell your healthcare provider if you take:

• Valproic acid (such as Depakene or Depakote)
• any medicines that impair or decrease your thinking, concentration, or muscle coordination
• birth control pills. Topamax may make your birth control pills less effective. Tell your healthcare provider if your menstrual bleeding changes while you are taking birth control pills and Topamax.

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.

Topamax can harm your unborn baby.

• If you takeTopamax during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant.
• Cleft lip and cleft palate may happen even in children born to women who are not taking any medicines and do not have other risk factors.
• There may be other medicines to treat your condition that have a lower chance of birth defects.
• All women of childbearing age should talk to their healthcare providers about using other possible treatments instead of Topamax. If the decision is made to use Topamax, you should use effective birth control (contraception) unless you are planning to become pregnant. You should talk to your doctor about the best kind of birth control to use while you are taking Topamax.
• Tell your healthcare provider right away if you become pregnant while taking Topamax. You and your healthcare provider should decide if you will continue to take Topamax while you are pregnant.
• Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if Topamax has caused metabolic acidosis during your pregnancy.
• Pregnancy Registry: If you become pregnant while taking Topamax, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed. Topamax may be excreted in human breast milk. The effects of this exposure on infants are unknown.

• Take Topamax exactly as prescribed.
• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
• Topamax tablets should be swallowed whole. Do not chew the tablets. They may leave a bitter taste.
• Topamax Sprinkle Capsules (regular release) may be swallowed whole or may be opened and sprinkled on a teaspoon of soft food. Drink fluids right after eating the food and medicine mixture to make sure it is all swallowed.
• Topamax Sprinkle Capsules (extended release) can be taken without regard to meals. Swallow capsule whole and intact. Do not sprinkle on food, chew or crush.
• Do not store any medicine and food mixture for later use.
• Topamax can be taken before, during, or after a meal. Drink plenty of fluids during the day. This may help prevent kidney stones while taking Topamax.
• If you take too much Topamax, call your healthcare provider or poison control center right away or go to the nearest emergency room.
• If you miss a single dose of Topamax, take it as soon as you can. However, if you are within 6 hours of taking your next scheduled dose, wait until then to take your usual dose of Topamax, and skip the missed dose. Do not double your dose. If you have missed more than one dose, you should call your healthcare provider for advice.
• Do not stop taking Topamax without talking to your healthcare provider. Stopping Topamax suddenly may cause serious problems. If you have epilepsy and you stop taking Topamax suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking Topamax slowly.
• Your healthcare provider may do blood tests while you take Topamax.

Take Topamax exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. For most patients, the dosage is gradually increased until the minimum effective dosage is reached. This occurs over at least four weeks.

Epilepsy (seizures)

• For children ages 2 to 9 years of age, dosing of Topamax (topiramate) is typically based on weight. 
• The recommended dose for Topamax (topiramate) monotherapy to treat seizures in adults and children 10 years of age and older is 400 mg/day in two divided doses.
• The recommended dose range for Topamax (topiramate) as as adjunctive therapy for the treatment of seizures in adults is 200 mg to 400 mg/day in two divided doses.
  • Patients receiving other medicines for epilepsy in addition to Topamax (topiramate) as adjunctive therapy may require a lower dose of Topamax.

Migraine

The recommended total daily dose of Topamax (topiramate) to prevent migraine headaches is 100 mg/day in two divided doses.

If you take too much Topamax, call your local Poison Control Center or seek emergency medical attention right away.

• Store Topamax Tablets at room temperature, 59°F to 86°F (15°C to 30°C).
• Store Topamax Sprinkle Capsules at or below 77°F (25°C).
• Keep Topamax in a tightly closed container.
• Keep Topamax dry and away from moisture and light.
• Keep Topamax and all medicines out of the reach of children.