INDICATION
TOPIRAMATE + VITAMIN B12 is a compounded product and is not FDA-approved. The FDA does not verify the safety or effectiveness of compounded drugs.
TOPIRAMATE (Topamax®) is FDA approved to:
- 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 adolescents 12 years and older.
VITAMIN B12 is a dietary supplement utilized in many areas of the body principally for the proper function of your red blood cells, nerve cells, energy levels and mood. Additionally it is used to supplement B12 when other drugs may possibly decrease its level.
TOPIRAMATE + VITAMIN B12 is prescribed off-label and may help some adults with overweight and obesity lose weight and keep the weight off.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TOPIRAMATE + VITAMIN B12?
TOPIRAMATE + VITAMIN B12 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 + VITAMIN B12 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 + VITAMIN B12 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 + VITAMIN B12. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.
Like other antiepileptic drugs, TOPIRAMATE + VITAMIN B12 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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| • Thoughts about suicide or dying | • Feeling agitated or restless |
| • Attempts to commit suicide | • Trouble sleeping (insomnia) |
| • New or worse depression | • New or worse irritability |
| • New or worse anxiety | • Acting aggressive, being angry or violent |
| • Panic attacks | • Acting on dangerous impulses |
| • An extreme increase in activity and talking (mania) | • Other unusual changes in behavior or mood |
TOPIRAMATE + VITAMIN B12 may lower bone mineral density. TOPIRAMATE + VITAMIN B12 may decrease the density of bones when used over a long period.
TOPIRAMATE + VITAMIN B12 may have negative effects on growth in children
TOPIRAMATE + VITAMIN B12 may slow height increases and weight gain in children and adolescents when used over a long period
Do not stop TOPIRAMATE + VITAMIN B12 without first talking to a healthcare provider.
- Stopping TOPIRAMATE + VITAMIN B12 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.
- If you have epilepsy and you stop taking TOPIRAMATE + VITAMIN B12 suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking TOPIRAMATE + VITAMIN B12 slowly.
- If you miss a single dose of TOPIRAMATE + VITAMIN B12, 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 TOPIRAMATE + VITAMIN B12 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.
How can I 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.
TOPIRAMATE + VITAMIN B12 can harm your unborn baby.
- If you take TOPIRAMATE + VITAMIN B12 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 TOPIRAMATE + VITAMIN B12. If the decision is made to use TOPIRAMATE + VITAMIN B12, 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 TOPIRAMATE + VITAMIN B12.
- Tell your healthcare provider right away if you become pregnant while taking TOPIRAMATE + VITAMIN B12. You and your healthcare provider should decide if you will continue to take TOPIRAMATE + VITAMIN B12 while you are pregnant.
- If you take TOPIRAMATE + VITAMIN B12 during pregnancy, your baby may be smaller than expected at birth. The long-term effects of this are not known. Talk to your healthcare provider if you have questions about this risk during pregnancy.
- Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if TOPIRAMATE + VITAMIN B12 has caused metabolic acidosis during your pregnancy.
- Pregnancy Registry: If you become pregnant while taking TOPIRAMATE + VITAMIN B12, 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 TOPIRAMATE + VITAMIN B12 and other antiepileptic drugs during pregnancy.
Before taking TOPIRAMATE + VITAMIN B12, tell your healthcare provider about all of 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 or plan to breastfeed? TOPIRAMATE + VITAMIN B12 passes into breast milk. Breastfed babies may be sleepy or have diarrhea. It is not known if the TOPIRAMATE + VITAMIN B12 that passes into breast milk can cause serious harm to your baby. Talk to your healthcare provider about the best way to feed your baby if you take TOPIRAMATE + VITAMIN B12.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TOPIRAMATE + VITAMIN B12 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 that contains hormones (such as pills, implants, patches or injections). TOPIRAMATE + VITAMIN B12 may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you are using birth control and TOPIRAMATE + VITAMIN B12.
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 TOPIRAMATE + VITAMIN B12?
- Take TOPIRAMATE + VITAMIN B12 exactly as prescribed.
- Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
- Take TOPIRAMATE + VITAMIN B12 tablets whole. Do not chew the tablets. They may leave a bitter taste.
- TOPIRAMATE + VITAMIN B12 can be taken before, during, or after a meal. Drink plenty of fluids during the day. This may help prevent kidney stones while taking TOPIRAMATE + VITAMIN B12.
- If you take too much TOPIRAMATE + VITAMIN B12, call your healthcare provider right away or go to the nearest emergency room.
- If you miss a single dose of TOPIRAMATE + VITAMIN B12, 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 TOPIRAMATE + VITAMIN B12 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 TOPIRAMATE + VITAMIN B12 without talking to your healthcare provider. Stopping TOPIRAMATE + VITAMIN B12 suddenly may cause serious problems. If you have epilepsy and you stop taking TOPIRAMATE + VITAMIN B12 suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking TOPIRAMATE + VITAMIN B12 slowly.
- Your healthcare provider may do blood tests while you take TOPIRAMATE + VITAMIN B12.
What should I avoid while taking TOPIRAMATE + VITAMIN B12?
- You should not drink alcohol while taking TOPIRAMATE + VITAMIN B12. TOPIRAMATE + VITAMIN B12 and alcohol can affect each other, causing side effects such as sleepiness and dizziness.
- Do not drive a car or operate machinery until you know how TOPIRAMATE + VITAMIN B12 affects you. TOPIRAMATE + VITAMIN B12 can slow your thinking and motor skills, and may affect vision.
Even when taking TOPIRAMATE + VITAMIN B12 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 TOPIRAMATE + VITAMIN B12?
TOPIRAMATE + VITAMIN B12 may cause serious side effects including:
See “What is the most important information I should know about TOPIRAMATE + VITAMIN B12?”
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 TOPIRAMATE + VITAMIN B12 is taken with a medicine called valproic acid (Depakene® or Depakote®).
Effects on thinking and alertness. TOPIRAMATE + VITAMIN B12 may affect how you think and cause confusion, problems with concentration, attention, memory, or speech. TOPIRAMATE + VITAMIN B12 may cause depression or mood problems, tiredness, and sleepiness.
Dizziness or loss of muscle coordination.
Serious skin reactions. TOPIRAMATE + VITAMIN B12 may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). TOPIRAMATE + VITAMIN B12 may also cause a rash with blisters and peeling skin over much of the body that may cause death (toxic epidermal necrolysis). Call your healthcare provider right away if you develop a skin rash or blisters.
Kidney stones. Drink plenty of fluids when taking TOPIRAMATE + VITAMIN B12 to decrease your chances of getting kidney stones.
Low body temperature. Taking TOPIRAMATE + VITAMIN B12 when you are also taking valproic acid can cause a drop in body temperature to less than 95°F, feeling tired, confusion, or coma.
Call your healthcare provider right away if you have any of the symptoms above.
The most common side effects of TOPIRAMATE + VITAMIN B12 include:
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| • Tingling of the arms and legs (paresthesia) | • Dizziness |
| • Not feeling hungry | • Sleepiness/drowsiness |
| • Nausea | • Slow reactions |
| • A change in the way foods taste | • Difficulty with memory |
| • Diarrhea | • Pain in the abdomen |
| • Weight loss | • Fever |
| • Nervousness | • Abnormal vision |
| • Upper respiratory tract infection | • Decreased feeling or sensitivity, especially in the skin |
| • Speech problems | |
| • Tiredness | |
Tell your healthcare provider about any side effect that bothers you or that does not go away. You are encouraged to report all side effects to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
These are not all the possible side effects of TOPAMAX