Migraine attacks can cause significant pain for hours to days and be so severe that all you can think about is finding a dark, quiet place to lie down. Topamax is used alone or with other medications to treat certain types of seizures including primary generalized tonic-clonic seizures formerly known as a grand mal seizure; seizure that involves the entire body and partial onset seizures seizures that involve only one part of the brain. Topamax is also used with other medications to control seizures in people who have Lennox-Gastaut syndrome a disorder that causes seizures and developmental delays. Topamax is also used to prevent migraine headaches but not to relieve the pain of migraine headaches when they occur. Topamax is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
Topamax (topiramate) is a seizure medicine, also called an anticonvulsant. Topiramate is used to treat seizures in adults and children who are at least 2 years old. Topamax is also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. This medicine will only prevent migraine headaches or reduce the number of attacks. It will not treat a headache that has already begun.
Topamax comes as a tablet to take by mouth. The tablets and sprinkle capsules are usually taken with or without food once or twice a day. The extended-release capsules are usually taken with or without food once a day. Take Topamax at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Topamax exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Topamax tablets have a bitter taste so you should swallow them whole. It is especially important that you not take Topamax tablets that have been broken for any length of time because tablets that are broken may lose their effectiveness over time.
While using topiramate, you may need frequent blood tests. If you need surgery, tell the surgeon ahead of time that you are using Topamax. Drink plenty of liquids while you are taking this medicine, to prevent kidney stones or an electrolyte imbalance. Do not stop using Topamax suddenly, even if you feel fine. Stopping suddenly may cause increased seizures.
Before Using Topamax. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Although appropriate studies on the relationship of age to the effects of topiramate have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of topiramate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving topiramate.
Before taking Topamax, tell your doctor if you have metabolic acidosis a disturbance in the body's acid-base balance that results in excessive acidity of the blood and you are taking metformin. Your doctor will probably tell you not to take metformin if you have metabolic acidosis and you are taking this of medication.
Tell your doctor if you or any family members have or have ever had kidney stones, and if you have ever thought about killing yourself or tried to do so. Also tell your doctor if you have or have ever had metabolic acidosis a disturbance in the body's acid-base balance that results in excessive acidity of the blood; osteopenia, osteomalacia, or osteoporosis conditions in which the bones are soft or brittle and may break easily; diabetes; glaucoma; any disease that affects your breathing such as asthma or chronic obstructive pulmonary disease; depression or abnormal moods; a growth problem; or liver or kidney disease. Also tell your doctor if you have diarrhea or if you develop diarrhea during your treatment.
Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you are pregnant or plan to become pregnant, your doctor may prescribe a different medication instead of Topamax because Topamax may harm the fetus. If you do not plan to become pregnant, you should use birth control to prevent pregnancy during your treatment with Topamax. Talk to your doctor about what type of birth control you should use, because taking Topamax may decrease the effectiveness of some types of birth control. If you become pregnant while you are taking Topamax, call your doctor right away, but do not stop taking Topamax before talking to your doctor.
If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Topamax. You should know that Topamax may make you drowsy, dizzy, confused, or unable to concentrate. Do not drive a car or operate machinery until you know how this medication affects you. If you are taking Topamax to control seizures, you should know that you may continue to have seizures during your treatment. You may need to avoid activities such as swimming, driving, and climbing so that you will not harm yourself or others if you lose consciousness during a seizure. Tell your doctor if you if you drink alcohol. Your doctor will probably tell you not to drink alcohol while taking Topamax.
You should know that Topamax can prevent you from sweating and make it harder for your body to cool down when it gets very hot. This happens most often in warm weather and to children who take Topamax. Avoid exposure to heat, drink plenty of fluids and tell your doctor if you have a fever, headache, muscle cramps, or an upset stomach, or if you are not sweating as usual. You should know that you may be more likely to develop a kidney stone while you are taking Topamax. Drink 6 to 8 glasses of water every day to prevent kidney stones from forming.
There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as Topamax, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior.
Follow the directions for using this medicine provided by your doctor. Take Topamax for migraine and other headache pain relief exactly as directed.
The recommended dose for Topamax monotherapy in adults is based on weight. During the titration period, the initial dose of Topamax should be 25 mg/day administered nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week. Dosage can be increased by 25-50 mg/day each subsequent week as tolerated. Titration to the minimum maintenance dose should be attempted over 5-7 weeks of the total titration period. Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25-50 mg/day weekly increments. The total daily dose should not exceed the maximum maintenance dose.
The recommended total daily dose of Topamax as adjunctive therapy in adults with partial onset seizures is 200 to 400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. It is recommended that therapy be initiated at 25 to 50 mg/day followed by titration to an effective dose in increments of 25 to 50 mg/day every week.
The recommended total daily dose of Topamax as treatment for adults for prophylaxis of migraine headache is 100 mg/day administered in two divided doses. The recommended titration rate for topiramate for migraine prophylaxis to 100 mg/day in the morning and evening.
Dose and titration rate should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used. Topamax can be taken without regard to meals.
The industry-funded researchers who authored the Journal of the American Medical Association study have been publicizing the use of Topamax to treat alcoholism, a use for which the drug is not approved by the Food and Drug Adminstration (FDA).
There may technically be nothing wrong with such publicity, if the researchers generated it and sent it out independently. But if Ortho-McNeil Janssen, Topamax manufacturer, was involved in the creation or dissemination of the information, or if company funding played any role in this publicity campaign – that could be a violation of federal law.
Here's what we know, based on the documents we have seen: The University of Virginia, the venue where the study was conducted with funding from Ortho-McNeil, sent members of the media information kits including the JAMA article as well as additional information that implicitly promotes the use of the drug for alcoholism. The lead author, from the University of Virginia, is also a consultant to Ortho; six of the other authors are full-time employees of Ortho-McNeil.
These kits include a question-and-answer sheet asking "Can my doctor prescribe me topiramate for alcohol dependence?" The answer, in effect, is yes: "Since topiramate is currently FDA-approved for seizures and migraines, it is available to your doctor to prescribe it to you off-label."
Doctors are legally able to prescribe drugs for "off-label" uses – those uses for which a drug is not FDA-approved. In fact, topiramate already has an off-label use – it has been prescribed as a weight-loss drug despite the fact that the FDA has not approved the drug for this purpose because it has never been proven to be a safe or effective weight-loss agent.
So the university is within its rights to state that doctors can prescribe the drug for off-label uses. But if the drug manufacturer had any hand in writing or funding the distribution of those media kits, it's another story.
FDA laws and regulations prohibit manufacturers from promoting or advertising off-label uses of their products. This is designed to prevent widespread use of drugs for purposes that the FDA has not fully evaluated.
If the promotional materials were directly provided or approved by topiramate manufacturer Ortho-McNeil Janssen, this would be a clear violation of the prohibition against off-label promotion. The FDA has agreed to investigate this and if there is illegal off-label promotion, the agency needs to require the company to stop this campaign. So, we do not recommend to use topiramate to treat alcohol dependence or for weight loss (another off-label use of the drug). This drug is only approved by the FDA to treat seizures and migraines.
Common side effects of Topamax include memory impairment, speech disturbance, anxiety, dysphasia, drowsiness, psychomotor disturbance, confusion, fatigue, diarrhea, paresthesia, nausea, ataxia, lack of concentration, diplopia, nervousness, dizziness, depression, visual disturbance, weight loss, dysgeusia, mood changes, and anorexia. Other side effects include arthralgia, and weakness.
Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of the following symptoms or those listed in this section, call your doctor immediately:
Topamax may cause osteoporosis (a condition in which bones can break more easily) in adults and rickets (abnormal, curved bone growth) in children. Topamax may also slow the growth of children and may decrease the final height that children reach.
Pain relievers are typically the first drugs recommended by doctors for migraine and headaches. Many of these medications are over-the-counter, or available without a doctor's prescription. Topamax also used in the treatment of obesity; migraine prevention; fibromyalgia; diabetic peripheral neuropathy; vulvodynia, and belongs to the drug class carbonic anhydrase inhibitor anticonvulsants. There is positive evidence of human fetal risk during pregnancy. Topamax is not a controlled substance under the Controlled Substance Act.