About TOPAMAX

Attention TOPAMAX Patients and Medical Professionals
Dispensing errors have been reported between TOPAMAX^® (topiramate) tablets and TOPROL-XL^®(metoprolol succinate) extended-release tablets.

Please be sure to check your tablets to ensure you are taking the right medicine.

*TOPROL-XL is Edegra a registered trademark of the AstraZeneca group of companies.

TOPAMAX^® is approved for migraine prevention in adults only. 
TOPAMAX^® is not used to stop a migraine after it starts. 

IMPORTANT SAFETY INFORMATION 

Warnings and Precautions

TOPAMAX^® may cause eye problems. Serious eye problems include: sudden decrease in vision with or without eye pain and redness; 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 professional 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. 

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, or 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. 

Like other antiepileptic drugs, TOPAMAX^® may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Pay attention to any changes and call your doctor 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), or other unusual changes in behavior or mood. 

TOPAMAX^® may affect how you think, and cause confusion, problems with concentration, attention, memory, or speech, depression or mood problems, tiredness, and sleepiness. 
Do not stop taking TOPAMAX^® without first talking to your doctor. Stopping TOPAMAX^® suddenly can cause serious problems. 

If you take TOPAMAX^® 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. 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. 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. 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. 

TOPAMAX^® may cause high blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. 

Taking TOPAMAX^® when you are also taking valproic acid can cause a drop in body temperature (hypothermia) to less than 95ºF, feeling tired, confusion, or coma. 

Adverse Reactions

The most common side effects of TOPAMAX^® include: tingling in arms and legs, loss of appetite, nausea, taste change, diarrhea, weight loss, nervousness, and upper respiratory tract infection. 

Tell your doctor about other medications that you are taking. Report 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 professional or pharmacist. 

Topamax / Topiramate Medication Profile

Topamax - generic topiramate - is an anticonvulsant medication approved by the US Food and Drug Administration (FDA) for use in treating epilepsy and migraine headaches. While Topamax has been and continues to be studied for use in the treatment of bipolar disorder, it is not FDA approved for such use. However, many doctors do prescribe Topamax off-label for bipolar disorder. Two recent clinical studies' results agreed with those of older studies, finding that Topamax was effective for bipolar disorder when used as an add-on to other mood stabilizers but not particularly effective when used alone.

Topamax comes in tablets Viagra Super Active and in capsules that may be opened and sprinkled onto soft food such as pudding, yogurt, ice cream, and other food that does not require chewing. If using Topamax sprinkle capsules, you should eat the entire serving of food immediately; do not store it for later.

Major Warnings

1. Metabolic Acidosis. Topamax use is associated with this condition, in which the blood becomes too acidic. There is a higher risk of developing metabolic acidosis in pediatric patients 15 and under. Symptoms are rapid breathing (hyperventilation), fatigue, refusal to eat, and stupor. This condition can be serious if not treated. The approved label for Topamax recommends measuring blood acidity when beginning treatment and periodic testing.
   
2. Glaucoma. A syndrome consisting of acute nearsightedness (myopia) associated with an eye disorder called secondary angle closure glaucoma has occurred in patients using Topamax. Symptoms generally appear within a month of starting Topamax treatment and include sudden blurring of vision, eye pain and sometimes redness or widely dilated pupils. If you experience any of these symptoms, contact your prescribing physician immediately. If the prescribing physician is not available, contact an ophthalmologist.
   
3. Decreased Sweating and Fever. This has primarily been reported in children, and patients should be monitored for these symptoms, especially in hot weather. Because many other prescribed and over-the-counter medications can make a person extra sensitive to heat, make sure your doctor and pharmacist know all the drugs the patient is taking. You may also wish to use a drug interaction checker.
   
4. Do not stop taking Topamax abruptly. There is an increased risk of seizures if this is done.
   
5. Kidney Stones. There is an increased risk of developing kidney stones when taking Topamax. Be sure to drink plenty of fluids.
   
6. Renal Impairment. Since Topamax is cleared from the body through the kidneys, dosage may need to be adjusted in patients with renal impairment, particularly in those aged 65 and older.

Drug Interactions

1. Other Anticonvulsants. In clinical trials, combining Tegretol (Carbamazepine) with Topamax resulted in a 40% decrease in the level of Topamax available. With Lamictal (Lamotrigine), the level of Topamax increased 15%, and with Depakote (Valproic Acid), both drugs' concentrations were lowered 11-14%. However, Topamax and Depakote combined create a risk for a condition called hyperammonemic encephalopathy. Symptoms are acute alteration in level of consciousness and/or cognitive function with lethargy or vomiting.
   
2. Oral Contraceptives. There is a risk of decreased contraceptive protection and breakthrough bleeding when taking Topamax with contraceptives containing estrogen.

There are a number of other possible drug interactions. Read the prescribing information carefully and again, make sure your doctor and pharmacist know all the other medications, both prescribed and over-the-counter, that you are taking.

Pregnancy/Breast-Feeding
Animal studies showed a significant danger to the fetus from Topamax, and in humans, there is a significantly increased risk of birth defects known as oral clefts. It is imperative to consult your prescribing doctor if you are pregnant or planning to become pregnant. Topamax should be used during pregnancy only if the potential benefit outweighs the potential risk to the unborn child. Although there are no controlled studies on the secretion of Topamax in milk, evidence suggests it is secreted extensively, and again, weigh the benefits and risks carefully.

Side Effects
The most commonly reported side effect of Topamax is parasthesia, or tingling of the extremities. The side effects that most caused people to drop out of clinical trials were sleepiness and fatigue. Reports of fatigue increased at higher dosages. Since there is a potential for dizziness, confusion and difficulty concentrating, do not drive or operate machinery until you know how you react to this medication.

Other common side effects include:

• Loss of appetite
• Weight loss
• Difficulties with memory, concentration or attention
• In children, upper respiratory infection

Much has been made about the possibility of losing weight on Topamax. In clinical trials, weight decrease occurred in up to 21% of subjects, usually less than that, and was dose-dependent, with the greatest number of people losing weight on 400mg per day. Since the risk of side effects increases with a higher dose, each person must evaluate his or her own response to the drug.

Disclaimer: This is not intended to be all-inclusive or to replace information provided by your doctor or with the prescription from the manufacturer.