Drug Notebook

FDA Alerts

Special Alerts:

[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

  • Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
  • Felbamate (marketed as Felbatol)
  • Gabapentin (marketed as Neurontin)
  • Lamotrigine (marketed as Lamictal)
  • Levetiracetam (marketed as Keppra)
  • Oxcarbazepine (marketed as Trileptal)
  • Pregabalin (marketed as Lyrica)
  • Tiagabine (marketed as Gabitril)
  • Topiramate (marketed as Topamax)
  • Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
  • Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic and http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.

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topiramate
(toe PYRE a mate)

What is topiramate?
Topiramate is a seizure medication, also called an anticonvulsant. Topiramate is used alone or in combination with other medications to prevent seizures in adults and children who are at least 2 years old. Topiramate is also used to prevent migraine headaches. Topiramate will only prevent migraine headaches or reduce the number of attacks. It will not treat a headache that has already begun. Topiramate may also be used for other purposes not listed in this medication guide.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Topamax 100MG Tablets MCNEIL60/$369.87 or 180/$1094.65
Topamax 200MG Tablets MCNEIL60/$427.58 or 180/$1243.15
Topamax 25MG Tablets MCNEIL60/$138.93 or 180/$395.41
Topamax 50MG Tablets MCNEIL60/$260.81 or 180/$752.54

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What are the possible side effects of topiramate?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Stop taking topiramate and call your doctor at once if you have any of these serious side effects:

  • sudden vision loss, pain around or behind your eyes;

  • dry mouth, increased thirst, confusion, drowsiness, decreased sweating, increased body temperature, and hot, dry skin,

  • nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting, or seizure (convulsions); or

  • severe pain in your side or lower back, painful or difficult urination.

Less serious side effects may include:

  • slowed thinking, memory problems, trouble concentrating;

  • problems with speech or balance;

  • numbness or tingling;

  • sleep problems (insomnia);

  • tired feeling;

  • headache, dizziness; or

  • loss of appetite, weight loss.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take topiramate?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Topiramate can be taken with or without food. Take the medicine with a full glass of water. The topiramate tablet should be swallowed whole. It has a bitter taste when chewed or broken.

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What is the most important information I should know about topiramate?
Seek emergency medical attention if you have a sudden change in vision and pain around or behind the eyes. These may be early signs of a serious side effect of topiramate. Do not stop taking topiramate without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking topiramate suddenly. You will need to use less and less before you stop the medication completely. Contact your doctor if your seizures get worse or you have them more often while taking topiramate.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect topiramate?
Before taking topiramate, tell your doctor if you are taking any of the following medicines: amitriptyline (Elavil, Etrafon); atropine (Donnatal, and others); benztropine (Cogentin); glycopyrrolate (Robinul); hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic); methscopolamine (Pamine) or scopolamine (Transderm-Scop); risperidone (Risperdal); bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Topiramate has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity, embryotoxicity, and maternal toxicity. There are no controlled data in human pregnancy. Topiramate should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

In rats, an increased frequency of limb malformations, embryotoxicity and maternal toxicity was observed at doses ranging from 0.5 to 10 times the recommended human dose on a mg/m2 basis. Mice studies have also demonstrated fetal malformations (primarily craniofacial defects) when topiramate was administered during the period of organogenesis. The lowest dose which resulted in mice fetal malformations was 20% of the recommended human dose. Rabbit studies have also demonstrated embryo/fetal mortality. Physicians are encouraged to register patients before fetal outcome is known (e.g., ultrasound, results of amniocentesis, etc) into the Antiepileptic Drug (AED) Pregnancy Registry at 1-888-233-2334 or 1-888-AED-AED4. This is an ongoing study at the Massachusetts General Hospital/Harvard Medical School. This study is designed to monitor the outcomes of pregnant women exposed to antiepileptic drugs in order to determine which therapies are associated with increased risk.

There are no data on the excretion of topiramate into human milk.

Topiramate has been demonstrated to be excreted into the milk of lactating rats.

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Who should NOT use this medication?

  • Known hypersensitivity to topiramate or any ingredient in the formulation.

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What happens if I overdose?
Seek emergency medical treatment if you think you have used too much of this medicine. Overdose symptoms may include drowsiness, dizziness, agitation or depression, blurred vision, problems with speech or balance, stomach pain, chest pain, fast or pounding heartbeats, feeling light-headed, fainting, and seizure (convulsions).

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What should I discuss with my healthcare provider before taking topiramate?
Do not use this medication if you are allergic to topiramate. Before taking topiramate, tell your doctor if you are allergic to any drugs, or if you have: kidney disease or a history of kidney stones; liver disease; glaucoma; asthma, emphysema, or bronchitis; or if you have recently had surgery. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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