"March 4, 2011 -- Taking the epilepsy drug topiramate (Topamax) during pregnancy raises the risk of oral cleft birth defects such as cleft lip and cleft palate, according to a new warning issued by the FDA.
New drug registry data show "...
Topamax Patient Information including How Should I Take
In this Article
- What is topiramate (Topamax)?
- What are the possible side effects of topiramate (Topamax)?
- What is the most important information I should know about topiramate (Topamax)?
- What should I discuss with my healthcare provider before taking topiramate (Topamax)?
- How should I take topiramate (Topamax)?
- What happens if I miss a dose (Topamax)?
- What happens if I overdose (Topamax)?
- What should I avoid while taking topiramate (Topamax)?
- What other drugs will affect topiramate (Topamax)?
- Where can I get more information?
What should I discuss with my healthcare provider before taking topiramate (Topamax)?
You should not use topiramate if you are allergic to it.
To make sure you can safely take topiramate, tell your doctor if you have any of these other conditions:
- kidney disease or a history of kidney stones;
- liver disease;
- a history of depression or suicide attempt;
- a growth disorder;
- a history of metabolic acidosis;
- osteoporosis or low bone density;
- asthma, emphysema, or other breathing disorder; or
- if you are pregnant or plan to become pregnant while using topiramate.
You may have thoughts about suicide while taking topiramate. Tell your doctor if you have new or worsening symptoms of depression, anxiety, or suicidal thoughts. Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits.
FDA pregnancy category D. Taking topiramate during pregnancy may increase the risk of cleft lip and/or cleft palate in the newborn. Do not start taking topiramate without telling your doctor if you are pregnant or planning to become pregnant. Use effective birth control while you are taking topiramate.
Seizure control is very important during pregnancy. The benefit of preventing seizures may outweigh any risks posed by taking topiramate. Follow your doctor's instructions about taking topiramate while you are pregnant.
Although topiramate may harm an unborn baby, having a seizure during pregnancy could harm both mother and baby. If you become pregnant while taking topiramate, do not stop taking the medicine without your doctor's advice.
Topiramate can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking topiramate. If you are not planning a pregnancy while taking topiramate, use effective birth control, and tell your doctor if you become pregnant during treatment.
Topiramate can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take topiramate (Topamax)?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.
Topiramate can be taken with or without food. The topiramate tablet should be swallowed whole. It has a bitter taste when chewed or broken.
You may open the topiramate capsule and sprinkle the medicine into a spoonful of applesauce or other soft food to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.
Drink plenty of liquids while you are taking topiramate. This will lower your risk of having kidney stones or an electrolyte imbalance. Call your doctor if you have ongoing vomiting or diarrhea. You can easily become dehydrated while taking this medication.
If you need surgery, tell the surgeon ahead of time that you are using topiramate. You may need to stop using the medicine for a short time.
Do not stop using topiramate without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using topiramate suddenly. You may 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. To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.
Wear a medical alert tag or carry an ID card stating that you take topiramate. Any medical care provider or dentist who treats you should know that you are taking a seizure medication.
Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
Additional Topamax Information
- Topamax Drug Interactions Center: topiramate oral
- Topamax Side Effects Center
- Topamax Overview including Precautions
- Topamax FDA Approved Prescribing Information including Dosage
Topamax - User Reviews
Topamax User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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