Topiramate is used alone or together with other medicines to help treat certain types of seizures (eg, partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome). This medicine will not cure epilepsy and will only work to control seizures for as long as you continue to take it. It is also used to help prevent migraine headaches.
This medicine is available only with your doctor's prescription.
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.
Appropriate studies have not been performed on the relationship of age to the effects of topiramate capsules or tablets, or Qudexy™ extended-release capsules for the treatment of seizures in children younger than 2 years of age (when used alone or together with other medicines). Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of Trokendi™ extended-release capsules for the treatment of seizures in children younger than 6 years of age.
Appropriate studies have not been performed on the relationship of age to the effects of topiramate capsules or tablets for the prevention of migraine headaches in children younger than 12 years of age. Safety and efficacy have not been established.
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.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Topiramate may be taken with or without food.
Swallow the Trokendi XR™ extended-release capsule whole. Do not open, crush, or chew the capsule.
Avoid drinking alcohol with Qudexy™ XR or Topamax®, or avoid for 6 hours before and 6 hours after taking the Trokendi XR™ capsule.
Swallow the tablet whole. Do not break, crush, or chew it. The tablet may taste bitter if it is held in the mouth or chewed.
The Topamax® sprinkle capsule or Qudexy™ XR extended-release capsule may be swallowed whole or opened and sprinkled on a small amount (1 teaspoon) of soft food like applesauce. Swallow the food mixture immediately without chewing. Do not store the mixture for use at a later time.
Drink extra water with this medicine to help prevent kidney stones.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose or forget to use your medicine, use it as soon as you can. If your next regular dose of Topamax® capsule or tablet is less than 6 hours away, wait until then to use the medicine and skip the missed dose.
If you miss more than 1 dose of Topamax® capsule or tablet, contact your doctor for instructions about how to re-start it.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your or your child's progress at regular visits to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
Birth control pills containing estrogen may not work properly if you take them with topiramate. To keep from getting pregnant, use an additional form of birth control together with your birth control pill. If you have any questions about this, check with your doctor or pharmacist.
This medicine may cause vision changes, clumsiness or unsteadiness, dizziness, drowsiness, or trouble with thinking or speaking. Make sure you know how you or your child react to this medicine before you drive, use machines, climb in high places, swim, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, prescription pain medicines, or sleep medicines. Check with your doctor before taking any of these medicines while you or your child are using topiramate.
Check with your doctor immediately if you or your child have changes in vision or pain around the eyes during and after treatment with this medicine. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).
This medicine may make you sweat less which will cause your body temperature to increase. Use extra care not to become overheated during exercise or hot weather with this medicine. Overheating may result in heat stroke and hot baths or saunas may make you dizzy or feel faint.
Topiramate may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.
This medicine may cause nausea, muscle tremors, breathing problems, eating problems, fast heartbeats, restlessness, and abdominal or stomach pain. Tell your doctor right away if you or your child have any of these symptoms. You might have a serious condition called metabolic acidosis (too much acid in the blood).
This medicine may cause slow growth. For children, the doctor will need to keep track of height and weight to make sure that the child is growing properly.
Do not suddenly stop taking this medicine without checking first with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you or your child to gradually reduce the amount you are taking before stopping it completely.
Check with your doctor right away if you or your child are having unusual drowsiness, dullness, tiredness, weakness, feelings of sluggishness, mental depression or anxiety, nightmares or unusually vivid dreams, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.
Check with your doctor right away if you or your child have sudden back pain, abdominal or stomach pain, pain while urinating, or bloody or dark urine. These may be symptoms of kidney stones.
Tell your doctor if your or your child's skin feels like it is burning, crawling, itching, or if you have numbness, prickling, "pins and needles", or tingling feeling after using topiramate.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.