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Drug monograph for the active ingredient in Topamax

The following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

TOPIRAMATE (Systemic)

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Some commonly used brand names are:

In the U.S.—

• Topamax

In Canada—

• Topamax

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Category

• Anticonvulsant
• migraine headache prophylactic

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Description

Topiramate (toe-PYRE-a-mate) is used to help control some types of seizures in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to help control seizures for as long as you continue to take it. Topiramate is also used to help prevent migraine headaches in adults.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S. and Canada)
• Capsules (U.S and Canada.)

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Before Using This Medicine

In deciding to use a medicine, the risks of taking topiramate must be weighed against the good it will do. This is a decision you and your doctor will make. For topiramate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to topiramate. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Topiramate has not been studied in pregnant women. However, studies in pregnant animals have shown that topiramate may cause birth defects in the offspring, as well as adverse effects in the mother, when given in doses many times higher than the human dose. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether topiramate passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Although there is no specific information comparing the use of topiramate in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults. This medicine is not approved for use to help prevent migraine headaches in children.

Note:

Studies in children have shown that some children are at higher risk for oligohidrosis (decreased sweating) and hyperthermia (unusually high body temperature), especially in warm or hot weather. This can sometimes result in heat stroke and hospitalization.

Older adults—In studies done to date that have included adults older than 60 years of age, topiramate has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—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 topiramate, it is especially important that your health care professional know if you are taking any of the following:

• Anticholinergics (medicine for abdominal or stomach spasms or cramps or drying up a runny nose) or
• Acetazolamide (e.g., Diamox) or
• Dichlorphenamide (e.g., Daranide)—Taking these medicines with topiramate may increase the chance of getting kidney stones. It may also increase body temperature and decrease sweating which could cause serious unwanted effects.

• Carbamazepine (e.g., Tegretol)—Blood levels of topiramate may be decreased. Your doctor may need to adjust the dosage of either or both medicines.

• Oral contraceptives (birth control pills) containing estrogen—Topiramate may decrease the effects of these medicines. Contraceptive failure may result. Additional birth control measures may be needed to decrease the risk of pregnancy.

• Phenytoin (e.g., Dilantin)—Blood levels of topiramate may be decreased. Your doctor may need to adjust the dosage of either or both medicines.

• Valproic acid (e.g., Depakene, Depakote)—Blood levels of topiramate and/or valproic acid may be decreased. Your doctor may need to adjust the dosage of either or both medicines. Patients who take topiramate together with valproic acid can develop a serious condition called hyperammonemic encephalopathy. If you develop unusual tiredness/weakness, vomiting, or changes in mental status, you should tell your doctor right away.

Other medical problems—The presence of other medical problems may affect the use of topiramate. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or
• Fatty diet or
• Kidney disease or
• Lung problems, severe or
• Status epilepticus (e.g., a state of epilepsy where you have many seizures in a row and do not gain consciousness) or
• Surgery—These problems may make a condition called metabolic acidosis (e.g., abnormal amounts of acid in your blood) occur or make it worse.

• History of kidney stones—Risk of having kidney stones again may be increased.

• Kidney problems or
• Liver problems—Higher blood levels of topiramate may result and increase the chance of side effects.

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Proper Use of This Medicine

Take this medicine every day exactly as ordered by your doctor in order to improve your condition as much as possible. Do not take more or less of it, and do not take it more or less often than your doctor ordered.

Topiramate may be taken with or without food, on a full or an empty stomach. Swallow the tablets whole, without breaking, crushing, or chewing them. The bitter taste may be more noticeable if the tablets are held in the mouth or chewed. The capsules may be swallowed whole, or the contents of the capsule may be opened and the contents sprinkled on a small amount (teaspoonful) of soft food (such as applesauce, custard, ice cream, oatmeal, pudding, or yogurt) and swallowed immediately without chewing

Dosing—The dose of topiramate 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 topiramate. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets 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 taking topiramate .

• For oral dosage form (tablets or capsules):
  • To help prevent seizures
    • Adults and Children (age 10 years or older)—At first, 50 milligrams (mg) a day in 2 divided doses for the first week. Your doctor may increase your dose gradually every week if needed and tolerated, but the usual dose is not greater than 400 mg a day taken in 2 divided doses.
  • To help prevent seizures (taken with other medicines)
    • Adults—At first, 25 or 50 milligrams (mg) a day for the first week. Your doctor may increase your dose gradually every week if needed and tolerated, but the usual dose is not greater than 400 mg a day.
    • Children (age 2 to 16 years)—At first, 25 milligrams (mg) nightly for the first week. Your doctor may increase your dose gradually every 1 or 2 weeks to be taken in two divided doses.
  • To help prevent migraine headaches:
    • Adults—At first, 25 milligrams (mg) a day for the first week. Your doctor may increase your dose gradually every week if needed and tolerated, but the usual dose is not greater than 100 mg a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—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.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly, and to check for unwanted effects.

This medicine may cause some people to have blurred vision, double vision, clumsiness or unsteadiness, or to become dizzy, drowsy, or have trouble in thinking. Make sure you know how you react to this medicine before you drive, use machines, 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, other allergies, or colds; prescription pain medicines, or sleep medicines. Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

Check with your doctor immediately if you experience a decrease in vision, blurred vision, double vision or pain around the eyes.

Check with your doctor right away if you experience fatigue, loss of appetite, abnormal heart rate, decreased awareness, or severe sleepiness.

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking topiramate. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are using topiramate. If you have any questions about this, check with your doctor or pharmacist.

These medicines may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine , since overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking this medicine.

Do not stop taking topiramate without first checking with your doctor . Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

It is important that you drink plenty of fluids every day during therapy with topiramate to help prevent kidney stones from forming.

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Side Effects of This Medicine

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 as soon as possible if any of the following side effects occur:

More common

Any vision problems, especially blurred vision, double vision, eye pain or rapidly decreasing vision; burning, prickling, or tingling sensations; clumsiness or unsteadiness; confusion; continuous, uncontrolled back-and-forth or rolling eye movements; dizziness; drowsiness; eye redness; generalized slowing of mental and physical activity; increased eye pressure; memory problems; menstrual changes; menstrual pain; nervousness; speech or language problems; trouble in concentrating or paying attention; unusual tiredness or weakness

Less common

Abdominal pain; fever, chills, or sore throat; lessening of sensations or perception; loss of appetite; mood or mental changes, including aggression, agitation, apathy, irritability, and mental depression; red, irritated, or bleeding gums; weight loss

Rare

Blood in urine; decrease in sexual performance or desire; difficult or painful urination; eye pain; frequent urination; hearing loss; itching; loss of bladder control; lower back or side pain; nosebleeds; pale skin; red or irritated eyes; ringing or buzzing in ears; skin rash; swelling; troubled breathing

Incidence not determined

Abdominal or stomach pain; Blistering, peeling, loosening of skin; blisters in the mouth; blisters on the trunk, scalp, or other areas; bloating; clay-colored stools; confusion; constipation; cough; diarrhea; fatigue; fever; increased rate of breathing; itching; joint or muscle pain; loss of appetite; pain or tenderness in upper abdomen; red, irritated eyes; red skin lesions, often with a purple center; sores, ulcers, or white spots in mouth or on lips; unusual tiredness or weakness; yellow eyes or skin

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Breast pain in women; nausea; tremors

Less common

Back pain; chest pain; constipation; heartburn; hot flushes; increased sweating; leg pain

Topiramate may cause a change in your sense of taste.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

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Revised: 10/17/2005

The information contained in the Thomson Healthcare products is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse or pharmacist can provide you with advice on what is safe and effective for you.

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