Topiramate, Oral

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KEY POINTS

• This medicine is taken by mouth to help prevent certain types of seizures. It is also used to help prevent migraines in adults and teens. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• Keep all appointments for tests and checkups to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiseizure

Generic and brand names: topiramate, oral; Qudexy XR; Topamax Tablets; Topamax Sprinkle Capsules; Trokendi XR

What is this medicine used for?

This medicine is taken by mouth to help prevent certain types of seizures. It is also used to help prevent migraines in adults and teens.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Depression or thoughts of suicide
• Glaucoma
• Kidney disease or kidney stones
• Liver disease
• Lung disorders or breathing problems
• Metabolic acidosis (too much acid in the blood)
• Soft, weak, or brittle bones

Tell your healthcare provider if you drink alcohol. Do NOT drink alcohol at least 6 hours before and 6 hours after taking Trokendi XR.

Also, tell your healthcare provider if you often have diarrhea or if you are on a diet high in fat and low in carbohydrate (ketogenic diet).

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Hormone-based forms of birth control may not be reliable when taking this medicine. Use nonhormonal forms of birth control such as a condom, diaphragm, or sponge while taking this medicine. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Your healthcare provider will start you on a low dosage and then slowly increase your dosage to the amount that is most effective for you. Take this medicine exactly as directed by your healthcare provider, along with any other medicine your healthcare provider may prescribe. Do not take more of this medicine than directed by your healthcare provider. Do not stop taking this medicine without your healthcare provider's approval. You may have to gradually reduce your dosage. Seizures may get worse if you suddenly stop taking this medicine.

Check with your healthcare provider before using this medicine in children. Some brands should not be used in children under a certain age.

This medicine comes in regular tablets, extended release capsules, and sprinkle capsule forms. If you are not sure which form of this medicine you have, ask your healthcare provider or pharmacist.

Swallow the capsules whole. If you have the sprinkle capsules or Qudexy XR capsules, they may be opened and the contents sprinkled on a teaspoonful of soft food such as applesauce, pudding, ice cream, or yogurt. Swallow the food right away, without chewing. Then drink a full glass of water or milk. Do NOT sprinkle Trokendi XR capsules on food, chew, or crush. Swallow them whole. Do NOT drink alcohol at least 6 hours before and 6 hours after taking Trokendi XR. Alcohol may cause serious side effects such as severe drowsiness or dizziness, or an increase in seizures.

Do not crush or chew the tablets because they have a very bitter taste. If you cannot swallow the tablets, tell your healthcare provider.

This medicine can be taken with or without food.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: drowsiness, dizziness, restlessness, blurred vision, trouble talking, stomach pain, loss of balance, lightheadedness, fainting, seizures.

What should I watch out for?

Antiseizure medicines may increase suicidal thoughts or actions in some people. Call your healthcare provider right away if you or your family notices any disturbing changes in your thoughts or behavior, such as:

• More outgoing or aggressive behavior than normal
• Confusion
• Hallucinations
• Worsening of depression or suicidal thoughts.

If taken by a pregnant woman, this medicine may increase the risk that the baby will be born with a cleft lip or cleft palate. Talk with your provider about this.

If you develop eye pain, blurred vision, or other sudden vision changes, contact your healthcare provider right away. If this condition is not treated properly, it can lead to vision loss.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Alcohol changes the way the medicine works and may cause side effects. Do not drink alcohol or take other medicines unless your healthcare provider approves.

This medicine can increase the level of acid in your blood (metabolic acidosis). This can lead to soft or brittle bones, kidney stones, or cause growth problems in children. Drink plenty of fluids while you are taking this medicine to help prevent kidney stones. Talk with your healthcare provider about this.

This medicine may cause decreased sweating and an increase in body temperature. Be careful not to get overheated during hot weather and exercise. Drink plenty of liquid while taking this medicine.

This medicine may cause drowsiness, dizziness, confusion, or trouble concentrating. Do not drive or operate machinery until you are fully alert.

You need regular checkups and blood tests while taking this medicine. Keep all appointments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; severe rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Eye pain; blurred or double vision; confusion; memory problems; trouble concentrating; problems with walking or talking; unusual tiredness or weakness; severe nausea, vomiting, or stomach pain; fast breathing; severe drowsiness; severe dizziness; depression or thoughts of suicide; unusual mood or behavior changes; fever; decreased sweating; fast or irregular heartbeat; chest pain; loss of appetite; bloody urine; painful urination; numbness or tingling in hands or feet; worsening seizures; unusual bruising or bleeding; increased menstrual bleeding; severe muscle pain; tremors or shaking.

Other: Nervousness, nausea, headache, change in sense of taste, diarrhea, weight loss, dry mouth, stuffy or runny nose, hair loss, trouble sleeping, mild dizziness, mild drowsiness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), midazolam (Versed), and oxazepam
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), propantheline, and trihexyphenidyl
• Antidepressants such as amitriptyline, amoxapine, citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), maprotiline, mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), protriptyline (Vivactil), sertraline (Zoloft), trazodone, trimipramine (Surmontil), venlafaxine (Effexor), and vilazodone (Viibryd)
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Aspirin and medicines that contain aspirin
• Buprenorphine (Buprenex, Butrans)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Diabetes medicines such as metformin (Fortamet, Glucophage, Riomet) and pioglitazone (Actos)
• Dichlorphenamide (Keveyis)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as chlorthalidone and hydrochlorothiazide (Microzide)
• Doxepin (Silenor)
• Glaucoma medicines such as acetazolamide (Diamox), brinzolamide (Azopt), dorzolamide (Cosopt, Trusopt), and methazolamide (Neptazane)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Lithium (Lithobid)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), fondaparinux (Arixtra), prasugrel (Effient), rivaroxaban (Xarelto), and warfarin (Coumadin)
• Mefloquine
• Methenamine (Hiprex, Urex)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as evening primrose oil, ginkgo biloba, gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Orlistat (alli, Xenical)
• Other antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), valproic acid (Depacon, Depakene, Depakote), and zonisamide (Zonegran)
• Pain medicines such as codeine, hydrocodone/acetaminophen (Norco, Vicodin), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as butabarbital (Butisol), eszopiclone (Lunesta), flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.