(e zog' a been)

Brand Name(s): Potiga^®

IMPORTANT WARNING:

Ezogabine can cause changes to the retina (layer of tissue located at the back of the eye) that can lead to vision loss. These vision changes may be permanent. Tell your doctor immediately if you notice any vision changes while taking this medication.

Your doctor will order an eye exam before treatment and every 6 months while taking ezogabine. Keep all appointments with your doctor and your eye doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ezogabine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risk(s) of taking ezogabine.

IMPORTANT NOTICE:

Ezogabine is no longer available in the United States after June 30, 2017. If you are currently taking ezogabine, you should call your doctor to discuss switching to another treatment.

WHY is this medicine prescribed?

Ezogabine is used along with other medications to control partial onset seizures (seizures that involve only one part of the brain) in adults. Ezogabine is in a class of medications called anticonvulsants. It works by reducing abnormal electrical activity in the brain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ezogabine comes as a tablet to take by mouth. It is usually taken with or without food three times a day. Take ezogabine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Swallow the tablets whole; do not split, chew, dissolve, or crush them.

Your doctor will probably start you on a low dose of ezogabine and gradually increase your dose, not more than once every week.

Take ezogabine exactly as prescribed. Ezogabine may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

Ezogabine may help control your condition but will not cure it. It may take a few weeks or longer before you feel the full benefit of ezogabine. Continue to take ezogabine even if you feel well. Do not stop taking ezogabine without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking ezogabine, your seizures may happen more often. Your doctor will probably decrease your dose gradually over at least 3 weeks.

What SPECIAL PRECAUTIONS should I follow?

Before taking ezogabine,

• tell your doctor and pharmacist if you are allergic to ezogabine, any other medications, or any of the ingredients in ezogabine tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); certain antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E.E.S., Erythrocin), or moxifloxacin (Avelox); chloroquine (Aralen); antihistamines; carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril), chlorpromazine; citalopram (Celexa); digoxin (Cardoxin, Digitek, Lanoxicaps, Lanoxin); disopyramide (Norpace); dofetilide (Tikosyn); droperidol (Inapsine); flecainide (Tambocor); haloperidol (Haldol); ipratropium (Atrovent); medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems; mesoridazine (Serentil); methadone (Dolophine); pentamidine (NebuPent, Pentam); phenytoin (Dilantin, Phenytek); pimozide (Orap); procainamide (Pronestyl); quinidine (in Nuedexta); sotalol (Betapace); thioridazine; and vandetanib (Caprelsa). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had benign prostatic hyperplasia (BPH; enlarged prostate) or any other condition that causes difficulty urinating, heart failure or other heart problems, a long QT interval (a heart problem that may cause irregular heartbeat, fainting, or sudden death), low levels of potassium or magnesium in your blood, or kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant or are breastfeeding. If you become pregnant while taking ezogabine, call your doctor.

• you should know that ezogabine may make you dizzy, drowsy, confused, or unable to concentrate. Do not drive a car or operate machinery until you know how this medication affects you.

• ask your doctor about the safe use of alcoholic beverages while you are taking ezogabine. Alcohol can make the dizziness and drowsiness caused by ezogabine worse.

• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking ezogabine for the treatment of epilepsy or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as ezogabine to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as ezogabine, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Ezogabine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• problems with coordination, balance, or walking
• memory problems
• dizziness
• drowsiness, confusion, or trouble concentrating
• tiredness
• weakness
• difficulty or inability to speak or understand speech or written language
• feelings of numbness, tingling, pricking, burning, or creeping on the skin
• uncontrollable shaking of a part of the body
• abnormal color of urine
• nausea
• constipation
• weight gain

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• inability to begin urinating
• changes in color (blue) of skin, lips, or fingernails
• pain when urinating
• weak urine stream
• difficulty emptying your bladder
• blood in urine
• difficulty thinking clearly, understanding reality, or using good judgment
• hallucinations (seeing things or hearing voices that do not exist)

Ezogabine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Store ezogabine in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets are left so you will know if any are missing.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• irritability
• aggressive behavior
• agitation
• irregular heartbeat

What OTHER INFORMATION should I know?

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking ezogabine.

Do not let anyone else take your medication. Ezogabine is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: August 15, 2017.