Pronunciation:

e-ZOG-a-been

Brand Names:

• Potiga

Warnings:

Retinal abnormalities that can progress to vision loss were seen in about one-third of patients after approximately 4 years of ezogabine treatment. The retinal abnormalities exhibited fundoscopic features similar to those of retinal pigment dystrophies. The reversibility and rate of progression of the retinal abnormalities is unknown. Accordingly, ezogabine is only indicated for patients who have experienced refractory results with other treatments and in whom the benefits of ezogabine exceed the risk of vision loss. Visual monitoring (including visual acuity, dilated fundus photography, optical coherence tomography, and possibly fluorescein angiograms, perimetry, and electroretinograms) is indicated at baseline and 6-month intervals thereafter with ezogabine therapy. Discontinue use if retinal pigmentary abnormalities or vision changes are detected unless no other treatment options are available and in patients who do not gain substantial clinical benefit after adequate ezogabine titration .

Uses of This Medicine:

Ezogabine is used together with other medicines to control partial seizures (convulsions) in the treatment of epilepsy.

Ezogabine belongs to a class of medicines called anticonvulsants. It acts in the brain to prevent seizures. However, this medicine cannot cure epilepsy and will only work to control seizures as long as you continue to take it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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:

Allergies—

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ezogabine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of ezogabine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related prostate and kidney problems, which may require caution and an adjustment in the dose for patients receiving ezogabine.

Breast-feeding—

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.

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 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.

• Calcifediol
• Carbamazepine
• Fosphenytoin
• Lamotrigine
• Orlistat
• Phenytoin

Other interactions—

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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

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:

• Congestive heart failure or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood)—Use with caution. May cause side effects to become worse.

• Depression or
• Hallucinations or
• Heart rhythm problems (eg, QT prolongation) or
• Mood disorder or
• Urinary retention (urinating problem)—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take 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.

You may take this medicine with or without food.

Swallow the tablet whole. Do not crush, break, dissolve, or chew it.

Avoid drinking alcohol with this medicine. Alcohol may cause higher blood levels and more unwanted effects.

Dosing—

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.

• For oral dosage form (tablets):
  • For seizures:
    • Adults—At first, 100 milligrams (mg) 3 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 400 mg 3 times a day.
    • Older Adults—At first, 50 mg 3 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 250 mg 3 times 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—

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.

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 decide if you should continue to take it.

Check with your doctor right away if blurred vision or vision changes occur with this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause problems with urination. Call you doctor right away if you have trouble emptying your bladder or pain while urinating.

Using this medicine for a long time may cause your skin, nails, lips, mouth, or eyes to have a blue or brown color. Tell your doctor right away if you notice any color changes with this medicine.

Ezogabine may cause some people to be agitated, irritable, or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, or feeling nervous, restless, or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you notice any of these adverse effects, tell your doctor right away.

Ezogabine may cause some people to become dizzy, drowsy, or have blurred vision or double vision. 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 or not able to see well. If these reactions are especially bothersome, check with your doctor.

Contact your doctor right away if you have symptoms of heart rhythm problems such as feeling dizzy, feeling faint, or having a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Do not suddenly stop taking this medicine without checking first with your doctor. If you have been instructed to stop taking ezogabine, ask your doctor how to slowly decrease the dose. This will decrease your chance of having more seizures.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

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.

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 immediately if any of the following side effects occur:

More common

Decrease in the frequency of urination

decrease in the urine volume

difficulty with passing urine (dribbling)

painful urination

shakiness in the legs, arms, hands, or feet

Less common

Bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine

burning while urinating

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

difficult urination

general feeling of discomfort or illness

muscle twitching or jerking

rapid weight gain

rhythmic movement of the muscles

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Agitation

back pain

black, tarry stools

bleeding gums

blurred vision

change in consciousness

chest pain

chills

cloudy urine

confusion

cough

difficult or labored breathing

dizziness

drowsiness

fainting

fever

headache

irritability

loss of consciousness

pain in the lower back or side

pinpoint red spots on the skin

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stiff neck

swollen glands

tightness in the chest

unusual bleeding or bruising

vomiting

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:

More common

Being forgetful

clumsiness or unsteadiness

dizziness or lightheadedness

double vision

feeling of constant movement of self or surroundings

seeing double

sensation of spinning

sleepiness or unusual drowsiness

Less common

Absence of or decrease in the body movement

acid or sour stomach

belching

changes in patterns and rhythms of speech

confusion about identity, place, and time

cough

diarrhea

difficulty having a bowel movement (stool)

difficulty with swallowing

dry mouth

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

feeling, seeing, or hearing things that are not there

heartburn

increased appetite

increased sweating

indigestion

joint pain

lack or loss of strength

loss of appetite

loss of memory

muscle aches and pains

problems with speech or speaking

runny nose

severe mood or mental changes

shivering

slurred speech

stomach discomfort, upset, or pain

sweating

trouble sleeping

trouble walking

unusual behavior

weight gain

Incidence not known

False or unusual sense of wellbeing

hair loss or thinning of the hair

muscle spasms

rash

uncontrolled eye movements

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.