Ezogabine (Oral)

Ezogabine is used along with other medicines to help control partial seizures (convulsions) in people with epilepsy.

Ezogabine is part of a group of medicines known as anticonvulsants. It works in the brain to prevent seizures. However, this medicine cannot cure epilepsy and will only help control seizures as long as you keep taking it.

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

It is very important that your doctor checks your progress at regular visits. This will help your doctor see if the medicine is working properly and decide if you should continue taking it.

Check with your doctor right away if you experience blurred vision or any changes in your vision while using this medicine. Your doctor may want you to see an ophthalmologist (eye doctor) for an eye check-up.

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

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

Ezogabine may cause some people to feel agitated, irritable, or show other unusual behaviors, such as feeling sad or hopeless, getting upset easily, or feeling nervous, restless, or hostile. It may also lead some individuals to have suicidal thoughts or become more depressed. If you notice any of these side effects, tell your doctor immediately.

Ezogabine may cause some people to feel dizzy, drowsy, or have blurred vision or double vision. Make sure you know how this medicine affects you before driving, operating machinery, or doing anything else that could be dangerous if you are not alert or cannot see well. If these effects are particularly troubling, consult your doctor.

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

Do not suddenly stop taking this medicine without consulting your doctor first. If you have been told to stop taking ezogabine, ask your doctor how to gradually decrease the dose. This will lower your risk of having more seizures.

This medicine may be habit-forming. If you feel that the medicine is not as effective as before, do not take more than your prescribed dose. Contact your doctor for guidance.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against the benefits it may provide. The following points should be considered for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on how ezogabine affects children. Its safety and effectiveness for this age group have not been established.

Geriatric

Although studies on how ezogabine affects older adults have not been performed, no specific problems have been identified for this age group so far. However, older patients are more likely to have age-related prostate and kidney issues, which may require careful monitoring and dose adjustments for those taking ezogabine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together with caution. If you are taking this medicine, it is very important that your healthcare professional knows if you are also taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily a complete list.

Using this medicine with any of the following is generally not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may change the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. The following interactions have been selected based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following may increase the risk of certain side effects, though it may be unavoidable in some situations. If used together, your doctor may change the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Ethanol

Other Medical Problems

Having other medical issues may affect how this medicine works. Be sure to inform your doctor if you have any other medical conditions, especially:

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

• Depression or
• Hallucinations or
• Heart rhythm problems (e.g., QT prolongation) or
• Mood disorder or
• Urinary retention (urination problem)—Use with caution. May worsen these conditions.

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

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do happen, 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 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 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 well-being
• Hair loss or thinning of 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.

In the U.S.

• Potiga

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.