ezogabine

e-ZOG-a-been

Commonly used brand name(s)

In the U.S.

• Potiga

Available Dosage Forms:

• Tablet

Uses For ezogabine

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, ezogabine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

ezogabine is available only with your doctor's prescription.

Before Using ezogabine

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 ezogabine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ezogabine 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.

Pediatric

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.

Geriatric

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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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 ezogabine, 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 ezogabine 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.

• Carbamazepine


• Digoxin


• Lamotrigine


• Phenytoin

Interactions with Food/Tobacco/Alcohol

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 ezogabine 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 ezogabine, 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 ezogabine. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure or


• Depression or


• Drug abuse or dependence, history of or


• Electrolyte imbalance (e.g., low magnesium or potassium in the blood) or


• Enlarged prostate or


• Heart disease or


• Heart rhythm problems (e.g., QT prolongation, long QT syndrome) or


• Mental illness or


• Urinating problems (e.g., urinary retention, benign prostatic hypertrophy)—Use with caution. May make these conditions worse.

• Kidney disease, moderate to severe or receiving dialysis or


• Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Your doctor will adjust your dose if you have this condition.

Proper Use of ezogabine

Take ezogabine 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. To do so may increase the chance of side effects.

ezogabine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take ezogabine with or without food.

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

Dosing

The dose of ezogabine 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 ezogabine. 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) three times a day (300 mg per day). Your doctor may gradually increase your dose over several weeks as needed and tolerated. However, the dose is usually not more than 400 mg three times a day (1200 mg per day).
    
    
    • Older Adults—At first, 50 mg three times a day (150 mg per day). Your doctor may gradually increase your dose over several weeks as needed and tolerated. However, the dose is usually not more than 250 mg three times a day (750 mg per day).
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of ezogabine, 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 ezogabine

It is very important that your doctor check your progress at regular visits. This is necessary to allow dose adjustments and to check for serious unwanted effects. Blood tests may also be needed to check for unwanted effects.

If you develop any unusual or strange thoughts and behavior while using ezogabine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

ezogabine may cause problems with urination. Call you doctor right away if you have trouble emptying your bladder, a weak urine system, pain while urinating, or if you are unable to start urinating.

Ezogabine may cause some people to become dizzy, drowsy, or have blurred or double vision. Make sure you know how you react to ezogabine 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.

ezogabine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.

Do not suddenly stop taking ezogabine 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 to occur again.

ezogabine 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.

It is important to tell your doctor if you become pregnant while taking ezogabine. Your doctor may want you to join the North American Antiepileptic Drug Pregnancy Registry. The registry is used by pregnant patients who are taking ezogabine.

Avoid drinking alcohol while you are using ezogabine.

Before you have any medical tests, tell the medical doctor in charge that you are taking ezogabine. The results of some tests (e.g., serum and urine bilirubin) may be affected by ezogabine.

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.

ezogabine Side Effects

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


• trouble with urinating


• 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


• shortness of breath


• 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


• wheezing

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


• fear or nervousness


• 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 memory problems with speech or speaking


• runny nose


• severe mood or mental changes


• shivering


• slurred speech


• stomach discomfort, upset, or pain


• sweating


• trouble with sleeping


• trouble with speaking


• trouble with walking


• unusual behavior


• weight gain

Incidence not known

• False or unusual sense of well-being


• 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.

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