Peganone (Oral)

Ethotoin is used to control tonic-clonic (grand mal) and complex partial seizures. This medicine is an anticonvulsant that works in the brain tissue to stop seizures.

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

It is very important that your doctor check the progress of you or your child at regular visits while you or your child are using this medicine to see if it is working properly and to allow for a change in the dose. Blood and urine tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking seizure medicines.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely.

Ethotoin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

Call your doctor right away if you or your child have a fever; nosebleeds; skin rash; small red or purple spots on the skin; a sore throat; unusual bruising or bleeding; unusual tiredness or weakness; or generally feel ill. These may be signs that you have an infection or a bleeding problem.

Lymph node problems may occur while using this medicine. Check with your doctor right away if you or your child have swollen, painful, or tender lymph glands in your neck, armpit, or groin.

In deciding to use a medicine, you and your doctor need to consider the risks versus the benefits of the medicine. For this medicine, keep the following in mind:

Allergies

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

Pediatric

So far, studies have not shown any specific problems for children that would limit the usefulness of ethotoin. However, safety and effectiveness have not been established in children younger than 1 year old.

Geriatric

Studies have not shown any specific problems for older adults that would limit the usefulness of ethotoin. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may need careful monitoring and possibly a dose adjustment for those taking ethotoin.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medicine while breastfeeding. Weigh the potential benefits against the risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if they can interact. In these cases, your doctor may need to adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been highlighted due to their potential importance and are not necessarily all-inclusive.

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

• Calcifediol
• Orlistat

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Ginkgo

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtimes or with specific foods due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional how to take your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Blood disorders or
• Liver problems—This medicine should not be used in patients with these conditions.

• History of depression or
• Megaloblastic anemia—Use with caution, as this may worsen these conditions.

Along with its needed effects, Peganone (Oral) may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Enlarged gums
• shakiness and unsteady walk
• unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

• Blistering, peeling, or loosening of the skin
• chest pain
• cough
• diarrhea
• fever and chills
• general feeling of discomfort or illness
• hair loss
• headaches
• hives or itching
• joint or muscle pain
• numbness
• red, irritated eyes
• red skin lesions, often with a purple center
• shortness of breath or troubled breathing
• skin rash
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred or loss of vision
• change in consciousness
• disturbed color perception
• double vision
• drowsiness
• halos around lights
• loss of consciousness
• nausea
• night blindness
• overbright appearance of lights
• tunnel vision

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 Peganone. Your health care professional may also 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:

Incidence not known

• Dizziness
• sleeplessness
• trouble sleeping
• unable to sleep
• uncontrolled eye movements
• vomiting

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.

• Peganone

Chemical Class: Hydantoin (class)

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 should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take this medicine after meals.

It is best to plan your doses so they are evenly spaced during the day. Talk with your doctor if you have questions about when to take this medicine.

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, 1000 milligrams (mg) per day, divided and given in 4 to 6 doses per day. Your doctor may increase your dose as needed. The usual dose is 2000 to 3000 mg per day. Children 1 year of age and older—Dose is based on age and body weight and must be determined by your doctor. The usual dose is 500 to 1000 milligrams (mg) per day, divided and given in 4 to 6 doses per day. Infants younger than 1 year of age—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.