Ethotoin

Ethotoin is an anti-epileptic medicine, also called an anticonvulsant.

Ethotoin is used alone or in combination with other medicines to treat seizures in adults and children who are at least 1 year old.

Ethotoin may also be used for purposes not listed in this medication guide.

You should not use ethotoin if you have liver disease or a blood cell disorder (such as anemia, hemophilia, and others).

You should not use this medicine if you are allergic to ethotoin or if you have:

• liver disease; or
• a blood cell disorder (such as anemia, hemophilia, and others).

To make sure ethotoin is safe for you, tell your doctor if you have:

• mood problems, depression;
• a history of suicidal thoughts or actions;
• folic acid (or folate) deficiency; or
• if you take a blood thinner (warfarin, Coumadin, Jantoven).

Some people have thoughts about suicide while taking an anticonvulsant. Your doctor will need to check your progress at regular visits while you are taking ethotoin. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category D. Do not start or stop taking ethotoin during pregnancy without your doctor's advice. Seizure control is very important during pregnancy. Ethotoin may cause harm to an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant while taking ethotoin for seizures.

There may be other seizure medicines that can be more safely used during pregnancy. Follow your doctor's instructions about taking this medicine while you are pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of ethotoin on the baby.

If you have taken ethotoin during pregnancy, be sure to tell the doctor who delivers your baby about your ethotoin use. Both you and the baby may need to receive medicine to prevent excessive bleeding during delivery and just after birth.

Ethotoin can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with ethotoin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

If you switch to ethotoin from taking another anti-epileptic medicine, do not stop taking the other medicine without your doctor's advice. Carefully follow your doctor's instructions about timing and dosage when switching from one seizure medicine to another.

Seizures are sometimes treated with a combination of drugs. Use all medicines as directed by your doctor. Read the medication guide or patient instructions provided with each medicine. Do not change your doses or medication schedule without your doctor's advice.

Take ethotoin after eating. Take your doses at regular intervals to keep a steady amount of the drug in your body at all times.

If a child is taking this medicine, tell your doctor if the child has any changes in weight. Ethotoin doses are based on weight in children.

Ethotoin can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, sore throat).

While using ethotoin, you may need frequent blood and urine tests.

Do not stop using ethotoin suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

Wear a medical alert tag or carry an ID card stating that you take ethotoin. Any medical care provider who treats you should know that you take seizure medicine.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include vision changes, nausea, extreme drowsiness, and trouble standing or walking.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Ethotoin is part of the drug class:

• Hydantoin derivatives

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking ethotoin with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you take medicines that affect blood clotting such as warfarin (Coumadin, Jantoven).

Before you take ethotoin, tell your healthcare provider if you:

• have or have had depression, mood problems, or suicidal thoughts or behavior
• have any other medical conditions
• are pregnant or breastfeeding

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Ethotoin is an anti-epileptic medication, also called an anticonvulsant.

Ethotoin is used alone or in combination with other medications to treat seizures in adults and children.

Ethotoin may also be used for other purposes not listed in this medication guide.

You should not use this medication if you are allergic to ethotoin or if you have liver disease or a blood cell disorder (such as anemia, hemophilia, and others).

Ethotoin can cause a decrease in many types of blood cells (white cells, red cells, platelets). Call your doctor at once if you have any unusual bleeding, weakness, or any signs of infection, even if these symptoms first occur after you have been using the medication for several months.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Contact your doctor if your seizures get worse or you have them more often while taking ethotoin.

Carry an ID card or wear a medical alert bracelet stating that you are taking ethotoin, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

You should not use this medicine if you are allergic to ethotoin or if you have:

• liver disease; or

• a blood cell disorder (such as anemia, hemophilia, and others).

To make sure ethotoin is safe for you, tell your doctor if you have:

• mood problems, depression;

• a history of suicidal thoughts or actions;

• folic acid (or folate) deficiency; or

• if you take a blood thinner (warfarin, Coumadin, Jantoven).

Some people have thoughts about suicide while taking an anticonvulsant. Your doctor will need to check your progress at regular visits while you are taking ethotoin. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category D. Do not start or stop taking ethotoin during pregnancy without your doctor's advice. Seizure control is very important during pregnancy. Ethotoin may cause harm to an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant while taking ethotoin for seizures.

There may be other seizure medicines that can be more safely used during pregnancy. Follow your doctor's instructions about taking this medicine while you are pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of ethotoin on the baby.

If you have taken ethotoin during pregnancy, be sure to tell the doctor who delivers your baby about your ethotoin use. Both you and the baby may need to receive medicine to prevent excessive bleeding during delivery and just after birth.

Ethotoin can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Take ethotoin 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.

ethotoin 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 ethotoin 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 ethotoin.

Dosing

The dose of ethotoin 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 ethotoin. 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 ethotoin, 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.

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 ethotoin 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 ethotoin while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from 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 ethotoin 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 ethotoin. Check with your doctor right away if you or your child have swollen, painful, or tender lymph glands in your neck, armpit, or groin.

• It is used to help control certain kinds of seizures.

• If you have an allergy to ethotoin or any other part of ethotoin.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Blood problems or liver disease.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ethotoin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Peganone: 250 mg [DSC]

Peganone: 250 mg [scored]

Stabilizes the seizure threshold and prevents the spread of seizure activity

Absorption

Rapid

Metabolism

Saturable, hepatic; forms metabolites; the relationship between dose and ethotoin and metabolite concentrations is non-linear.

Excretion

Urine (Naestoft 1976)

Half-Life Elimination

3 to 9 hours

There are no dosage adjustment provided in the manufacturer’s labeling.

Administer after food to decrease GI distress.