Description
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.
Before Using
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ethotoin in children. However, safety and efficacy have not been established in children younger than 1 year of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ethotoin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving ethotoin.
Breastfeeding
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.
Drug Interactions
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
- Orlistat
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Ginkgo
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
- Blood disorders or
- Liver problems—Should not be used in patients with these conditions.
- Depression, history of or
- Megaloblastic anemia—Use with caution. May make these conditions worse.
Proper Use
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.
- For seizures:
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
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 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 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.
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:
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 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:
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.
DRG-20072667
