Trimethadione (Oral)

Trimethadione is used to control absence (petit mal) seizures in patients with epilepsy who have not had success with other medicines. This medicine is an anticonvulsant that acts on the brain tissue to stop seizures.

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

It is very important for your doctor to monitor your and your child's progress closely while using this medicine to ensure it is working properly and to allow for dose adjustments. Blood and urine tests may be needed to check for any unwanted effects.

Do not stop taking this medicine without first consulting your doctor. Stopping a seizure medicine suddenly in a patient with epilepsy can lead to seizures that will not stop (status epilepticus). Your doctor may want you or your child to gradually reduce the amount being used before stopping completely.

Trimethadione may cause some people to feel agitated, irritable, or show other unusual behaviors. It may also lead some individuals to have suicidal thoughts and tendencies or to feel more depressed. If you, your child, or your caregiver notice any of these side effects, inform your doctor immediately.

This medicine may cause symptoms similar to lupus or myasthenia. Contact your doctor right away if you or your child experience droopy eyelids, a rash on the cheeks or other areas of the body, sensitivity of the skin to sunlight, joint or muscle pain, chest pain, swelling of the feet, ankles, and legs, weakness in the arms or legs, difficulty swallowing, speech problems, or swollen glands.

Inform your doctor immediately if you or your child feels unusually weak, begins bruising easily, has bleeding gums or nosebleeds, seems to be getting sick more often, has a fever, swollen glands, or a persistent sore throat. These could be signs of a serious issue with the number of blood cells in your body.

Serious skin reactions can occur with this medicine. Contact your doctor right away if you or your child develop a severe skin rash, blistering, peeling, or loosening of the skin, red skin lesions, sores or ulcers on the skin, or experience fever or chills while using this medicine.

This medicine may cause dizziness or drowsiness. Do not drive or engage in any activities that could be dangerous until you know how this medicine affects you.

Consult your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). Using alcohol or other CNS-affecting medicines with trimethadione may worsen side effects such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble sleeping. Examples of medicines that affect the CNS include antihistamines or cold and allergy medicines, sedatives, tranquilizers, sleeping medications, antidepressants, anti-anxiety medications, prescription pain medicines or narcotics, medications for attention deficit and hyperactivity disorder, other seizure medications or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, please consider the following:

Allergies

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

Pediatric

There have not been appropriate studies on how trimethadione affects children. However, no specific problems for children have been reported so far.

Geriatric

There is no information available on how trimethadione affects older adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there is a chance of interaction. In these situations, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are based on their potential significance and may not include all possible interactions.

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

• Ginkgo

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around meal times, or with certain types of food, as interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Blood disorder, severe or
• Kidney disease, severe or
• Liver disease, severe—This medicine should not be used in patients with these conditions.

• Depression, history of or
• Eye problems—Use with caution. It may worsen these conditions.

Along with its necessary effects, a medicine can also cause some unwanted effects. Not all side effects may happen, but if they do, they may require medical help.

Check with your doctor right away if any of the following side effects happen:

Incidence not known

• Black, tarry stools
• Bleeding gums
• Blistering, peeling, or loosening of the skin
• Blisters, hives, or itching
• Blood in the urine or stools
• Blurred vision
• Changes in blood pressure
• Changes in vision, especially night blindness
• Chest pain
• Cloudy or dark urine
• Cough
• Cracks in the skin
• Decreased vision
• Diarrhea
• Difficulty breathing, chewing, swallowing, or talking
• Double vision
• Drooping eyelids
• Fever with or without chills
• General feeling of discomfort or illness
• General feeling of tiredness or weakness
• Glare or snowy image caused by bright light
• Hair loss
• Headache
• High fever
• Increased irritability
• Increased sensitivity of the eyes to sunlight
• Light-colored stools
• Loss of bladder control
• Loss of heat from the body
• Lower back or side pain
• Muscle or joint pain
• Muscle weakness
• Nausea
• Nosebleeds
• Painful or difficult urination
• Pale skin
• Personality changes
• Pinpoint red spots on the skin
• Red, irritated eyes
• Red, swollen skin
• Scaly skin
• Severe tiredness
• Skin rash
• Small red or purple spots on the skin
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Swelling of the face, hands, legs, and feet
• Swollen, painful, or tender lymph glands in the neck, armpit, or groin
• Total body jerking
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Upper right abdominal pain
• Vaginal bleeding
• Vomiting
• Yellow eyes and skin

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

Symptoms of overdose

• Loss of consciousness
• Shakiness and unsteady walk
• Unsteadiness, trembling, or other problems with muscle control or coordination

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. Your health care professional may also be able to suggest ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Dizziness or lightheadedness
• Drowsiness
• Feeling of constant movement of self or surroundings
• Hiccups
• Loss of appetite
• Sensation of spinning
• Stomach pain or distress
• Trouble sleeping
• Weight loss

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.

Chemical Class: Oxazolidinedione

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 chew this tablet or swallow it whole.

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 (chewable tablets):For seizures: Adults—0.9 to 2.4 grams (g) per day in 3 or 4 equally divided doses (eg, 300 to 600 milligrams [mg] tablet 3 or 4 times daily). Your doctor may increase your dose as needed. Children—The dose is usually. 0.3 to 0.9 g per day in 3 or 4 equally divided doses.

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 in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm