Tridione

Before taking trimethadione,

• tell your doctor and pharmacist if you are allergic to trimethadione, any other medications, or any of the ingredients of trimethadione tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention medications for colds or allergies; medications for depression; medications for pain; other medications for seizures; sedatives; sleeping pills; or tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had , a blood disorder, depression, mood problems, suicidal (thinking about harming or killing yourself or planning or trying to do so) thoughts or behavior, or eye, kidney, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Women who can become pregnant generally should not take trimethadione. However, you and your doctor may decide that trimethadione is needed to treat your condition. In that case you must: talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while using this medication, call your doctor. Trimethadione may harm the fetus.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking trimethadione.
• you should know that this drug may make you dizzy or drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• avoid use of alcoholic beverages while you are taking trimethadione. Alcohol may make the side effects from trimethadione worse.
• you should know that your mental health may change in unexpected ways and you may become suicidal while you are taking trimethadione. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as trimethadione to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as trimethadione, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or to end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Do not drink alcohol while taking this medicine.

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking trimethadione with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety or depression.

Other drugs may interact with trimethadione, 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.

Tridione can cause serious side effects, including:

1. Rash. This may need to be treated in a hospital and may be life-threatening. Call your healthcare provider right away if you have any of these symptoms:

• skin rash
• hives
• sores in your mouth

2. Blood problems that can be life-threatening. Call your healthcare provider right away if you have any of these symptoms:

• Fever, swollen glands, or sore throat that come and go or do not go away
• Frequent infections or an infection that does not go away
• Easy bruising
• Red or purple spots on your body
• Bleeding gums or nose bleeds
• Severe fatigue or weakness

3. Liver problems. Call your healthcare provider right away if you have any of these symptoms:

• yellowing of your skin or the whites of your eyes (jaundice)
• dark urine
• nausea or vomiting
• loss of appetite
• pain on the right side of your stomach (abdomen)

4. Kidney problems that may be life-threatening.

5. Eye problems. Call your healthcare provider right away if you have any new changes in your vision such as:

• problems seeing in bright light
• blurred vision

6. Birth defects in your unborn baby.

• Women who can become pregnant should talk to their healthcare provider about using other possible treatments instead of Tridione. If the decision is made to use Tridione, women should use effective birth control (contraception). Talk with your healthcare provider if you are pregnant or plan to become pregnant. Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.
• Tell your healthcare provider right away if you become pregnant while taking Tridione. You and your healthcare provider should decide if you will continue to take Tridione while you are pregnant.
• If you become pregnant while taking Tridione , talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
• Tell your healthcare provider right away if you are breastfeeding or plan to breastfeed. It is unknown if Tridione passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Tridione.

7. Like other antiepileptic drugs, Tridione may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

8. Symptoms that are like the symptoms of lupus or myasthenia gravis. Call your healthcare provider right away if you have any of these symptoms:

• droopy eyelids
• a rash on your cheeks or other parts of your body
• sensitivity to the sun
• new joint or muscle pains
• chest pain or shortness of breath
• swelling of your feet, ankles, and legs
• weakness of your arms or legs
• problems swallowing
• speech problems
• swollen glands (enlarged lymph nodes)

Tridione can cause blurred vision and drowsiness. Do not drive or operate heavy machinery until you know how Tridione affects you.

Do not stop Tridione without first talking to a healthcare provider. Stopping Tridione suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Do not take Tridione if you are allergic to Tridione or to any of its ingredients.

Before taking Tridione, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• blood problems
• kidney problems
• liver problems
• eye problems
• depression, mood problems or suicidal thoughts or behavior
• are pregnant or breastfeeding
• any other medical conditions

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

Take Tridione exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Tridione dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication

The recommended dose range for Tridione in adults is 300 to 600 mg, three or four times a day.

The recommended dose range for Tridione in children is 100 to 300 mg, three or four times a day.

• Store Tridione in the refrigerator at 36˚ to 46˚F (2˚ to 8˚C).
• Keep Tridione in a tightly closed container.
• Keep this and all medicines out of the reach of children.

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

Trimethadione is used to treat absence seizures (also called "petit mal" seizures) in adults and children.

Trimethadione is usually given after other seizure medicines have been tried without success.

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

Tridione has been shown to prevent pentylenetetrazol-induced and thujone-induced seizures in experimental animals; the drug has a less marked effect on seizures induced by picrotoxin, procaine, cocaine, or strychnine. Unlike the hydantoins and antiepileptic barbiturates, Tridione does not modify the maximal seizure pattern in patients undergoing electroconvulsive therapy.

Tridione has a sedative effect that may increase to the point of ataxia when excessive doses are used. A toxic dose of the drug in animals (approximately 2 g/kg) produced sleep, unconsciousness, and respiratory depression.

Trimethadione is rapidly absorbed from the gastrointestinal tract. It is demethylated by liver microsomes to the active metabolite, dimethadione.

Approximately 3% of a daily dose of Tridione is recovered in the urine as unchanged drug. The majority of trimethadione is excreted slowly by the kidney in the form of dimethadione.

Applies to trimethadione: oral tablet chewable

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• vision problems, droopy eyelids;

• the first sign of any skin rash, no matter how mild;

• unusual muscle weakness, trouble speaking or swallowing;

• swelling in your feet or ankles;

• low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed;

• lupus-like syndrome--joint pain or swelling with fever, swollen glands, muscle aches, chest pain, butterfly-shaped skin rash on your cheeks;

• kidney problems--little or no urinating, painful or difficult urination, rapid weight gain;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea;

• drowsiness;

• changes in mood or behavior; or

• increased seizures.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Use is not recommended unless this drug is clearly shown to be essential. US FDA pregnancy category: Not assigned Comments: -This drug can harm a developing fetus. -Women of childbearing potential should use adequate contraception while taking this drug.

-There are multiple reports in the clinical literature which indicate that the use of anticonvulsant drugs during pregnancy results in an increased incidence of birth defects in the offspring. Data are more extensive with respect to trimethadione, paramethadione, phenytoin, and phenobarbital than with other anticonvulsant drugs. -Anticonvulsant drugs such as this drug should be administered to women of childbearing potential only if they are clearly shown to be essential in the management of their seizures. Effective means of contraception should accompany the use of this drug in such patients. If a patient becomes pregnant while taking this drug, termination of the pregnancy should be considered. A patient who requires therapy with this drug and who wishes to become pregnant should be advised of the risks. -Maternal ingestion of anticonvulsant drugs, particularly barbiturates, is associated with a neonatal coagulation defect that may cause bleeding during the early (usually within 24 hours of birth) neonatal period. The possibility of the occurrence of this defect with the use of this drug should be kept in mind. The defect is characterized by decreased levels of vitamin k-dependent clotting factors, and prolongation of either the prothrombin time or the partial thromboplastin time, or both. It has been suggested that prophylactic vitamin k be given to the mother one month prior to, and during delivery, and to the infant, IV, immediately after birth. To provide information regarding the effects of in utero exposure to this drug, physicians are advised to recommend that pregnant patients taking this drug enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.