Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 09 October 2017

Indication(s)

INDICATIONS TRIDIONE (trimethadione) is indicated for the control of petit mal seizures that are refractory to treatment with other drugs.

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Advisory information

contraindications
CONTRAINDICATIONS TRIDIONE is contraindicated in patients with a known hypersensitivity to the drug.
Special warnings and precautions
PRECAUTIONS Abrupt discontinuation of TRIDIONE may precipitate petit mal status. TRIDIONE should always be withdrawn gradually unless serious adverse effects dictate otherwise. In the latter case, another anticonvulsant may be substituted to protect the patient. Usage During Pregnancy and Lactation See WARNINGS . Information for Patients Physicians should inform patients and their caregivers of the availability of a Medication Guide, and they should be instructed to read the Medication Guide prior to taking Tridione. Patients should be instructed to take Tridione only as prescribed. Suicidal Thinking and Behavior Patients, their caregivers, and families should be counseled that AEDs, including Tridione, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to the healthcare providers. Pregnancy Registry Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see WARNINGS ).
Adverse reactions
ADVERSE REACTIONS The following side effects, some of them serious, have been associated with the use of TRIDIONE (trimethadione). Gastrointestinal Nausea, vomiting, abdominal pain, gastric distress. CNS/Neurologic Drowsiness, fatigue, malaise, insomnia, vertigo, headache, paresthesias, precipitation of grand mal seizures, increased irritability, personality changes. Drowsiness usually subsides with continued therapy. If it persists, a reduction in dosage is indicated. Hematologic Bleeding gums, epistaxis, retinal and petechial hemorrhages, vaginal bleeding, neutropenia, leukopenia, eosinophilia, thrombocytopenia, pancytopenia, agranulocytosis, hypoplastic anemia, and fatal aplastic anemia. Dermatologic Acneiform or morbilliform skin rash that may progress to exfoliative dermatitis or to severe forms of erythema multiforme. Other Hiccups, anorexia, weight loss, hair loss, changes in blood pressure, albuminuria, hemeralopia, photophobia, diplopia. Fatal nephrosis has occurred. Hepatitis has been reported rarely. Lupus erythematosus, and lymphadenopathies simulating malignant lymphoma, have been reported. Pruritus associated with lymphadenopathy and hepatosplenomegaly has occurred in hypersensitive individuals. A myasthenia gravis-like syndrome has been reported.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION TRIDIONE is administered orally. Usual Adult Dosage 0.9-2.4 grams daily in 3 or 4 equally divided doses (i.e., 300−600 mg 3 or 4 times daily). Initially, give 0.9 gram daily; increase this dose by 300 mg at weekly intervals until therapeutic results are seen or until toxic symptoms appear. Maintenance dosage should be the least amount of drug required to maintain control. Children's Dosage Usually 0.3-0.9 gram daily in 3 or 4 equally divided doses.

More information

Category Value
Authorisation number NDA005856
Agency product number R7GV3H6FQ4
Orphan designation No
Product NDC 0074-3753
Date Last Revised 27-09-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder AbbVie Inc.