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ODAN-ETHOSUXIMIDE is a brand name for Ethosuximide, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ODAN-ETHOSUXIMIDE (ethosuximide) is indicated for the control of absence (petit mal) epilepsy. 1.1 Pediatrics Pediatrics (3-17 years): Safety and effectiveness in pediatric patients below the age of 3 years have not been established (see 4.2 Recommended Dose and Dosage Adjustment). 1.2 Geriatrics No data are available…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations As with other anticonvulsants, it is important to proceed slowly when increasing or decreasing dosage, as well as when adding or eliminating other medication. Abrupt withdrawal of anticonvulsant medication may precipitate absence (petit mal) status.
Patients taking ethosuximide should be advised of the importance of adhering strictly to the prescribed dosage regimen. 2 Recommended Dose and Dosage Adjustment Initial dose: children aged 3 to 6 years, 250 mg daily; older patients, 500 mg daily in divided doses.
The dose thereafter must be individualized according to response and tolerance. g. increase daily dose by 250 mg every 4 to 7 days until control is achieved with minimal side effects. 5 g in divided doses frequently controls ODAN-ETHOSUXIMIDE (Ethosuximide capsules), Product Monograph Page 5 of 17 seizures; however, it may be necessary to exceed this amount by slow increases and careful evaluation of patient’s response.
5 g daily, in divided doses, should be administered only under the strictest supervision of the physician. The optimal dose for most children is 20 mg/kg/day. This dose has given average plasma levels within the accepted therapeutic range of 280 to 710 mcmol/L (40 to 100 mcg/mL).
Subsequent dose schedules can be based on effectiveness and plasma level determinations. Ethosuximide may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dosage for most children is 20 mg/kg/day.
4 Administration Ethosuximide can be taken with or without food. 5 Missed Dose In case of missed dose, the next dose should be taken as scheduled. A double dose should not be taken.
5 Post-Market Adverse Reactions Gastrointestinal: Gastrointestinal symptoms occur frequently and include anorexia, vague gastric upset, nausea and vomiting, cramps, epigastric and abdominal pain, weight loss, and diarrhea. There have been reports of gum hypertrophy and swelling of the tongue.
Genitourinary: microscopic hematuria and vaginal bleeding.
Hemopoietic:
Leukopenia, agranulocytosis, pancytopenia, aplastic anemia, with or without bone marrow suppression, eosinophilia, and thrombocytopenia. ODAN-ETHOSUXIMIDE (Ethosuximide capsules), Product Monograph Page 9 of 17 Integumentary: Dermatologic manifestations which have occurred with the administration of ethosuximide have included urticarial, Stevens-Johnson syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), systemic lupus erythematosus, and pruritic erythematous rashes.
Miscellaneous: myopia and hirsutism.
Nervous system:
Neurologic and sensory reactions reported during therapy with ethosuximide have included drowsiness, headache, dizziness, euphoria, hiccups, irritability, hyperactivity, lethargy, fatigue, and ataxia. Psychiatric or psychological aberrations associated with ethosuximide administration have included disturbances of sleep, night terrors, inability to concentrate, and aggressiveness.
These effects may be noted particularly in patients who have previously exhibited psychological abnormalities. There have been rare reports of paranoid psychosis, increased libido, and increased state of depression with overt suicidal intentions.
, Hematologic). 1 Dosing Considerations As with other anticonvulsants, it is important to proceed slowly when increasing or decreasing dosage, as well as when adding or eliminating other medication. Abrupt withdrawal of anticonvulsant medication may precipitate absence (petit mal) status.
Patients taking ethosuximide should be advised of the importance of adhering strictly to the prescribed dosage regimen. 2 Recommended Dose and Dosage Adjustment Initial dose: children aged 3 to 6 years, 250 mg daily; older patients, 500 mg daily in divided doses.
The dose thereafter must be individualized according to response and tolerance. g. increase daily dose by 250 mg every 4 to 7 days until control is achieved with minimal side effects. 5 g in divided doses frequently controls ODAN-ETHOSUXIMIDE (Ethosuximide capsules), Product Monograph Page 5 of 17 seizures; however, it may be necessary to exceed this amount by slow increases and careful evaluation of patient’s response.
5 g daily, in divided doses, should be administered only under the strictest supervision of the physician. The optimal dose for most children is 20 mg/kg/day. This dose has given average plasma levels within the accepted therapeutic range of 280 to 710 mcmol/L (40 to 100 mcg/mL).
Subsequent dose schedules can be based on effectiveness and plasma level determinations. Ethosuximide may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dosage for most children is 20 mg/kg/day.
4 Administration Ethosuximide can be taken with or without food. 5 Missed Dose In case of missed dose, the next dose should be taken as scheduled. A double dose should not be taken. 5 OVERDOSAGE Symptoms: Acute overdoses may produce nausea, vomiting, and CNS depression including coma with respiratory depression.
A relationship between ethosuximide toxicity and its plasma levels has not been established. The therapeutic range is 280 to 710 mcmol/L, although levels as high as 1,050 mcmol/L have been reported without signs of toxicity.
• ODAN-ETHOSUXIMIDE is contraindicated in patients who are hypersensitive to ethosuximide or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• ODAN-ETHOSUXIMIDE should not be used in patients who are hypersensitive to succinimides or components of these products.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ethosuximide in Canada.
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Treatment:
Treatment should include emesis (unless the patient is or could rapidly become obtunded, comatose, or convulsing) or gastric lavage, activated charcoal, cathartics and general supportive measures. Hemodialysis may be useful to treat ethosuximide overdose.
Forced diuresis and exchange transfusions are ineffective. For management of a suspected drug overdose, contact your regional poison control centre. ) ODAN-ETHOSUXIMIDE: 250 mg ethosuximide per capsule. Available in HDPE bottles of 60, 100 and 500.
ODAN-ETHOSUXIMIDE (Ethosuximide capsules), Product Monograph Page 6 of 17 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. Driving and Operating Machinery Ethosuximide may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a motor vehicle or other such activity requiring alertness; therefore the patient should be cautioned accordingly.
Hematologic Blood dyscrasias, including some with fatal outcomes, have been reported to be associated with the use of ethosuximide; therefore, periodic blood counts should be performed. , sore throat, fever) develop, blood count determinations should be considered at that point.
, sore throat, fever) suggesting an infection. Drug-Induced Immune Thrombocytopenia Drug-induced immune thrombocytopenia (DITP) has been reported with ethosuximide. In the reported cases, the onset of symptoms occurred 1 to 3 weeks after initiation of ethosuximide; one patient had recurrence of symptoms within 1 day of a subsequent re-challenge with the drug.
In those cases in which the platelet count was specified, the nadir was 2,000 and 3,000/mm3. When DITP is suspected, discontinue ODAN-ETHOSUXIMIDE, monitor serial platelet counts, and treat as appropriate. If possible, assess the presence of drug-dependent antiplatelet antibodies.
Avoid future use of ODAN- ETHOSUXIMIDE in patients with history of ethosuximide-induced DITP. Hepatic/Biliary/Pancreatic Ethosuximide is capable of producing morphological and functional changes in the animal liver. In humans, abnormal liver function studies have been reported.
Administer ethosuximide with extreme caution to patients with known liver disease. Periodic liver function studies are advised for all patients receiving the drug. Immune Case of systemic lupus erythematosus have been reported with the use of ethosuximide.
The physician should be alert to this possibility. Neurologic Ethosuximide, when used alone in mixed types of epilepsy, may increase the frequency of grand mal seizures in some patients. Psychiatric Suicidal Ideation and Behavior Suicidal ideation and behavior have been reported in patients treated with antiepileptic agents in several indications.
All patients treated with antiepileptic drugs, irrespective of indication, should be monitored for sign of suicidal ideation and behavior and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behavior emerge.
ODAN-ETHOSUXIMIDE (Ethosuximide capsules), Product Monograph Page 7 of 17 An FDA meta-analysis of randomized placebo controlled trials, in which antiepileptic drugs […]