Ethoxa 250 mg/5 ml Suspension 120 ml
Delta Pharma
Delta Pharma
Composition
Each 5 ml contains 250 mg ethosuximide.
Excipients: sucrose (1.5 g/5 ml), sodium benzoate, sodium citrate, glycerin, flavorings, purified water.
Product Description
Antiepileptic drug from the succinimide group.
Chemical name: α-ethyl-α-methylsuccinimide.
Suppresses paroxysmal activity (3 cycles/sec) characteristic of absence seizures.
Indications for use
Absence seizures, including complicated forms.
Myoclonic seizures in adolescents.
Atypical and complex absences when other drugs are ineffective or not tolerated.
Method of administration and dosage
Adults and children over 6 years: initial dose 500 mg/day, increase by 250 mg every 5–7 days until control is achieved (usually 1000–1500 mg/day).
In some cases up to 2000 mg/day.
Children 0–6 years: starting dose 250 mg/day (5 ml), gradual increase.
Optimal dose 20 mg/kg/day, maximum 1000 mg/day.
Administer orally, preferably during or after meals.
Contraindications
Hypersensitivity to ethosuximide, succinimides, or excipients.
Porphyria.
Precautions
Suicidal thoughts and behavior have been reported with antiepileptic drugs.
Liver and kidney function: monitor in case of impairment.
Withdrawal: taper gradually to avoid breakthrough seizures.
Sucrose content: consider in patients with diabetes or hereditary carbohydrate metabolism disorders.
Adverse reaction / Side effects
Blood and lymphatic system: rare dyscrasias, thrombocytopenia.
Nervous system: drowsiness, dizziness, ataxia, depression, psychosis, sleep disturbances.
Gastrointestinal: weight loss, diarrhea, abdominal pain, anorexia.
Skin: rare rash, erythema nodosum.
Other: irritability, hyperactivity, night terrors, myopia, vaginal bleeding.
Pregnancy and lactation
Slightly increased risk of congenital malformations.
Use during pregnancy only after careful risk-benefit assessment.
Ethosuximide is excreted in breast milk; breastfeeding is not recommended.
Storage conditions
Store at temperatures not exceeding 30 °C, out of reach of children.
Protect from light and freezing.
Packaging
Carton box containing a 120 ml glass bottle and package leaflet.
Ethoxa 250 mg/5 ml Suspension 120 ml