Ethoxa 250 mg/5 ml Suspension 120 ml

Ethoxa 250 mg/5 ml Suspension 120 ml

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