Finished product reference
Ethosuximide
Syrup · Oral · 250 mg/5mL · 240 mL
- List code
- 513
- Pharmacologic class
- Anti-epileptic Agent
Indications
INDICATIONS AND USAGE Ethosuximide capsule is indicated for the control of absence (petit mal) epilepsy.
Dosage and administration (summary)
DOSAGE AND ADMINISTRATION Ethosuximide capsules are administered by the oral route. The initial dose for patients 3 to 6 years of age is one capsule (250 mg) per day; for patients 6 years of age and older, 2 capsules (500 mg) per day. The dose thereafter must be individualized according to the patient's response. Dosage should be increased by small increments. One useful method is to increase the daily dose by 250 mg every four to seven days until control is achieved with minimal side effects. Dosages exceeding 1.5 g daily, in divided doses, should be administered only under the strictest supervision of the physician. The optimal dose for most pediatric patients is 20 mg/kg/day.
Contraindications
CONTRAINDICATION Ethosuximide should not be used in patients with a history of hypersensitivity to succinimides.
Warnings and precautions
WARNINGS Blood Dyscrasias: Blood dyscrasias, including some with fatal outcome, have been reported to be associated with the use of ethosuximide; therefore, periodic blood counts should be performed. Should signs and/or symptoms of infection (e.g., sore throat, fever) develop, blood counts should be considered at that point. 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.
Storage and supply
HOW SUPPLIED Ethosuximide Capsules USP, 250 mg are clear orange-colored, oblong-shaped, soft gelatin capsules, imprinted "HP 532" with white ink and are supplied as follows: Bottle of 120 capsules NDC 62135-790-12 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Dispense in a tight container as defined in the USP.
Source: Ethosuximide (Ethosuximide) — US FDA prescribing information, 2024-10-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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