Get your patient on Ethosuximide - Ethosuximide capsule (Ethosuximide)

Ethosuximide capsule is indicated for the control of absence (petit mal) epilepsy.

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. This dose has given average plasma levels within the accepted therapeutic range of 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 dose for most pediatric patients is 20 mg/kg/day.

Ethosuximide should not be used in patients with a history of hypersensitivity to succinimides.

Body As A Whole: Allergic reaction, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

Gastrointestinal System: 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.

Hemopoietic System: Hemopoietic complications associated with the administration of ethosuximide have included leukopenia, agranulocytosis, pancytopenia, with or without bone marrow suppression, eosinophilia and thrombocytopenia (see WARNINGS ).

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.

Integumentary System: Dermatologic manifestations which have occurred with the administration of ethosuximide have included urticaria, pruritic erythematous rashes, Stevens-Johnson syndrome, and hirsutism.

Special Senses: Myopia .

Genitourinary System: Vaginal bleeding, microscopic hematuria.

Ethosuximide is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha- methyl-succinimide, with the following structural formula:

Each ethosuximide capsule contains 250 mg ethosuximide, USP. Also contains: D & C yellow No. 10, FD & C red # 3, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglyceride, polyethylene glycol 400, and sorbitol solution and printing ink white IH-edible oil (Dewaxed Bleached Shellac Resins, Isopropyl Alcohol, Propylene Glycol, Sodium Lauryl Sulphate and Titanium Dioxide).

Ethosuximide suppresses the paroxysmal three cycle per second spike and wave activity associated with lapses of consciousness which is common in absence (petit mal) seizures. The frequency of epileptiform attacks is reduced, apparently by depression of the motor cortex and elevation of the threshold of the central nervous system to convulsive stimuli.

Ethosuximide Capsules USP, 250 mg supplied as orange coloured, oblong shaped soft gelatin capsules printed with "250" in white ink, containing colourless to orange colour viscous liquid.

NDC: 64380-878-06: Bottles of 100. Each capsule contains 250 mg ethosuximide.

Store at 25° C (77° F); excursions permitted to 15–30° C (59–86° F) [see USP Controlled Room Temperature].

Manufactured by:

Strides Pharma Science Ltd.

Bengaluru - 562106 India

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised: 05/2022

Medication Guide available at: www.strides.com/medication-guides