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.

To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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

Each Ethosuximide Capsule, USP intended for oral administration contains 250 mg of Ethosuximide, USP and contains the following inactive ingredients: FD&C red # 40 aluminum lake, FD&C yellow # 6 aluminum lake, gelatin, glycerin, light mineral oil, methyl paraben, polyethylene glycol, propyl paraben, and sorbitol. The capsule shell is imprinted with white imprinting ink containing opacode white S-1-7078 as colorant which contains the following inactive ingredients: ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze, simethicone and titanium dioxide.

Meets the USP Dissolution Test 2.

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 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) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP.

Manufactured for:
Chartwell RX, LLC.
Congers, NY 10920

L71775

Rev. 10/2023

Print Medication Guides at: www.chartwellpharma.com/medguides

Print Medication Guides at: www.chartwellpharma.com/medguides