ETHOSUXIMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ETHOSUXIMIDE (UNII: 5SEH9X1D1D) (ETHOSUXIMIDE - UNII:5SEH9X1D1D)

Available from:

Avera McKennan Hospital

INN (International Name):

ETHOSUXIMIDE

Composition:

ETHOSUXIMIDE 250 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ETHOSUXIMIDE- ETHOSUXIMIDE CAPSULE
AVERA MCKENNAN HOSPITAL
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ETHOSUXIMIDE CAPSULES, USP
DESCRIPTION
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: polyethylene glycol
400, NF. The capsule contains FD&C yellow No. 6; FD&C red No. 3;
gelatin, NF; glycerin, USP; and
sorbitol.
CLINICAL PHARMACOLOGY
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.
INDICATIONS AND USAGE
Ethosuximide is indicated for the control of absence (petit mal)
epilepsy.
CONTRAINDICATION
Ethosuximide should not be used in patients with a history of
hypersensitivity to succinimides.
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.
EFFECTS ON LIVER AND KIDNEYS
Ethosuximide is capable of producing morphological and functional
changes in the animal liver. In
humans, abnormal liver and renal function studies have been reported.
Ethosuximide should be
administered with extreme caution to patients with known liver or
renal disease. Periodic urinalysis and
liver function studies are advised for all patients receiving the
drug.
SYSTEMIC LUPUS ERYTHEMATOSUS
Cases of systemic lupus erythematosus have been reported with the use
of ethosuximide. The physician
should be alert to this possibility.
SUICIDAL BEHAVIOR AND IDEATION
Antiepileptic drugs (AEDs), including ethosuximide, increase the risk
of suicid