ETHOSUXIMIDE 250 mg/5mL
ETHOSUXIMIDE · SOLUTION · PAI Holdings, LLC dba PAI Pharma
ETHOSUXIMIDE is a solution containing ethosuximide at 250 mg/5mL, taken oral. Manufactured by PAI Holdings, LLC dba PAI Pharma.
Key Facts
- Brand Name
- ETHOSUXIMIDE
- Generic Name
- ETHOSUXIMIDE
- NDC Code (Product)
0121-0670- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- Strength
- 250 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA040253
- Drug Class
- Anti-epileptic Agent [EPC]
- Marketing Start
- 11/22/2000
Recall History
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Pfizer Inc.
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Akorn, Inc.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Pfizer Inc.
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Ethosuximide is indicated for the control of absence (petit mal) epilepsy.
Dosage & Administration
DOSAGE AND ADMINISTRATION Ethosuximide is administered by the oral route. The initial dose for patients 3 to 6 years of age is one teaspoonful (250 mg) per day; for patients 6 years of age and older, 2 teaspoonfuls (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.
Warnings
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; one patient had recurrence of symptoms within 1 day of a subsequent re-challenge with the drug. In those cases in which the platelet count was specified, the nadir was 2,000 and 3,000/mm 3 . When DITP is suspected, discontinue ethosuximide, monitor serial platelet counts, and treat as appropriate. If possible, assess the presence of drug-dependent antiplatelet antibodies. Avoid future use of ethosuximide in patients with history of ethosuximide-induced DITP. 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 repor…
Contraindications
CONTRAINDICATIONS Ethosuximide should not be used in patients with a history of hypersensitivity to succinimides.
Drug Interactions
Drug Interactions Since ethosuximide may interact with concurrently administered antiepileptic drugs, periodic serum level determinations of these drugs may be necessary (e.g., ethosuximide may elevate phenytoin serum levels and valproic acid has been reported to both increase and decrease ethosuximide levels).
Adverse Reactions
ADVERSE REACTIONS 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, incr…
Frequently Asked Questions
What is ETHOSUXIMIDE used for?
ETHOSUXIMIDE contains ETHOSUXIMIDE. It is a solution taken oral. Consult your doctor for specific uses.
Is ETHOSUXIMIDE a controlled substance?
ETHOSUXIMIDE is not classified as a controlled substance by the DEA.
What is the generic name for ETHOSUXIMIDE?
The generic name for ETHOSUXIMIDE is ETHOSUXIMIDE. There are 8 other brand versions of ETHOSUXIMIDE.
What is the NDC code for ETHOSUXIMIDE 250 mg/5mL?
The NDC (National Drug Code) for ETHOSUXIMIDE 250 mg/5mL is 0121-0670, listed by PAI Holdings, LLC dba PAI Pharma.