Celontin 300 mg/1
methsuximide · CAPSULE · Parke-Davis Div of Pfizer Inc
Celontin is a capsule containing methsuximide at 300 mg/1, taken oral. Manufactured by Parke-Davis Div of Pfizer Inc.
Key Facts
- Brand Name
- Celontin
- Generic Name
- methsuximide
- NDC Code (Product)
0071-0525- Manufacturer
- Parke-Davis Div of Pfizer Inc
- Strength
- 300 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA010596
- Drug Class
- Anti-epileptic Agent [EPC]
- Marketing Start
- 02/08/1957
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Celontin is indicated for the control of absence (petit mal) seizures that are refractory to other drugs.
Dosage & Administration
DOSAGE AND ADMINISTRATION Optimum dosage of Celontin must be determined by trial. A suggested dosage schedule is 300 mg per day for the first week. If required, dosage may be increased thereafter at weekly intervals by 300 mg per day for the three weeks following to a daily dosage of 1.2 g. Because therapeutic effect and tolerance vary among patients, therapy with Celontin must be individualized according to the response of each patient. Optimal dosage is that amount of Celontin which is barely sufficient to control seizures so that side effects may be kept to a minimum. Celontin may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal).
Warnings
WARNINGS Blood dyscrasias Blood dyscrasias, including some with fatal outcome, have been reported to be associated with the use of succinimides; therefore, periodic blood counts should be performed. Should signs and/or symptoms of infection (eg, sore throat, fever) develop, blood counts should be considered at that point. Effects on Liver It has been reported that succinimides have produced morphological and functional changes in animal liver. For this reason, methsuximide 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 succinimides. The physician should be alert to this possibility. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including Celontin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or beh…
Contraindications
CONTRAINDICATIONS Methsuximide should not be used in patients with a history of hypersensitivity to succinimides.
Drug Interactions
Drug Interactions Since Celontin (methsuximide) may interact with concurrently administered antiepileptic drugs, periodic serum level determinations of these drugs may be necessary (eg, methsuximide may increase the plasma concentrations of phenytoin and phenobarbital).
Adverse Reactions
ADVERSE REACTIONS Gastrointestinal System: Gastrointestinal symptoms occur frequently and have included nausea or vomiting, anorexia, diarrhea, weight loss, epigastric and abdominal pain, and constipation. Hemopoietic System: Hemopoietic complications associated with the administration of methsuximide have included eosinophilia, leukopenia, monocytosis, and pancytopenia with or without bone marrow suppression. Nervous System : Neurologic and sensory reactions reported during therapy with methsuximide have included drowsiness, ataxia or dizziness, irritability and nervousness, headache, blurred vision, photophobia, hiccups, and insomnia. Drowsiness, ataxia, and dizziness have been the most frequent side effects noted. Psychologic abnormalities have included confusion, instability, mental slowness, depression, hypochondriacal behavior, and aggressiveness. There have been rare reports of psychosis, suicidal behavior, and auditory hallucinations. Integumentary System : Dermatologic manifestations which have occurred with the administration of methsuximide have included urticaria, Stevens-Johnson syndrome, and pruritic erythematous rashes. Cardiovascular : Hyperemia. Genitourinary Syste…
Frequently Asked Questions
What is Celontin used for?
Celontin contains methsuximide. It is a capsule taken oral. Consult your doctor for specific uses.
Is Celontin a controlled substance?
Celontin is not classified as a controlled substance by the DEA.
What is the generic name for Celontin?
The generic name for Celontin is methsuximide. There are 1 other brand versions of methsuximide.
What is the NDC code for Celontin 300 mg/1?
The NDC (National Drug Code) for Celontin 300 mg/1 is 0071-0525, listed by Parke-Davis Div of Pfizer Inc.