Data from FDA - Curated by EPG Health - Last updated 20 December 2016

Indication(s)

INDICATIONS AND USAGE Celontin is indicated for the control of absence (petit mal) seizures that are refractory to other drugs.

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Advisory information

contraindications
CONTRAINDICATIONS Methsuximide should not be used in patients with a history of hypersensitivity to succinimides.
Special warnings and precautions

PRECAUTIONS General It is recommended that the physician withdraw the drug slowly on the appearance of unusual depression, aggressiveness, or other behavioral alterations.

As with other anticonvulsants, it is important to proceed slowly when increasing or decreasing dosage, as well as when adding or eliminating other medication.

Abrupt withdrawal of anticonvulsant medication may precipitate absence (petit mal) status.

Methsuximide, when used alone in mixed types of epilepsy, may increase the frequency of grand mal seizures in some patients.

Information for Patients Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking Celontin.

Instruct patients to take Celontin only as prescribed.

Methsuximide may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a motor vehicle or other such activity requiring alertness; therefore, the patient should be cautioned accordingly.

Patients taking methsuximide should be advised of the importance of adhering strictly to the prescribed dosage regimen.

Patients should be instructed to promptly contact their physician if they develop signs and/or symptoms suggesting an infection (eg, sore throat, fever).

ADVICE TO THE PHARMACIST AND PATIENT: Since methsuximide has a relatively low melting temperature (124° F), storage conditions which may promote high temperatures (closed cars, delivery vans, or storage near steam pipes) should be avoided.

Do not dispense or use capsules that are not full or in which contents have melted.

Effectiveness may be reduced.

Protect from excessive heat (104° F).

Patients, their caregivers, and families should be counseled that AEDs, including Celontin, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.

Behaviors of concern should be reported immediately to healthcare providers.

Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant.

This registry is collecting information about the safety of antiepileptic drugs during pregnancy.

To enroll, patients can call the toll free number 1-888-233-2334 (see PRECAUTIONS: Pregnancy section).

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).

Pregnancy To provide information regarding the effects of in utero exposure to Celontin, physicians are advised to recommend that pregnant patients taking Celontin enroll in the (NAAED) Pregnancy Registry.

This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves.

Information on the registry can also be found at the website: http://www.aedpregnancyregistry.org/.

See WARNINGS. Pediatric Use See DOSAGE AND ADMINISTRATION.

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 System: Proteinuria, microscopic hematuria.

Body as a Whole: Periorbital edema.

Usage information

Dosing and 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).

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).

More information

Category Value
Authorisation number NDA010596
Agency product number 0G76K8X6C0
Orphan designation No
Product NDC 0071-0525
Date Last Revised 25-07-2014
Type HUMAN PRESCRIPTION DRUG
RXCUI 197949
Storage and handling Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Protect from excessive heat 40°C (104°F).
Marketing authorisation holder Parke-Davis Div of Pfizer Inc