Product Description.:
PD 525, 300mg
capsule , yellow , oblong oblong
PD within a circleBlack ink
Each Celontin capsule contains 150 mg or 300 mg methsuximide, USP. Also contains starch, NF. The capsule contains colloidal silicon dioxide, NF D&C yellow No. 10 FD&C yellow No. 6 gelatin, NF and sodium lauryl sulfate, NF.
INDICATIONS
Celontin is indicated for the control of absence (petit mal) seizures that are refractory to other drugs.
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. The smaller capsule (150 mg) facilitates administration to small children.
Celontin may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal).
SIDE EFFECTS
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.
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).
