WARNINGS
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.
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.
Cases of systemic lupus erythematosus have been reported
with the use of succinimides. The physician should be
alert to this possibility.
Usage in Pregnancy:
Reports suggest an association between the use of anticonvulsant
drugs by women with epilepsy and an elevated incidence
of birth defects in children born to these women. Data
are more extensive with respect to phenytoin and phenobarbital,
but these are also the most commonly prescribed anticonvulsants;
less systematic or anecdotal reports suggest a possible
similar association with the use of all known anticonvulsant
drugs.
The reports suggesting an elevated incidence of birth
defects in children of drug-treated epileptic women cannot
be regarded as adequate to prove a definite cause and
effect relationship. There are intrinsic methodologic
problems in obtaining adequate data on drug teratogenicity
in humans; the possibility also exists that other factors,
eg, genetic factors or the epileptic condition itself,
may be more important than drug therapy in leading to
birth defects. The great majority of mothers on anticonvulsant
medication deliver normal infants. It is important to
note that anticonvulsant drugs should not be discontinued
in patients in whom the drug is administered to prevent
major seizures because of the strong possibility of precipitating
status epilepticus with attendant hypoxia and threat to
life. In individual cases where the severity and frequency
of the seizure disorder are such that the removal of medication
does not pose a serious threat to the patient, discontinuation
of the drug may be considered prior to and during pregnancy,
although it cannot be said with any confidence that even
minor seizures do not pose some hazard to the developing
embryo or fetus.
The prescribing physician will wish to weigh these considerations
in treating or counseling epileptic women of childbearing
potential.
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:
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).
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:
See
WARNINGS
.
Pediatric Use:
See DOSAGE AND ADMINISTRATION.
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