PEGANONE (ETHOTOIN TABLETS, USP) CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. THERE ARE MULTIPLE REPORTS IN THE CLINICAL LITERATURE WHICH INDICATE THAT THE USE OF ANTIEPILEPTIC DRUGS DURING PREGNANCY RESULTS IN AN INCREASED INCIDENCE OF BIRTH DEFECTS IN THE OFFSPRING. ALTHOUGH DATA ARE MORE EXTENSIVE WITH RESPECT TO PHENYTOIN AND PHENOBARBITAL, REPORTS INDICATE A POSSIBLE SIMILAR ASSOCIATION WITH THE USE OF OTHER ANTIEPILEPTIC DRUGS. THEREFORE, ANTIEPILEPTIC DRUGS SHOULD BE ADMINISTERED TO WOMEN OF CHILD-BEARING POTENTIAL ONLY IF THEY ARE CLEARLY SHOWN TO BE ESSENTIAL IN THE MANAGEMENT OF THEIR SEIZURES.

ANTIEPILEPTIC 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 RISK TO BOTH MOTHER AND THE UNBORN CHILD. CONSIDERATION SHOULD, HOWEVER, BE GIVEN TO DISCONTINUATION OF ANTIEPILEPTICS PRIOR TO AND DURING PREGNANCY WHEN THE NATURE, FREQUENCY AND SEVERITY OF THE SEIZURES DO NOT POSE A SERIOUS THREAT TO THE PATIENT. IT IS NOT, HOWEVER, KNOWN WHETHER EVEN MINOR SEIZURES CONSTITUTE SOME RISK TO THE DEVELOPING EMBRYO OR FETUS.

REPORTS HAVE SUGGESTED THAT THE MATERNAL INGESTION OF ANTIEPILEPTIC DRUGS, PARTICULARLY BARBITURATES, IS ASSOCIATED WITH A NEONATAL COAGULATION DEFECT THAT MAY CAUSE BLEEDING DURING THE EARLY (USUALLY WITHIN 24 HOURS OF BIRTH) NEONATAL PERIOD. THE POSSIBILITY OF THE OCCURRENCE OF THIS DEFECT WITH THE USE OF PEGANONE SHOULD BE KEPT IN MIND. THE DEFECT IS CHARACTERIZED BY DECREASED LEVELS OF VITAMIN K-DEPENDENT CLOTTING FACTORS, AND PROLONGATION OF EITHER THE PROTHROMBIN TIME OR THE PARTIAL THROMBOPLASTIN TIME, OR BOTH. IT HAS BEEN SUGGESTED THAT VITAMIN K BE GIVEN PROPHYLACTICALLY TO THE MOTHER ONE MONTH PRIOR TO AND DURING DELIVERY, AND THE INFANT, INTRAVENOUSLY, IMMEDIATELY AFTER BIRTH.

IF PEGANONE IS USED DURING PREGNANCY, OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THIS DRUG, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS.

General

Blood dyscrasias have been reported in patients receiving PEGANONE. Although the etiologic role of PEGANONE has not been definitely established, physicians should be alert for general malaise, sore throat and other symptoms indicative of possible blood dyscrasia.

There is some evidence suggesting that hydantoin-like compounds may interfere with folic acid metabolism, precipitating a megaloblastic anemia. If this should occur during gestation, folic acid therapy should be considered.

Laboratory Tests

Liver function tests should be performed if clinical evidence suggests the possibility of hepatic dysfunction. Signs of liver damage are indication for withdrawal of the drug.

It is recommended that blood counts and urinalyses be performed when therapy is begun and at monthly intervals for several months thereafter. As in patients receiving other hydantoin compounds and other antiepileptic drugs, blood dyscrasias have been reported in patients receiving PEGANONE (ethotoin tablets, USP). Marked depression of the blood count is indication for withdrawal of the drug.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No data are available on long-term potential for carcinogenicity in animals or humans.

Pregnancy

Pregnancy Category D. See “WARNINGS” section.

Nonteratogenic Effects

Reports have suggested that the maternal ingestion of antiepileptic drugs, particularly barbiturates, is associated with a neonatal coagulation defect that may cause bleeding during the early (usually within 24 hours of birth) neonatal period. The possibility of the occurrence of this defect with the use of PEGANONE should be kept in mind. See “WARNINGS” section.

Nursing Mothers

Ethotoin is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants from ethotoin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in the pediatric population were established on the basis of open-label, uncontrolled experience in patients down to the age of one with various types of seizures.

Geriatric Use

Clinical studies of Peganone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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