Generic Dilantin Er

PHENYTOIN
(Dilantin)
Phenytoin is an anticonvulsant administered orally or intravenously in the treatment of seizure disorders. Phenytoin is also used to treat digitalis-induced cardiac arrhythmias. The usual oral dosage is 300-600 mg/d; intravenous doses up to 18 mg/kg/d are sometimes used in the treatment of status epilepticus. A serum concentration of 10-20 mcg/mL is considered to be therapeutic in most patients.

Teratogenic Risk
Magnitude of teratogenic risk to child born after exposure during gestation: Small to moderate.
Quality and quantity of data on which risk estimate is based: Fair to good
This assessment is based on data for continuous treatment of maternal seizure disorders with phenytoin throughout pregnancy. No data are available on the effects of acute exposure.

A "fetal hydantoin syndrome," which consists of an unusual and characteristic pattern of anomalies, has been described in about 10% of infants born to epileptic women who took phenytoin during pregnancy. Typical features of this syndrome include apparent ocular hypertelorism, flat nasal bridge, and nail hypoplasia. None of these features is of great clinical importance, but some authors believe that cleft palate, congenital heart disease, microcephaly, developmental delay, and prenatal and postnatal growth retardation also occur as occasional manifestations of fetal hydantoin syndrome. This conclusion is controversial, however. Other authorities believe that most of the anomalies that occur more frequently among the children of epileptic women taking phenytoin during pregnancy than among the children of normal untreated women are due to underlying familial factors or effects of maternal epilepsy per se rather than to the teratogenic action of phenytoin. Distal digital hypoplasia is one feature in the children that does appear to be due to maternal phenytoin treatment during pregnancy.
Although many large epidemiologic studies of the offspring of epileptic women have been published, currently available data are incapable of resolving this controversy because assessment of the effects of phenytoin exposure is confounded by many other factors. Among these confounders are the facts that most women with seizures are treated with some anticonvulsant drug, that many women are treated with more than one anticonvulsant at a time, that women who are not treated or are treated with a single agent probably have milder disease, and that phenytoin exposure rarely occurs in women without seizures.
This much seems clear: The frequency of major malformations among the children of epileptic women treated with phenytoin during pregnancy is about twice as great as the frequency of such anomalies in the general population. The risk of malformations in the offspring is probably even greater if the mother requires treatment with other anticonvulsants in addition to phenytoin during pregnancy or if the mother has previously had a child with features of fetal hydantoin syndrome. Genetic factors in the fetus may be important in determining whether or not congenital anomalies occur when a pregnant epileptic woman is treated with phenytoin.
Full-scale IQs, performance IQs, and Visual Motor Integration Test scores were significantly lower among 20 four- to eight-year-old children whose mothers took phenytoin during pregnancy than among controls. None of the children tested in this study was mentally retarded. Global IQ averaged ten points lower than controls in a study of 34 eighteen- to thirty-six-month-old children of mothers who were treated with phenytoin during pregnancy.
Prenatal diagnosis by means of ultrasound examination has been advocated for pregnant epileptic women who are being treated with anticonvulsant medication, but such screening does not appear to be very sensitive for the kinds of anomalies most often seen in the children of these women.
Phenytoin, in doses producing therapeutic blood levels or in greater doses, is teratogenic in mice, rats, and rabbits. Cleft palate, cardiac defects, and skeletal anomalies are the malformations most frequently observed. Frequent embryonic death but no increase in fetal malformations was observed among pregnant rhesus monkeys treated with phenytoin in doses that caused maternal toxicity even though they produced blood levels only 1-2 times those considered to be therapeutic in humans. Behavioral alterations have been demonstrated among the offspring of rats and rhesus monkeys treated during pregnancy with phenytoin in doses that produce blood levels similar to those used therapeutically in humans.
Exposure to phenytoin during embryogenesis has also been associated with an increased risk of tumor development in humans; neuroblastoma and other neoplasms have been reported in such children with surprisingly high frequency. Malignancy in childhood is rare, however, and the risk of neoplasia in a child who was exposed to phenytoin during gestation is probably small.
Perinatal and neonatal hemorrhage associated with deficiency of vitamin K-dependent clotting factors has been observed in infants of women treated with phenytoin during pregnancy. Administration of vitamin К to these infants appears to be useful both prophylactically and therapeutically.

Risk Related to Breast-feeding
Phenytoin is excreted into breast milk. The amount of phenytoin that the nursing infant would be expected to ingest is between 1-15% of the lowest therapeutic dose. No adverse effects in the infants were found in these studies.
Serum levels of phenytoin in six infants were found to be between 0-2% of the lowest therapeutic serum level in adults.
EPILEPSY

EPILEPSY CLASSIFICATION: PETIT MAL AND GRAND MAL EPILEPSY
The nervous system may give off stimuli with irregular seizures marked by attacks of unconsciousness, with or without convulsive movements. The condition is called epilepsy. The common classification is petit mal, which is characterized by short lapses of unconsciousness and sudden momentary pauses in conversation or movement, rarely lasting more than thirty seconds. Brain-wave machines show that this is minor and slow. Grand mal epilepsy is a complete epileptic seizure, with a sudden loss of consciousness, convulsions, blueness, and dilated pupils, followed by spasms of all the voluntary muscles. The eyes rotate upward, the head may be extended, there may be some frothing of the mouth, sometimes loss of urine. Then the convulsions disappear; the patient may be temporarily confused and fall into a deep sleep. During an epileptic attack the electric rhythm, as shown by the brain wave, is of increased rate and high voltage. Nowadays, epilepsy is not feared as it was formerly because much more is understood about it. Only a small per cent of people with epilepsy have mental disturbance of any kind. Many drugs have been found which are capable of subduing or controlling the epilepsy, among them derivatives of phenobarbital. Especially valuable is Dilantin. All these drugs must be prescribed by a doctor. Any such drugs should be chosen and prescribed by the doctor according to their successful use in the individual patient. In some cases convulsions are diminished by using a special diet, called the ketogenic diet, which produces an acid tendency in the blood. Any person with epilepsy should have a physician whom he sees at fairly regular intervals and who is familiar with his condition.
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EPILEPSY

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