Phenytoin Sodium Full Prescribing Information
Brand Name: Dilantin
Generic Name: Phenytoin Sodium
Dilantin, Phenytoin Sodium, is an anticonvulsant used to treat seizures. Usage, dosage, side effects of Dilantin.
Other Brand Names: Dilantin Infatabs Chewable, Dilantin Kapseals, Diphen, Diphentoin, Diphenylan, Sodium, Dyatoin, Phenytex, Prompt Phenytoin Sodium
Outside U.S., Brand Names also known as: Aleviatin; Antisacer; Cumatil; Difhydan; Di-hydan; Dintoina; Diphantoine; Diphantoine-Z; Ditoin; Ditomed; Epamin; Epanutin; Epilan-D; Epilantin; Epileptin; Epsolin; Eptoin; Fenatoin NM; Fenidantoin S 100; Fenitron; Fenytoin; Hidanil; Hydantin; Hydantol; Lehydan; Neosidantoina; Nuctane; Phenhydan; Phenilep; Phenytoin KP; Pyoredol; Zentropil
Dilantin patient information (in plain English)
Phenytoin Sodium is an anticonvulsant used to treat seizures. It may also be used to treat other conditions as determined by your doctor.
Phenytoin is an antiepileptic drug which can be useful in the treatment of epilepsy. The primary site of action appears to be the motor cortex where spread of seizure activity is inhibited. Possibly by promoting sodium efflux from neurons, phenytoin tends to stabilize the threshold against hyperexcitability caused by excessive stimulation or environmental changes capable of reducing membrane sodium gradient.
Phenytoin reduces the maximal activity of brain stem centers responsible for the tonic phase of tonic-clonic (grand mal) seizures.
Steady-state therapeutic levels are achieved at least 7 to 10 days after initiation of therapy with recommended doses of 300 mg/day.
Phenytoin Sodium Capsules is indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.
Abrupt withdrawal of phenytoin in epileptic patients may precipitate status epilepticus. When, in the judgment of the clinician, the need for dosage reduction, discontinuation, or substitution of alternative antiepileptic medication arises, this should be done gradually. However, in the event of an allergic or hypersensitivity reaction, rapid substitution of alternative therapy may be necessary. In this case, alternative therapy should be an antiepileptic drug not belonging to the hydantoin chemical class.
There have been a number of reports suggesting a relationship between phenytoin and the development of lymphadenopathy (local or generalized) including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin's Disease. Although a cause and effect relationship has not been established, the occurrence of lymphadenopathy indicates the need to differentiate such a condition from other types of lymph node pathology. Lymph node involvement may occur with or without symptoms and signs resembling serum sickness, e.g., fever, rash and liver involvement.
In all cases of lymphadenopathy, follow-up observation for an extended period is indicated and every effort should be made to achieve seizure control using alternative antiepileptic drugs.
Acute alcoholic intake may increase phenytoin serum levels while chronic alcoholic use may decrease serum levels.
In view of isolated reports associating phenytoin with exacerbation of porphyria, caution should be exercised in using this medication in patients suffering from this disease.
Usage in Pregnancy
A number of reports suggests an association between the use of antiepileptic drugs by women with epilepsy and a higher 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 antiepileptic drugs; less systematic or anecdotal reports suggest a possible similar association with the use of all known antiepileptic drugs.
The reports suggesting a higher 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; 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 antiepileptic medication deliver normal infants. It is important to note that 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 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.
In addition to the reports of increased incidence of congenital malformation, such as cleft lip/palate and heart malformations, in children of women receiving phenytoin and other antiepileptic drugs, there have more recently been reports of a fetal hydantoin syndrome. This consists of prenatal growth deficiency, microcephaly and mental deficiency in children born to mothers who have received phenytoin, barbiturates, alcohol, or trimethadione. However, these features are all inter-related and are frequently associated with intrauterine growth retardation from other causes.
There have been isolated reports of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy.
An increase in seizure frequency during pregnancy occurs in a high proportion of patients, because of altered phenytoin absorption or metabolism. Periodic measurement of serum phenytoin levels is particularly valuable in the management of a pregnant epileptic patient as a guide to an appropriate adjustment of dosage. However, postpartum restoration of the original dosage will probably be indicated.
Neonatal coagulation defects have been reported within the first 24 hours in babies born to epileptic mothers receiving phenobarbital and/or phenytoin. Vitamin K has been shown to prevent or correct this defect and has been recommended to be given to the mother before delivery and to the neonate after birth.
Infant breast-feeding is not recommended for women taking this drug because phenytoin appears to be secreted in low concentrations in human milk.
The liver is the chief site of biotransformation of phenytoin; patients with impaired liver function, elderly patients, or those who are gravely ill may show early signs of toxicity.
A small percentage of individuals who have been treated with phenytoin has been shown to metabolize the drug slowly. Slow metabolism may be due to limited enzyme availability and lack of induction; it appears to be genetically determined.
Phenytoin should be discontinued if a skin rash appears (see WARNINGS regarding drug discontinuation). If the rash is exfoliative, purpuric, or bullous or if lupus erythematosus, Stevens-Johnson syndrome, or toxic epidermal necrolysis is suspected, use of this drug should not be resumed and alternative therapy should be considered. (See ADVERSE REACTIONS.) If the rash is of a milder type (measles-like or scarlatiniform), therapy may be resumed after the rash has completely disappeared. If the rash recurs upon reinstitution of therapy, further phenytoin medication is contraindicated.
Phenytoin and other hydantoins are contraindicated in patients who have experienced phenytoin hypersensitivity. Additionally, caution should be exercised if using structurally similar compounds (e.g., barbiturates, succinimides, oxazolidinediones and other related compounds) in these same patients.
Phenytoin may cause changes in your gums. Brush and floss your teeth on a regular schedule and have regular dental check-ups.
Hyperglycemia, resulting from the drug's inhibitory effects on insulin release, has been reported. Phenytoin may also raise the serum glucose level in diabetic patients.
Osteomalacia has been associated with phenytoin therapy and is considered to be due to phenytoin's interference with Vitamin D metabolism.
Phenytoin is not indicated for seizures due to hypoglycemic or other metabolic causes. Appropriate diagnostic procedures should be performed as indicated.
Phenytoin is not effective for absence (petit mal) seizures. If tonic-clonic (grand mal) and absence (petit mal) seizures are present, combined drug therapy is needed.
Serum levels of phenytoin sustained above the optimal range may produce confusional states referred to as "delirium," "psychosis," or "encephalopathy," or rarely irreversible cerebellar dysfunction. Accordingly, at the first sign of acute toxicity, plasma levels are recommended. Dose reduction of phenytoin therapy is indicated if plasma levels are excessive; if symptoms persist, termination is recommended.
BEFORE USING THIS MEDICINE: Some medicines or medical conditions may interact with this medicine. Inform your doctor or pharmacist of all prescription and over-the-counter medicine that you are taking. Additional monitoring of your dose or condition may be needed if you are taking amiodarone, anticoagulants, antineoplastic agents, benzodiazepines, carbamazepine, chloramphenicol, cimetidine, corticosteroids, cyclosporine, diazoxide, disopyramide, disulfiram, doxycycline, felbamate, fluconazole, fluoxetine, folic acid, isoniazid, itraconazole, mexiletine, phenacemide, phenylbutazone, oxyphenbutazone, primidone, quinidine, methoxsalen, trioxsalen, birth control pills, rifampin, sulfonamides, theophylline, trimethoprim, valproic acid, or vigabatrin. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. Use of this medicine IS NOT RECOMMENDED if you have a history of heart conditions.
There are many drugs which may increase or decrease phenytoin levels or which phenytoin may affect. Serum level determinations for phenytoin are especially helpful when possible drug interactions are suspected. The most commonly occurring drug interactions are listed.
- Drugs which may increase phenytoin serum levels include: acute alcohol intake, amiodarone, chloramphenicol, chlordiazepoxide, diazepam, dicumarol, disulfiram, estrogens, H2-antagonists, halothane, isoniazid, methylphenidate, phenothiazines, phenylbutazone, salicylates, succinimides, sulfonamides, tolbutamide, trazodone.
- Drugs which may decrease phenytoin levels include: carbamazepine, chronic alcohol abuse, reserpine, and sucralfate. Moban brand of molindone hydrochloride contains calcium ions which interfere with the absorption of phenytoin. Ingestion times of phenytoin and antacid preparations containing calcium should be staggered in patients with low serum phenytoin levels to prevent absorption problems.
- Drugs which may either increase or decrease phenytoin serum levels include: phenobarbital, sodium valproate, and valproic acid. Similarly, the effect of phenytoin on phenobarbital, valproic acid and sodium valproate serum levels is unpredictable.
- Although not a true drug interaction, tricyclic antidepressants may precipitate seizures in susceptible patients and phenytoin dosage may need to be adjusted.
- Drugs whose efficacy is impaired by phenytoin include: corticosteroids, coumarin anticoagulants, digitoxin, doxycycline, estrogens, furosemide, oral contraceptives, quinidine, rifampin, theophylline, vitamin D.
- For women taking birth control pills, this medicine may decrease the effectiveness of your birth control pill. To prevent pregnancy, use an additional form of birth control while you are taking this medicine.
Central Nervous System: The most common manifestations encountered with phenytoin therapy are referable to this system and are usually dose-related. These include nystagmus, ataxia, slurred speech, decreased coordination and mental confusion. Dizziness, insomnia, transient nervousness, motor twitchings, and headaches have also been observed. There have also been rare reports of phenytoin induced dyskinesias, including chorea, dystonia, tremor and asterixis, similar to those induced by phenothiazine and other neuroleptic drugs.
Gastrointestinal System: Nausea, vomiting, constipation, toxic hepatitis and liver damage.
Integumentary System: Dermatological manifestations sometimes accompanied by fever have included scarlatiniform or morbilliform rashes. A morbilliform rash (measles-like) is the most common; other types of dermatitis are seen more rarely. Other more serious forms which may be fatal have included bullous, exfoliative or purpuric dermatitis, lupus erythematosus, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Hemopoietic System: Hemopoietic complications, some fatal, have occasionally been reported in association with administration of phenytoin. These have included thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, and pancytopenia with or without bone marrow suppression. While macrocytosis and megaloblastic anemia have occurred, these conditions usually respond to folic acid therapy. Lymphadenopathy including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin's Disease have been reported.
Connective Tissue System: Coarsening of the facial features, enlargement of the lips, gingival hyperplasia, hypertrichosis and Peyronie's Disease.
Immunologic: Hypersensitivity syndrome (which may include, but is not limited to, symptoms such as arthralgias, eosinophilia, fever, liver dysfunction, lymphadenopathy or rash), systemic lupus erythematosus, and immunoglobulin abnormalities.
Symptoms: The lethal dose in children is not known. The lethal dose in adults is estimated to be 2 to 5 grams. Symptoms of overdose may include unusual eye movements, unsteadiness, nausea, dizziness, confusion, tremor, slurred speech, drowsiness, and loss of consciousness. Death is due to respiratory and circulatory depression.
In acute overdosage the possibility of other CNS depressants, including alcohol, should be borne in mind.
If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.
There is no known antidote. Treatment should be symptomatic and supportive.
Do not exceed the recommended dosage or take this medicine for longer than prescribed.
Do not stop taking this medicine without first checking with your doctor. To prevent seizures, continue taking this medicine on a regular schedule.
- Follow the directions for using this medicine provided by your doctor.
- Take this medicine with food if it upsets your stomach.
- Store this medicine at room temperature, away from heat and light.
- If you miss a dose of this medicine, take it as soon as possible. If it is within 4 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss doses for 2 or more days in a row or you have questions about the dose, check with your doctor as soon as possible.
Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.
IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.
Adults: Divided daily dosage: Patients who have received no previous treatment may be started on one 100-mg Extended Phenytoin Sodium Capsule three times daily and the dosage then adjusted to suit individual requirements. For most adults, the satisfactory maintenance dosage will be one capsule three to four times a day. An increase up to two capsules three times a day may be made, if necessary.
Infatabs and Suspensions: Patients who have received no previous treatment may be started on 2 Infatabs 3 times daily or on 5 mL of Dilantin-125 suspension 3 times daily, and the dose then adjusted to suit individual requirements. For some adults, the satisfactory maintenance dosage will be 8 Infatabs daily; an increase to 12 may be made, if necessary. With Dilantin-125, an increase to 25 mL daily may be made if necessary.
Once-a-day dosage: In adults, if seizure control is established with divided doses of three 100-mg Phenytoin Sodium Capsules capsules daily, once-a-day dosage with 300 mg of extended phenytoin sodium capsules may be considered. Once-a-day dosage offers a convenience to the individual patient or to nursing personnel for institutionalized patients and is intended to be used only for patients requiring this amount of drug daily. A major problem in motivating noncompliant patients may also be lessened when the patient can take this drug once a day. However, patients should be cautioned not to miss a dose, inadvertently. Only extended phenytoin sodium capsules are recommended for once-a-day dosing.
Pediatric Dosage: Capsules, Infatabs and Suspensions: Initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 to 8 mg/kg. Children over 6 years old may require the minimum adult dose (300 mg/day).
Extended-release capsules, tablets, and solution.
The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.
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