Phenytoin Ikapharmindo

Phenytoin sodium.

Capsule: Each capsule contains: Phenytoin Sodium 100 mg.
Injection: Each ampoule (2 ml) contains Phenytoin Sodium 100 mg (50 mg/ml).

Capsule: Drug Actions: Phenytoin sodium is an anticonvulsant that can be used for the treatment of epilepsy, the main work of phenytoin is in the motor cortex where spread of attack activity is inhibited, perhaps by increasing the flow of sodium out of nerve. Phenytoin sodium tends to stabilize the threshold against hyperexcitability caused by excessive stimulation or environmental changes that could reduce membrane sodium gradient.
Injection: Actions: Phenytoin Sodium is an anticonvulsant which is useful in the treatment of status epilepticus of the grand mal type. 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 changes capable of reducing membrane sodium gradient. This includes the reduction of post-tetanic potentiation at synapses. Loss of post-tetanic potentiation prevents cortical seizure foci from detonating adjacent cortical areas. Phenytoin reduces the maximal activity of brain stem centers responsible for the tonic phase of grand mal seizures.
Non-Therapeutic Effects: The toxicity signs associated with intravenous administration of Sodium Phenytoin are cardiovascular collapse and/or central nervous system depression. Hypotension may occur when the drug is administered rapidly by the intravenous route. The rate of administration is very important, it should not exceed 50 mg per minute (1 ml solution per minute). At this rate toxicity should be minimized. Severe cardiotoxic reactions and fatalities have been reported with atrial and ventricular conduction depression and ventricular fibrillation. Severe complications are most commonly encountered in elderly and gravely ill patients. Parenteral Phenytoin sometimes causes drowsiness, nystagmus, circumoral tingling, vertigo, nausea and rarely vomiting. These effects are usually observed at a plasma concentration above 20 mcg/ml which is just above the usual therapeutic plasma level.

Capsule: To control the type of epilepsy attack, tonic and psychomotor (grand mal and temporal lobus).
Injection: Parenteral Phenytoin Sodium is indicated for the control of status epilepticus of the grand mal type, and prevention and treatment of seizures occurring during neurosurgery.

Capsule: The dose given depends on the individual patient response and drug levels in blood.
The beginning should be given in divided doses (usually 2 times a day).
Adults: Initial dose of 300 mg in 2 divided doses. Maintenance dose is usually 300-400 mg or 3-5 mg/kg body weight per day (maximum 600 mg).
Children: Initial dose is 5 mg/kg body weight per day, divided in 2 doses, with recommended maintenance dose is 4-7 mg/kg body weight per day.
Injection: Intravenous administration rate should not exceed 50 mg per minute. Phenytoin sodium has a relatively narrow safety margin. The intravenous route is preferred in the treatment of status epilepticus, because of the delay in absorption in intramuscular administration.
Status Epilepticus: Intravenous administration: 150 to 250 mg injected slowly, followed by 100 to 150 mg if necessary 30 minutes afterwards. Higher doses may be required to control seizures. Dosage for children is usually determined in accordance with bodyweight taking 150 lbs as the weight of an adult. The pediatric dose may also be calculated based on 250 mg per square meter of body surface. When the patient's extremities are completely immobilised by convulsions or the veins are inaccessible, medication can be administered intramuscularly during the attack. If Phenytoin does not terminate the seizures, use other anti-convulsants, intravenous barbiturates, general anesthesia, or other measures may be considered.
Neurosurgery: Prophylactic dosage of 100 to 200 mg (2 to 4 ml) intramuscularly at about 4 hour intervals during surgery and to be continued during the post-operative period.

Injection: The lethal dose for adults is estimated to be 2 to 5 grams. Initial symptoms include nystagmus, ataxia and dysarthria. The patient may become comatose, pupils unresponsive and hypotension occurs. Death is due to respiratory depression and apnea. treatment is nonspecific since there is no known antidote. If the gag reflex is absent, the airway should be supported by oxygen. Vasopressors and assisted ventilation may be necessary for central nervous system, respiratory and cardiovascular depression. Finally, hemodialysis may be considered, since Phenytoin is not completely bound to plasma proteins. Total exchange transfusion can be utilized in the treatment of severe intoxication in children.

Capsule: Hypersensitive to phenytoin or other hydantoin.
Injection: Patients hypersensitive to Sodium Phenytoin preparations.
Intravenous administration of Phenytoin is also contraindicated in sinus bradycardia.

Capsule: It should not be given to the petit mal patients because it can exacerbate the attack.
Sudden termination of treatment in patients with epilepsy can lead to status epilepticus.
Administration in pregnant women with consideration of the possibility congenital malformations, neonatal defects coagulation and haemorrhage in newborns.
Caution when used in patients with liver dysfunction and in elderly patients.
Phenytoin not indicated for attack that caused by hipoglikemia.
During take this medicine don't drive motor vehicle or run engine.
Caution when used in patients with blood dyscrasia.
Stop the treatment if there is "skin rash".
Phenytoin may interfere with vitamin D metabolism and can lead to osteomalacia.
Not recommended administration in lactating women, due to phenytoin excreted through breast milk.
Injection: Abrupt withdrawal of Phenytoin in epileptic patients may precipitate status epilepticus.
Dosage reduction, discontinuation or substitution of alternative anticonvulsant medication should be done gradually.
Intravenous administration should not exceed 50 mg (1 ml solution) per minute in adults. Do not use solutions that are hazy or contain precipitates.
The drug should be used with caution in patients with impaired liver function or blood dyscrasia
During the usage of this drug. It is prohibited to drive vehicle or work with machinery.
Phenytoin is not indicated for seizures due to hypoglycemic or other causes that are not known with certainty.

Capsule: Administration in pregnant women with consideration of the possibility congenital malformations, neonatal defects coagulation and haemorrhage in newborns.
Not recommended administration in lactating women, due to phenytoin excreted through breast milk.
Injection: Usage in Pregnancy: A number of reports suggests a possible correlation between administration of antiepileptic drugs and congenital malformation. Therefore the advantages of using the drug in pregnancy should be carefully weighed against the risks to the foetus. Addition of Sodium Phenytoin solution to an infusion is not recommended due to decreasing drug solubility and possible formation of precipitate. Biotransformation occurs in the liver. Early intoxication symptoms were observed in patients with liver function disorders, elderly patients and those with severe disease. A small number of patients when administered Phenytoin showed slow metabolism. The slow metabolism may be caused by a limited quantity of enzymes and lack of enzyme induction, the latter is probably due to genetic factors. Drugs intended for the treatment of tonic-clonic epilepsy are not effective for petit mal epilepsy. If both seizures are present, a combined drug therapy is needed. Each injection of intravenous Sodium Phenytoin should be followed by an injection of sterile saline solution through the same needle or intravenous catheter to avoid local irritation due to the alkalinity of the solution. Continuous infusion should be avoided.

Injection: Central nervous system: nystagmus, ataxia, slurred speech, mental confusion, dizziness, insomnia, nervousness, motor twitchings and headache.
Gastrointestinal system: nausea, vomiting, toxic constipation, hepatitis and liver damage.
lntegumentary system: morbilliform rash (measles-like).
Hemopoietic system: thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, pancytopenia, macrocytosis and megaloblastic anaemia, lymphadenopathy.
Connective tissue system: coarsening of the facial features, enlargement of the lips, gingival hyperplasia, hypertichosis and Peyronie's Disease.
Cardiovascular system: periarteritis nodosa
Immunology system: hypersensitivity syndrome (arthralgia, cosinophilia, fever, liver dysfunction, lymphadenopathy or rashes), systemic lupus erythematosus, abnormal immunoglobulins.

Capsule: Nausea, vomiting, dizziness, ataksia, nystagmus, speaking difficulty, tremors, sleeping difficulty, diplopia, constipation, hepatitis, bone marrow depression, lupus systemic erythematosus, Steven-Johnson syndrome, lymphadenopathy, leukopenia, thrombocytopenia, agranulocytosis, megaloblastic anemia due to folic acid deficiency.

Capsule: Phenytoin effect is enhanced when given along with dicomarol, disulfiram and isoniazid and also if given together with chloramphenicol, halothane, phenyramidol, sulthiamine, viloxasine and thyroid preparations. Phenytoin effects are reduced by the presence of alcohol and phenobarbitone.
Phenytoin may decrease the plasma levels of carbamazepine, valproic acid, etosuksimid and promidon.
Phenytoin is a potent enzyme inductor that can reduce the effectiveness of oral anti-coagulants. antibiotics (doxycycline, rifampicin, chloramfenicol), oral contraceptives, antiarrhythmics (disopiramid, mexiletine, quiridine), digitoxine, analgesics (meperidine, methadone), cyclosporine, corticosteroids and theophylline.
Injection: Drugs which may increase phenytoin serum levels include: Amiodarone, Chloramphenicol, Chlordiazepoxide, Diazepam, Dicumarol, Disulfiram, Halothane, Isoniazid, Methylphenidate, Phenothiazines, Phenylbutazone, Salicylates, Ethosuximide, Sulfonamides, Tolbutamide, Trazodone, Estrogens, H₂-antagonists, acute Alcohol intake.
Drugs which may decrease phenytoin levels include: Carbamazepine, chronic Alcohol abuse, Reserpine and Sucralfate.
Drugs which may either increase or decrease phenytoin serum levels include: Phenobarbital, Sodium Valproate and Valproic Acid.
Although not a true drug interaction, tricyclic antidepressants may precipitate seizures in susceptible patients and phenytoin dosage may need to be adjusted.
Drugs which efficacy is impaired by phenytoin include: Corticosteroids, Coumarin, anticoagulants, Digitoxin, Doxycycline, Furosemide, Quinidine, Rifampin, Theophylline, Estrogens, oral contraceptives and Vitamin D.

Capsule: Store in a dry place, below 25°C.
Injection: Store in a dry place below 25°C, protect from light.

Anticonvulsants

N03AB02 - phenytoin ; Belongs to the class of hydantoin derivatives antiepileptics.

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