Fenitron 100mg 50 Caps, Phenytoin Sodica
INDICATIONS: Phenytoin is indicated for the control of seizures tonic-clonic (grand mal) and complex partial seizures (psychomotor, temporal lobe), and for the prevention and treatment of seizures occurring during or following neurosurgery events.
Phenytoin has also been used in the treatment of migraine, trigeminal neuralgia and certain psychoses. It has also been used in cardiac arrhythmias, digitalis intoxication and post-treatment in myocardial infarction.
CONTRAINDICATIONS: Phenytoin is contraindicated in patients hypersensitive to phenytoin, its inactive ingredients or other hydantoins.
General: Phenytoin is not indicated in absence seizures (petit mal). In cases of coexisting tonic-clonic seizures (grand mal) and absence seizures (petit mal), is indicated for combination therapy.
Phenytoin is not indicated in those crises that are secondary to hypoglycemia or other causes of metabolic origin. In these cases should be carried out relevant diagnostic procedures.
Phenytoin should not be stopped abruptly by the possibility of increased frequency of seizures, including status epilepticus. When a clinical trial required a lower dose or stopping the drug treatment regimen change make another anticonvulsant medication should be performed gradually. However, in case of occurrence of allergic or hypersensitivity reactions after administration, the rapid replacement with alternative therapy may be necessary. In this case, the new drug should not be belonging to a family of hydantoins.
A small percentage of subjects has shown to be poor metabolizers. Slow metabolism appears related to low availability enzyme, being a phenomenon that lacks hepatic induction and appears to be genetically determined.
Acute alcohol intake may cause increased blood levels of phenytoin, while chronic use can cause decreased concentrations.
DOSAGE AND ADMINISTRATION: Oral.
Doses should be individualized to provide maximum benefit. In some cases, the determination of drug levels in serum in order to adjust the optimal dose may be necessary. Optimum control without clinical signs of toxicity occurs more often with serum levels of 10-20 mcg / mL, although some cases of tonic-clonic epilepsy (grand mal) can be controlled with lower serum levels of phenytoin.
With recommended doses required an assessment of the levels of phenytoin in serum within a period of 7 to 10 days to achieve stable concentrations and should not be carried out changes in dosage (increase or decrease) with intervals of less than 7 10 days.
Divided daily dose: For patients who have not received previous treatment may be started with the administration of 300 mg a day, to be taken in three equal divided doses, and should subsequently be adjusted to individual requirements. For most adult patients satisfactory maintenance dose will be from 300 to 400 mg daily, to be taken in 3 or 4 equally divided doses respectively. Can be increased to a dose of 600 mg a day, if necessary.
Impregnation nonemergency dose in adult patients: A loading dose or urgent as initial therapy in adults who require stable concentrations reached quickly and is not appropriate use of the intravenous route may be used for such purposes.
This treatment schedule should be used only confined to clinics or hospitals where phenytoin serum levels can be monitored patients. Patients with liver or kidney disease should not be treated by this scheme.
Recommended dosage is 1 g impregnation phenytoin administered in three divided doses at intervals of two hours. The usual maintenance dose should be instituted within 24 hours after administration of the loading dose, with constant determinations of serum.
Dose in pediatric patients: Initially 5 mg / kg / day, divided into two to three same doses, with subsequent adjustments individualized, up to 300 mg daily. The usual recommended maintenance dose is from 4 to 8 mg / kg.
Children older than 6 years and adolescents may require the minimum adult (300 mg / day) dose. If the daily dose can not be divided into two doses, most of the dose should be given at bedtime.
- Drug Name: Fenitron
- Comparable patent medicine: Epamin / fenitron
- Active ingredient: Phenytoin
- Presentation: Tablets
- Concentration: 100 mg
- Extended release tablets: No
- Laboratory: PSICOFARMA,S.A. de C.V.
- Box of 50 pills.
- Made in: Mexico