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Epamin SP INJ 250mg 5ml, Phenytoin

Epamin SP INJ 250mg 5ml, Phenytoin
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Epamin SP INJ 250mg 5ml, Phenytoin


THERAPEUTIC INDICATIONS: Phenytoin is indicated for the control of seizures tonic-clonic (grand mal) and complex partial seizures (psychomotor, temporal lobe) as well as for the prevention and treatment of attacks during or after neurosurgical 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 (grand mal) and absence seizures (petit mal), combined therapy is indicated.

Phenytoin is not indicated in those crises that are secondary to hypoglycemia and other causes of metabolic origin. In these cases must be carried out relevant diagnostic procedures.

The administration of phenytoin should not be stopped abruptly by the possibility of increased frequency of seizures, including status epilepticus. When a clinical trial of dose reduction is required to suspend its management or therapeutic regimen of change of other anticonvulsant medication should be carried out gradually. However, in cases of allergic reactions or hypersensitivity reactions following administration may be necessary for the rapid replacement with an alternative treatment. In this case, the new drug should not be owned by one of the hydantoins family.

A small percentage of subjects has shown to be poor metabolizers. The slow metabolism seems to be related to low availability enzyme, being a phenomenon that no induction of hepatic and seems to be genetically determined.

Acute alcohol intake may cause increased blood levels of phenytoin, while chronic use can result in lowering of their concentration.


Doses should be individualized to provide maximum benefit. In some cases it may be necessary to determine the serum drug levels to adjust the optimal dose. Optimum control without clinical signs of toxicity occurs more often with serum levels between 10-20 mcg / ml, although some cases of tonic-clonic epilepsy (grand mal) can be controlled with lower levels of phenytoin in serum.

With the recommended doses are required to make an assessment of serum phenytoin levels 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 to 10 days.


Divided daily doses: For patients who have not received previous treatment can be started with the administration of 300 mg a day, to be taken in three equally divided doses, and should subsequently be adjusted to individual requirements. For most adult patients satisfactory maintenance dose is 300 to 400 mg per day, which will be taken in 3 or 4 equally divided doses, respectively. May be increased to a dose of 600 mg per day, if necessary.

Non-urgent loading dose in adult patients: You can use a loading dose or urgent as initial therapy in adults requiring concentrations quickly reach stable and is not appropriate to use the IV for that purpose.

This treatment schedule should be used only in patients confined to hospitals or clinics where phenytoin serum levels can be monitored. Patients with liver or kidney disease should not be treated by this scheme.

The recommended loading dose is 1 g of phenytoin in three divided doses administered at intervals of two hours. The usual maintenance dose should be instituted within 24 hours after administering the loading dose, with constant determinations of serum.

Pediatric dose: Initially 5 mg / kg / day divided in two to three equal doses, with subsequent adjustments individualized to a maximum of 300 mg a day. Typically, the recommended maintenance dose is 4 to 8 mg / kg.

Children over 6 years and adolescents: May require minimum adult dose (300 mg / day). If the daily dose can not be divided into two doses, most of the dose should be given before bedtime.

Name of medicine: Epamin
Comparable patent medicine: Dilantin
Active ingredient: Phenytoin
Presentation: Tablets
Concentration: 100 mg
Extended-release tablets: No
Lab: Pfizer, Inc. de CV
Box of 50 pills.
Made in: Mexico

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