Medicinal Products

DILANTIN 250 mg / 5 mL

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Phenytoin
laboratory: Keocyt

IV injectable solution
Box of 10 bottles of 5 ml
All forms

Indication

1) in neurology

· Treatment of status epilepticus in adults and children, monotherapy or combination therapy.

· Prevention of epileptic seizures in the acute phase after neurosurgical intervention or in severe head trauma when oral administration of phenytoin is not possible.

2) in cardiology

· Ventricular rhythm disorders during digitalis intoxication.

Dosage DILANTIN 250 mg / 5 mL Solution for injection IV Box of 10 vials of 5 ml

Exclusive intravenous route.

Dosage:

1) in neurology

· Treatment of status epilepticus in adults and children, monotherapy or combination therapy.

Charge Dose

In adults: 18 mg / kg

In children: 10 to 15 mg / kg

In the newborn: 8 to 12 mg / kg

In the elderly: 10 to 15 mg / kg

In case of inefficiency this loading dose may be followed by one or more doses of 5 mg / kg, without exceeding 30 mg / kg / 24 hours and under control of plasma levels.

Speed ​​of administration

1 mg / kg / min, not exceeding 50 mg / min (in adults and children), 25 mg / min (in the elderly).

The loading dose will be administered in 20-60 minutes.

Maintenance treatment

After 6-12 hours and as long as oral administration is impossible:

In adults: 7 to 10 mg / kg / 24 h

In the newborn: 3 to 5 mg / kg / 24 h

· Prevention of epileptic seizures in the acute phase after neurosurgical intervention or in severe head trauma when oral administration of phenytoin is not possible .

In patients not already receiving phenytoin orally:

The dosage is the same as in the state of ill-constituted (loading dose, followed by doses calculated according to the plasma concentrations obtained).

In patients already receiving phenytoin by the oral route:

Initial dose of 9 mg / kg, followed by doses based on plasma concentrations.

2) in cardiology

· 200 to 1000 mg in slow IV without exceeding 50 mg per minute.

Administration mode

Exclusive intravenous route.

DILANTIN can be injected directly, but it is preferable to dilute it in physiological saline to obtain a concentration close to 5 mg / ml (because of the risk of precipitation, DILANTIN can be diluted only in an isotonic solution of chloride sodium).

The solution will be injected into a large vein with a large needle or catheter, preferably with an electric syringe. A particular venous route will be reserved for it because of a risk of precipitation if other substances were added to it. Each injection of DILANTIN solution for injection should be followed by injection of isotonic sodium chloride into the same needle or catheter to reduce local venous irritation due to the pH of the DILANTIN solution.

monitoring:

Check pulse and blood pressure every two minutes. A drop in blood pressure, a bradycardia must imperatively slow down the rate of injection.

Continuous or subcontinuous monitoring of the electrocardiogram is strongly recommended, especially in the elderly or at risk. We will try to identify any signs of respiratory distress. A determination of serum phenytoin levels may be necessary for the management of status epilepticus and the establishment of maintenance therapy.

Other measures including concomitant injection of benzodiazepine or barbiturate with a short half-life may be necessary to rapidly control epileptic seizures.

Against indications

This medicine MUST NOT be used in case of:

Hypersensitivity to phenytoin, hydantoin derivatives, or any of the constituents of the product.

· In combination with St. John's wort ..

Dilantin side effects

The signs of toxicity associated with the intravenous use of this product mainly result in cardiovascular collapse and / or central nervous system depression.

Immune system

Anaphylactoid and anaphylactic reactions.

Hypersensitivity syndrome can occur.

The rare occurrence of cross reactions between phenytoin, carbamazepine and phenobarbital should make it prudent to replace phenytoin with either of these molecules.

Cardiovascular system

Cases of ventricular fibrillation and ventricular and atrial conduction depression have been reported. These severe complications are more common in elderly or critically ill patients.

Central nervous system

Most often: nystagmus, ataxia, poorly articulated speech, slowed coordination, mental confusion and also insomnia, dizziness, headaches, paresthesia and drowsiness.

Rarely: dyskinesia including chorea, dystonia, tremors similar to those induced by phenothiazines and other neuroleptics.

Exceptionally: peripheral neuropathy predominantly sensitive in case of prolonged treatment.

Gastrointestinal system

Nausea, vomiting and constipation.

Cutaneous-mucous system

Most often: feverish eruption.

Rarely: more severe manifestations of fatal outcome including, lupus erythematosus, exfoliative or purpura bullous dermatitis, Stevens-Johnson syndrome, toxic necrosis of the epidermis.

Gingival hypertrophy, thickening of the lips, hypertrichosis and Peyronie's disease.

Hematological system

Thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis and pancytopenia with or without bone marrow failure sometimes fatal.

Exceptionally: macrocytic and megaloblastic anemia.

Rare cases of lymphadenopathy have been reported with lymphoid hyperplasia, pseudolymphoma and malignant lymphoma.

Injection site

Local irritation, inflammation, brittleness, cutaneous necrosis have been reported with or without extravasation of the product.

Other

Dysgeusia, systemic lupus erythematosus, periarteritis nodules, hepatitis, liver injury and immunological abnormalities have also been described.

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