Dipheninum

Dipheninum – drug with anticonvulsant action.

Form of release and structure

Dipheninum is released in the form of tablets (in planimetric bezjyacheykovy packagings on 10 pieces, on 1 or 2 packagings in a cardboard pack).

Active agent is a part of 1 tablet: Phenytoinum – 100 mg.

Indications to use

• Epilepsy (big convulsive attacks), epileptic seizures in neurosurgery, the epileptic status with toniko-clonic attacks (treatment and prevention);
• Ventricular arrhythmias (including connected with intoxication glycosides or tricyclic antidepressants);
• Epileptiform neuralgia (as means of the second row or along with carbamazepine).

Contraindications

• Sinus bradycardia;
• AV blockade of the II-III degree;
• Sinuatrial blockade;
• Morganyi-Adams-Stokes's syndrome;
• Cachexia;
• Heart failure;
• Porphyria;
• Functional disturbances of kidneys and liver;
• Pregnancy (except cases when the advantage for mother is higher than estimated harm for a fruit) and the lactation period;
• Hypersensitivity to drug components.

Route of administration and dosage

Dipheninum is accepted inside.

The adult drug usually appoint 3-4 mg/kg in an initial daily dose. The dose is gradually increased before achievement of optimum therapeutic effect. As a rule, the supporting daily dose makes 200-500 mg a day in one or several receptions.

To children usually appoint 5 mg/kg a day in 2 receptions with the subsequent increase in a dose, but it is no more than 300 mg in day. The supporting daily dose for children makes 4-8 mg/kg.

Side effects

During therapy development of disturbances from some systems of an organism which are shown with various frequency is possible:

• Alimentary system: perhaps – injuries of a liver, nausea, a lock, vomiting, toxic hepatitis. For the first 6 months of treatment the hyperplasia beginning with an ulitis can develop (meets at patients up to 23 years more often);
• Central and peripheral nervous system: perhaps – an ataxy, a nystagmus, changes of mood, confusion of consciousness, muscular weakness, dizziness, trembling of hands, lacks of coordination of movements, passing nervousness, sleep disorders, stutter or the greased speech; seldom – a peripheral neuropathy;
• Endocrine system: perhaps – enlargement of features, including expansion of a tip of a nose, a thickening of lips and promotion of a mandible, a hypertrichosis;
• Musculoskeletal system: perhaps – a palmar fibromatosis; seldom – a peripheral polyarthropathy. At long therapy without observance of the diet satisfying the need for vitamin D or at a lack of sunlight there can be rickets and osteomalacy;
• System of a hemopoiesis: seldom – megaloblastny anemia, thrombocytopenia, a granulocytopenia, a leukopenia, a pancytopenia, an agranulocytosis;
• Metabolism: perhaps – the disturbance of digestion of glucose caused by insulin release inhibition, development of a hypocalcemia and disturbance of metabolism of vitamin D;
• Allergic reactions: seldom – skin rash which can be a symptom of heavier skin reactions, an eosinophilia, a medicinal lymphadenopathy, fever;
• Others: seldom – Peyroni's disease.

Special instructions

With hypersensitivity to one of hydantoic anticonvulsants hypersensitivity and to other medicines of this group is possible.

Sudden phase-out of Difenin at the patients having epilepsy can lead to development of a withdrawal. In need of sharp cancellation of therapy (for example, at development of hypersensitivity reactions or allergic reactions) it is necessary to use the anticonvulsant drugs which are not relating to hydantoin derivatives.

Phenytoinum is intensively metabolized in a liver therefore the patient with functional disturbances of a liver, and also to elderly patients it is necessary to adjust the dosing mode.

During therapy, especially long, it is recommended to keep to the diet satisfying the need for vitamin D, it is also necessary to provide influence of UF of radiation.

When using Difenin's at children in a growth period the risk of development of disturbances from connecting fabric increases.

Concentration of Phenytoinum in plasma can increase at an acute drunkenness; at an alcoholism – to decrease.

During Difenin's reception the speed of psychomotor reactions is slowed down that needs to be considered when working, the requiring special attention and bystry psychomotor reactions, including control of motor transport.

Medicinal interaction

At simultaneous use of Difenin with some medicines there can be undesirable effects:

• The medicines exerting the oppressing impact on the central nervous system: strengthening of the oppressing influence on the central nervous system is possible;
• Antifungal means, clozapine, digitoxin, glucocorticosteroids, are oestrogenic, дикумарол, furosemide, doxycycline, oral contraceptives, quinidine, rifampicin, vitamin D: change of their therapeutic action is possible;
• Amiodaronum, antifungal means (including флуконазол, B Amphotericinum, Miconazolum, кетоконазол, итраконазол), metronidazole, sulfonamides, blockers of histamine H1 receptors, chlordiazepoxide, Tolbutamidum, chloramphenicol, salicylates, дикумарол, diazepam, a halothane, fluoxetine, an isoniazid, methylphenidate, омепразол, are oestrogenic, suktsinimida, Sulfinpyrazonum, Trazodonum: increase in concentration of Phenytoinum in a blood plasma is possible that can lead to strengthening of its therapeutic action and increase in risk of development of side effects;
• Acetazoleamide: development of osteomalacy, rickets is possible;
• Phenobarbital, derivatives of a fenotiazin (including Chlorpromazinum, prochlorperazine, thioridazine), antineoplastic means: increase or decrease in concentration of Phenytoinum in a blood plasma is possible (Difenin's influence on concentration in plasma of phenobarbital is unpredictable);
• Valproic acid: within the first several weeks of therapy the general concentration of Phenytoinum in a blood plasma can decrease;
• Acyclovir: reduction of concentration of Phenytoinum in a blood plasma and decrease in its efficiency is possible;
• Verapamil, нимодипин, фелодипин: reduction of their concentration in a blood plasma;
• Desipramine, pyridoxine in a dose of 200 mg: reduction of its concentration in a blood plasma is possible;
• Imipraminum, кларитромицин, ритонавир, фелбамат: increase in concentration of Phenytoinum in a blood plasma is possible;
• Paracetamol: decrease in its efficiency;
• Vigabatrin, carbamazepine, Reserpinum, folic acid, сукральфат: reduction of therapeutic action of Phenytoinum and its concentration in a blood plasma is possible;
• Theophylline: decrease in their concentration in a blood plasma and efficiency is possible;
• Sukralfat: reduction of absorption of Phenytoinum;
• Phenylbutazone, Cimetidinum, Disulfiramum, diltiazem, nifedipine, габапентин: increase in concentration of Phenytoinum in a blood plasma with the subsequent development of toxic reactions is possible;
• Folic acid: decrease in efficiency of Phenytoinum;
• Ciprofloxacin: change of concentration of Phenytoinum in a blood plasma is possible, interaction of drugs is ambiguous.

Terms and storage conditions

To store in protected from light, the place, dry, unavailable to children, at a temperature of 5-30 °C.

Period of validity – 4 years.