Neuleptil

Neuleptil – antipsychotic medicine.

Form of release and structure

Dosage forms of production of Neuleptil:

• Capsules: the size No. 4, gelatinous firm, opaque, white, in capsules is the yellow powder which almost does not have a smell (on 10 pieces in blisters, on 5 blisters in a cardboard pack);
• Solution for intake: transparent, yellowy-brown, fluorescent, has a mint smell (on 30 or 125 ml in dark neutral glass bottles (type III), on 1 bottle in a cardboard pack complete with a dropper (on 30 ml) or the plastic syringe doser (on 125 ml)).

Is a part of 1 capsule:

• Active agent: Periciazinum – 10 mg;
• Auxiliary components: a calcium hydrophosphate dihydrate – 137 mg, magnesium stearate – 3 mg;
• Capsule cover: titanium dioxide (E171) – 3%, gelatin – to 100% (capsule lump – 150 mg).

Is a part of 1 ml of solution:

• Active agent: Periciazinum – 40 mg;
• Auxiliary components: sucrose – 250 mg, ascorbic acid – 8 mg, tartaric acid – 16,5 mg, glycerin (глицерол) – 150 mg, oil of leaves of a peppermint – 0,4 mg, ethanol of 96% – 97,4 mg, caramel (E150d) – 2 mg, the purified water – to 1 ml.

Indications to use

Capsules

• Behavior disorders with aggression (symptomatic therapy);
• Chronic psychoses, including schizophrenia (in particular its deficiental form) and the chronic delirium proceeding with a violent state and interpretative mechanisms (stage or auxiliary therapy).

Solution for intake
The indication to use are manifestations of aggression against the background of mental disorders.

Contraindications

Absolute:

• Closed-angle glaucoma;
• Parkinson's disease;
• Ischuria against the background of prostate diseases;
• Porphyria, agranulocytosis in the anamnesis;
• Simultaneous use with a levodopa;
• Hypersensitivity to drug components.

Relative (care at purpose of Neuleptil against the background of the following diseases / states is required):

• Diseases of cardiovascular system;
• Renal/liver failure;
• Advanced age (because of probability of development of excessive hypotensive and sedative effects).

It is reasonable to limit therapy duration to drug at pregnant women. At the end of duration of gestation, whenever possible, it is recommended to reduce Neuleptil doses along with the antiparkinsonichesky means adjusting them capable to exponentiate atropinopodobny action of neuroleptics. After the delivery at the child it is necessary to control a condition of digestive and nervous systems.

Due to the lack of necessary data Neuleptil use by the feeding women is not recommended.

Route of administration and dosage

Neuleptil is accepted inside.

The mode of dosing is defined by indications and age of the patient.

The daily dose should be accepted in 2-3 receptions, placing emphasis evening hours.

The average daily adult dose usually is in limits of 30-100 mg, if necessary its increase up to 200 mg is possible.

To children of 3 years Neuleptil appoint 0,1-0,5 mg/kg in a daily dose.

Side effects

As a rule, Neuleptil is well transferred by patients, however, in certain cases perhaps development of disturbances which expressiveness is defined by pharmacological properties of a neuroleptic.

At small initial doses there can be following side effects:

• Autonomic nervous system: orthostatic hypotonia, anticholinergic effects in the form of a lock, dryness in a mouth, ischurias, accommodation paresis;
• Nervous system: drowsiness or sedative action (are usually stronger expressed at the beginning of a therapy course), apathy, changes of mood, a condition of depression and alarm.

Reception of Neuleptil in higher doses can lead to development of such disturbances as:

• Nervous system: early dyskinesia (in the form of a spastic wryneck, oculomotor crises, a lockjaw и.т.п.), extrapyramidal frustration (in the form of an akineziya, sometimes in combination with a muscle hyper tone (is eliminated partially at purpose of anticholinergic antiparkinsonichesky drugs), motor excitement, an akathisia, a hyperkinesia hyper tone); at prolonged treatment – late dyskinesia;
• Endocrine system and metabolism: impotence, frigidity, a giperprolaktinemiya (in the form of an amenorrhea, a galactorrhoea, a gynecomastia), increase in body weight, a hyperglycemia, decrease in tolerance to glucose, thermal control disturbances.

The disturbances which are arising in more exceptional cases and not depending on the accepted dose:

• Skin reactions: photosensitization, allergic skin reactions;
• Organ of sight: the decrease in a tone of eyeglobes, brownish deposits in an anterior chamber of an eye connected with Neuleptil accumulation (as a rule, on sight impact is not exerted);
• Hemopoietic system: seldom – an agranulocytosis (carrying out regular control of the general blood test is recommended), a leukopenia.

Also there is a probability of emergence of the following side effects:

• Cholestatic jaundice;
• The positive serological test for existence of antinuclear antibodies which is not followed by clinical manifestations of a lupoid eritematoz;
• The malignant antipsychotic syndrome which is shown inexplicable fever, pallor of integuments, a hyperthermia and dysfunction of the autonomic nervous system (at emergence of these symptoms therapy should be interrupted).

Isolated cases of sudden death (possibly, there were reasons of cardiological character), and also inexplicable cases of sudden death were celebrated.

Special instructions

In pediatrics it is recommended to use drug in the form of peroral solution.

At development of fever or accession of an infection it is necessary to conduct a research of the general blood test (for an agranulocytosis exception).

Alcohol intake during therapy is not recommended.

Patients with epilepsy, because of ability of Neuleptil to reduce an excitation threshold of a cerebral cortex, need clinical and, whenever possible, elektroentsefalografichesky observation.

It is necessary to consider that therapy can lead to lengthening of an interval of QT and, respectively, increase in probability of developing of serious ventricular arrhythmias like torsade de point (constitute potential danger as can lead to sudden death).

Lengthening of an interval of QT in particular amplifies against the background of a hypopotassemia, bradycardia and the acquired owing to drug intake or inborn lengthening of an interval of QT. Before a course of treatment it is required to conduct careful laboratory and medical researches for an exception of probability of emergence of these risk factors.

To patients, in particular those whose profession is connected with control of vehicles, it is necessary to consider probability of emergence of drowsiness, especially at the beginning of a therapeutic course.

Medicinal interaction

Between Neuleptil and a levodopa existence of mutual antagonism is established. The combination of these drugs is contraindicated.

It is inexpedient to appoint Neuleptil at the same time with the following drugs:

• Alcohol and drugs containing it: strengthening of sedation of Neuleptil, is preferential in the form of decrease in reaction that constitutes special danger to patients whose work is connected with control of vehicles;
• Sultoprid: increase in probability of development of ventricular disturbances of a rhythm, in particular, fibrillations of ventricles;
• Guanetidin and similar to it medicines: decrease in its anti-hypertensive activity (it is recommended to use other antihypertensives).

Because of decrease in absorption of Neuleptil in digestive tract, respect for care at its use with antacids (salts, hydroxides and oxides of magnesium, calcium and aluminum) is required. At the combined use not less than 2 hours are recommended to observe an interval.

At the combined use with the following drugs it is necessary to consider probability of development of the following effects:

• Anti-hypertensive means (all): increase in their action and probability of development of orthostatic hypotonia (because of cumulative action);
• Other drugs which oppress work of a nervous system – morphine derivatives, the majority of blockers histamine _{H1 receptors} with sedative action, benzodiazepines, barbiturates, anxiolytics which are not derivatives of benzodiazepines, a clonidine and drugs it containing: strengthening of the oppressing action on the central nervous system (has essential value, in particular, at control of vehicles);
• Antidepressants, atropine and other holinoblokator, Imipraminum derivatives, antiparkinsonichesky means with anticholinergic action, Disopyramidum: cumulation of the undesirable effects connected with cholinolytic action (in the form of an ischuria, locks, dryness in a mouth, etc.);
• Anxiolytics, analgetics, drugs for an anesthesia, hypnagogues, ethanol: strengthening of their effects;
• Gepato-and nephrotoxic drugs: strengthening of their side effects;
• Tricyclic antidepressants, Maprotilinum, monoamine oxidase inhibitors: strengthening and lengthening of anticholinergic and sedative effects;
• Thiazide diuretics: strengthening of a hyponatremia;
• Drugs with the content of lithium: decrease in absorption in digestive tract, increase in speed of removal of lithium, strengthening of expressiveness of extrapyramidal disturbances;
• Beta adrenoblockers: strengthening of anti-hypertensive effect, the risk of development of arrhythmias, irreversible retinopathy and late dyskinesia is possible;
• Alpha and beta адреностимуляторы (Epinephrinum) and sympathomimetics (ephedrine): paradoxical lowering of arterial pressure;
• Amantadin, amitriptyline, antihistaminic and other means with holinoblokiruyushchy effect: increase in anticholinergic activity;
• Anti-thyroid drugs: increase in risk of development of an agranulocytosis;
• The means lowering appetite (except a fenfluramin): reduction of their efficiency;
• Apomorphinum: strengthening of its oppressing action on the central nervous system and decrease in its emetic action;
• Prolactin: increase in its concentration in plasma;
• Bromocriptinum: decrease in its action.

Terms and storage conditions

To store in protected from light, the place, unavailable to children, at a temperature up to 25 °C.

Period of validity:

• Capsules – 5 years;
• Solution for intake – 4 years.