Neuleptil drops 4% 125ml

drops

Composition

100 ml of solution 4% contain: peritsiazin - 4 g.

Excipients: tartaric acid, Ascorbic acid, concentrated sugar syrup, glycerin, ethyl alcohol 95%, peppermint essential oil, caramel (E 150), purified water.

Packing

In the bottle 125 ml solution. In a cardboard bundle one bottle.

Mechanism of action

Neuleptil is a neuroleptic of piperidine phenothiazine derivatives. It has a moderate antipsychotic and sedative effect without a stimulating component. It has adrenolytic, antispasmodic, parasympatolytic, antiemetic, hypothermic action. Potentiates the activity of narcotic and non-narcotic analgesics and hypnotic drugs. It has a distinct sedative effect, reduces aggressiveness, excitability, disinhibition. It has a sedative effect.

In connection with the selective normalizing influence on the behavior of Neuleptil called "corrector of behavior."

Indications and usage

Neuleptil 4% solution for oral administration, is indicated for the manifestations of aggressiveness in mental disorders.

Contraindications

Absolute:
- Hypersensitivity to peritsiazin.
- angle-closure glaucoma.
- Retention of urine against the background of prostate diseases.
- Parkinson's disease.
- Agranulocytosis, porphyria in history.
- Concomitant levodopa therapy.

With caution, the drug should be used in patients with:

- Diseases of the cardiovascular system.
- Renal and / or liver failure.
- In elderly patients (may develop excessive sedative and hypotensive effects).

Pregnancy and Breastfeeding

Experimental studies in animals did not reveal the teratogenic effect of the drug. Studying the teratogenic action of peritsiazin in humans has not been conducted. As with other phenothiazine derivatives, the findings of various epidemiological prospective studies on the possible risk of developmental malformations in the fetus are controversial.There is no data on the effect of the administration of Neulepta during pregnancy on the development of the fetal brain. In rare cases, the following disorders have been reported in newborns whose mothers received long-term treatment with large doses of Neuleptil: gastrointestinal disorders (abdominal distension, etc.) associated with the atropine-like effect of phenothiazines; extrapyramidal disorders. Thus, the risk of teratogenic effects of the drug, if any, is insignificant. It is advisable to limit the duration of the appointment of the drug during pregnancy. If possible, at the end of pregnancy, it is advisable to reduce the doses of Neuleptil and their anti-Parkinsonian remedies that can potentiate the atropine-like effect of neuroleptics.

In newborns, the state of the nervous system and the function of the gastrointestinal tract should be monitored.

Due to the lack of data on the penetration of the drug into breast milk, it is not recommended to breastfeed while taking the drug.

Dosage and administration

The dosage regimen varies greatly depending on the evidence and the age of the patient. The average daily dose should be given in 2 or 3 doses, with an emphasis on evening hours. In adults, the average daily dose can vary from 30 mg to 100 mg. In some cases, an allowable increase in the daily dose of up to 200 mg. In children older than 3 years, the average daily dose is from 0.1 mg to 0.5 mg per kg of body weight.

Adverse reactions

Neuleptil is usually well tolerated, but in some cases the following undesirable reactions may occur, the severity of which varies depending on the pharmacological properties of the neuroleptic.

Small initial doses: autonomic nervous system disorders, orthostatic hypotension, anticholinergic effects such as dry mouth, constipation, accommodation paresis, urinary retention.

Nervous system disorders: sedation or drowsiness, which are more pronounced at the beginning of treatment, apathy, anxiety, mood changes, a state of depression.

Higher doses: early dyskinesias (spasmodic torticollis, oculomotor crises, trismism, etc.), tardive dyskinesia observed during long-term treatment, extrapyramidal disorders, akinesia, sometimes combined with muscle hypertonus and partially eliminated when prescribing anticholinergic antiparkinson therapy, Icropic therapy units. excitement, akathisia.

Endocrine and metabolic disorders: impotence, frigidity, hyperprolactinemia: amenorrhea, galactorrhea, gynecomastia, weight gain, impaired thermoregulation, hyperglycemia, impaired glucose tolerance.

Less frequently occurring and dose-independent reactions: allergic skin reactions, photosensitivity; rarely - granulocytosis: regular monitoring of the complete blood count is recommended, leukopenia.

Ophthalmic disorders: decrease in the tone of the eyeballs, brownish deposits in the anterior chamber of the eye due to accumulation of the drug, usually not affecting vision.

Others: positive serological test for the presence of antinuclear antibodies, without clinical manifestations of lupus erythematosus, the possibility of developing cholestatic jaundice, malignant neuroleptic syndrome In the case of the development of unexplained fever, antipsychotic therapy should be stopped immediately, as this may be one of the symptoms of the malignant neuroleptic syndrome described in the procedure. clinical manifestations of which are pallor of the skin, hyperthermia and dysfunction autonomic nervous system. Although this effect Neuleptil, like other neuroleptics, is associated with individual intolerance, for its occurrence there are predisposing factors, such as dehydration or organic brain damage. Among the patients taking the phenothiazine neuroleptics, isolated cases of sudden death, possibly caused by cardiologic causes, as well as unexplained cases of sudden death were noted.

Special notes

In the event of a fever or infection, a general blood test should be conducted, as there were reports of the possibility of developing agranulocytosis. Not taking alcohol during treatment.

For patients with epilepsy, due to the ability of the drug to lower the threshold of excitability of the cerebral cortex, should be carried out clinical and, if possible, electroencephalographic observation.

Neuroleptics of the phenothiazine series can prolong the QT interval, which increases the risk of serious ventricular atrial fibrillation, which is potentially dangerous, as it can lead to sudden death. Lengthening of the QT interval is particularly enhanced in the presence of bradycardia, hypokalemia, and congenital or acquired (as a result of medication) prolongation of the QT interval.Before prescribing therapy with neuroleptics, as an absolutely necessary factor of treatment, and, if the clinical picture allows, to eliminate the possible appearance of risk factors, it is necessary to conduct medical and laboratory research.

Caution should be exercised when applying peritsiazina: in elderly patients, due to their high predisposition to the development of sedation and orthostatic hypotension; in patients with severe cardiovascular pathology, due to hemodynamic disturbances and ECG changes; in patients with hepatic and / or renal insufficiency, due to the risk of overdose.

Patients, especially those who are drivers of vehicles or persons working with other mechanisms, should be informed about the possibility of drowsiness in them in connection with taking the drug, especially at the beginning of treatment.

Levodopa: mutual antagonism between levodopa and Neuleptil was found. Extrapyramidal disorders should not be treated with levodopa during treatment with Neuleptil (reduction or loss of neuroleptic activity). If Neuleptil is prescribed to patients suffering from parkinsonism and receiving levodopa, it is illogical to continue taking levodopa, since it increases mental disturbances and cannot affect the receptors blocked by neuroleptics.

Alcohol: Enhancing the sedative effect of Neuleptil: reduced response, which can be dangerous for those driving and using mechanisms. Avoid alcohol and drugs containing alcohol.
Guanethidine and similar drugs: reduction of the hypotensive activity of guanethidine, by reducing the penetration of guanethidine into the fibers of the sympathetic nerves, which is associated with the effect of the drug. Use other antihypertensive drugs.
Sultopride: increased risk of ventricular arrhythmias, in particular ventricular fibrillation.

Antacids (salts, oxides and hydroxides of Magnesium, aluminum and calcium): decreased absorption of Neuleptil in the gastrointestinal tract. If possible, the interval between taking antacids and Neulepti should be at least two hours.

Antihypertensives (all): increased hypotensive action and risk of orthostatic hypotension (cumulative action).
Other drugs that inhibit the nervous system are morphine derivatives. Most of the blockers of histamine H 1 receptors with sedative action, barbiturates, benzodiazepines, anxiolytics that are not derived from benzodiazepines, clopidine and preparations containing it. An increase in the inhibitory effect on the central nervous system can be essential, in particular, when driving vehicles and using other mechanisms.
Atropine and other anticholinergics, antidepressants, imipramine derivatives, antiparkinsonic drugs with anticholinergic action. Disopyramide - the possibility of accumulation of undesirable effects associated with anticholinergic effects, such as urinary retention, constipation, dry mouth, etc.

Enhances the effects of anxiolytics, analgesics, anesthetics, hypnotics, ethanol, as well as side effects of hepato-and nephrotic drugs.

When used together with tricyclic antidepressants, maprotiline, MAO inhibitors :

Elongation and enhancement of sedative and anticholinergic effects with thiazide diuretics is possible.

Increased hyponatremia, with Li + - reduced absorption in the gastrointestinal tract, increased rate of excretion of Li +, increased severity of extrapyramidal disorders, early signs of intoxication Li + (nausea and vomiting) can be masked by the anti-emetic effect of phenothiazines.

When combined with beta-adrenergic blockers, it enhances the hypotensive effect, increases the risk of developing irreversible retinopathy, arrhythmias and tardive dyskinesia.

Appointment of alpha- and beta-adrenostimulyatorov (epinephrine) and sympathomimetics (ephedrine) can lead to a paradoxical decrease in blood pressure.

Amitriptyline, amantadine, antihistamines and other drugs with anticholinergic effects increase anticholinergic activity.

Antithyroid drugs increase the risk of agranulocytosis. Reduces the effect of appetite suppressants (with the exception of fenfluramine). Reduces the efficacy of apomorphine emetic, enhances its inhibitory effect on the central nervous system.Increases plasma concentration of prolactin and interferes with the action of Bromocriptine .

Overdose can cause severe extrapyramidal disorders and coma.
Treatment should be symptomatic and carried out in a specialized unit.

Store at a temperature not higher than + 25 ° С in a dark place.

4 years.