Neuleptil is an antipsychotic.
Release form and composition
- Solution for oral administration: transparent, yellow-brown, fluorescent, has the smell of mint (30 ml in dark glass bottles with a dropper, in a cardboard box 1 bottle; 125 ml in dark glass bottles, in a cardboard box 1 bottle complete with plastic dosing syringe);
- Capsules: size No. 4, hard gelatin, opaque, white; the contents are practically odorless, yellow powder (10 pieces in blisters, in a carton pack 5 blisters).
Active ingredient - peritsiazin: in 1 ml - 40 mg, in 1 capsule - 10 mg.
Additional components of the capsules:
- Excipients: magnesium stearate and calcium hydrophosphate dihydrate;
- The composition of the capsule: gelatin and titanium dioxide.
Auxiliary substances of the solution: glycerol (glycerin), sucrose, tartaric acid, ascorbic acid, purified water, ethanol 96%, caramel (Е150d), peppermint leaf oil.
Indications for use
- Symptomatic treatment of behavioral disorders accompanied by aggressiveness;
- Auxiliary or staged therapy of chronic psychosis: schizophrenia (especially the deficient form), chronic delirium with a violent state and interpretative mechanisms.
- Parkinson's disease;
- Urinary retention due to prostate disease;
- Angle-closure glaucoma;
- Porphyria, agranulocytosis in history;
- Simultaneous use of levodopa;
- Hypersensitivity to the drug.
Relative (Neuleptil should be used with extreme caution due to the risk of complications):
- Renal / hepatic impairment;
- Diseases of the cardiovascular system;
- Elderly age.
Dosing and Administration
Neuleptil take inside. The daily dose is divided into 2-3 doses with an emphasis on evening hours.
The dose is determined individually depending on the indication and the age of the patient.
The average daily intake for adults is 30-100 mg. In some cases, it can be increased to 200 mg.
For children over 3 years old, the drug is prescribed in the form of an oral solution. Daily dose - 0.1-0.5 mg / kg body weight.
Neuleptil is usually well tolerated, side effects are rare.
When taken in small initial doses:
- Nervous system: drowsiness and sedation (especially pronounced at the beginning of treatment), mood changes, anxiety, depression, apathy;
- Autonomic nervous system: orthostatic hypotension and anticholinergic effects (accommodation paresis, constipation, urinary retention, dry mouth).
When taken in higher doses:
- Nervous system: early dyskinesias (oculomotor crises, spastic torticollis, trismism, etc.), extrapyramidal disorders (motor agitation, hyperkinesia-hypertonus, akathisia, akinesia, sometimes combined with muscle hypertonus); with prolonged use - tardive dyskinesia;
- Metabolic and endocrine disorders: galactorrhea, amenorrhea, gynecomastia, frigidity, impotence, weight gain, hyperprolactinemia, impaired thermoregulation, decreased glucose tolerance, hyperglycemia.
The following side effects are less common and do not depend on the dose:
- Hematological disorders: rarely - leukopenia, agranulocytosis;
- Ophthalmologic disorders: brownish deposits in the anterior chamber of the eye (they are usually not affected by vision), reduction in the tone of the eyeballs;
- Skin reactions: photosensitivity, allergic reactions;
- Other: positive serological test for the presence of antinuclear antibodies (without clinical manifestations of lupus erythematosus), cholestatic jaundice, neuroleptic malignant syndrome (fever, hyperthermia, pale skin, dysfunction of the autonomic nervous system), isolated cases of sudden death.
During treatment, it is recommended to refrain from the use of alcoholic beverages.
In the event of a fever or infection, it is necessary to perform a complete blood count, since there is a risk of developing agranulocytosis.
Neuleptil is able to lower the threshold of excitability of the cerebral cortex, for this reason, patients with epilepsy should be clinically monitored and, if possible, electroencephalographic.
Neuroleptics of the phenothiazine series, including Neuleptil, can increase the QT interval, which increases the risk of developing serious ventricular pirouette arrhythmias, which can lead to sudden death.
Lengthening of the QT interval is particularly enhanced in the case of congenital or acquired (due to the intake of certain drugs) lengthening of the QT interval, as well as in the presence of hypokalemia or bradycardia. For this reason, before the appointment of Neuleptil and to eliminate risk factors, it is recommended to conduct medical and laboratory tests.
Since the drug can cause drowsiness (especially at the beginning of therapy), caution should be exercised during treatment when driving and performing potentially hazardous types of work that require reaction speed and concentration.
In the course of experimental studies in animals, Neuleptil's teratogenic effect has not been identified, however, it is advisable to limit the duration of use of the drug during pregnancy. There are rare cases of occurrence in newborns whose mothers received periciazin for a long time in high doses, extrapyramidal and gastrointestinal disorders. For this reason, at the end of pregnancy, if possible, it is recommended to reduce the dose of Neuleptil, and in newborns to control the function of the digestive system and the state of the nervous system.
Neuleptil contraindicated to apply simultaneously with levodopa, because between them established the presence of mutual antagonism. During Neuleptil use, levodopa cannot be used to treat extrapyramidal disorders. The same goes for parkinsonian sufferers who take levodopa.
It is inappropriate to use Neuleptil in combination with the following drugs:
- Sultopride: the risk of developing ventricular arrhythmias (in particular ventricular fibrillation) increases;
- Guanethidine: its hypotensive activity decreases (other antihypertensive agents should be used);
- Ethanol: Periciazine's sedative effect increases, resulting in reduced reactions, which can be dangerous for patients driving vehicles and working with complex mechanisms.
When using Neuleptil with antacids (salts, oxides and hydroxides of aluminum, calcium and magnesium), special care should be taken, since There is a decrease in periciazine absorption in the gastrointestinal tract. The interval between taking these drugs should be at least 2 hours.
In the case of Neuleptil use with the following drugs, the possibility of their interaction should be considered:
- Antihypertensive drugs: their antihypertensive effect and the risk of orthostatic hypotension increase;
- Other drugs that have a depressant effect on the central nervous system (morphine derivatives), clopidine and drugs containing it, benzodiazepines, barbiturates, most histamine H 1 receptor blockers with a sedative effect, anxiolytics that are not benzodiazepine derivatives: the inhibitory effect on the nervous system increases ;
- Disopyramide, imipramine derivatives, antidepressants, antiparkinsonic drugs with anticholinergic action, atropine and other holinoblokatory: possible cumulation of undesirable effects, such as dry mouth, constipation, urinary retention;
- Analgesics, anxiolytics, anesthetics, hypnotics, ethanol: their effects are enhanced;
- Hepato-and nephrotoxic drugs: their side effects increase;
- Monoamine oxidase inhibitors, tricyclic antidepressants, maprotiline: a sedative and anticholinergic effect is prolonged and enhanced;
- Thiazide diuretics: may increase hyponatremia;
- Lithium preparations: their absorption in the gastrointestinal tract decreases and the rate of excretion increases, the intensity of extrapyramidal disorders increases;
- Beta-blockers: increased hypotensive effect, high risk of arrhythmias, irreversible retinopathy, tardive dyskinesia;
- Alpha- and beta-adrenostimulants (epinephrine), sympathomimetics (ephedrine): paradoxical reduction in blood pressure is possible:
- Amantadine, amitriptyline, antihistamines and other drugs with anticholinergic effect: anticholinergic activity increases;
- Antithyroid drugs: the risk of agranulocytosis increases;
- Drugs that decrease appetite (with the exception of fenfluramine), apomorphine: their effectiveness decreases;
- Bromocriptine: its effect is leveled;
- Prolactin: its concentration in the blood plasma increases.
Terms and conditions of storage
Store at a temperature up to 25 ºС in a dark place inaccessible to children.
The shelf life of the solution - 4 years, capsules - 5 years.