Periciazine

Brand Sanofi-aventis

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Clinical Pharmacology

Pharmacodynamics
Periciazine is a neuroleptic from the group of piperidine derivatives of phenothiazine, the antidopaminergic activity of which leads to the development of a therapeutic antipsychotic (without a stimulating component), as well as anti-emetic and hypothermic effects of the drug. However, the development of its side effects (extrapyramidal syndrome, movement disorders and hyperprolactinemia) is also associated with antidopaminergic activity.
Periciazine's anti-dopaminergic activity is moderately pronounced, due to which it has a moderate antipsychotic effect in moderate extrapyramidal disorders. Due to the blocking effect of Periciazine on the adrenoreceptors of the reticular formation of the brain stem and central histamine receptors, the drug has a distinct sedative effect, which can also be a desirable clinical effect, especially in vicious and irritable forms of affect, and a decrease in aggressiveness is not accompanied by the appearance of lethargy and inhibition. Compared with chlorpromazine, periciazine has a more pronounced antiserotonin, antiemetic and central sedative effect, but less pronounced antihistamine action.
Periciazine reduces aggressiveness, excitability, disinhibition, so that it is effective for behavior disorders. Because of the normalizing effect on the behavior of Periciazine called "corrector behavior."
Peripheral H Block₁- histamine receptors cause the antiallergic effect of the drug. The blockade of peripheral adrenergic structures is manifested by its hypotensive action. In addition, the drug has anticholinergic activity.

Pharmacokinetics
After oral administration, periciazine is well absorbed, however, like other phenothiazine derivatives, it undergoes intensive first-rate metabolism in the intestine and / or liver, therefore, after it is ingested, the concentration of unchanged periciazine in plasma is lower than with i / m administration and varies widely.
After ingestion of 20 mg of Periciazine (2 capsules), the maximum plasma concentration is reached within 2 hours and is 150 ng / ml (410 nmol / l).
Communication with plasma proteins is 90%. Periciazine intensively penetrates the tissue, as it easily passes through histohematogenous barriers, including the blood-brain barrier.
Most of the periciazine is metabolized in the liver by hydroxylation and conjugation. Excreted bile metabolites can be reabsorbed in the intestine. The half-life of periciazine is 12-30 hours; elimination of metabolites is even longer. Conjugated metabolites are excreted in the urine, and the rest of the drug and its metabolites in the bile and feces.
In elderly patients, the metabolism and elimination of phenothiazines slows down.

Indications

- Acute psychotic disorders.
- Chronic psychotic disorders such as schizophrenia.
- Chronic non-schizophrenic delusional disorders.
- Chronic hallucinatory psychosis (for the treatment and prevention of recurrence).

Composition

active substance: periciazine
Excipients: sucrose, ascorbic acid, tartaric acid, glycerol (glycerin), peppermint leaf oil, ethanol 96%, caramel (Е150d), purified water.

Periciazine is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Neuleptil	Sanofi-aventis	France	drops
Neuleptil	Sanofi-aventis	France	capsules

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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 range 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 ranges from 0.1 mg to 0.5 mg per kg of body weight.

Adverse reactions

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

Low initial doses:

Disorders of the autonomic nervous system: 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:

Nervous system disorders: early dyskinesias (spastic torticollis, oculomotor crises, trisism, etc.), late dyskinesia observed during long-term treatment; extrapyramidal disorders (akinesia, sometimes combined with muscle hypertonus and partially eliminated when prescribing anticholinergic antiparkinsonian drugs; hyperkinesia-hypertonus, motor agitation; akathisia).

Endocrine and metabolic disorders: impotence, frigidity; hyperprolactinemia: amenorrhea, galactorrhea, gynecomastia; weight gain; disturbances of thermoregulation; hyperglycemia, reduced glucose tolerance.

Less frequent dose-related reactions:

Skin reactions: allergic skin reactions; photosensitization.

Hematological disorders: rarely - agranulocytosis (regular monitoring of the complete blood count is recommended); leukopenia.

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

Other:

Positive serological test for the presence of antinuclear antibodies, without clinical manifestations of lupus erythematosus.

The possibility of developing cholestatic jaundice.

Malignant neuroleptic syndrome: if an unexplained fever develops, antipsychotic therapy should be stopped immediately, as this may be one of the symptoms of the neuroleptic syndrome described in the use of neuroleptics, the clinical manifestations of which are skin paleness, hyperthermia and autonomic nervous system dysfunction.

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 patients taking the phenothiazine neuroleptics, isolated cases of sudden death, possibly caused by cardiac causes, as well as unexplained cases of sudden death were noted.

Contraindications

Absolute:

angle-closure glaucoma;
urinary retention on the background of prostate diseases;
Parkinson's disease;
agranulocytosis, porphyria in history;
concomitant levodopa therapy;
hypersensitivity to Periciazinea.

Carefully the drug should be used in patients with diseases of the cardiovascular system, renal and / or liver failure, in elderly patients (excessive sedative and hypotensive effects may develop).

Drug interactions

Combinations of drugs, the use of which is contraindicated:

Levodopa: the presence of mutual antagonism between levodopa and neuleptila has been established.Extrapyramidal disorders should not be treated with levodopa during treatment with neuleptila (reduction or loss of neuroleptic activity).

If necessary, the appointment of neuleptila patients suffering from parkinsonism and taking levodopa, it is illogical to continue taking levodopa, as it increases mental disorders and can not affect the receptors blocked by neuroleptics.

Inappropriate combinations of drugs:

Alcohol: increased sedation neuleptila: reduced reaction, which can be dangerous for those who drive vehicles and use mechanisms. Avoid alcohol and drugs containing alcohol.

Guanethidine and similar drugs: reducing 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.

Sultoprid: increased risk of ventricular arrhythmias, in particular ventricular fibrillation.

Combinations of drugs, the use of which requires caution:

Antacids (salts, oxides and hydroxides of magnesium, aluminum and calcium): a decrease in the absorption of neuleptila in the gastrointestinal tract. If possible, the interval between taking antacids and neuleptil should be at least two hours.

Combinations of drugs, the use of which there is an interaction that should be taken into account:

Antihypertensive drugs (all): an increase in the hypotensive effect and the risk of orthostatic hypotension (cumulative action). For guanethidine, see the section "Inappropriate combinations of drugs."

Other drugs that inhibit the nervous system are morphine derivatives. Most histamine H blockers₁-receptors with a sedative effect, barbiturates, benzodiazepines, anxiolytics that are not benzodiazepine derivatives, clopidine and preparations containing it: an increase in the inhibitory effect on the central nervous system may be essential, in particular, while driving and using other mechanisms.

Atropine and other anticholinergics, antidepressants, imipramine derivatives, antiparkinsonic drugs with anticholinergic effects; Disopyramide - the possibility of cumulation 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 nephrotoxic drugs. When used together with tricyclic antidepressants, maprotiline, MAO inhibitors - prolongation and increase of sedative and anticholinergic effects is possible, with thiazide diuretics - increased hyponatremia, with Li⁺ - reduction of absorption in the digestive tract, an increase in the rate of elimination of Li⁺, increased severity of extrapyramidal disorders, early signs of intoxication Li⁺ (nausea and vomiting) may be masked by the antiemetic effect of phenothiazines. When combined with beta-blockers contributes to the strengthening of the hypotensive effect, the risk of developing irreversible retinopathy, arrhythmias and tardive dyskinesia is possible. Appointment of alpha- and beta-adrenomimetics (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 reducing agents (with the exception of fenfluramine). Reduces the efficacy of apomorphine. enhances its depressant effect on the central nervous system.Increases plasma concentration of prolactin and interferes with the action of bromocriptine.

Pregnancy and Lactation

Pregnancy

Experimental studies in animals did not reveal the teratogenic effect of the drug. Studying the teratogenic effects of Periciazine in humans has not been conducted. As with other phenothiazine derivatives, the findings of various epidemiological prospective studies of the possible risk of developmental malformations in the fetus are contradictory. 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 Neuleptila:

gastrointestinal disorders (bloating, 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 desirable to reduce the doses of Neuleptil and their anti-Parkinsonian remedies that can potentiate the atropine-like effects of neuroleptics. In newborns, the state of the nervous system and the function of the gastrointestinal tract should be monitored.

Lactation

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.

Special instructions

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, clinical and, if possible, electroencephalographic observation should be conducted.

Neuroleptics of the phenothiazine series may prolong the QT interval, which increases the risk of serious ventricular torsade de point ventricular arrhythmias that are potentially dangerous (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 occurrence of risk factors, it is necessary to conduct medical and laboratory research.

Care should be taken when applying Periciazinea:

in elderly patients, due to their high predisposition to the development of sedation and orthostatic hypotension;
in patients with severe cardiovascular disease, due to hemodynamic disturbances and ECG changes;
in patients with hepatic and / or renal insufficiency, due to the risk of overdose.

Impact on ability to drive vehicles or other mechanisms.

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