Periciazine (Capsules) Instructions for Use

ATC Code

N05AC01 (Periciazine)

Active Substance

Periciazine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antipsychotic drug (neuroleptic)

Pharmacotherapeutic Group

Psycholeptics. Antipsychotic agents. Piperazine derivatives of phenothiazine

Pharmacological Action

Antipsychotic agent (neuroleptic), a piperidine derivative of phenothiazine. It has antipsychotic, sedative, and pronounced antiemetic effects. It possesses adrenergic-blocking and pronounced anticholinergic activity and causes a hypotensive effect. Compared to chlorpromazine, it has more pronounced antiserotonin activity and exerts a stronger central sedative effect.

The mechanism of antipsychotic action is associated with the blockade of postsynaptic dopaminergic receptors in the mesolimbic structures of the brain. It also has an alpha-adrenergic blocking effect, suppresses the release of hormones from the pituitary and hypothalamus. The blockade of dopamine receptors increases the release of prolactin by the pituitary gland.

The central antiemetic effect is due to the inhibition or blockade of dopamine D₂ receptors in the chemoreceptor trigger zone of the cerebellum; the peripheral effect is due to the blockade of the vagus nerve in the gastrointestinal tract. The antiemetic effect is enhanced, apparently, due to anticholinergic, sedative, and antihistamine properties.

Pharmacokinetics

Clinical data on the pharmacokinetics of periciazine are limited.

Phenothiazines have high plasma protein binding. They are excreted mainly by the kidneys and partially with bile.

Indications

Psychopathy (of excitable and hysterical nature), psychopath-like states in schizophrenia, paranoid states in organic, vascular presenile and senile diseases, as an adjunct in psychotic disorders to overcome residual symptoms with a predominance of hostility, impulsivity, and aggressiveness.

ICD codes

Dosage Regimen

Capsules

The initial daily dose is 5-10 mg; in patients with increased sensitivity to phenothiazines – 2-3 mg. Average daily doses are 30-40 mg, frequency of administration is 3-4 times/day, preferably in the evening.

For children and elderly individuals, the initial dose is 5 mg/day, then the dose is gradually increased to 10-30 mg/day.

Maximum daily dose for adults is 60 mg.

Adverse Reactions

From the central nervous system: insomnia, agitation, akathisia, blurred vision, depressed state, early dyskinesia (spasmodic torticollis, oculomotor crisis, trismus), extrapyramidal syndrome, tardive dyskinesia.

From the cardiovascular system: postural hypotension, cardiac arrhythmias.

From the digestive system: cholestatic jaundice.

From the respiratory system: nasal congestion, respiratory depression (in predisposed patients).

From the endocrine system: impotence, frigidity, amenorrhea, galactorrhea, gynecomastia, hyperprolactinemia.

From metabolism: weight gain (possibly significant).

From the hematopoietic system: leukopenia (mainly with long-term use in high doses); rarely – agranulocytosis.

Dermatological reactions: photosensitization.

Effects due to anticholinergic action: dry mouth, constipation, accommodation disturbances, urinary retention.

Contraindications

Severe cardiovascular diseases, pronounced depression of the central nervous system, history of toxic agranulocytosis, angle-closure glaucoma, porphyria, prostate diseases, pregnancy, lactation.

Use in Pregnancy and Lactation

Adequate and strictly controlled clinical studies on the safety of periciazine use during pregnancy have not been conducted.

It should be noted that phenothiazines are excreted in breast milk. This can cause drowsiness and increases the risk of dystonia and tardive dyskinesia in the child.

Use in Hepatic Impairment

Phenothiazines should be used with particular caution in cases of impaired liver function.

Pediatric Use

In children, especially with acute illnesses, the development of extrapyramidal symptoms is more likely when using phenothiazines.

Geriatric Use

Periciazine should be used with caution in elderly patients.

Special Precautions

Periciazine should be used with caution in cases of hypersensitivity to other phenothiazine drugs, in elderly patients (increased risk of excessive sedative and hypotensive effects), and in debilitated and weakened patients.

Phenothiazines should be used with particular caution in patients with pathological changes in the blood picture, in cases of impaired liver function, alcohol intoxication, Reye’s syndrome, as well as in breast cancer, cardiovascular diseases, predisposition to the development of glaucoma, Parkinson’s disease, gastric and duodenal ulcers, urinary retention, chronic respiratory diseases (especially in children), epileptic seizures, vomiting.

In case of hyperthermia, which is one of the elements of Neuroleptic Malignant Syndrome (NMS), Periciazine should be immediately discontinued.

In children, especially with acute illnesses, the development of extrapyramidal symptoms is more likely when using phenothiazines.

During treatment, alcohol consumption should be avoided.

Effect on the ability to drive vehicles and operate machinery

It should be used with caution in patients engaged in potentially hazardous activities requiring high speed of psychomotor reactions.

Drug Interactions

With simultaneous use with drugs that have a depressant effect on the central nervous system, with ethanol, and ethanol-containing drugs, an enhancement of the depressant effect on the central nervous system and respiratory depression is possible.

With simultaneous use with agents causing extrapyramidal reactions, an increase in the frequency and severity of extrapyramidal disorders is possible.

With simultaneous use, an enhancement of the anticholinergic effects of other agents is possible, while the antipsychotic effect of the neuroleptic may decrease.

With simultaneous use with anticonvulsant drugs, a decrease in the seizure threshold is possible; with drugs for the treatment of hyperthyroidism – the risk of developing agranulocytosis increases; with drugs causing arterial hypotension – pronounced orthostatic hypotension is possible.

With simultaneous use with tricyclic antidepressants, maprotiline, MAO inhibitors, the risk of developing Neuroleptic Malignant Syndrome (NMS) increases.

With simultaneous use, a decrease in the action of amphetamines, levodopa, clonidine, guanethidine, epinephrine is possible.

With simultaneous use with antacids, antiparkinsonian drugs, lithium salts, a disturbance in the absorption of phenothiazines is possible.

With simultaneous use with fluoxetine, the development of extrapyramidal symptoms and dystonia is possible.

With simultaneous use with ephedrine, a weakening of its vasoconstrictor effect is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.