Index of drugs

Maintenance treatment for schizophrenia and other psychoses, especially with symptoms such as hallucinations, delusions, thinking disorders, agitation, anxiety, hostility and aggressiveness.

1 amp. (1 ml) contains 200 mg of zuclopenthixol decanoate.

A thioxanthene derivative with a strong antipsychotic effect. The mechanism of action is associated with the blockade of dopaminergic receptors and 5-HT receptors. Zuklopentixol has a strong affinity for dopaminergic D receptors₁ and D₂, α₁-renergic and 5-HT₂but does not show affinity for cholinergic muscarinic receptors. It has weak affinity for histamine H receptors₁ and does not block α receptors₂-Adrenergic. Zuclopentixol shows transient sedation-dependent, dose-related effects. After intramuscular administration, the drug achieves the maximum concentration in the blood within 3-7 days. Plasma proteins are approximately 98-99% bound. It is metabolized in the liver; metabolites are devoid of neuroleptic activity. It is excreted mainly in the faeces, in a small amount in the urine. T_0,5 is about 3 weeks

Hypersensitivity to zuklopentixol or other ingredients of the preparation. Circulatory collapse. Limited awareness regardless of the etiology (eg alcohol poisoning, barbiturates or opioids). Coma.

Use in children is not recommended (no clinical experience). Caution use in patients with organic cerebral syndrome, seizures, mental retardation, opioid and alcohol abusers, severe liver dysfunction, diabetes (there may be need to modify antidiabetic treatment) and risk factors for stroke. Patients who are given long-term treatment, especially high-dose, should be carefully monitored and subjected to periodic testing to determine if a maintenance dose can be reduced. The drug may cause QT interval prolongation - care should be taken in patients with risk factors for QT prolongation: with a genetic predisposition, hypokalaemia, hypomagnesemia, history of cardiovascular disease (including QT prolongation, bradycardia <50 beats / min, fresh acute myocardial infarction, cardiac arrhythmia). People who are taking antipsychotics often have acquired risk factors for the development of venous thromboembolism, so before and during treatment with zuclopenthixol, all possible risk factors for this disease should be identified and preventive measures should be taken. The drug is not intended for the treatment of behavioral disorders associated with dementia.

During pregnancy, use only if the anticipated benefits to the mother outweigh the potential risk to the fetus. Newborns whose mothers received neuroleptics in late pregnancy or during delivery may show signs of toxicity - lethargy, muscle tremors and hyperactivity, and low Apgar score. Exposure to antipsychotics in the third trimester of pregnancy poses a risk of neonatal side effects including extrapyramidal symptoms and / or withdrawal symptoms that may vary in severity and duration after childbirth (agitation, hypertonia, tremors, drowsiness, respiratory distress syndrome, feeding) - newborns should be monitored. Zuklopentixol does not penetrate to breast milk to a small extent - during treatment with the preparation, a woman may continue breast-feeding if clinically significant; It is recommended to watch the baby, especially in the first four weeks after birth.

Most often they occur at the beginning of treatment, and their severity and incidence generally decrease during therapy. Very common: drowsiness, akathisia, hyperkinesia, hypokinesia, dryness of the oral mucosa.Common: tachycardia, palpitations, tremor, dystonia, hypertension, dizziness, headache, paresthesia, attention disorders, amnesia, abnormal gait, accommodation disturbances, abnormal vision, dizziness, congestion and nasal congestion, shortness of breath, salivation, constipation , vomiting, indigestion, diarrhea, urination disorders, urinary retention, polyuria, increased sweating, pruritus, muscular pain, increased appetite, weight gain, asthenia, fatigue, malaise, pain, insomnia, depression, anxiety, nervousness, abnormal dreams, agitation, decreased sex drive. Uncommon: tardive dyskinesia, hyperreflexia, dyskinesia, parkinsonism, syncope, ataxia, speech disorders, hypotension, convulsions, migraine, involuntary eye rotation, mydriasis, hyperaesthesia, tinnitus, abdominal pain, nausea, bloating with gas donation, rash, photosensitivity, pigmentation disorders, seborrhea, dermatitis, purpura, muscle stiffness, trismus, torticollis, decreased appetite, weight loss, hypotension, hot flushes, thirst, injection site reaction, hypothermia, fever, abnormal liver function tests, ejaculation disorders, erectile dysfunction, orgasmic disorders in women, vaginal dryness, listlessness, nightmares, increased sex drive, confusion. Rare: QT prolongation (in ECG), thrombocytopenia, neutropenia, leukopenia, agranulocytosis, hyperprolactinemia, hyperglycemia, impaired Glucose tolerance, hyperlipidemia, hypersensitivity, anaphylactic reaction, gynecomastia, galactorrhea, amenorrhea, priapism. Very rare: neuroleptic malignant syndrome, venous thromboembolic disease (including cases of pulmonary embolism and deep vein thrombosis), hepatitis, jaunts. Not known: drug discontinuation in a newborn. In addition, rare cases of prolongation of the QT interval, ventricular arrhythmias (incltorsade de pointes) and cases of sudden, unexplained deaths. Abrupt discontinuation may lead to withdrawal symptoms: nausea, vomiting, anorexia, diarrhea, watery runny nose, sweating, muscle pain, paresthesia, insomnia, agitation, anxiety and anxiety.

Intramuscularly. Adults: in order to achieve maximal inhibition of psychotic symptoms with minimal side effects, dosage and intervals between injections should be determined individually, in maintenance therapy, the dose is usually 200-400 mg every 2-4 weeks, in some patients it may be necessary to administer higher doses or shorter intervals between successive doses. When switching from oral to Zuclopentixol, the following dose should be calculated: x mg daily zuclopentixol administered orally corresponds to 8x mg zuclopenthixol decanoate every 2 weeks or 16x mg zuclopentixol decanoate every 4 weeks. In the first week after intramuscular administration, the preparation should be continued orally, gradually reducing its dose. When switching from zuclopenthixol acetate to zuclopenthixol decanoate: with the last injection of zuclopentixol 100 mg acetate, intramuscular 200-400 mg zuclopentixol decanoate in a 200 mg / ml solution should be administered, the injection should be repeated every 2 weeks, larger volumes may be required dose or shorter intervals between injections. Patients previously treated with other depot medications should receive doses calculated as follows: 200 mg zuclopenthixol decanoate corresponds to 25 mg flupheenez decanoate or 40 mg cis (Z) -flupenticol decanoate or 50 mg Haloperidol decanoate. Subsequent doses of zuclopenthixol decanoate and intervals between injections should be determined in accordance with the patient's response to treatment. Elderly patients should receive doses at the lower end of the dose range. In patients with impaired hepatic function, caution should be exercised when selecting the dose and, if possible, the concentration of zuclopenthixol decanoate in the blood. There is no need to change the dosage in patients with impaired renal function. If the volume of the injected drug is greater than 2 ml, the divided dose should be injected into two different places.