NEULEPTIL
Side effects
Neuleptil® is usually well tolerated, however, in some cases, the following adverse reactions may occur, the occurrence of which may or may not depend on the dose taken, and in the latter case, be a consequence of increased individual sensitivity of the patient.
From the central nervous system
Sedation or drowsiness, more pronounced at the beginning of treatment and usually disappearing after a few days.
- Apathy, anxiety, mood changes.
— In some cases, paradoxical effects are possible: insomnia, agitation, sleep inversion, increased aggressiveness and increased psychotic symptoms.
— Extrapyramidal disorders (more often occurring when using the drug in high doses):
- acute dystonia or dyskinesia (spasmodic torticollis, oculogyric crises, trismus, etc.), usually occurring within 4 days after starting treatment or increasing the dose;
- parkinsonism, which often develops in elderly patients and/or after long-term treatment (weeks or months) and is partially eliminated by the appointment of anticholinergic antiparkinsonian drugs and is manifested by the appearance of one or more of the following symptoms: tremor (very often the only manifestation of parkinsonism) , rigidity, akinesia in combination with or without muscle hypertonicity;
- tardive dystonia or dyskinesia, usually (but not always) occurring with long-term treatment and/or use of the drug in high doses, and can occur even after cessation of treatment (if they occur, anticholinergic antiparkinsonian drugs have no effect and may cause deterioration);
- akathisia, usually observed after taking high initial doses.
- Respiratory depression (possible in patients with predisposing factors to the development of respiratory depression, for example in patients receiving other drugs that can depress breathing, in elderly patients, etc.).
From the autonomic nervous system
- Anticholinergic effects (dry mouth, accommodation paresis, urinary retention, constipation, paralytic ileus).
From the cardiovascular system
- Decreased blood pressure, usually postural hypotension (more common in elderly patients and patients with decreased circulating blood volume, especially at the beginning of treatment and when using high initial doses).
- Arrhythmias, including atrial arrhythmias, atrioventricular block, ventricular tachycardia, including potentially fatal torsade de pointes, more likely when using high doses (see sections "Contraindications", subsection "With caution"; "Interaction with others medicines"; "Special instructions").
- ECG changes, usually minor: prolongation of the QT interval, ST segment depression, appearance of the U wave and T wave changes.
- When using antipsychotics, cases of thromboembolism have been observed, including pulmonary embolism (sometimes fatal) and cases of deep vein thrombosis (see section "Special instructions").
Endocrine and metabolic disorders (more often occurring when using the drug in high doses)
- Hyperprolactinemia, which can lead to amenorrhea, galactorrhea, gynecomastia, impotence, frigidity.
- Increase in body weight.
— Thermoregulation disorders.
- Hyperglycemia, decreased glucose tolerance.
Skin and allergic reactions
— Allergic skin reactions, skin rash.
— Bronchospasm, laryngeal edema, angioedema, hyperthermia and other allergic reactions.
— Photosensitivity (more often when using the drug in high doses).
— Contact skin sensitization (see section “Special instructions”).
Hematological disorders
- Leukopenia (observed in 30% of patients receiving high doses of antipsychotics).
- Extremely rare: agranulocytosis, the development of which does not depend on the dose, and which can occur either immediately or after leukopenia lasting for two to three months.
Ophthalmological disorders
- Brownish deposits in the anterior chamber of the eye, pigmentation of the cornea and lens due to the accumulation of the drug, usually not affecting vision (especially when using high doses of phenothiazine derivatives for a long time).
From the liver and biliary tract
Very rare: cholestatic jaundice and liver damage, predominantly cholestatic or mixed, requiring discontinuation of the drug.
Other
- Malignant neuroleptic syndrome, a potentially fatal syndrome that can occur when taking all antipsychotics and is manifested by hyperthermia, muscle rigidity, autonomic disorders (pallor, tachycardia, unstable blood pressure, increased sweating, shortness of breath) and disturbances of consciousness up to coma. The occurrence of neuroleptic malignant syndrome requires immediate cessation of antipsychotic treatment. Although this effect of pericyazine and other antipsychotics is associated with idiosyncrasy, there are predisposing factors for its occurrence, such as dehydration or organic brain damage.
Positive serological test for the presence of antinuclear antibodies, without clinical manifestations of lupus erythematosis.
- Very rare: priapism.
- Nasal congestion.
- Very rare: development of withdrawal syndrome with abrupt cessation of treatment with high doses of pericyazine, manifested by nausea, vomiting, insomnia and the possibility of exacerbation of the underlying disease or the development of extrapyramidal disorders.
Among patients taking phenothiazine antipsychotics, isolated cases of sudden death, possibly caused by cardiac causes, have been reported (see sections “Contraindications”, subsection “With caution”; “Special instructions”), as well as unexplained cases of sudden death.
Compound
Depending on the release form, the chemical composition of the drug may differ. In 100 ml. Neuleptil drops (4% oral solution) contain 4 grams of pericyazine (the active medicinal compound), as well as such excipients as: purified water (100 ml.), glycerin (15 g.), ascorbic acid (0.8 g. ), peppermint leaf oil ( 0.04 g), sucrose (25 g) and E150d (caramel, 0.2 g), tartaric acid (1.65 g) and 96% ethanol (9 .74 g).
One Neuleptil capsule contains 10 mg. pericyazine , as well as such auxiliary compounds as magnesium stearate (3 mg.) and calcium hydrogen phosphate dihydrate (137 mg.). The capsule itself contains chemicals such as gelatin and titanium dioxide .
special instructions
If a side effect of the drug such as fever , you should immediately consult a doctor in order to conduct a blood test and rule out agranulocytosis . During treatment with Neuleptil, it is prohibited to drink alcoholic beverages.
When using the drug during treatment of patients with epilepsy , constant electroencephalological monitoring . In addition, special attention should be paid to the following groups of patients when treating with pericyazine:
- To old people;
- people suffering from diseases of the cardiovascular system ;
- people with renal and liver failure .
drowsiness may occur when taking the drug , especially at first, patients should avoid any activity that requires increased attention (driving a vehicle or working with potentially dangerous mechanisms).
Pharmacodynamics and pharmacokinetics
Since the drug belongs to the group of antipsychotics , which, in turn, are piperidine phenothiazine derivatives , Neuleptil blocks serotonergic, adrenergic and dopaminergic D2 receptors , as well as m-cholinergic receptors . A drug without a stimulant component has an antipsychotic , and in addition, sedative, antiemetic, parasympatholytic, adrenolytic and hypothermic effect .
The drug potentiates the activity of non-narcotic as well as narcotic hypnotics and analgesics . In addition, the drug, having a sedative effect on the body, reduces the level of aggressiveness and excitability, and also acts as a sleeping pill. Since Neuleptil is characterized by a selective normalizing effect , this drug is classified as a means of correcting the behavior of children.
Contraindications
This medicine is not recommended for use if you have the following conditions:
- closed glaucoma;
- Parkinson's disease;
- porphyria and agranulocytosis , including in history;
- prostate diseases .
In addition, you should not take Neuleptil together with Levodopa during the therapeutic treatment of Parkinson's , as well as in case of hypersensitivity to the active compound periciazine and to other components of the drug. The drug should be used with extreme caution in elderly patients, as well as those suffering from liver or kidney failure and diseases of the cardiovascular system .
Release form
As a rule, a bottle made of dark glass with a fluorescent yellow-brown solution with a mint odor, a nominal volume of 30 or 125 ml, intended for oral administration, is placed in one cardboard package. For ease of use of the drug, the drug is equipped with a special dispenser syringe.
Hard gelatin capsules No. 4 containing the active compound in the form of an odorless yellow powder are packaged in blisters of 10 pieces and placed in a cardboard package.
Side effects
When taking Neuleptil, the following side effects of the drug may occur:
- dyskinesia ( oculomotor crisis , trismus , spasmodic torticollis );
- anticholinergic effects;
- depression and sudden mood swings;
- extrapyramidal disorders;
- dry mouth;
- hypotension;
- constipation;
- urinary retention;
- paresis of accommodation;
- impotence;
- amenorrhea;
- frigidity;
- drowsiness;
- galactorrhea;
- hyperprolactinemia;
- hypertemia;
- gynecomastia;
- weight gain;
- jaundice;
- agranulocytosis;
- photosensitivity.
During pregnancy (and lactation)
Although the use of the drug during pregnancy is not prohibited, in some cases, during long-term therapeutic treatment with Neuleptil, women experienced extrapyramidal and gastrointestinal disorders , for example, bloating and others. Therefore, first of all, it is advisable to find out whether the expected benefits of taking the drug will exceed the possible harm.
In addition, it is recommended to reduce the duration of drug treatment during pregnancy . If medical necessity requires the use of the drug in the third trimester, then it is recommended to monitor nervous system .
Due to the lack of reliable data on the effect of the drug on breast milk, Neuleptil is not recommended for use during lactation .
Neuleptil drops, instructions for use (Method and dosage)
First of all, it is worth emphasizing that the dosage of the drug, as well as the schedule for its use, depends on the patient’s condition, the complexity of the disease, as well as the doctor’s prescriptions. In addition, the form of release of the drug is not least important.
In accordance with the instructions for Neuleptil drops should be taken orally:
- for adult patients in a dosage of 30 to 100 mg. 2-3 times a day;
- for children over 3 years of age in a dosage of 0.1 to 0.5 mg. per kilogram of body weight.
The above doses may be adjusted in case of urgent medical need. However, the maximum daily dose of the drug for adults should not exceed 200 mg. The drug in capsules is used during the treatment of adult patients and similar doses of 30 to 100 mg are used. per day.
Interaction
It is strictly prohibited to use this drug in combination with Levodopa , since mutual antagonism between these two drugs has been established. The effectiveness of Neuleptil is significantly reduced when drinking alcohol, as well as when taking Guanethidine, Sultopride and other drugs related to antihypertensive drugs and affecting ventricular fibrillation.
Great care should be taken when using Neuleptil together with antihypertensives , drugs that affect the nervous system, as well as antacids, anticholinergics , including atropine .
