|The name of the preparation
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Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The preparation contains the substance:amisulpride
The drug is available on prescription
What is ApoSuprid?
A neuroleptic drug from the group of benzamide derivatives.
What does ApoSuprid contain and how does it work?
Amisulpride is a neuroleptic drug used to treat various forms of schizophrenia. Its mechanism of action is based on interaction with Dopamine
-dependent receptors (D2 and D3). However, it does not show affinity for serotonin, -renergic, histaminergic H receptors1
In high doses, the preparation strongly blocks post-synaptic D2 receptors in the limbic system. When used at lower doses, it blocks the presynaptic D2 and D3 receptors. The effect of this action is the release of dopamine and the so-called disinhibition. Therefore, the preparation is effective both in the case of exacerbation of symptoms of schizophrenia and in the alleviation of negative symptoms, such as lowering mood and slowing down.
The preparation causes unwanted extrapyramidal symptoms.
When should I use ApoSuprid?
The preparation is indicated for the treatment of: acute and chronic schizophrenia with positive symptoms (such as delusions, hallucinations, thinking disorders) and / or negative (such as blunting feelings, emotional and social withdrawal), including those with the predominance of negative symptoms.
When not to use this preparation?
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients.
Contraindications to the use of the preparation are also:
· Tumors, whose increase depends on the level of prolactin
· Breastfeeding period
· Severe renal failure
· Parallel use of drugs that can cause type-heart rhythm disturbancestorsade de pointes or levodopa.
It should not be used in children and adolescents up to 15 years of age.
Take special care with ApoSuprid?
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
Symptoms of so-called "neuroleptic malignant syndrome" may occur during treatment, such as:
· Muscle stiffness
· Impaired autonomic nervous system function
· Increase in creatinine kinase in the blood.
In this case, you should immediately consult a doctor, because the neuroleptic syndrome can be a direct threat to life.
If you have kidney failure, your doctor will probably recommend a dose reduction.
People with diabetes or an increased risk of diabetes should have their blood sugar checked regularly during treatment.
Caution should be exercised in people with epilepsy, because the preparation may lower the seizure threshold.
In the elderly (after the age of 65), extreme caution should be exercised due to the possibility of hypotension and excessive sedation.
Special care should be taken when using the preparation in patients with Parkinson's disease, as it may exacerbate the symptoms of the disease (it can be used only when neuroleptic treatment is necessary).
As a result of the sudden discontinuation of the preparation (especially at high doses), acute withdrawal symptoms such as nausea, vomiting and insomnia have been rarely reported. Psychotic symptoms may also recur and movement disorders (such as akathisia, dystonia and dyskinesias) may occur. For this reason, it is recommended to stop the drug gradually.
The preparation causes a dose-dependent prolongation of the QT interval on the ECG, this may result in severe ventricular arrhythmias (such astorsades de pointes
). Exercise caution when:
· Co-existing bradycardia (bradycardia, below 55 heart beats per minute)
· Co-existing hypokalemia (reduction of potassium in the blood)
Congenital or acquired prolonged QT interval
· Concomitant use of drugs that prolong the QT interval).
For people who require long-term treatment, the doctor will probably perform an ECG test before starting treatment.
Caution should be exercised in people with risk factors for cerebral infarction, because there is an increased risk of cerebrovascular adverse events in this group of patients.
The use of other antipsychotic drugs is not recommended.
Information on additional components of the preparation:
The preparation contains lactose; should not be used in people with rare hereditary galactose intolerance, primary lactase deficiency or malabsorption of Glucose
Does this preparation affect the ability to drive vehicles?
The preparation may impair your ability to drive or use machines. Be careful when using it!
Dosage of ApoSuprid
The preparation is in the form of tablets. It is intended for oral use. Use the preparation as recommended. Do not exceed the recommended dose, because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.
The doctor adjusts the dose individually depending on the patient's reaction to the medicine. Doses above 300 mg should be administered in 2 divided doses.
In acute psychotic disorders, 400-800 mg / day, sometimes up to 1200 mg / day, are used. Doses above 1200 mg / day are not recommended. In people with positive and negative symptoms, the dose should be chosen so as to optimally control positive symptoms (400-800 mg / day). In patients with the predominance of negative symptoms 50-300 mg / day. For maintenance therapy, the lowest effective dose should be used.
In the elderly, be especially careful because of the possibility of orthostatic hypotension or excessive sedation (sedation). In people with renal insufficiency, the doctor will adjust the dose depending on the creatinine clearance. No dosage adjustment is needed for liver problems.
Can I use ApoSuprid during pregnancy and breastfeeding?
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug.
It is not recommended to use the product during pregnancy, unless in the doctor's opinion the benefits for the mother outweigh the threat to the fetus.
Women of childbearing potential should use an effective method of contraception during treatment with the preparation.
Due to the lack of data, it is not recommended to use the product during breastfeeding.
Can I use other preparations in parallel?
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Concomitant use of the preparation with drugs that may cause occurrence is contraindicatedtorsades de pointes
Class Ia antiarrhythmics, such as quinidine disopyramide, procainamide
Class III antiarrhythmics, such as Amiodarone
· Other medicines such as bepridil, cisapride, sultopride, thioridazine, methadone, intravenous Erythromycin
, intravenous vincamine, halofantrine, pentamidine, sparfloxacyin
· and other.
Caution should be exercised when using the preparation in parallel with:
· Levodopa (mutual antagonism of levodopa and neuroleptics)
· Medicines that increase the risk of occurrencetorsades de pointes
or prolongation of the QT interval
· Drugs causing bradycardia (ß-blockers, Calcium
channel blockers such as diltiazem, Verapamil
, clonidine, guanfacine, digitalis glycosides)
· Medicines that reduce the level of potassium in the blood or electrolyte disturbances (diuretics, laxatives, intravenous amphotericin B, glucocorticoids, tetracosactide
· Neuroleptics such as pimozide, Haloperidol
· Drugs with inhibitory effects on the central nervous system (including narcotic, anxiolytic drugs, analgesics, antihistamines (H1 receptor antagonists with sedative effect), barbiturates, benzodiazepines and other anxiolytics, clonidine and its derivatives
· Medicines used in hypertension and other medicines that lower blood pressure
· Dopaminergic agonists (except levodopa) because amisulpride may reduce their effect.
During treatment with amisulpride, alcohol should not be consumed, medicines containing alcohol should not be used because of the severity of the sedative effect.
What side effects can occur?
Like all medicines, ApoSuprid can cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Very commonly, extrapyramidal symptoms may occur, eg tremor, stiffness, hypokinesia, increased salivation, akathisia, dyskinesia.
Common: weight loss, hypotension, acute dystonia (tics or cramps in the neck, eyes or jaw muscles), drowsiness, dizziness, gastrointestinal disturbances such as constipation, nausea, vomiting, dry mouth, increase in serum prolactin (this may be the cause of mellitus, amenorrhea or menstrual disorders, gynecomastia, pain or breast enlargement, the occurrence of benign prolactin-secreting pituitary tumor (prolactinoma) and impotence), insomnia, anxiety, agitation, and orgasm disorders.
Uncommon: Elevated liver enzymes, in particular transaminases, bradycardia, usually after long-term treatment, have been observed with tardive dyskinesia characterized by involuntary movements of primarily the tongue and / or facial muscles, convulsions, hyperglycemia, and allergic reactions.
Rarely may occur: symptoms after a sudden discontinuation of treatment with high doses of the drug such as: nausea, vomiting and insomnia, recurrence of psychotic symptoms, movement disorders
(such as akathisia, dystonia, and dyskinesia).
Very rarely, QT prolongation and cases of ventricular arrhythmias may occur (torsade de pointes) and ventricular tachycardia, which may lead to ventricular fibrillation, cardiac arrest and death, neuroleptic malignant syndrome.
The neonatal withdrawal syndrome, the occurrence of venous thromboembolism, including cases of pulmonary embolism and deep vein thrombosis may occur with unknown frequency.
Other preparations on the Polish market containing amisulpride
Solian (coated tablets)