Universal reference book for medicines
Product name: EGLONYL ® (EGLONYL ® )

Active substance: sulpiride

Type: Antipsychotic drug (antipsychotic)

Manufacturer: SANOFI-AVENTIS FRANCE (France) manufactured by SANOFI WINTHROP INDUSTRIE (France)
Composition, form of production and packaging
Capsules hard gelatinous, size 4, opaque, white or white with a yellowish-grayish hue; the contents of the capsules are a uniform yellowish white powder.
1 caps.
Sulpiride 50 mg
Excipients: lactose monohydrate - 66.92 mg, methyl cellulose - 580 μg, talc - 1.3 mg, magnesium stearate - 1.2 mg.
The composition of the shell capsule: gelatin - 98%, titanium dioxide (E171) - 2%.
15 pcs. - blisters (2) - packs of cardboard.
Tablets are white or white with a yellowish tint of color, with a risk on one side, engraving "SLP200" on the other side and a chamfer on both sides.
1 tab.
Sulpiride 200 mg
Auxiliary substances: potato starch - 53.36 mg, lactose monohydrate - 23 mg, methylcellulose - 2.64 mg, silicon colloidal dioxide - 15 mg, talc - 2 mg, magnesium stearate - 4 mg.
12 pcs. - blisters (1) - packs of cardboard.
12 pcs. - blisters (5) - packs of cardboard.
The solution for the / m administration is clear, colorless or almost colorless, odorless or almost odorless.
1 ml of 1 amp.
Sulpiride 50 mg 100 mg
Excipients: sulfuric acid - 14.36 mg, sodium chloride - 9.5 mg, water d / and - up to 2 ml.
2 ml - ampoules with a break point and two rings (6) - contour plastic packaging (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Sulpiride is an atypical neuroleptic from the group of substituted benzamides.
Sulpiride has a moderate neuroleptic activity in combination with stimulating and thymoanaleptic (antidepressant) action.
Neuroleptic effect is associated with antidophaminergic action. In the central nervous system, sulpiride blocks predominantly dopaminergic receptors of the limbic system, and affects the neostriatic system only slightly, it has an antipsychotic effect. The peripheral action of sulpiride is based on oppression of presynaptic receptors. With an increase in the amount of dopamine in the central nervous system, the improvement in mood is associated with a decrease in the development of symptoms of depression.
The antipsychotic effect of sulpiride is manifested in doses of more than 600 mg / day, in doses up to 600 mg / day, the stimulating and antidepressant effect predominates.
Sulpiride has no significant effect on adrenergic, cholinergic, serotonin, histamine, and GABA receptors.
In small doses, sulpiride can be used as an additional agent in the treatment of psychosomatic diseases, in particular, it is effective in stopping the negative mental symptoms of peptic ulcer of the stomach and duodenum. In irritable bowel syndrome, sulpiride reduces the intensity of abdominal pain and leads to an improvement in the clinical state of the patient.
Low doses of sulpiride (50-300 mg / day) are effective in dizziness, regardless of etiology. Sulpirid stimulates the secretion of prolactin and has a central antiemetic effect (suppression of the emetic center) by blocking the dopamine D2 receptors in the trigger zone of the vomiting center.
PHARMACOKINETICS
With the introduction of 100 mg of C max sulpiride in blood plasma is achieved after 30 minutes and is 2.2 mg / l.
When C max is administered, the sulpiride in the plasma is reached after 3-6 hours and is 0.73 mg / l with 1 tablet containing 200 mg and 0.25 mg / ml for 1 capsule containing 50 mg.
The biological availability of dosage forms intended for oral administration is 25-35% and is characterized by significant individual variability.
Sulpiride has a linear kinetics after taking doses in the range of 50 to 300 mg.
Sulpiride diffuses quickly into the body tissues: the visible V d in the equilibrium state is 0.94 l / kg.
Binding to plasma proteins is approximately 40%.
Small amounts of sulpiride appear in breast milk and penetrate the placental barrier.
In the human body, sulpiride is only slightly exposed to metabolism: 92% of the administered IM dose is excreted unchanged in the urine.
Sulpiride is excreted mainly through the kidneys, by way of a caducous filtration. Full clearance 126 ml / min. T 1/2 of the drug is 7 hours.
INDICATIONS
As a monotherapy or in combination with other psychotropic drugs:
- Acute and chronic schizophrenia;
- acute delirious states;
- Depression of various etiologies;
- neurosis and anxiety in adult patients, with ineffectiveness of conventional methods of treatment (only for capsules 50 mg);
- severe behavioral disorders (agitation, self-mutilation, stereotypy) in children over the age of 6, especially in combination with autism syndromes (only for 50 mg capsules).
DOSING MODE
Solution for intramuscular injection
In acute and chronic psychoses treatment is started with IM injections at a dose of 400-800 mg / day and continue in most cases for 2 weeks. The goal of therapy is to achieve a minimally effective dose.
With the / m introduction of sulpiride, the usual rules for IM injections are observed: deep into the outer upper quadrant of the gluteus muscle, the skin is pre-treated with an antiseptic.
Depending on the clinical picture of the disease in / m, sulpiride injections are prescribed 1-3 times / day, which allows you to quickly soften or stop the symptoms. As soon as the patient's condition allows, you should move on to taking the drug inside. The course of treatment is determined by the doctor.
Tablets and capsules are taken 1-3 times / day, washed down with a small amount of liquid, regardless of food intake.
The goal of therapy is to achieve a minimally effective dose.
It is not recommended to take the drug in the afternoon (after 16 hours) due to increased levels of activity.
Pills
Acute and chronic schizophrenia, acute delirious psychosis, depression: daily dose is from 200 to 1000 mg, divided into several receptions.
Capsules
Neurosis and anxiety in adult patients: the daily dose is 50 to 150 mg for 4 weeks as much as possible.
Severe behavioral disorders in children : a daily dose of 5 to 10 mg / kg body weight.
Doses for the elderly: the initial dose of sulpiride should be 1 / 4-1 / 2 dose for adults.
Doses in patients with impaired renal function
Due to the fact that sulpiride is excreted from the body mainly through the kidneys, it is recommended to reduce the dose of sulpiride and / or to increase the interval between the administration of individual doses of the drug depending on the parameters of CC:
KK (ml / min) Dose of Sulpiride compared with standard (%) Increase in the interval between Sulpiride
30-60 ml / min 70 1.5 times
10-30 ml / min 50 2 times
less than 10 ml / min 30 3 times
SIDE EFFECT
The undesirable phenomena that develop as a result of taking sulpiride are similar to undesirable phenomena caused by other psychotropic drugs, but their frequency of development is, in general, less.
On the part of the endocrine system: it is possible to develop reversible hyperprolactinaemia, the most frequent manifestations of which are galactorrhea, amenorrhea, menstrual cycle disorder, less often - gynecomastia, impotence and frigidity. During treatment with sulpiride, there may be increased sweating, an increase in body weight.
On the part of the digestive system: increased activity of liver enzymes.
From the side of the central nervous system: sedation, drowsiness, dizziness, tremor, early dyskinesia (spasmodic torticollis, oculogic crises, trismus), which occurs when an anticholinergic antiparkinson agent is administered, rarely - extrapyramidal syndrome and related disorders (akinesia, sometimes combined with muscle hypertonia and partially eliminated with anticholinergic antiparkinson agents, hyperkinesia-hypertonus, motor agitation, acacia). There were cases of late dyskinesia characterized by involuntary rhythmic movements, mostly of language and / or persons with long-term courses of treatment, which can be observed during treatment courses with all neuroleptics: the use of antiparkinsonian drugs is ineffective or can cause symptoms worsening. With the development of hyperthermia, the drug should be discarded. an increase in body temperature may indicate the development of malignant neuroleptic syndrome (CNS).
From the side cardiovascular system: tachycardia, it is possible to increase or decrease blood pressure, in rare cases, the development of orthostatic hypotension, prolongation of the QT interval, very rare cases of the syndrome "torsade depointes".
Allergic reactions: a skin rash is possible.
CONTRAINDICATIONS
- Prolactin-dependent tumors (eg, pituitary prolactinoma and breast cancer);
hyperprolactinemia;
- acute intoxication with ethanol, hypnotics, opioid analgesics;
- affective disorders, aggressive behavior, manic psychosis;
- pheochromocytoma;
- the period of breastfeeding;
- Children's age till 18 years (for tablets and a solution for the / m introduction);
- Children under 6 years (for capsules);
- in combination with sultopride, dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lizard, pergolide, pyribedil, pramipexole, kinagolide, ropinirole);
- hypersensitivity to sulpiride or other ingredient of the drug.
Due to the presence of lactose in the formulation, it is contraindicated in congenital galactosemia, glucose malabsorption / galactose syndrome, or lactase deficiency.
Carefully:
It is not recommended to prescribe sulpiride to pregnant women, except when the doctor, having estimated the ratio of benefit and risk to the pregnant and fetus, decides that the use of the drug is necessary.
It is not recommended to prescribe sulpiride in combination with ethanol, levodopa, drugs capable of causing ventricular arrhythmias of the "torsade de pointes" type (antiarrhythmics of class 1a (quinidine, hydroquinidine, disopyramide) and class III (amiodarone, sotalol, dofetilide, ibutilide)), neuroleptics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, amisulpride, tiaprid, pimozide, haloperidol, droperidol) and other drugs such as: bepridil, cisapride, difemanyl, intravenous erythromycin, misolastine, intravenous gynofantrine, pentamidine, sparfloxacin, moxifloxacin, and so on.
Precautions should be observed when prescribing sulpiride to patients with renal and / or hepatic insufficiency, a history of malignant neuroleptic syndrome, epilepsy or seizures in history, severe heart disease, hypertension, patients with Parkinsonism, dysmenorrhea, and old age.
PREGNANCY AND LACTATION
Experiments on animals have not revealed a teratogenic effect. A small number of women taking low doses of sulpiride during pregnancy (about 200 mg / day) did not have a teratogenic effect. There is no data on the use of higher doses of sulpiride. There is also no evidence of the potential effect of neuroleptic drugs taken during pregnancy on the development of the fetal brain. Therefore, as a precaution, it is preferable not to use sulpiride during pregnancy.
However, in the case of using this drug during pregnancy, it is recommended, as far as possible, to limit the dose and duration of treatment. In newborns whose mothers received long-term treatment with high doses of antipsychotics, gastrointestinal symptoms (bloating, etc.), associated with atropine-like effects of certain drugs (especially in combination with anti-Parkinson drugs), and extrapyramidal syndrome were rarely observed.
With prolonged treatment of the mother, or with the use of high doses, as well as in the case of the appointment of the drug shortly before the birth, the monitoring of the activity of the nervous system of the newborn is justified.
The drug penetrates into breast milk, so you should stop taking the drug during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Precautions should be observed when prescribing sulpiride to patients with renal insufficiency.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Precautions should be taken when administering sulpiride to patients with hepatic insufficiency.
APPLICATION FOR CHILDREN
Contraindication: children under 18 years of age (for tablets and solution for intravenous administration); children under 6 years (for capsules).
APPLICATION IN ELDERLY PATIENTS
Doses for the elderly: the initial dose of sulpiride should be 1 / 4-1 / 2 doses for adults.
SPECIAL INSTRUCTIONS
Malignant neuroleptic syndrome: with the development of hyperthermia of undiagnosed origin, sulpiride should be discontinued, as this may be one of the signs of a malignant syndrome described with the use of neuroleptics (pallor, hyperthermia, autonomic dysfunction, impaired consciousness, rigidity of muscles).
Signs of autonomic dysfunction, such as increased sweating and labile blood pressure, may precede the onset of hyperthermia and, therefore, represent early warning signs.
Although such an effect of neuroleptics may have an idiosyncratic origin, it appears that some of the risk factors may predispose to it, for example, dehydration or organic brain damage.
Increase in the QT interval: Sulpiride prolongs the QT interval depending on the dose. This action, which is known to increase the risk of developing a serious ventricular arrhythmia, such as "torsade de pointes", is more pronounced in the presence of bradycardia, hypokalemia, or congenital or acquired prolonged QT interval (combination with the drug eliciting the QT interval).
If the clinical situation allows, it is recommended, prior to the appointment of the drug, to be convinced of the absence of factors that may contribute to the development of this type of arrhythmia:
- a bradycardia with a number of strokes less than 55 bpm,
- hypokalemia,
- congenital elongation of the QT interval,
- simultaneous treatment with a drug capable of causing a pronounced bradycardia (less than 55 bpm), hypokalemia, slowing of intracardiac conduction or prolongation of the QT interval.
Except in cases of urgent intervention, patients requiring treatment with neuroleptics are advised to conduct an electrocardiogram during the status assessment.
In exceptional cases, this drug should not be used in patients with Parkinson's disease.
In patients with impaired renal function, reduced doses should be used and control enhanced; In severe forms of renal failure, intermittent courses of treatment are recommended.
Control during treatment with sulpiride should be strengthened:
- in patients with epilepsy, since the convulsive threshold can be lowered;
- in the treatment of elderly patients who show great sensitivity to postural hypotension, sedation and extrapyramidal effects.
Consumption of alcohol or the use of drugs containing ethyl alcohol during treatment with the drug is strictly prohibited.
Impact on the ability to drive vehicles and manage mechanisms
During treatment with Egonilom it is prohibited to drive vehicles and work with mechanisms that require increased attention, as well as alcohol intake.
OVERDOSE
Experience with the overdose of suylpiride is limited. Specific symptoms are absent, can be observed: dyskinesia with spastic torticollis, bulging tongue and trism, blurred vision, arterial hypertension, sedation, nausea, extrapyramidal symptoms, dry mouth, vomiting, increased sweating and gynecomastia, possible ZNS development. Some patients have parkinsonism syndrome.
Treatment: Sulpiride is partially excreted in hemodialysis. Due to the absence of a specific antidote, symptomatic and supportive therapy should be used, with careful monitoring of respiratory function and constant monitoring of cardiac activity (risk of prolongation of the QT interval), which should continue until the patient fully recovered. Central action cholinergic blockers are prescribed in the development of severe extrapyramidal syndrome.
DRUG INTERACTION
Contraindicated combinations
Dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lizard, pergolide, pyribedil, pramipexole, kinagolide, ropinirole), in addition to patients suffering from Parkinson's disease: there is mutual antagonism between dopaminergic receptor agonists and neuroleptics. In extrapyramidal syndrome, induced by neuroleptics, dopaminergic receptor agonists are not used, in such cases, anticholinergics are used.
Sultopride: the risk of ventricular arrhythmias increases, in particular of atrial fibrillation.
Unrecommended combinations
Preparations that can cause ventricular arrhythmias of the "torsade de pointes" type: antiarrhythmics of class Ia (quinidine, hydroquinidine, disopyramide) and class III (amiodarone, sotalol, dofetilide, ibutilide), some antipsychotics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, amisulpride, thiapride, haloperidol, droperidol, pimozide) and other drugs such as: bepridil, cisapride, difemanyl, intravenous erythromycin, misolastine, intravenous vinamine, etc.
Ethanol: increases the sedative effect of neuroleptics. Violation of attention creates a danger for driving and transporting machinery. Avoid the consumption of alcoholic beverages and the use of drugs containing ethyl alcohol.
Levodopa: there is a mutual antagonism between levodopa and neuroleptics. Patients suffering from Parkinson's disease, it is necessary to prescribe a minimum effective dose of both drugs.
Agonists of dopaminergic receptors (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, kinagolid, ropinirole) in patients with Parkinson's disease: between dopaminergic agonists and neuroleptics receptors exist mutual antagonism. The above formulations may cause or exacerbate psychoses. If you need neuroleptic treatment of a patient suffering from Parkinson's disease, and receiving dopaminergic antagonist, the latter should reduce the dose gradually until canceled (abrupt withdrawal of dopaminergic agonists may lead to the development of neuroleptic malignant syndrome).
Halofantrine, pentamidine, sparfloxacin, moxifloxacin:enhanced risk of ventricular arrhythmias, particularly "torsade de pointes". When possible, you should cancel the antimicrobial agent, causing ventricular fibrillation. If the combination is unavoidable, pre-check the QT interval and monitor ECG.
Combinations that require caution
Drugs that cause bradycardia (calcium channel blockers with bradycardic effect: diltiazem, verapamil, beta-blockers, clonidine, guanfacine, alkaloids, digitalis, cholinesterase inhibitors: donepezil, rivastigmine, tacrine, ambenonium chloride, galantamine, pyridostigmine, neostigmine): enhanced risk of ventricular arrhythmias particularly "torsade de pointes". It is recommended that clinical and ECG monitoring.
Drugs that decrease blood levels of potassium (kaliyvyvodyaschie diuretics, laxatives stimulating character, amfoterschin B (w / w), glucocorticoids, tetracosactide):enhanced risk of ventricular arrhythmias, particularly "torsade de pointes". Before the appointment of the drug should be eliminated and establish the clinical hypokalemia, cardiographic control, as well as control the level of electrolytes.
Combinations to be taken into account:
Antihypertensive drugs: increased hypotensive action and increased the possibility of postural hypotension (additive effect).
Other CNS depressants: morphine derivatives (analgesics, antitussives and substitution therapy), barbiturates, benzodiazepines and other anxiolytics, hypnotics, antidepressants, sedatives, sedative antagonists, histamine H 1receptors, antihypertensives central action, baclofen, thalidomide - CNS depression, attention deficits poses a danger to driving vehicles and working on the machines.
Sucralfate, antacids containing Mg2 + and / or A13 +, reduce bioavailability of dosage forms for oral administration of 20-40%. Sulpiride be administered 2 hours prior to their reception.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. Store at a temperature not higher than 30 ° C in the reach of children. Shelf life - 3 years. Do not use after the expiry date stated on the package.
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