Eglonil (tablets, capsules, injections): instructions for use, price, reviews of doctors and patients, analogues, composition

One tablet contains 0.2 g or 0.05 g of the active ingredient. sulpiride and additional substances (potato starch, methyl cellulose, talc, lactose monohydrate, silicon dioxide, magnesium stearate).

In a solution for intramuscular injection (1 ampoule) sulpiridecontains 0.1 g + sodium chloride, water and sulfuric acid.

In solution for internal use per 100 ml sulpiride 0.5 g + excipients.

Release form

The medicine is released in the form of gelatin capsules, solid, yellow-gray hue, inside a white-yellow powder. Packages of 15 or 30 capsules.

Yellowish pills, with a risk on one side and the inscription “SLP200” on the other, packs of 12, 60 pieces.

Colorless injection solutionodorless ampoules. Packages of 6 ampoules.

Pharmacodynamics and pharmacokinetics

The drug has a fairly moderate antipsychotic effect. The active substance selectively blocks dopamine receptorswhile not exerting strong sedation. To a small extent, the drug acts as antidepressant and stimulant.

Depending on the dose, it can eliminate rave and hallucinations or just increase tone and lower anhedonia. In very significant doses, sedation occurs.

After half an hour (for intramuscular) or 5 hours (inside), the effect of the drug occurs. The conclusion is carried out by the kidneys, is not metabolized, the half-life is about 7 hours.

Indications for use of Eglonil

  • abulia,
  • confusion and rave,
  • agramatism,
  • retardation and other psychoses,
  • neurosis,
  • sluggish schizophrenia,
  • psychosomatic diseases.

Eglonil also serves as an indication for use. stomach ulcer and duodenal ulcer.

Injection solution

Intramuscular injections are given, the daily dosage is from 400 to 800 mg (the dose is divided into 2-3 procedures). The maximum course of therapy is 2 weeks.

During the procedure, the technique of introducing intramuscular injections is followed.

The place of the needle puncture is determined in the outer upper quadrant of the gluteal muscle. The needle is immersed deep enough. Before injection, the skin is treated with an antiseptic solution.

Egonil in the form of a solution is used to mitigate and stop the symptomatic manifestations. When progression in therapy is achieved, a transition to the tablet form is carried out.

Pharmachologic effect

Sulpiride is an atypical antipsychotic from the group of substituted benzamides.

Sulpiride has moderate antipsychotic activity in combination with a stimulating and thymoanaleptic (antidepressant) effect.

The antipsychotic effect is associated with an antidopaminergic effect. In the central nervous system, sulpiride blocks mainly dopaminergic receptors of the limbic system, and has little effect on the neostriatal system, it has an antipsychotic effect. The peripheral effect of sulpiride is based on the inhibition of presynaptic receptors. With an increase in the amount of dopamine in the central nervous system, an 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, a stimulating and antidepressant effect prevails.

Sulpiride has no significant effect on adrenergic, cholinergic, serotonin, histamine and GABA receptors.

In small doses, sulpiride can be used as an additional tool in the treatment of psychosomatic diseases, in particular, it is effective in stopping the negative mental symptoms of gastric ulcer and duodenal ulcer. With irritable bowel syndrome, sulpiride reduces the intensity of abdominal pain and leads to an improvement in the clinical condition of the patient.

Low doses of sulpiride (50-300 mg / day) are effective for dizziness, regardless of etiology. Sulpiride stimulates prolactin secretion and has a central antiemetic effect (inhibition of the emetic center) due to blockade of the dopamine D2 receptors of the trigger zone of the emetic center.

Dosage Forms

reg. No: P N012589 / 02 of 02/02/11 - indefinitely
Eglonil ®
reg. No: P N012589 / 03 from 03.30.11 - indefinitely
reg. No .: LS-001769 from 10.19.11 - current
reg. No: P N012589 / 01 dated 10/14/11 - indefinitely

Pharmacokinetics

With intramuscular injection of 100 mg of the drug, the maximum concentration of sulpiride in blood plasma is reached after 30 minutes and is 2.2 mg / L.

When administered orally, the maximum concentration of sulpiride in plasma is reached after 3-6 hours and is 0.73 mg / l when taking one tablet containing 200 mg and 0.25 mg / ml for one capsule containing 50 mg.
The bioavailability of dosage forms intended for oral administration is 25-35% and is characterized by significant individual variability.
Sulpiride has linear kinetics after taking doses in the range of 50 to 300 mg. Sulpiride rapidly diffuses into the body tissue: the apparent volume of distribution in the equilibrium state is 0.94 l / kg.
Plasma protein binding is approximately 40%.
Small amounts of sulpiride appear in breast milk and cross the placental barrier.
In the human body, sulpiride is only slightly metabolized: 92% of the administered intramuscular dose is absorbed in the urine unchanged.
Sulpiride is excreted mainly through the kidneys, by glomerular filtration. Full clearance 126 ml / min. The half-life of the drug is 7 hours.

Instructions for Eglonil (Method and dosage)

The dosage, method of administration and duration should be prescribed by a specialist.

When using tablets, the daily dose can be about 0.2 - 1 gram, capsules - 0.05-0.15 g. The dose is divided into 3 doses, the course is about a month.

To achieve a quick effect or relief of acute symptoms, injections of the drug are prescribed intramuscularly.

According to the instructions for use of Eglonil, when using the drug in ampoules, the daily dose is 0.4-0.8 g. Injections are carried out three times a day, for 2 weeks, then switch to tablets or capsules.

It is recommended to apply the product no more than 4 hours before bedtime, in order to avoid insomnia.

Tablets

Therapy with the use of tablets provides for the oral use of the drug in a daily dosage of 200 to 1000 mg.

The dose is divided into 2-3 doses. It is important to distribute the time of the procedures so that the last dose is taken until 16-00. This will help to avoid problems with insomnia.

The product is swallowed whole, washed down with a glass of water. No need to adjust to meals.

The purpose of using oral agents is to achieve a therapeutic effect for various mental disorders, the nervous system, as well as preventing the development of relapse (for prevention).

Most often, the tablet form is used for schizophrenia, depression, acute delirious psychosis.

Dosage and administration

creatinine clearance (ml / min)dose of sulpiride compared to standard (%)increase in the interval between receptions of Sulpiride
30-60 ml / min701.5 times
10-30 ml / min502 times
less than 10 ml / min303 times

Side effect
Adverse events that develop as a result of taking sulpiride are similar to adverse events caused by other psychotropic drugs, but their frequency of development is generally less.
From the endocrine system: reversible hyperprolactinemia may develop, the most common manifestations of which are galactorrhea, amenorrhea, menstrual irregularities, less commonly gynecomastia, impotence and frigidity. During treatment with sulpiride, excessive sweating, an increase in body weight may be noted. From the digestive system: increased activity of liver enzymes. From the side of the central nervous system: sedation, drowsiness, dizziness, tremor, early dyskinesia (spastic torticollis, oculogyric crises, trismus), which occurs when prescribing an anticholinergic antiparkinson drug, rarely extrapyramidal syndrome and related disorders (akinesia, sometimes combined with muscle hypertension and partially eliminated anticholinergic antiparkinson drugs, hyperkinsia-hypertonicity, motor agitation, akathasia).
Cases of tardive dyskinesia, characterized by involuntary rhythmic movements, mainly of the tongue and / or face, were noted during long courses of treatment, which can be observed during treatment with all antipsychotics: the use of anti -arkinson drugs is ineffective or can cause worsening of symptoms.
With the development of hyperthermia, the drug should be discontinued, because an increase in body temperature may indicate the development of malignant antipsychotic syndrome (ZNS).
From the cardiovascular system: tachycardia, an increase or decrease in blood pressure is possible, in rare cases, the development of orthostatic hypotension, lengthening of the QT interval, very rare cases of the development of the "torsade de pointes" syndrome are possible.
Allergic reactions: skin rash is possible.

Overdose
Experience with overdose of sulpiride is limited. There are no specific symptoms, there may be: dyskinesia with spastic torticollis, protrusion of the tongue and trismus, blurred vision, arterial hypertension, sedation, nausea, extrapyramidal symptoms, dry mouth, vomiting, increased sweating and gynecomastia, possibly the development of central nervous system. Some patients have Parkinson's syndrome. Sulpiride is partially excreted during hemodialysis.
In 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 (the risk of prolonging the QT interval), which should continue until the patient recovers completely, central anticholinergic drugs are prescribed for the development of severe extrapyramidal syndrome.

Interactions with other drugs
Contraindicated combinations
Dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, pyribedil, pramipexole, kinagolid, ropinirole), except for patients with Parkinson's disease. Mutual antagonism exists between dopaminergic receptor agonists and antipsychotics. In extrapyramidal syndrome induced by antipsychotics, dopaminergic receptor agonists are not used; in such cases, anticholinergics are used.
Sultoprid
The risk of ventricular arrhythmias, in particular atrial fibrillation, is increased.
Not recommended combinations
Drugs that can cause ventricular arrhythmias of the “torsade de pointes” type: antiarrhythmic drugs of class Ia (quinidine, hydroquinidine, disopyramide) and class III (amiodarone, sotalol, dofetilide, ibutilide), some antipsychotics (thioridazine, chlorpromazine, levomepromazine, triflumezine, trifluzemaz, amisulpride, tiapride, haloperidol, droperidol, pimozide) and other drugs, such as: beprids, cisapride, difemanip, intravenous erythromycin, misolastine, intravenous vincamine, etc.
Alcohol
Alcohol enhances the sedative effect of antipsychotics. Violation of attention creates a danger to driving vehicles and working on machines. Avoid drinking alcohol and taking medications that contain alcohol.
Levodopa
Mutual antagonism between levodopa and antipsychotics. Patients with Parkinson's disease should be prescribed the minimum effective dose of both drugs.
Dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, pyribedil, pramipexole, kinagolide, ropinirole) in patients with Parkinson's disease.
Mutual antagonism exists between dopaminergic receptor agonists and antipsychotics. The above drugs can cause or exacerbate psychosis. If neuroleptic treatment is necessary for a patient suffering from Parkinson's disease and receiving a dopaminergic antagonist, the dose of the latter should be gradually reduced until canceled (abrupt cancellation of dopaminergic agonists can lead to the development of malignant antipsychotic syndrome).
Halofantrine, pentamidine, sparfloxacin, moxifloxacin.
The risk of ventricular arrhythmias, in particular torsade de pointes, is increasing.
If possible, you should cancel the antimicrobial drug that causes ventricular arrhythmia.
If combinations cannot be avoided, first check the QT interval and ensure ECG monitoring.

Combinations requiring caution
Drugs that cause bradycardia (calcium channel blockers with bradycardia: diltiazem, verapamil, beta-blockers, clonidine, guanfacine, digitalis alkaloids, cholinesterase inhibitors: donepezil, rivastigmine, tacrine, ambenminyndium chloride, non-girnamide chloride,
The risk of ventricular arrhythmias, in particular torsade de pointes, is increasing.
Clinical and ECG monitoring is recommended.
Drugs that lower the level of potassium in the blood (potassium-excreting diuretics, laxatives of a stimulating nature, amphotericin B (intravenously), glucocorticoids, tetracosactide).
The risk of ventricular arrhythmias, in particular torsade de pointes, is increasing.
Before prescribing the drug, hypokalemia should be eliminated and clinical, cardiographic control, as well as electrolyte level control, should be established.
Combinations to consider:
Antihypertensive drugs: increased hypotensive effect and increased possibility of postural hypotension (additive effect).
Other central nervous system depressants:
Morphine derivatives (analgesics, antitussive drugs and substitution therapy), barbiturates, benzodiazepines and other anxiolytics, hypnotics, sedative antidepressants, sedative histamine H receptor antagonists1, central antihypertensive drugs, baclofen, thalidomide.
Oppression of the central nervous system. Violation of attention creates a danger to driving vehicles and working on machines.
Sucralfate, antacids containing Mg 2+ and / or A 13+, reduce the bioavailability of dosage forms for oral administration by 20-40%. Sulpiride should be prescribed two hours before they are taken.

special instructions
Malignant antipsychotic syndrome: with the development of hyperthermia of undiagnosed origin, sulpiride should be abolished, as this may be one of the signs of the malignant syndrome described with the use of antipsychotics (pallor, hyperthermia, autonomic dysfunction, impaired consciousness, muscle stiffness).
Signs of autonomic dysfunction, such as increased sweating and labile blood pressure, can precede the onset of hyperthermia and, therefore, represent early warning signs.
Although such an action of antipsychotics may have an idiosyncratic origin, it seems that some risk factors may predispose to it, for example, dehydration or organic brain damage.
OT interval increase: sulpiride lengthens the QT interval depending on the dose. This action, which is known to increase the risk of developing serious ventricular arrhythmias, such as torsade de pointes, is more pronounced in the presence of bradycardia, hypokalemia, or a congenital or acquired prolonged QT interval (combination with a drug that causes an extension of the QT interval).
If the clinical situation allows, it is recommended prior to prescribing the drug to verify the absence of factors that can contribute to the development of this type of arrhythmia:

  • bradycardia with the number of strokes less than 55 beats / min.
  • hypokalemia
  • congenital lengthening of the QT interval,
  • simultaneous treatment with a drug that can cause severe bradycardia (less than 55 bpm), hypokalemia, slowing of intracardiac conduction or lengthening of the QT interval.
Except in cases of urgent intervention, patients who require treatment with antipsychotics are recommended to conduct an ECG during the status assessment process.
Except 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 strengthened; in severe forms of renal failure, alternating courses of treatment are recommended.
Control during treatment with sulpiride should be enhanced:
  • In patients with epilepsy, since the convulsive threshold can be lowered,
  • In the treatment of elderly patients who are more sensitive to postural hypotension, sedation and extrapyramidal effects
The consumption of alcohol or the use of drugs containing alcohol during treatment with the drug is strictly prohibited.

Impact on the ability to drive vehicles and mechanisms
During treatment with Eglonil it is forbidden to drive vehicles and work with mechanisms that require increased attention, as well as alcohol intake.

Release form
200 mg tablets:
12 tablets in a blister of PVC / Al foil. 1 or 5 blisters with instructions for use in a cardboard box.
Capsules 50 mg:
15 capsules per blister of PVC / Al foil. 2 blisters with instructions for use in a cardboard box.
Solution for intramuscular injection of 50 mg / mp:
2 ml in ampoules of colorless glass with a fracture ring and the application of three rings. 6 ampoules are placed in a contour packaging made of PVC. 1 contour package with ampoules together with instructions for use in a cardboard box.

Shelf life
3 years.
Do not use after the expiration date indicated on the package.

Storage conditions
Store at a temperature not exceeding 30 ° C.
Keep out of the reach of children.
List B.

Holidays from pharmacies: on prescription.

Manufacturer
Sanofi Winthrop Industry - 82 Raspay Avenue, 94250, Gentilly, France
Claims of consumers should be sent to the address in Russia:
115035, Moscow, st. Sadovnicheskaya, house 82, p. 2

Indications of the drug Eglonil ®

Acute and chronic psychoses (lethargy, delirium, confusion, agramatism, abulia), schizophrenia, neurotic states accompanied by lethargy, psychosomatic symptoms (especially with gastric and duodenal ulcers and hemorrhagic rectocolitis).

Overdose

May occur: dyskinesia, cramps, torticollis, visual impairment, arterial hypertension, nausea and dry mouth, sweating and weakness extrapyramidal effect.

Hemodialysis gives partial relief. Therapy - according to symptoms, closely monitor breathing and heart rate. Possible application anticholinergic drugs of central action.

Capsules

This form of the drug is used to eliminate the symptoms characteristic of neurosis and other disorders of adult patients, inadequate changes in children's behavior.

Adults are prescribed a daily norm of the drug - 50-150 mg, for children - 5-10 mg for each kg of the child’s weight.

The maximum course of therapy is 1 month.

Doses for patients who have impaired renal function are reduced in order to reduce the burden on them. The therapy is carried out under strict control by medical personnel.

Interaction

Concomitant use is contraindicated. cabergoline, kinagolide, levodopa and Eglonila.

Do not combine with others sedatives means and ethanol, to avoid mutual amplification of effects.

With caution, combine with blood pressure lowering drugs.

Medications with side effects that are at risk paroxysmal ventricular tachycardiashould not be combined with Eglonil.

Concomitant use with: pentamidine, lumefantrine, halofantrine, antifungal agents, amantadine, apomorphine, bromocriptine, entacapone, lisuride, pramipexole, selegiline, disopyramide, quinidine, sotalol, ibutilide, dofetilide, cisapride, chloromethromidomideromidomeridomethromidomeridomerit etc.

Side effects

Compared with other psychotropic substances, sulpiride causes side effects. with less intensity.

Basically, the negative reaction of the body is due to violations of the dosage, the use of the drug. But most often, complications develop against the background of a long course of therapy.

Among the possible manifestations:

  • increased activity of liver enzymes,
  • menstrual irregularities (including its absence for 6 months), frigidity, decreased potency,
  • unreasonable weight gain,
  • spontaneous outflow of milk from the mammary glands (observed regardless of the gender and age of the patient),
  • improper head position caused by pathological tension of the muscles of the cervical spine,
  • tonic spasm of chewing muscles,
  • drowsiness,
  • trembling fingers
  • dizziness.

In rare cases, extrapyramidal syndrome is fixed with signs characteristic of the pathology:

  • motor excitement
  • internal anxiety
  • impaired motor activity.

A psychotropic agent in large doses can have a negative effect on the heart and blood vessels.

Among the possible side effects in this area:

  • horse racing
  • lowering blood pressure due to insufficient blood flow to the brain,
  • tachycardia.

Pirouette tachycardia is extremely rare.

Contraindications

- prolactin-dependent tumors (e.g., pituitary prolactinomas and breast cancer),

- acute intoxication with ethanol, hypnotics, opioid analgesics,

- affective disorders, aggressive behavior, manic psychosis,

- breastfeeding period,

- children's age up to 18 years (for tablets and solution for i / m administration),

- children's age up to 6 years (for capsules),

- in combination with sultopride, dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, pyribedil, pramipexole, kinagolid, ropinirole),

- Hypersensitivity to sulpiride or another ingredient of the drug.

Due to the presence of lactose in the preparation, it is contraindicated in congenital galactosemia, glucose / galactose malabsorption syndrome or lactase deficiency.

The appointment of sulpiride for pregnant women is not recommended, unless the doctor, having assessed the ratio of benefit and risk to the pregnant woman and the fetus, decides that the use of the drug is necessary.

The use of sulpiride in combination with ethanol, levodopa, drugs that can cause ventricular arrhythmias of the "torsade de pointes" type (antiarrhythmic drugs of class 1a (quinidine, hydroquinidine, disopyramide) and class III (amiodarone, sotalol, dofetilide, ibutilide)), some antipsychotics (thioridazine, chlorpromazine, levomepromazine, trifluoperazin, cyamemazine, amisulpride, tiapride, pimozide, haloperidol, droperidol) and other drugs, such as: bepridil, cisapride, diphemanil, intravenous erythromastin, m vincamine, halofantrine, pentamidine, sparfloxacin, moxifloxacin, etc.

Precautions must be observed when prescribing sulpiride to patients with renal and / or liver failure, a history of malignant antipsychotic syndrome, epilepsy, or seizures in history, severe heart disease, arterial hypertension, patients with parkinsonism, dysmenorrhea, in old age.

Pregnancy and lactation

Pregnancy
Maternal mental health should preferably be maintained throughout pregnancy to avoid decompensation. If drug therapy is needed to ensure mental health, it must be started or continued in effective doses throughout pregnancy.
Analysis of the exposures that took place during pregnancy did not see any particular teratogenic effect of sulpiride.
Injectable forms of antipsychotics, used in emergency cases, can cause
the mother has hypotension.
The use of sulpiride can be considered at any stage of pregnancy. Newborns exposed to antipsychotic drugs (including Eglonil) during the third trimester of pregnancy are at risk of side effects, including extrapyramidal and / or withdrawal symptoms, which may vary in intensity and duration after birth. The following reactions have been reported: agitation, hypertension, hypotension, tremors, drowsiness, respiratory distress, and feeding difficulties. Therefore, newborns should be closely monitored.
Breastfeeding
Since the drug passes into breast milk, breastfeeding is not recommended during treatment.

Dosage regimen

Intramuscular solution

In acute and chronic psychoses, treatment begins with a / m injection at a dose of 400-800 mg / day and continues in most cases for 2 weeks. The goal of therapy is to achieve the minimum effective dose.

With the v / m administration of sulpiride, the usual rules for v / m injection are observed: deep into the outer upper quadrant of the gluteus maximus, the skin is pre-treated with an antiseptic.

Depending on the clinical picture of the disease, IM injections of sulpiride are prescribed 1-3 times / day, which allows you to quickly mitigate or stop the symptoms. As soon as the patient's condition allows, you should proceed 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 the minimum effective dose.

It is not recommended to take the drug in the afternoon (after 16 hours) due to an increase in activity level.

Acute and chronic schizophrenia, acute delirious psychosis, depression: the daily dose is from 200 to 1000 mg, divided into several doses.

Neurosis and anxiety in adult patients: the daily dose is from 50 to 150 mg for 4 weeks maximum.

Severe behavioral disorders in children: the daily dose is from 5 to 10 mg / kg body weight.

Doses for the elderly: the initial dose of sulpiride should be 1 / 4-1 / 2 doses for adults.

Doses in patients with impaired renal function

Due to the fact that sulpiride is excreted mainly through the kidneys, it is recommended to reduce the dose of sulpiride and / or increase the interval between the administration of individual doses of the drug, depending on the parameters of QC:

QC (ml / min)Dose of Sulpiride compared to the standard (%)Increasing the interval between receptions of Sulpiride
30-60 ml / min701.5 times
10-30 ml / min502 times
less than 10 ml / min303 times

Side effect

Adverse events that develop as a result of taking sulpiride are similar to adverse events caused by other psychotropic drugs, but their frequency of development is generally less.

From the endocrine system: the development of reversible hyperprolactinemia is possible, the most common manifestations of which are galactorrhea, amenorrhea, menstrual irregularities, less commonly gynecomastia, impotence and frigidity. During treatment with sulpiride, excessive sweating, an increase in body weight may be noted.

From the digestive system: increased activity of liver enzymes.

From the side of the central nervous system: sedation, drowsiness, dizziness, tremor, early dyskinesia (spastic torticollis, oculogyric crises, trismus), which occurs when prescribing an anticholinergic antiparkinson drug, rarely extrapyramidal syndrome and related disorders (akinesia, sometimes combined with muscle and hypertension partially eliminated when prescribing anticholinergic antiparkinson drugs, hyperkinesia-hypertonicity, motor agitation, akathasia). Cases of tardive dyskinesia, characterized by involuntary rhythmic movements, mainly of the tongue and / or face, were noted during long courses of treatment, which can be observed during treatment with all antipsychotics: the use of antiparkinson drugs is ineffective or can cause worsening of symptoms. With the development of hyperthermia, the drug should be discontinued, because an increase in body temperature may indicate the development of malignant antipsychotic syndrome (ZNS).

From the cardiovascular system: tachycardia, possible increase or decrease in blood pressure, in rare cases, the development of orthostatic hypotension, lengthening of the QT interval, very rare cases of the development of the "torsade depointes" syndrome.

Allergic reactions: skin rash is possible.

Dosage

Eglonil® capsules are taken orally with a small amount of liquid, regardless of the meal.

In all cases, the minimum effective dose should be used. If the clinical condition of the patient allows, treatment should begin with low doses. The minimum effective dose is selected by gradually increasing the dose until the desired effect is achieved.

Short-term symptomatic treatment of anxiety conditions with the ineffectiveness of conventional methods of treatment.

The daily dose is 50-150 mg for no more than 4 weeks.

Children over 6 years old

Severe behavioral disorders (agitation, self-harm, stereotype), especially with autism syndromes.

The daily dose is 5-10 mg / kg body weight.

Doses for the elderly

The initial dose of sulpiride should be 1 / 4-1 / 2 doses for adults.

Doses in patients with impaired renal function

Due to the fact that sulpiride is excreted mainly through the kidneys, it is recommended to reduce the dose of sulpiride and / or increase the interval between taking individual doses of the drug depending on the creatinine clearance: when creatinine clearance is 30-60 ml / min, the dose of sulpiride should be reduced by 30 %, and the intervals between doses should be increased by 1.5 times, with creatinine clearance of 10-30 ml / min, the dose of sulpiride should be reduced by 2 times, and the intervals between doses should be increased by 2 times, with creatine clearance less than 10 ml / min, the dose of sulpiride should be reduced by 70%, and the intervals between doses of the drug should be increased 3 times.

Pregnancy and lactation

Animal experiments did not reveal teratogenic effects. In a small number of women who took low doses of sulpiride (approximately 200 mg / day) during pregnancy, there was no teratogenic effect. With regard to the use of higher doses of sulpiride, data are not available. There is also no evidence of the potential effect of antipsychotic drugs taken during pregnancy on fetal brain development.Therefore, as a precaution, it is preferable not to use sulpiride during pregnancy.

However, in the case of the use of this drug during pregnancy, it is recommended to limit the dose and duration of treatment as far as possible. In newborns whose mothers received long-term treatment with high doses of antipsychotics, gastrointestinal symptoms (bloating, etc.) associated with the atropine-like action of some drugs (especially in combination with antiparkinson 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 prescribing the drug shortly before childbirth, control over the activity of the nervous system of the newborn is justified.

The drug passes into breast milk, so you should stop taking the drug during breastfeeding.

Reviews of patients taking the drug

Vladimir, 54 years old:

Neurologist advised Eglonil tablets. The daily dose was 50 mg for the first 2 days, and 100 mg for the next 5 days.

The psychoemotional state has improved significantly. In combination with outdoor recreation in the sanatorium, therapy was more than successful.

Larisa, 47 years old:

For 10 days I took Eglonil at 50 mg per day. In the evenings before going to bed, my husband and I arranged walks, and in the morning jogs. Through the efforts of a specialist and a loved one, she returned to normal.


Doctors reviews

Irina Vladimirovna, medical experience 12 years:

Side effects are more common with prolonged use of tablets. In my practice, this was noted once in the scheme: a three-week dose of 100 mg. Weight gain is also possible.

I recommend antipsychotics in short courses (up to 1 week), this will help the patient more easily endure difficult life situations.

Varvara Vasilievna, medical experience 26 years:

The course of therapy is determined depending on the degree of complexity of the patient's condition (on average 1-3 weeks). To prevent the development of side effects, I recommend sparing dosages.

The drug works well when all the requirements are observed, especially with regard to alcohol, combination with other pharmacological products and the time of taking the tablets (the last part of the daily dose is used until 16-00).

I do not use Eglonil if the heart rate is less than 55 beats / min.

Analogs

In some cases, for a number of reasons, it is not possible to use Eglonil, so there is a need to select an analogue.

Doing it yourself is strictly prohibited. The drug should not only correspond to the pharmacological properties of the original, but also be suitable for the patient's symptoms.

You can’t do without qualified help.

Among the effective substitutes, the following funds are allocated:

  • Betamax ,
  • Restful ,
  • Sulpiride-ZN,
  • Solex .


The drug Eglonil has both structural analogues and drugs that have a similar pharmacological effect.

The substitute's abstract should be carefully studied before starting treatment, especially in the sections of contraindications and methods of use.

Application features

Malignant antipsychotic syndrome: with the development of hyperthermia of undiagnosed origin, sulpiride should be abolished, as this may be one of the signs of the malignant syndrome described with the use of antipsychotics (pallor, hyperthermia, autonomic dysfunction, impaired consciousness, muscle stiffness).
Signs of autonomic dysfunction, such as increased sweating and labile blood pressure, can precede the onset of hyperthermia and, therefore, represent early warning signs.
Although such an action of antipsychotics may have an idiosyncratic origin, it seems that some risk factors may predispose to it, for example, dehydration or organic brain damage.
Increase in QT interval. sulpiride lengthens the QT interval depending on the dose. This action, which is known to increase the risk of developing serious ventricular arrhythmias, such as torsade de pointes, is more pronounced in the presence of bradycardia, hypokalemia, or a congenital or acquired prolonged QT interval (combination with a drug that causes an extension of the QT interval).
If the clinical situation allows, it is recommended to verify the absence of factors that can contribute to the development of this type of arrhythmia before prescribing the drug:
- bradycardia with the number of strokes less than 55 beats / min.
- hypokalemia,
- congenital lengthening of the QT interval,
- simultaneous treatment with a drug that can cause severe bradycardia (less
55 bpm), hypokalemia, slowing of intracardiac conduction or lengthening

QT interval (See Contraindications and Interactions with Other Medicines).
Except in cases of urgent intervention, patients who require treatment with antipsychotics are recommended to conduct an ECG during the status assessment process.
Brain stroke
In a randomized, placebo-controlled clinical trial involving elderly patients with dementia treated with atypical antipsychotics, there was an increased risk of stroke in relation to placebo. The reason for this increased risk is unknown. It cannot be ruled out that there is an increased risk in connection with other antipsychotic drugs and in other patient populations ›:. This drug should be used with caution in the case of patients with risk factors for stroke.
This medication is not recommended for use with alcohol, levodopa, lithium, antiparkinsonian dopamine agonists, antiparasitic drugs that can cause torsade de pointes, methadone, other antipsychotics and drugs, and can cause torsade de pointes (see Interactions with other medicinal products. means).
Keep in mind the risk of developing tardive dyskinesia, even at low doses, especially in elderly patients.
Since the safety and effectiveness of sulpiride have not been fully studied in children, precautions should be observed when using this drug (see Dosage and Method of Use). An annual clinical examination is recommended to assess learning ability due to the effect of sulpiride on cognitive function. The dosage should be regularly adjusted depending on the clinical condition of the children.
The use of hard capsules is contraindicated in children under 6 years of age, as they may choke.
This drug contains lactose, and therefore is not recommended for patients with congenital galactosemia, glucose and galactose malabsorption syndrome and lactase deficiency.
Elderly patients with dementia:
Pozhilt patients with psychosis on the background of dementia receiving treatment with antipsychotics, increased risk of death. An analysis of seventeen placebo-controlled studies (average duration 10 weeks), mainly in patients taking atypical antipsychotics, saw an increase in the risk of death in the group of patients taking drugs, 1.6 - 1.7 times compared with patients in a placebo group. During the average 10-week period of controlled studies, the mortality rate in the group of patients receiving the drug was about 4.5%, while in the placebo group it was about 2.6%. Despite the fact that the causes of death in clinical trials of atypical antipsychotics were different, most of the deaths were cardiovascular (heart failure, sudden death) or infectious (pneumonia). The results of epidemiological studies suggest that, as in the case of atypical antipsychotics, treatment with traditional antipsychotics can also lead to increased mortality.
The extent to which results indicating an increase in mortality in epidemiological studies may be due to the use of antipsychotics and not to other patient characteristics is not clear.
Venous thromboembolism:
When using antipsychotics, cases of venous thromboembolism, sometimes fatal, have been reported. Therefore, antipsychotics should be used with caution in

patients with risk factors for thromboembolism (see section "Side effects").

Drug interaction

Dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, pyribedil, pramipexole, kinagolide, ropinirole), except for patients suffering from Parkinson's disease: there are mutual antagonists between dopaminergic receptor antagonists and antipsychotics. In extrapyramidal syndrome induced by antipsychotics, dopaminergic receptor agonists are not used; in such cases, anticholinergics are used.

Suloprid: increased risk of ventricular arrhythmias, in particular atrial fibrillation.

Drugs that can cause ventricular arrhythmias of the “torsade de pointes” type: antiarrhythmic drugs of class Ia (quinidine, hydroquinidine, disopyramide) and class III (amiodarone, sotalol, dofetilide, ibutilide), some antipsychotics (thioridazine, chlorpromazine, levomepromazine, triflumezine, trifluzemaz, amisulpride, tiapride, haloperidol, droperidol, pimozide) and other drugs, such as: bepridil, cisapride, diphemanil, intravenous erythromycin, misolastine, intravenous vincamine, etc.

Ethanol: enhances the sedative effect of antipsychotics. Violation of attention creates a danger to driving vehicles and working on machines. Avoid the consumption of alcoholic beverages and the use of medicines containing ethyl alcohol.

Levodopa: there is a mutual antagonism between levodopa and antipsychotics. Patients with Parkinson's disease should be given the minimum effective dose of both drugs.

Dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, pyribedil, pramipexole, kinagolide, ropinirole) in patients with Parkinson's disease: there are mutual antagonists between antagonists of dopaminergic receptors and antipsychotics. The above drugs can cause or exacerbate psychosis. If neuroleptic treatment is necessary for a patient suffering from Parkinson's disease and receiving a dopaminergic antagonist, the dose of the latter should be gradually reduced until canceled (abrupt cancellation of dopaminergic agonists can lead to the development of malignant antipsychotic syndrome).

Halofantrine, pentamidine, sparfloxacin, moxifloxacin: the risk of ventricular arrhythmias, in particular "torsade de pointes", is increased. If possible, you should cancel the antimicrobial drug that causes ventricular arrhythmia. If combinations cannot be avoided, first check the QT interval and ensure ECG monitoring.

Combinations requiring caution

Drugs that cause bradycardia (calcium channel blockers with bradycardia: diltiazem, verapamil, beta-blockers, clonidine, guanfacine, digitalis alkaloids, cholinesterase inhibitors: donepezil, rivastigmine, tacrine, galbamide amyndinmind) , in particular "torsade de pointes". Clinical and ECG monitoring is recommended.

Drugs that lower blood potassium levels (potassium-releasing diuretics, stimulant laxatives, amphoteric B (iv), glucocorticoids, tetracosactides): the risk of ventricular arrhythmias, in particular "torsade de pointes", is increased. Before prescribing the drug, hypokalemia should be eliminated and clinical, cardiographic control, as well as electrolyte level control, should be established.

Combinations to consider:

Antihypertensive drugs: increased hypotensive effect and increased possibility of postural hypotension (additive effect).

Other central nervous system depressants: morphine derivatives (analgesics, antitussive drugs and replacement therapy), barbiturates, benzodiazepines and other anxiolytics, hypnotics, sedative antidepressants, sedative histamine H 1 receptor antagonists, central antihypertensive drugs, baclofen, thalidomide - creates a danger to driving vehicles and working on machines.

Sucralfate, antacids containing Mg2 + and / or A13 +, reduce the bioavailability of dosage forms for oral administration by 20-40%. Sulpiride should be prescribed 2 hours before they are taken.

Special instructions

Malignant antipsychotic syndrome: with the development of hyperthermia of undiagnosed origin, sulpiride should be abolished, as this may be one of the signs of the malignant syndrome described with the use of antipsychotics (pallor, hyperthermia, autonomic dysfunction, impaired consciousness, muscle stiffness).

Signs of autonomic dysfunction, such as increased sweating and labile blood pressure, can precede the onset of hyperthermia and, therefore, represent early warning signs.

Although such an action of antipsychotics may have an idiosyncratic origin, it seems that some risk factors may predispose to it, for example, dehydration or organic brain damage.

Increased QT interval: Sulpiride prolongs the QT interval depending on the dose. This action, which is known to increase the risk of developing serious ventricular arrhythmias, such as torsade de pointes, is more pronounced in the presence of bradycardia, hypokalemia, or a congenital or acquired prolonged QT interval (combination with a drug that causes an extension of the QT interval).

If the clinical situation allows, it is recommended prior to prescribing the drug to verify the absence of factors that can contribute to the development of this type of arrhythmia:

- bradycardia with the number of strokes less than 55 beats / min,

- congenital lengthening of the QT interval,

- simultaneous treatment with a drug that can cause severe bradycardia (less than 55 beats / min), hypokalemia, slowing of intracardiac conduction or lengthening of the QT interval.

Except in cases of urgent intervention, patients who require treatment with antipsychotics are recommended to conduct an ECG during the status assessment process.

Except 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 strengthened; in severe forms of renal failure, alternating courses of treatment are recommended.

Control during treatment with sulpiride should be enhanced:

- in patients with epilepsy, since the convulsive threshold can be lowered,

- in the treatment of elderly patients who are more sensitive to postural hypotension, sedation and extrapyramidal effects.

The consumption of alcohol or the use of drugs containing ethyl alcohol during treatment with the drug is strictly prohibited.

Influence on the ability to drive vehicles and control mechanisms

During treatment with Eglonil it is forbidden to drive vehicles and work with mechanisms that require increased attention, as well as alcohol.

Precautionary measures

Patients with diabetes or diabetes risk factors who have started treatment with sulpirmdom should undergo appropriate blood glucose monitoring.
Except 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 strengthened; in severe forms of renal failure, alternating courses of treatment are recommended.
Monitoring of sulpiride treatment should be enhanced:
in patients with epilepsy, since the convulsive threshold can be lowered, there have been more cases of convulsive seizures in patients treated with sulpiride (see Adverse effect). Therefore, patients with a history of epilepsy during treatment with sulpiride should be closely monitored,
in the treatment of elderly patients who are more sensitive to postural hypotension, sedation and extrapyramidal effects.
Cases of leukopenia, neutropenia, and agranulocytosis have been reported using antipsychotic drugs, including Eglonil. Unexplained infections or unexplained fever may be signs of leukopenia, an analysis must be done immediately


Impact on the ability to drive vehicles and mechanisms
The attention of patients, especially those who drive a car or work with working mechanisms, should be paid to the possibility of drowsiness when using this medication (see Side effect).

Pregnancy and lactation

Animal experiments did not reveal teratogenic effects. In a small number of women who took low doses of sulpiride (approximately 200 mg / day) during pregnancy, there was no teratogenic effect. With regard to the use of higher doses of sulpiride, data are not available. There is also no evidence of the potential effect of antipsychotic drugs taken during pregnancy on fetal brain development. Therefore, as a precaution, it is preferable not to use sulpiride during pregnancy.

However, in the case of the use of this drug during pregnancy, it is recommended to limit the dose and duration of treatment as far as possible. In newborns whose mothers received long-term treatment with high doses of antipsychotics, gastrointestinal symptoms (bloating, etc.) associated with the atropine-like action of some drugs (especially in combination with antiparkinson 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 prescribing the drug shortly before childbirth, control over the activity of the nervous system of the newborn is justified.

The drug passes into breast milk, so you should stop taking the drug during breastfeeding.

Watch the video: Side Effects of Antipsychotic Drugs. Schizophrenia (February 2020).