Eglonil solution for injection 50mg / ml, 2 ml No. 6

As monotherapy or in combination with other psychotropic drugs.

• acute and chronic schizophrenia;

• acute delirious conditions;

• depression of various etiologies;

• neuroses and anxiety in adult patients, with the ineffectiveness of conventional treatment methods (only for 50 mg capsules);

• severe behavioral disorders (agitation, self-harm, stereotypy) in children over the age of 6, especially in combination with autism syndromes (only for 50 mg capsules).

Solution for intramuscular administration
In acute and chronic psychoses, treatment begins with intramuscular injections 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 intramuscular injection of sulpiride, the usual rules for intramuscular injections are observed: deep into the outer upper quadrant of the gluteus maximus, the skin is pretreated with an antiseptic.
Depending on the clinical picture of the disease, intramuscular injections of sulpiride are prescribed 1-3 times a day, which can quickly alleviate or stop symptoms. As soon as the patient's condition allows, one should proceed to taking the drug inside. The course of treatment is determined by the doctor.
Tablets and capsulestake 1-3 times a day 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 4 pm) due to the increased activity level.
Tablets:
Acute and chronic schizophrenia, acute delirious psychosis, depression: the daily dose is 200 to 1000 mg, divided into several doses.
Capsules:
Neuroses and anxiety in adult patients: the daily dose is 50 to 150 mg for a maximum of 4 weeks.
Severe behavioral disorders in children: the daily dose is 5 to 10 mg / kg body weight.
Doses for the elderly:the initial dose of sulpiride should be? -? doses 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 increase the interval between the administration of individual doses of the drug, depending on the creatinine clearance parameters.

1 ml of solution contains as active ingredient:
Sulpiride - 50 mg.
Excipients: sulfuric acid, sodium chloride, water for injection

• hypersensitivity to sulpiride or another ingredient in the drug

• prolactin-dependent tumors (eg, pituitary prolactinomas and breast cancer)

• hyperprolactinemia

• acute intoxication with alcohol, sleeping pills, narcotic analgesics

• mood disorders, aggressive behavior, manic psychosis

• pheochromocytoma

• breastfeeding period

• children under 18 years of age (for tablets and solution for intramuscular administration)

• children under 6 years of age (for capsules)

• in combination with:

  • Sultoprid.

  • Dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, kinagolide, ropinirole) (see 'Interactions with other drugs'),

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

With caution
It is not recommended to prescribe sulpiride to pregnant women, except in cases where the doctor, having evaluated the balance of benefits and risks for the pregnant woman and the fetus, decides that the use of the drug is necessary.
It is not recommended to prescribe sulpiride in combination with: alcohol, levodopa, drugs 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 neuroleptics (thioridasein, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, amisulpride, tiapride, pimozide, haloperidol, droperidol) and other drugs, such as: bepridil, cisapride, difemanil, intravenous erytholacinetamycin, sphemanil, intravenous erytholokinfamycin, sphaloxanthin etc.
Precautions must be taken when prescribing sulpiride to patients with renal and / or hepatic insufficiency, a history of neuroleptic malignant syndrome, a history of epilepsy or convulsive seizures, severe heart disease, arterial hypertension, patients with parkinsonism, with dysmenorrhea, in old age.

Trade name: EglonilЃ

International non-proprietary name:

sulpiride

Dosage form:

tablets, capsules, solution for intramuscular administration

Composition of the
Tablet:
1 tablet contains as active ingredient:
Sulpiride - 200 mg.
Excipients: potato starch, lactose monohydrate, methylcellulose, colloidal silicon dioxide, talc, magnesium stearate.
Capsules:
1 capsule contains as active ingredient:
Sulpiride - 50 mg.
Excipients: lactose monohydrate, methylcellulose, talc, magnesium stearate.
The capsule shell contains: gelatin, titanium dioxide.
Solution for intramuscular administration of
1 ml of solution contains as active ingredient:
Sulpiride - 50 mg.
Excipients: sulfuric acid, sodium chloride, water for injection

Description
Tablets:
Tablets are white or slightly yellowish with a break line on one side and the brand name 'SLP200' on the other.
Capsules:
Hard gelatin capsules, size No. 4, opaque, white or white with a yellowish-gray shade.
The contents of the capsules are a homogeneous yellowish-white powder.
Solution for intramuscular injection:
Clear, colorless or almost colorless liquid, odorless or almost odorless.

Pharmacotherapeutic group:

antipsychotic agent (neuroleptic).

ATX code: N05AL01.

Pharmacological properties
Sulpiride is an atypical neuroleptic from the group of substituted benzamides.
Sulpiride has a moderate neuroleptic activity in combination with a stimulating and thymoanaleptic (antidepressant) effect. The neuroleptic effect is associated with anti-dopaminergic action. In the central nervous system, sulpiride predominantly blocks the dopaminergic receptors of the limbic system, and has little effect on the neostriatal system, it has an antipsychotic effect. The peripheral action of sulpiride is based on the suppression of presynaptic receptors. An increase in the amount of dopamine in the central nervous system (hereinafter referred to as the CNS) is associated with an improvement in mood, with a decrease - the development of symptoms of depression.
The antipsychotic effect of sulpiride is manifested in doses of more than 600 mg per day, in doses up to 600 mg per 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 relieving negative mental symptoms of gastric ulcer and duodenal ulcer. In irritable bowel syndrome, sulpiride reduces the intensity of abdominal pain and leads to an improvement in the patient's clinical condition. Low doses of sulpiride (50-300 mg per day) are effective for dizziness, regardless of etiology. Sulpiride stimulates the secretion of prolactin and has a central antiemetic effect (suppression of the vomiting center) due to the blockade of dopamine D2 receptors in the trigger zone of the vomiting center.

Pharmacokinetics
With intramuscular injection of 100 mg of the drug, the maximum concentration of sulpiride in the blood plasma is reached after 30 minutes and is 2.2 mg / l.
When administered orally, the maximum plasma concentration of sulpiride 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 biological availability of dosage forms intended for oral administration is 25-35% and is characterized by significant individual variability. Sulpiride has linear kinetics after doses ranging from 50 to 300 mg. Sulpiride quickly diffuses into the tissues of the body: the apparent volume of distribution at steady 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 metabolized only to a small extent: 92% of the intramuscularly administered dose is excreted 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.

Indications for use
As monotherapy or in combination with other psychotropic drugs.

• acute and chronic schizophrenia;

• acute delirious conditions;

• depression of various etiologies;

• neuroses and anxiety in adult patients, with the ineffectiveness of conventional treatment methods (only for 50 mg capsules);

• severe behavioral disorders (agitation, self-harm, stereotypy) in children over the age of 6, especially in combination with autism syndromes (only for 50 mg capsules).

Contraindications

• hypersensitivity to sulpiride or another ingredient in the drug

• prolactin-dependent tumors (eg, pituitary prolactinomas and breast cancer)

• hyperprolactinemia

• acute intoxication with alcohol, sleeping pills, narcotic analgesics

• mood disorders, aggressive behavior, manic psychosis

• pheochromocytoma

• breastfeeding period

• children under 18 years of age (for tablets and solution for intramuscular administration)

• children under 6 years of age (for capsules)

• in combination with:

  • Sultoprid.

  • Dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, kinagolide, ropinirole) (see 'Interactions with other drugs'),

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

With caution
It is not recommended to prescribe sulpiride to pregnant women, except in cases where the doctor, having evaluated the balance of benefits and risks for the pregnant woman and the fetus, decides that the use of the drug is necessary.
It is not recommended to prescribe sulpiride in combination with: alcohol, levodopa, drugs 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 neuroleptics (thioridasein, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, amisulpride, tiapride, pimozide, haloperidol, droperidol) and other drugs, such as: bepridil, cisapride, difemanil, intravenous erytholacinetamycin, sphemanil, intravenous erytholokinfamycin, sphaloxanthin etc.
Precautions must be taken when prescribing sulpiride to patients with renal and / or hepatic insufficiency, a history of neuroleptic malignant syndrome, a history of epilepsy or convulsive seizures, severe heart disease, arterial hypertension, patients with parkinsonism, with dysmenorrhea, in old age.

Pregnancy and breastfeeding
Experiments on animals have not revealed teratogenic effects. In a small number of women who took low doses of sulpiride (about 200 mg / day) during pregnancy, there was no teratogenic effect. No data are available for the use of higher doses of sulpiride. There is also no evidence of the potential effect of antipsychotic drugs taken during pregnancy on fetal brain development.
Therefore, as a precautionary measure, it is preferable not to use sulpiride during pregnancy.
However, in the case of using this drug during pregnancy, it is recommended to limit the dose and duration of the course of treatment as much as possible. In newborns whose mothers received long-term treatment with high doses of antipsychotics, gastrointestinal symptoms (bloating, etc.) associated with the atropine-like effect of certain drugs (especially in combination with antiparkinsonian drugs), as well as 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 delivery, control over the activity of the newborn's nervous system is justified.
The drug passes into breast milk, so you should stop taking the drug during breastfeeding.

Method of administration and dosage

Solution for intramuscular administration
In acute and chronic psychoses, treatment begins with intramuscular injections 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 intramuscular injection of sulpiride, the usual rules for intramuscular injections are observed: deep into the outer upper quadrant of the gluteus maximus, the skin is pretreated with an antiseptic.
Depending on the clinical picture of the disease, intramuscular injections of sulpiride are prescribed 1-3 times a day, which can quickly alleviate or stop symptoms. As soon as the patient's condition allows, one should proceed to taking the drug inside. The course of treatment is determined by the doctor.
Tablets and capsulestake 1-3 times a day 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 4 pm) due to the increased activity level.
Tablets:
Acute and chronic schizophrenia, acute delirious psychosis, depression: the daily dose is 200 to 1000 mg, divided into several doses.
Capsules:
Neuroses and anxiety in adult patients: the daily dose is 50 to 150 mg for a maximum of 4 weeks.
Severe behavioral disorders in children: the daily dose is 5 to 10 mg / kg body weight.
Doses for the elderly:the initial dose of sulpiride should be? -? doses 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 increase the interval between the administration of individual doses of the drug, depending on the creatinine clearance parameters.

Side effect
Adverse events resulting from taking sulpiride are similar to those caused by other psychotropic drugs, but the frequency of their development is generally less.
On the part of the endocrine system: the development of reversible hyperprolactinemia is possible, the most common manifestations of which are galactorrhea, amenorrhea, menstrual irregularities, less often - gynecomastia, impotence and frigidity. During treatment with sulpiride, there may be increased sweating, weight gain. 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 an anticholinergic antiparkinsonian drug is prescribed, rarely extrapyramidal syndrome and related disorders (akinesia, sometimes combined with muscle hypertonia and anticholinergic antiparkinsonian drugs, hyperkinsia-hypertonicity, motor agitation, akatasia).
There have been cases of tardive dyskinesia, characterized by involuntary rhythmic movements, mainly of the tongue and / or face 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 canceled, because an increase in body temperature may indicate the development of neuroleptic malignant syndrome (NMS).
From the side of the cardiovascular system: tachycardia, an increase or decrease in blood pressure is possible, in rare cases, the development of orthostatic hypotension, prolongation of the QT interval, very rare cases of the development of the 'torsade de pointes' syndrome is possible.
Allergic reactions: skin rash is possible.

Overdose
Experience with overdose of suilpiride is limited. There are no specific symptoms, there can be observed: 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 ZNS. 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 (risk of prolongation of the QT interval), which should continue until the patient is fully recovered, anticholinergic blockers of central action are prescribed in the development of severe extrapyramidal syndrome.

Interactions with other drugs
Contraindicated combinations
Dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, kinagolide, ropinirole), except for patients with Parkinson's disease. There is mutual antagonism between dopaminergic receptor agonists and antipsychotics. With extrapyramidal syndrome induced by neuroleptics, dopaminergic receptor agonists are not used; in such cases, anticholinergics are used.
Sultoprid
Increases the risk of ventricular arrhythmias, in particular atrial fibrillation.
Not recommended combinations
Drugs that can cause ventricular arrhythmias of the 'torsade de pointes' type: class Ia antiarrhythmics (quinidine, hydroquinidine, disopyramide) and class III (amiodarone, sotalol, dofetilide, ibutilide), some antipsychotics (thioridazine, chlorpromazine, levomepromazine, trifamoperazine, cyfamoperazine amisulpride, tiapride, haloperidol, droperidol, pimozide) and other drugs such as: bepridsh, cisapride, difemanip, intravenous erythromycin, mizolastine, intravenous vincamine, etc.
Alcohol
Alcohol enhances the sedative effect of antipsychotics. Violation of attention poses a danger to driving vehicles and working on machine tools. The consumption of alcoholic beverages and the use of medicines containing alcohol should be avoided.
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, piribedil, pramipexole, kinagolide, ropinirole) in patients with Parkinson's disease.
There is mutual antagonism between dopaminergic receptor agonists and antipsychotics. The above drugs can induce 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 withdrawal of dopaminergic agonists can lead to the development of neuroleptic malignant syndrome).
Halofantrine, pentamidine, sparfloxacin, moxifloxacin.
The risk of ventricular arrhythmias, in particular 'torsade de pointes', increases.
If possible, the antimicrobial agent causing ventricular arrhythmias should be discontinued.
If the combination cannot be avoided, the QT interval should be checked first and the ECG should be monitored.

 омбинации, требующие осторожности
ѕрепараты, вызывающие брадикардию (блокаторы кальциевых каналов с брадикардическим действием: дилтиазем, верапамил, бета-адреноблокаторы, клонидин, гуанфацин, алкалоиды наперст¤нки, ингибиторы холинэстеразы: донепезил, ривастигмин, такрин, амбенони¤ хлорида, галантамин, пиридостигмин, неостигмин)
”силиваетс¤ риск желудочковых аритмий, в частности 'torsade de pointes'.
–екомендуетс¤ проводить клинический и Ё v контроль.
ѕрепараты, снижающие уровень кали¤ в крови (калийвывод¤щие диуретики, слабительные стимулирующего характера, амфотерицин ¬ (внутривенно), глюкокортикоиды, тетракозактид).
”силиваетс¤ риск желудочковых аритмий, в частности 'torsade de pointes'.
ѕеред назначением препарата следует устранить гипокалиемию и установить клинический, кардиографический контроль, а также контроль уровн¤ электролитов.
 омбинации, которые следует принимать во внимание:
јнтигипертензивные препараты: усиление гипотензивного действи¤ и увеличение возможности постуральной гипотензии (аддитивное действие).
ѕрочие депрессанты центральной нервной системы:
ѕроизводные морфина (анальгетики, противокашлевые средства и заместительна¤ терапи¤), барбитураты, бензодиазепины и другие анксиолитики, снотворные, седативные антидепрессанты, седативные антагонисты гистаминовых рецепторов H1, гипотензивные средства центрального действи¤, баклофен, талидомид.
”гнетение центральной нервной системы. Ќарушение внимани¤ создает опасность дл¤ вождени¤ транспорта и работы на станках.
—укральфат, антацидные средства, содержащие Mg2+ и/или ј13+, снижают биодоступность лекарственных форм дл¤ приЄма внутрь на 20-40%. —ульпирид следует назначать за два часа до их приема.

ќсобые указани¤
«локачественный нейролептический синдром: при развитии гипертермии недиагностированного происхождени¤ сульпирид следует отменить, так как это может быть одним из признаков злокачественного синдрома, описанного при применении нейролептиков (бледность, гипертерми¤, вегетативна¤ дисфункци¤, нарушени¤ сознани¤, ригидность мышц).
ѕризнаки вегетативной дисфункции, такие как усиленное потоотделение и лабильное артериальное давление, могут предшествовать наступлению гипертермии и, следовательно, представл¤ть собой ранние настораживающие признаки.
’от¤ такое действие нейролептиков может иметь идиосинкразическое происхождение, по- видимому, некоторые факторы риска могут предрасполагать к нему, например дегидраци¤ или органическое повреждение мозга.
”величение интервала ќ“: сульпирид удлин¤ет интервал QT в зависимости от дозы. Ёто действие, которое, как известно, усиливает риск развити¤ серьезной желудочковой аритмии, как например 'torsade de pointes', более выражено при наличии брадикардии, гипокалиемии или врожденного или приобретенного удлиненного интервала QT (комбинаци¤ с препаратом, вызывающим удлинение интервала QT).
?сли клиническа¤ ситуаци¤ позвол¤ет, рекомендуетс¤ до назначени¤ препарата убедитьс¤ в отсутствии факторов, которые могут способствовать развитию такого типа аритмии:

• брадикарди¤ с числом ударов менее 55 уд./мин.

• гипокалиеми¤,

• врожденное удлинение интервала QT,

• одновременное лечение препаратом, способным вызывать выраженную брадикардию (менее 55 уд./мин), гипокалиемию, замедление внутрисердечной проводимости или удлинение интервала QT.

«а исключением случаев срочного вмешательства, больным, которым требуетс¤ лечение нейролептиками, рекомендуетс¤ в процессе оценки статуса провести Ё v.
 роме исключительных случаев, этот препарат не должен примен¤тьс¤ у больных, страдающих болезнью ѕаркинсона.
” больных с нарушени¤ми почечной функции следует использовать уменьшенные дозы и усилить контроль; при т¤желых формах почечной недостаточности рекомендуетс¤ проведение перемежающихс¤ курсов лечени¤.
 онтроль при лечением сульпиридом должен быть усилен:

• ” больных эпилепсией, так как судорожный порог может быть понижен,

• ѕри лечении пожилых пациентов, про¤вл¤ющих большую чувствительность к постуральной гипотензии, седации и экстрапирамидным эффектам

ѕотребление алкогол¤ или применение лекарственных средств, содержащих спирт, в ходе лечени¤ препаратом, строго запрещаетс¤.

¬ли¤ние на способность управл¤ть транспортными средствами и механизмами
¬о врем¤ лечени¤ Ёглонилом запрещаетс¤ управление транспортными средствами и работа с механизмами, требующа¤ повышенного внимани¤, а также приЄм алкогол¤.

‘орма выпуска
“аблетки 200 мг:
12 таблеток в блистер из ѕ¬’/јл фольги. ѕо 1 или 5 блистеров с инструкцией по применению в картонную пачку.
 апсулы 50 мг:
ѕо 15 капсул в блистер из ѕ¬’/јл фольги. ѕо 2 блистера с инструкцией по применению в картонную пачку.
–аствор дл¤ внутримышечного введени¤ 50 мг/мп:
ѕо 2 мл в ампулы из бесцветного стекла с кольцом разлома и нанесением трех колец. ѕо 6 ампул помещают в контурную упаковку из ѕ¬’. ѕо 1 контурной упаковке с ампулами вместе с инструкцией по применению в картонную пачку.

—рок годности
3 года.
Ќе примен¤ть после истечени¤ срока годности указанного на упаковке.

”слови¤ хранени¤
’ранить при температуре не выше 30?—.
’ранить в недоступном дл¤ детей месте.
—писок Ѕ.

Dispensing from pharmacies: with prescription.