EGLONIL instructions for use, description of the drug EGLONIL: contraindications, side effects, dosages, composition - capsules; divisible tablets; injection solution in the Lekarst directory

Eglonil (in gastroenterology)

Eglonil

(eng.
Eglonil
) - an antipsychotic, a dopamine receptor blocker, used in gastroenterology as a prokinetic agent.

Dosage forms and composition of Eglonil

Eglonil is (was) approved in Russia in the form of the following dosage forms:

tablets containing 200 mg of active substance - sulpiride
capsules containing 50 mg sulpiride
solution for intramuscular administration, in the form of ampoules containing 100 mg of sulpiride each
oral solution in 200 ml glass bottles containing 1 mg of sulpiride (5 mg of sulpiride in 1 ml of solution)

In addition, Eglonil tablets contain excipients: potato starch, magnesium stearate, talc, lactose monohydrate, colloidal silicon dioxide, hypromellose.

Indications for use of Eglonil

In psychiatry and neurology:

Method of use of Eglonil and dose in the treatment of the digestive system

In the treatment of gastroenterological diseases, Eglonil is used only as part of complex therapy. Eglonil in the treatment of GERD
. One of the main reasons leading to an increase in spontaneous relaxations of the lower esophageal sphincter is an increase in the level of neuroticism in patients suffering from GERD; testing is relevant to assess the personality profile and correct the identified disorders. To assess the personality profile of patients with pathological gastroesophageal reflux identified by pH-metry, psychological testing is carried out, on the basis of which the dependence of the nature and severity of gastroesophageal reflux on individual personality characteristics is revealed and, along with standard therapy, patients with a depressive personality type are prescribed Eglonil 50 mg 3 times a day, which improves the prognosis of the disease (Maev I.V. et al.). In the presence of psychoform disorders in the form of anxiety, fear, irritability, masked and overt depression, Eglonil 50 mg 2-3 times a day for 3-4 weeks is widely used for GERD. Eglonil is an atypical analeptic; it has a prokinetic effect on the motility of the esophagus of the stomach and intestines due to the blockade of dopaminergic receptors, which explains its antiemetic effect. In addition, eglonil has axiolytic (anti-anxiety) and antidepressant effects (Degtyareva I.I.).

Egonil in the treatment of duodenostasis in combination with hypomotor dyskinesia of the gallbladder

. For compensated and subcompensated duodenostasis, the prokinetic agents metoclopramide or domperidone are prescribed, in addition to which it is possible, especially in the presence of depressive states, to use Eglonil 50 mg 2-3 times a day or 2 ml of a 5% solution intramuscularly 1-2 times a day (Maev I .V., Samsonov A.A.).

In the treatment of peptic ulcer with symptoms of vegetative neurosis in children

Eglonil 0.005 mg per kg of the child’s weight in 2 doses, morning and afternoon, gives a good effect (Shabalov N.P.).

Comparison of Eglonil with other drugs regarding the effect on the electrical activity of the upper gastrointestinal tract

Using the Gastroscan-GEM gastroenteric monitor, a comparative study of the effect of Eglonil, the “classical” prokinetic agent Motilium and the myotropic antispasmodic Duspatalin on the electrical activity of the upper gastrointestinal tract was carried out. The data obtained is shown in the table below:

A drug	Group affiliation	Pi/Ps		Kritm		Ai/As		Pi/Pi+1
A drug	Group affiliation	stomach	DPK	stomach	DPK	stomach	DPK	stomach/duodenal
Eglonil	antipsychotic	pad	pad	pad	pad	pad	pad	No
Motilium	prokinetic	height	pad	height	height	height	height	norm
Duspatalin	myotropic antispasmodic	pad	pad	No	No	No	No	No

Abbreviations: growth
- the indicator of peripheral electrogastrography increases after taking the drug,
decline
- decreases,
no
- the drug does not affect the indicator,
normal
- taking the drug normalizes the indicator. For indicators of electrical activity—peripheral electrogastrography indicators Pi/Ps, Kritm, Ai/As and Pi/Pi+1, see “Electrogastroenterography: study of the electrical activity of the stomach and intestines.” Duodenum - duodenum.

Eglonil reduces the electrical activity Pi/Ps, the rhythmicity of Kritm and the amplitude of contractions Ai/As of both the stomach and duodenum. Prokinetic Motilium increases the electrical activity of the stomach Pi/Ps and reduces the electrical activity of the duodenum, increases the rhythmicity of Kritm contractions of the upper gastrointestinal tract and normalizes the coordination of contractions of the stomach and duodenum Pi/Pi+1. The myotropic antispasmodic Duspatolin reduces the electrical activity of the stomach and duodenum Pi/Ps and does not affect the rhythm of Kritm and the coordination of contractions Pi/Pi+1 of the upper gastrointestinal tract (Smirnova G.O.).

Eglonil, like other prokinetics, have a predominantly stimulating effect on the smooth muscles of the gastrointestinal tract. In particular, it increases the tone and contractile activity of the stomach and duodenum, improves antroduodenal coordination, accelerates the evacuation of gastric contents and small intestinal transit (Avdeev V.G.):

Rice.
The effect of Eglonil on the motor function of the duodenum (Avdeev V.G.) a - motility on an empty stomach, b - motility after administration of Eglonil; 1 — manometry in the upper horizontal part of the duodenum; 2 — pH-metry in the upper horizontal part of the duodenum; 3 — pH-metry in the distal part of the duodenum. On the website gastroscan.ru in the literature catalog there is a section “Prokinetics”, containing medical articles concerning the treatment of diseases of the gastrointestinal tract with various prokinetics, including Eglonil.

general information

According to the pharmacological index, Eglonil belongs to the group “Neuroleptics”.
According to ATC, Eglonil is included in the group “N05A Antipsychotic drugs” and has the code “N05AL01 Sulpiride”. Eglonil is available from pharmacies with a prescription.

Other drugs containing the active ingredient sulpiride

The following drugs with the active substance sulpiride are (have been) registered in Russia: Betamax, Vero-Sulpiride, Prosulpin, Sulpiride, Sulpiride Belupo, Eglek.
In the USA, Canada and Australia, sulpiride is not approved for use. In many countries of the European Union, Latin America and Southeast Asia it is sold under the trade name Dogmatil. In the UK - Dolmatil, Sulpiride and Sulpor. In Japan - Abilit, Betamac T, Dogmatyl, Keityl, Margenol, Miradol, Pyrikappl, Skanozen, Sulpiride Choseido, Sulpiride Kyowa Yakuhin, Sulpiride Taisho, Sulpiride Taiyo, Sulpiride Towa Yakuhin, Youmathyle, as well as under many other trade names in various countries around the world .

Eglonil has contraindications, side effects and application features; consultation with a specialist is necessary.

Back to section

Eglonil®

Neuroleptic malignant syndrome

Neuroleptic malignant syndrome (NMS), which is a potentially fatal complication, and the occurrence of which is possible with the use of any antipsychotics, is characterized by pallor, hyperthermia, muscle rigidity, dysfunction of the autonomic nervous system, and impaired consciousness. Signs of autonomic nervous system dysfunction, such as increased sweating and lability of blood pressure and pulse, may precede the onset of hyperthermia and represent early warning symptoms. Cases with atypical manifestations of NMS without rigidity and increased muscle tone have been observed. In the case of hyperthermia of unknown origin, which can be regarded as either an early sign/symptom of NMS or atypical NMS, sulpiride should be immediately discontinued and medical monitoring of the patient should be established. The cause of the development of NMS remains unclear.

It is assumed that blockade of dopamine receptors in the striatum and hypothalamus plays a role in its mechanism; congenital predisposition (idiosyncrasy) cannot be ruled out. The development of the syndrome may be facilitated by intercurrent infection, dehydration, or organic brain damage.

QT prolongation

Sulpiride may cause QT prolongation. This effect is known to increase the risk of developing severe ventricular arrhythmias, such as torsade de pointes (see section "Side Effects").

Before using the drug, if the patient’s condition allows, it is necessary to exclude the presence of factors predisposing to the development of these severe rhythm disturbances (bradycardia less than 55 beats per minute; electrolyte disturbances, especially hypokalemia, hypomagnesemia; congenital prolongation of the QT interval, concomitant use of drugs that cause severe bradycardia (less than 55 beats per minute), hypokalemia, slowing of intracardiac conduction or prolongation of the QT interval (see sections "Precautions", "Side effects").

Patients with the above risk factors should be careful when prescribing sulpiride.

Hypokalemia and hypomagnesemia should be corrected before starting the drug; In addition, medical supervision and regular monitoring of blood electrolytes and ECG should be ensured.

Except in cases of urgent intervention, patients requiring treatment with antipsychotics are advised to undergo evaluation and ECG monitoring.

Extrapyramidal syndrome

For extrapyramidal syndrome caused by antipsychotics, m-anticholinergic drugs (rather than dopamine receptor agonists) should be prescribed (see section “Interaction with other drugs”). In patients with Parkinson's disease or dementia with Lewy bodies, Eglonil® should be prescribed only when absolutely necessary (due to an increased risk of developing or exacerbating symptoms of extrapyramidal disorders).

Stroke

In randomized clinical trials comparing some atypical antipsychotics with placebo in elderly patients with dementia, a threefold increase in the risk of cerebrovascular events was observed. The mechanism of this risk is unknown. An increase in this risk cannot be ruled out with other antipsychotics or in other patient populations, so sulpiride should be used with caution in patients with risk factors for stroke.

Elderly patients with dementia

In elderly patients with dementia-related psychosis, an increased risk of death was observed when treated with antipsychotic drugs. An analysis of 17 placebo-controlled studies (mean duration greater than 10 weeks) found that most patients treated with atypical antipsychotics had a 1.6 to 1.7 times greater risk of death than patients treated with placebo.

In a 10-week placebo-controlled study, the death rate was 4.5% with atypical antipsychotics in these patients and 2.6% with placebo.

Although the causes of death in clinical studies with atypical antipsychotics varied, most causes of death were either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature.

Observational studies have confirmed that, like treatment with atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may also increase mortality. The extent to which the increase in mortality may be due to the antipsychotic drug rather than certain patient characteristics is unclear.

Venous thromboembolic complications

Cases of venous thromboembolic complications, sometimes fatal, have been observed with the use of antipsychotic drugs. Therefore, sulpiride should be used with caution in patients with risk factors for the development of venous thromboembolic complications (see sections “With caution”, “Side effects”).

Mammary cancer

Sulpiride may increase the concentration of prolactin in the blood plasma. Therefore, when using sulpiride in patients with a history (including family history) of breast cancer, caution should be exercised (see section “With caution”). Such patients should be closely monitored.

Patients with epilepsy

Due to the fact that antipsychotics can lower the epileptogenic threshold, when prescribing sulpiride to patients with epilepsy, the latter should be under strict medical supervision.

Patients with Parkinson's disease taking dopamine receptor agonists

Except in exceptional cases, Eglonil® should not be used in patients with Parkinson's disease. If there is an urgent need for antipsychotic treatment in patients with Parkinson's disease taking dopamine receptor agonists, a gradual reduction in dosage of the latter should be carried out until complete discontinuation (abrupt withdrawal of dopamine receptor agonists may increase the patient's risk of developing neuroleptic malignant syndrome) (see sections "With caution", "Interaction with other drugs").

Patients with impaired renal function

Reduced doses should be used (see section "Dosage and Administration").

Patients with diabetes mellitus or with risk factors for developing diabetes mellitus

Since the development of hyperglycemia has been reported in patients taking atypical antipsychotic drugs, patients with an established diagnosis of diabetes mellitus or with risk factors for its development who are prescribed treatment with sulpiride should monitor their blood glucose concentrations.

Ethanol consumption

The consumption of alcoholic beverages containing ethanol or the use of medications containing ethanol during treatment with Eglonil® is strictly prohibited.

Leukopenia, neutropenia and agranulocytosis

During therapy with antipsychotics, including Eglonil®, leukopenia, neutropenia and agranulocytosis were observed. The development of unexplained infections or an increase in body temperature may be signs of blood disorders, which require immediate hematological studies.

Use in children

Due to the effect of sulpiride on cognitive processes in children, it is necessary to monitor learning ability annually. It is necessary to regularly adjust the dose taking into account the clinical condition of the child.

Special instructions for the use of the drug Eglonil

If hyperthermia develops, sulpiride should be discontinued. Hyperthermia may be a manifestation of neuroleptic malignant syndrome (pallor, hyperthermia and autonomic dysfunction). This precaution is especially important when using the drug in high doses. Caution should be exercised when treating elderly patients who are more susceptible to the effects of the drug. Since sulpiride is excreted by the kidneys, in patients with severe renal failure the drug should be used in reduced doses and an intermittent treatment regimen should be used. Patients with epilepsy require more careful monitoring (clinical and, if necessary, EEG), since sulpiride reduces the seizure threshold. In patients with Parkinson's disease, sulpiride is prescribed with caution according to strict indications. In patients with aggressive behavior or agitation with impulsivity, sulpiride should be prescribed together with sedatives. In children whose mothers took low doses of sulpiride (approximately 200 mg/day) during pregnancy, no increase in the incidence of birth defects was observed. There is no experience with using the drug in higher doses. There is also no data on the potential effect of antipsychotic drugs taken during pregnancy on fetal brain development. It seems advisable, if possible, to reduce the dose and reduce the duration of treatment with the drug during pregnancy. In newborns whose mothers underwent long-term treatment with antipsychotics in high doses, several cases of the development of extrapyramidal syndrome have been described. It is recommended to monitor the neurological status of children born to mothers receiving the drug for some time after birth. Since sulpiride passes into breast milk, breastfeeding should be discontinued during treatment with the drug. Drivers of vehicles and persons working with potentially dangerous mechanisms should be warned about the possibility of developing drowsiness while taking the drug.