Eglonyl ampoules 100mg/2ml №6

Composition

Solution for i / m administration:
1 vial (2 ml) contains Sulpiride 100 mg;
Excipients: sulfuric acid, sodium chloride, water d / i;
6 ampoules per pack.

Mechanism of action

Eglonyl is an atypical neuroleptic from the group of substituted benzamides. It has moderate neuroleptic activity in combination with stimulating and thymoanaleptic (anti-depressive) effects.

Neuroleptic effect is associated with anti-dopaminergic action. In the central nervous system, sulpiride mainly blocks the dopaminergic receptors of the limbic system, while the non-striated system has little effect, it has an antipsychotic effect. The peripheral action of sulpiride is based on the inhibition of presynaptic receptors. With an increase in the amount of dopamine in the CNS, 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 anti-depressant effect prevails.

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

In small doses, Eglonyl 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 / day) are effective for dizziness, regardless of etiology. Sulpiride stimulates the secretion of prolactin and has a central antiemetic effect (inhibition of the vomiting center) due to the blockade of the dopamine D2 receptors of the trigger zone of the vomiting center.

Indications and usage

As 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 the failure of conventional methods of treatment (only for 50 mg capsules);
• severe behavioral disorders (agitation, self-harm, stereotype) in children over the age of 6 years, especially in combination with autism syndromes (50 mg capsules only).

Dosage and administration

Usually Treatment begins with a / m injection at a dose of 400-800 mg per day and continue for 2 weeks. The goal of therapy is to achieve the minimum effective dose.

Depending on the clinical picture of the disease, intramuscular injection of sulpiride is prescribed 1-3 times a day, which allows you to quickly alleviate or stop the symptoms. As soon as the patient's condition allows, you should proceed to receive the drug inside. The course of treatment is determined by the doctor.

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

Contraindications

• Hypersensitivity to sulpiride or other components of the drug.
• prolactin-dependent tumors (for example, pituitary prolactinomas and breast cancer);
• hyperprolactinemia;
• acute intoxication with ethanol, hypnotics, opioid analgesics;
• affective disorders, aggressive behavior, manic psychosis;
• pheochromocytoma;
• breastfeeding period;
• children's age up to 18 years (for pills 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, lizurid, pergolid, piribedil, pramipexol, kinagolid, ropinirole);

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

Carefully:
It is not recommended that Eglonyl is prescribed for pregnant women, unless the doctor, having assessed the balance between benefits and risks for the pregnant woman and the fetus, decides that the use of the drug is necessary.

The administration of sulpiride in combination with ethanol, levodopa, drugs that can cause ventricular arrhythmias like "torsade de pointes" (class 1a antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide) and class III (amiodarone, sotalol,dofetil, ibutilid), some neuroleptic halofantrine, pentamidine, sparfloxacin, moxifloxacin, etc.

Precautions should be taken when prescribing Eglonyl to patients with renal and / or hepatic insufficiency, a history of neuroleptic malignant syndrome, epilepsy or convulsive history, severe heart disease, arterial hypertension, patients with parkinsonism, dysmenorrhea, elderly people.

On the part of the endocrine system: possible development of reversible hyperprolactinemia, the most frequent manifestations of which are galactorrhea, amenorrhea, menstrual disorders, less often gynecomastia, impotence and frigidity. During treatment with sulpiride, there may be increased sweating, weight gain.

Gastrointestinal: increased activity of liver enzymes.

From the side of the central nervous system: sedation, drowsiness, dizziness, tremor, early dyskinesia (spastic torticollis, ocular depression, trismism), taking place when prescribing an anticholinergic anti-parkinson drug, rarely - extrapyramidal syndrome and related disorders (akinesia,sometimes combined with muscle hypertonus and partially eliminated by the appointment of anticholinergic antiparkinsonnyh funds, hyperkinesia-hyper tone, 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 the course of treatment with all antipsychotics: the use of antiparkinsonian drugs is ineffective or may 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 (MNS).

From the side of cardio-vascular system: tachycardia, possible increase or decrease in blood pressure, in rare cases, the development of orthostatic hypotension, prolongation of the QT interval, very rare cases of the development of the syndrome "torsade depointes".

Allergic reactions: possible skin rash.

Special notes

Neuroleptic malignant syndrome: With the development of hyperthermia of non-diagnosed origin, Eglonyl should be canceled, as this may be one of the signs of the malignant syndrome described with the use of neuroleptics (pallor, hyperthermia, autonomic dysfunction, impaired consciousness, muscle rigidity).

Signs of autonomic dysfunction, such as increased sweating and abnormal blood pressure, may precede the onset of hyperthermia and, therefore, are early warning signs.

Although this neuroleptic effect may be of idiosyncratic origin, it appears that some risk factors may predispose to it, such as dehydration or organic brain damage.

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

If the clinical situation allows, it is recommended before the appointment of Eglonyl to ensure that there are no factors that may contribute to the development of this type of arrhythmia:
- bradycardia with the number of strokes less than 55 beats / min,
- hypokalemia,
- congenital prolongation of the QT interval,
- simultaneous treatment with a drug capable of causing marked bradycardia (less than 55 bpm), hypokalemia, slowing of intracardiac conduction or prolongation of the QT interval.

With the exception of cases of urgent intervention, patients who require treatment with neuroleptics are recommended to conduct an ECG in 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 should be strengthened; in severe forms of renal failure, intermittent treatment is recommended.

The control during treatment with Eglonyl should be strengthened:
- in patients with epilepsy, since the convulsive threshold can be lowered;
- in the treatment of elderly patients exhibiting greater sensitivity to postural hypotension, sedation and extrapyramidal effects.

Consumption of alcohol or the use of medicines containing ethyl alcohol during the course of drug treatment is strictly prohibited.

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

Store at a temperature not exceeding 30 ° C in the reach of children.

- 3 years.

The drug is available on prescription.