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Instruction for use: Eglek

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Packing: tablets

Active substance: Sulpiride

ATX

N05AL01 Sulpiride

Pharmacological group:

Neroleptics

The nosological classification (ICD-10)

F05.9 Delirium, unspecified: Infectious delirium; Acute delirious state; Predelirius

F20 Schizophrenia: Schizophrenic Conditions; An exacerbation of schizophrenia; Schizophrenia; Chronic schizophrenia; Dementia praecox; Bleuler's disease; Psychotic discordant; Dementia early; The febrile form of schizophrenia; Chronic schizophrenic disorder; Psychosis of the schizophrenic type; Acute form of schizophrenia; Acute schizophrenic disorder; Cerebral Organic Insufficiency in Schizophrenia; Acute attack of schizophrenia; Schizophrenic psychosis; Acute schizophrenia; Sluggish schizophrenia; Sluggish schizophrenia with apathoabulic disorders; Acute stage of schizophrenia with agitation

F32.9 Depressive episode, unspecified: Depressive and anxious-depressive conditions in patients with alcoholism, especially during the period of abstinence; Depressive disorders; Depressive states; Depression Depletion; Neurotic reactive-depressive conditions; Postpsychotic depression; Episodes of depression

F48.9 Neurotic disorder, unspecified: Neurosis; Secondary neurotic symptom; Other neurotic conditions; Neurosis with increased irritability; Neuroses; Neuroses of all kinds; Neuroses with retardation; Neuroses of the heart; Neurotic disorders in alcoholism; Neurotic disorders with retardation; Neurotic disorders with anxiety syndrome; Neurotic reactions; Neurotic symptoms with alcoholism; Neurotic states; Neurotic syndrome; Neurotic disorder; Attack of neurological dysfunction; School neurosis; Emotional Stress

H81.0 Meniere's disease: Disease / Meniere's syndrome; Meniere's Disease; Meniere's syndrome; Labyrinth hydrops; Endolymphatic hydrops

H81.2 Vestibular neuronitis: Vestibular neuritis; Vestibular neuritis; Cochleovestibular neuritis

H81.3 Other peripheral vertigo: Vertigo of peripheral origin

H81.4 Vertigo of central origin: Dizziness of labyrinth origin; Vestibular Dizziness; Dizziness of vascular origin

K25 Stomach ulcer: Helicobacter pylori; Pain syndrome with peptic ulcer disease; Pain syndrome with peptic ulcer of stomach and duodenum; Inflammation of the gastric mucosa; Inflammation of the mucous membrane of the gastrointestinal tract; Benign ulcer of the stomach; Disease of the stomach and duodenum, associated with Helicobacter pylori; Exacerbation of gastroduodenitis against ulcer disease; Exacerbation of peptic ulcer; Exacerbation of gastric ulcer; Organic Gastrointestinal Disease; Peptic ulcer of the stomach and duodenum; Postoperative Stomach Ulcer; Recovering ulcers; Symptomatic Stomach Ulcers Symptomatic ulcers of the stomach and duodenum; Chronic inflammatory disease of the upper GI tract associated with Helicobacter pylori; Eradication of Helicobacter pylori; Erotic-ulcerative lesions of the stomach; Erosive lesions of the stomach; Erosion of the gastric mucosa; Peptic Ulcer; Stomach ulcer; Ulcerative lesions of the stomach; Helicobacteriosis

K26 Ulcer of duodenum: Pain syndrome with duodenal ulcer; Pain syndrome with peptic ulcer of stomach and duodenum; Disease of the stomach and duodenum, associated with Helicobacter pylori; Exacerbation of peptic ulcer; Exacerbation of peptic ulcer of the duodenum; Peptic ulcer of the stomach and duodenum; Recurrence of duodenal ulcer; Symptomatic ulcers of the stomach and duodenum; Eradication of Helicobacter pylori; Erotic-ulcerative lesions of the duodenum; Erosion-ulcerative duodenal lesions associated with Helicobacter pylori; Erosive lesions of the duodenum; Peptic ulcer disease of the duodenum; Ulcerative duodenal lesions

K58 Irritable Bowel Syndrome: Irritable Bowel Syndrome; Colitis spastic; Irritable Bowel Syndrome; Irritable Small Bowel Syndrome; Syndrome of irritation of large intestine; Syndrome of irritation of the large intestine; Symptoms of irritation of the intestine; Irritated stomach mucosa; Irritation of the intestinal mucosa; Irritated Colon

Composition and release form

Solution for intramuscular injection 1 amp.

Sulpiride 100 mg

auxiliary substances: sodium chloride; sulfuric acid solution 1M; water for injections

in ampoules of 2 ml; in a pack of cardboard 10 ampoules, with a knife ampoule.

Tablets 1 table.

sulpiride 0.2 g

auxiliary substances: potato starch; lactose (milk sugar); methyl cellulose; calcium stearate; talc; silicon dioxide colloid (aerosil)

in polymer cans 12 pcs .; in a pack of cardboard 1 can.

Description of dosage form

Solution: clear, colorless or slightly colored liquid, odorless.

Tablets: white or white with a yellowish shade of color, flat-cylindrical.

Characteristic

Refers to the group of substituted benzamides.

Pharmachologic effect

Pharmacological action - neuroleptic, timolepticheskoe, psihostimuliruyuschee.

Has moderate neuroleptic activity in combination with stimulating and thymoanaleptic (antidepressant) action.

Neuroleptic effect is associated with antidophaminergic action. In the central nervous system, sulpiride blocks predominantly dopaminergic receptors of the limbic system. The neostriate system is slightly affected, but has an antipsychotic effect. Sulpirid stimulates the secretion of prolactin and has a central antiemetic effect (suppression of the emetic center) by blocking the dopamine D2 receptors in the trigger zone of the vomiting center. Sulpiride has no significant effect on adrenergic, cholinergic, serotonin, histamine, and GABA receptors.

The peripheral action of sulpiride is based on oppression of presynaptic receptors. Antipsychotic effect of sulpiride is manifested in doses of more than 600 mg / day, in doses up to 600 mg / day - the stimulating and antidepressant effect prevails.

In small doses, sulpiride can be used as an auxiliary in the treatment of psychosomatic diseases, in particular, peptic ulcer of the stomach and duodenum. In irritable bowel syndrome, sulpiride reduces the intensity of abdominal pain and leads to an improvement in the patient's condition.

Low doses of sulpiride (50-300 mg / day) are effective in dizziness, regardless of etiology.

Pharmacokinetics

After the / m introduction in a dose of 100 mg Cmax in blood plasma is 2.2 mg / l after 30 minutes. After oral administration, Cmax in the blood plasma is reached after 1.5-3 hours. Bioavailability is 27%. Binding to plasma proteins is less than 40%. Concentration in the central nervous system is 2-5% of the concentration in the blood plasma. Excreted in breast milk. In the body it is not metabolized and is excreted unchanged through the kidneys. T1 / 2 is 6-8 hours; T1 / 2 in patients with moderate and severe renal insufficiency significantly increases and is after a / m administration of 20-26 hours. These patients should reduce the dose and / or increase the interval between taking the drug.

Indications for the Eglek

As a monotherapy or in combination with other psychotropic drugs with:

- acute and chronic schizophrenia;

- acute delirious states;

- Depression of various etiologies;

- neuroses;

- dizziness of various etiologies (vertebrobasilar insufficiency, vestibular neuritis, Meniere's disease, condition after CCT, otitis media).

Auxiliary therapy for peptic ulcer of stomach and duodenum, irritable bowel syndrome.

Contraindications

Hypersensitivity to sulpiride, acute alcohol poisoning, hypnotics, narcotic analgesics, arterial hypertension, pheochromocytoma, hyperprolactinaemia, affect and aggression; period of breastfeeding, children's age (up to 14 years).

Application in pregnancy and lactation

Use in pregnancy is possible if the expected effect of therapy exceeds the potential risk to the fetus. Contraindicated during breastfeeding.

Side effects

On the part of the endocrine system: it is possible to develop reversible hyperprolactinemia, the most frequent manifestations of which are galactorrhea, menstrual cycle disorder, less often - gynecomastia, impotence and frigidity. There may be increased sweating, an increase in body weight.

On the part of the gastrointestinal tract: dry mouth, heartburn, nausea, vomiting, constipation, increased activity of transaminases and alkaline phosphatase in the blood serum.

From the side of the central nervous system: sedative effect, drowsiness, dizziness, headache, tremor, rarely - extrapyramidal syndrome, early and late dyskinesias, akathisia, oral automatism, aphasia. When used in small doses, there may be psychomotor agitation, anxiety, irritability, sleep disorder, visual acuity. With the development of hyperthermia, the drug should be discarded. an increase in body temperature may indicate the development of neuroleptic malignant syndrome.

From the cardiovascular system: tachycardia, it is possible to raise or lower BP, in rare cases - the development of orthostatic hypotension.

Allergic reactions: skin rash, itching, eczema are possible.

Interaction

Simultaneous reception with drugs that depress the central nervous system (narcotic analgesics, antihistamines, barbiturates, benzodiazepines and other anxiolytics) may lead to an increase in the sedative effect of these drugs.

Strengthens the sedative effect of alcohol.

It should avoid simultaneous prescription with levodopa due to mutual antagonism.

With the simultaneous administration of Eglek® and antihypertensive drugs, there is an increased risk of developing orthostatic hypotension.

Sucralfate, antacid agents containing Mg2 + and / or Al3 +, reduce the bioavailability of sulpiride in tablets by 20-40%.

Dosing and Administration

IM, inside. With the IM introduction of sulpiride, the usual rules for IM injections are observed: deep into the upper outer quadrant of the gluteus muscle.

Inside the tablets are taken regardless of food intake, washed down with a small amount of liquid, 1-3 times a day.

In acute and chronic psychoses treatment is started with IM injections in a dose of 200-800 mg / day (maximum 1200 mg / day) and continue in most cases within 2 weeks.

Depending on the clinical picture of the disease, IM injection Egleka® is prescribed 1-3 times a day, which allows you to quickly soften or stop the symptoms. As soon as the patient's condition allows, you should move on to taking the drug inside. The course of treatment is determined by the doctor.

Acute and chronic schizophrenia, acute delirious psychosis: the initial dose of Egleka® depends on the clinical picture of the disease and is 600-1200 mg per day, divided into several doses, maintaining doses of 300-800 mg per day.

Depression: from 150-200 mg to 600 mg per day, divided into several receptions.

Dizziness: 150-200 mg per day, in severe cases, the dose can be increased to 300-400 mg. The duration of treatment should be at least 14 days.

Auxiliary therapy for peptic ulcer of stomach and duodenum, irritable bowel syndrome: 100-300 mg of sulpiride per day, in 1 or 2 doses.

The maximum recommended daily dose is 1600 mg of sulpiride.

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 and / or increase the interval between the administration of individual doses of the drug depending on the creatinine clearance values (see table).

Table

Creatinine clearance, ml / min Dose Egleka® compared with the standard,% Increase the interval between Eglek's doses ®
60–30 70 1,5 times
30–10 50 2 times
less 10 30 3 times

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

For children older than 14 years, the standard dose of sulpiride is 3-5 mg / kg body weight.

Overdose

Symptoms: blurred vision, arterial hypertension, sedation, nausea, extrapyramidal disorders, dry mouth, vomiting, increased sweating and gynecomastia, possibly the development of neuroleptic malignant syndrome.

Treatment: symptomatic and supportive therapy, holinoblokatory central action to correct extrapyramidal disorders.

Precautionary measures

Precautions should be taken for patients with impaired renal function, with heart and blood vessel diseases, epilepsy or a history of convulsive syndrome, Parkinson's disease, elderly patients, young women with irregular menstrual cycles.

Special instructions

If hyperthermia occurs during the treatment with Eglekom®, the drug should be discontinued. Hyperthermia is a sign of the development of a malignant neuroleptic syndrome, manifested by pallor, hyperthermia, vegetative disorders. Although data on the development of the syndrome against the backdrop of treatment with Eglekom® are not available, caution is necessary, especially when administering high doses.

When prescribing the drug, patients with epilepsy need additional control, which includes both clinical observation and EEG, the drug lowers the threshold of convulsive readiness.

It is necessary to monitor the patient's neurological status, and with the simultaneous appointment of corrective antiparkinsonian drugs - also the functional state of the gastrointestinal tract.

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

During the treatment, it is prohibited to drive vehicles and work with mechanisms requiring increased attention.

It is not allowed to drink alcohol at the same time.

Storage conditions for Eglek

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of Eglek

3 years.

Do not use after the expiry date printed on the package.

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