Eglonil (sulpiride) ampoules 100 mg. 2 ml. №6

Description

Eglonil Storage:

active substance: sulpiride;

2 ml of solution contain 100 mg of sulpiride;

Eglonil Excipients:

sulfuric acid, sodium chloride, water for injections.

Eglonil Dosage form.

Solution for injection.

Main physical and chemical properties:

clear liquid, colorless or almost colorless, odorless or almost odorless.

Eglonil Pharmacotherapeutic group.

Antipsychotics. ATX code N05A L01.

Pharmacological properties.

Pharmacodynamics.

Sulpiride affects dopaminergic nerve transmission in the brain as a dopaminomimetic, thus having an activating effect. At higher doses, sulpiride also reduces productive symptoms.

Pharmacokinetics.

After intramuscular administration of a dose of 100 mg, the peak concentration of sulpiride in blood plasma is reached after 30 minutes and is 2.2 mg / liter.

Sulpiride is rapidly distributed in body tissues: the apparent volume of distribution in the steady state is 0.94 l / kg. Plasma protein binding is 40%.

It is found in small amounts in breast milk and may cross the placental barrier. Sulpiride is practically not metabolized in the human body; 92% of the administered dose of sulpiride by intravenous injection is excreted unchanged in the urine.

Excreted mainly by the kidneys by glomerular filtration. Its renal clearance is 126 ml / min. The plasma half-life is 7 hours.

Clinical characteristics.

Indication.

Short-term treatment of states of agitation and aggression in patients with acute and chronic mental disorders (schizophrenia, chronic non-schizophrenic disorders: paranoid states, chronic hallucinatory psychosis).

Contraindication.

Eglonil® is contraindicated in the following cases:

– Hypersensitivity to sulpiride or any of the excipients.

– Prolactin-dependent tumors (eg prolactin-secreting pituitary adenoma (prolactinoma) and breast cancer).

– Known or suspected diagnosis of pheochromocytoma.

– Acute porphyria.

– Combinations with non-antiparkinsonian dopamine agonists (cabergoline, rotigotine and quinagolide), combinations with levodopa or antiparkinsonian drugs (including ropinorol), combinations with mechitazine, citalopram and escitalopram (see other sections).

The drug in this dosage form is intended only for adult patients.

Interaction with other medicinal products and other forms of interaction.

Sedatives

Keep in mind that many drugs can have an additive inhibitory effect on the central nervous system and lead to decreased mental activity. These drugs include morphine derivatives (analgesics, cough medicines and replacement therapies), neuroleptics, barbiturates, benzodiazepines, non-benzodiazepine anxiolytics (such as meprobamate), hypnotics, sedative antidepressants (axetrimiprin, amitriptyramine, amitriptyline, -antihistamine, antihypertensive drugs with central action, baclofen and thalidomide.

Drugs that can cause paroxysmal ventricular tachycardia (torsades de pointes)

A number of drugs that have or do not have antiarrhythmic activity can lead to this serious heart rhythm disorder. Provoking factors are hypokalaemia (see “Potassium-sparing drugs”) and bradycardia (see “Drugs that cause bradycardia”) or the presence of congenital or acquired QT prolongation.

Such agents include, in particular, class I and III antiarrhythmic agents and some neuroleptics.

Dolasetron, erythromycin, spiramycin and vincamine enter into this interaction only in dosage forms for intravenous administration.

Concomitant administration of two “torsadogenic” (those that cause torsades de pointes) drugs is generally contraindicated. But the exceptions are methadone and some other substances:

antiparasitic drugs (halofantrine, lumefantrine, pentamidine) should not be combined with other drugs that may cause the development of paroxysmal ventricular tachycardia such as “pirouette” (torsades de pointes);

Neuroleptics that may cause paroxysmal ventricular tachycardia of the pirouette type (torsades de pointes) are also not recommended, but are not contraindicated for use in combination with other drugs that may cause paroxysmal ventricular tachycardia of the pirouette type (torsades de pointes).

Contraindicated combinations (see section “Contraindications”).

Citalopram, escitalopram

Increased risk of ventricular arrhythmias, especially polymorphic ventricular tachycardia.

Dopamine receptor agonists not for the treatment of Parkinson’s disease (cabergoline, quinagolide, rotigotine)

There is mutual antagonism between dopamine agonists and neuroleptics.

Levodopa and antiparkinsonian drugs (including ropinorol)

Between levodopa, antiparkinsonian drugs (amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, pyribedil, pramipexole, ropinorol, rasagiline, selegiline) and not

Iroleptics there is a mutual antagonism.

Dopamine agonists can cause or exacerbate mental disorders. If neuroleptics are required in patients with Parkinson’s disease receiving treatment with dopamine agonists, the dose of dopamine agonists should be gradually reduced (abrupt withdrawal exposes the patient to the risk of neuroleptic malignant syndrome), as concomitant use of drugs is contraindicated.