ÈGLONIL

Active material: Sulpyryd
When ATH: N05AL01
CCF: Antipsychotic drug (anxiolytic)
When CSF: 02.01.02.01
Manufacturer: SANOFI WINTHROP INDUSTRY (France)

Pharmaceutical form, composition and packaging

Capsules hard gelatin, size №4, opaque, white or white with a yellowish-greyish tint; contents of capsules – homogeneous powder of yellowish-white.

Excipients: lactose monohydrate, methyl cellulose, talc, magnesium stearate.

The composition of the shell: gelatin, Titanium dioxide.

15 PC. – blisters (2) – packs cardboard.

The solution for the / m clear, colorless or near colorless, odorless or almost odorless.

Excipients: sulfuric acid, sodium chloride, water d / and.

2 ml – ampoule (6) – contoured plastic packaging (1) – packs cardboard.

Pills white or slightly yellow color with a break line on one side and a brand name “SLP200” another.

Excipients: potato starch, lactose monohydrate, methyl cellulose, colloidal silicon dioxide, talc, magnesium stearate.

12 PC. – blisters (1) – packs cardboard.
12 PC. – blisters (5) – packs cardboard.

DESCRIPTION OF ACTIVE SUBSTANCES.

Pharmacological action

Antipsychotics (anxiolytic) from the group consisting of substituted benzamides. It has moderate antipsychotic, and antidepressant effects in combination with the activating action. The mechanism of action is associated with antipsychotic selective blockade of central dopamine D₂-receptors. Sedation is weak, alpha-adrenergic blocking activity is low, practically does not cause antimuscarinic effects. Rarely cause extrapyramidal disorders, therefore refers to “atipichnыm” neuroleptics. Promotes healing of ulcers of the stomach and duodenum.

Pharmacokinetics

After the / m at a dose of sulpiride 100 mg C_max plasma achieved through 30 m, after oral dose 200 mg – through 4.5 no. Oral bioavailability is 25-35% and characterized by considerable individual variability.

Sulpiride concentration in plasma is proportional to the dose.

Plasma protein binding is less than 40%. Sulpiride quickly penetrates into all tissues of the body, faster – the liver and kidneys, slowly – in brain tissue (wherein the major amount is stored in the hypophysis). Since breast milk is released 0.1% daily dose of sulpiride.

Excreted by the kidneys in unchanged form by glomerular filtration (92%). Total clearance (usually, equal to the kidney) is 126 ml / min. T_1/2 – about 7 no.

Testimony

Neurotic state, accompanied by inhibition; psychosomatic disorders, incl. gastric ulcer and duodenal ulcer, NYAK; acute and chronic psychosis, with a predominance of inhibition, agrammatizma, aʙulii; acute and chronic psychosis, accompanied by delirium or confusion, incl. schizophrenia.

Dosage regimen

Inside adults – 100-300 mg / day 2-3 admission. If necessary, introducing / m dose 100-800 mg / day. The children are used in a daily dose of 5 mg / kg.

The maximum dose: ingestion for adults – 1.6 g.

Side effect

CNS: excitation, dizziness, sleep disorders, oral automatism, afazija.

From the digestive system: dry mouth, heartburn, vomiting, constipation.

Cardio-vascular system: increased blood pressure.

On the part of the endocrine system: menstrual irregularities, decrease in sexual activity. Chronic administration of high doses – galactorrhea, gynecomastia.

Allergic reactions: skin rash, itch.

Contraindications

Pheochromocytoma, arterial hypertension, psychomotor agitation, Hypersensitivity to sulpiride.

Pregnancy and lactation

During pregnancy and lactation be used with caution and in minimal effective doses.

Cautions

To use caution in patients with Parkinson's, the elderly. In severe renal impairment is recommended that a dose reduction or conducting intermittent therapy.

In patients with epilepsy before treatment is necessary to pre-clinical and electrophysiological examination, tk. sulpiride lowers the seizure threshold.

In the event of hyperthermia, which is one of the elements of the CSN, sulpiride should be lifted immediately.

During treatment, avoid alcohol.

To use caution in children.

Effects on ability to drive vehicles and management mechanisms

During treatment should refrain from activities potentially hazardous activities, requiring increased attention and rapid psychomotor reactions.

Drug Interactions

With simultaneous use of medicines, CNS depressants (Opioid analgesics, hypnotics, trankvilizatorov, klonidina, Centrally acting antitussives), dampening effect on the central nervous system.

At simultaneous application with antihypertensive agents increased antihypertensive effect and increased risk of orthostatic hypotension.

In an application with levodopa decreases the effectiveness of sulpiride.

There are cases of severe extrapyramidal reactions, while the use of sulpiride with lithium carbonate.

In an application with fluoxetine may develop extrapyramidal symptoms and dystonia.