Prosulpin pills 200mg №30

Active substance

sulpiride (sulpiride)

Pharmacological group

Antipsychotic drug (neuroleptic)

Release form, composition and packaging

Pills white or almost white, round, flat, with a risk on one side.

Other ingredients: microcrystalline granulated cellulose, lactose monohydrate, granulated lactose, sodium carboxymethylamylopectin, corn starch, Magnesium stearate, povidone 90.

10 pieces. - blisters (3) - packs cardboard.

Registration No.

tab. 200 mg: 30 pcs. - P No. 015244/01, 10/31/08

PBX code

N05AL01

Description of the active components of the drug PROSULPIN^®.
The given scientific information is generalizing and cannot be used to make a decision about the possibility of using a particular drug.

Mechanism of action

Antipsychotic agent (neuroleptic) from the group of substituted benzamides. It has a moderate antipsychotic as well as an antidepressant effect in combination with an activating effect. The mechanism of antipsychotic action is associated with the selective blockade of central dopamine D₂-receptors. Sedative effect is weak, alpha-adrenoceptor blocking activity is low, practically does not cause antimuscarinic effects. Rarely causes extrapyramidal disorders, therefore, refers to "atypical" antipsychotics.Promotes healing of ulcerative lesions of the stomach and duodenum.

Pharmacokinetics

After i / m administration of Sulpiride at a dose of 100 mg C_max in plasma it is reached in 30 minutes, after oral administration in a dose of 200 mg - in 4.5 hours. Bioavailability when administered is 25-35% and is characterized by significant individual variability.

The concentration of sulpiride in plasma is proportional to the dose.

Plasma protein binding is not more than 40%. Sulpiride penetrates quickly into all tissues of the body, faster - into the liver and kidneys, more slowly - into the brain tissue (the main amount accumulates in the pituitary gland). With breast milk, 0.1% of the daily dose of sulpiride is excreted.

Excreted by the kidneys unchanged by glomerular filtration (92%). Total clearance (usually equal to renal) is 126 ml / min. T_1/2 - about 7 hours

Indications for use of the drug

Neurotic states, accompanied by inhibition; psychosomatic disorders, incl. with gastric ulcer and duodenal ulcer, UC; acute and chronic psychosis with a predominance of inhibition, agrammatism, abulia; acute and chronic psychosis, accompanied by delusions or confusion, including with schizophrenia.

Dosage and administration

Inside adults - 100-300 mg / day in 2-3 doses. If necessary, injected into the / m dose of 100-800 mg / day. In children, a daily dose of 5 mg / kg is used.

Maximum dose: when taken orally for adults - 1.6 g.

Side effect

From the side of the central nervous system: excitement, dizziness, sleep disorders, oral automatism, aphasia.

Gastrointestinal: dry mouth, heartburn, vomiting, constipation.

Cardiovascular: increase in blood pressure.

On the part of the endocrine system: menstrual disorders, decreased sexual activity. With long-term administration in high doses - galactorrhea, gynecomastia.

Allergic reactions: skin rash, itching.

Contraindications to the use of the drug

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

Pregnancy and lactation

In pregnancy and lactation use with caution and in the minimum effective doses.

Special notes

With caution used in patients with parkinsonism, the elderly. In severe renal failure, a dose reduction or intermittent course of treatment is recommended.

In patients with epilepsy, prior to treatment, a preliminary clinical and electrophysiological examination is necessary, since sulpiride lowers the threshold of convulsive readiness.

In the event of hyperthermia, which is one of the elements of the NNS, sulpiride should be immediately canceled.

During the period of treatment to prevent the use of alcohol.

Use with caution in children.

Influence on ability to drive motor transport and control mechanisms

During treatment, you should refrain from engaging in potentially hazardous activities that require increased attention and quick psychomotor reactions.

Drug interaction

With the simultaneous use of drugs that depress the central nervous system (opioid analgesics, hypnotics, tranquilizers, clonidine, antitussive drugs of central action), the inhibitory effect on the central nervous system is enhanced.

With simultaneous use with antihypertensive agents, the antihypertensive effect is enhanced and the risk of orthostatic hypotension increases.

When applied simultaneously with levodopa, the effectiveness of sulpiride decreases.

Cases of the development of heavy extrapyramidal reactions with simultaneous use of sulpiride with lithium carbonate are described.

With simultaneous use with Fluoxetine, it is possible to develop extrapyramidal symptoms and dystonia.