Sulpiride - instructions for use, dose, side effects, contraindications

Auxiliary substances: methylparahydroxybenzoate 6.0 mg, propyl parahydroxybenzoate 1.5 mg, propylene glycol 103.6 mg, citric acid monohydrate 50.0 mg, liquid maltitol 3073.5 mg, flavoring lemon (L573) 4,555 mg, flavor anise (L559) 4 , 18 mg, water purified to 5 ml.

Description:A colorless or slightly yellowish transparent solution with a characteristic smell of lemon or anise.

Pharmacotherapeutic group:Antipsychotic (antipsychotic) remedy.

ATX: & nbsp

N.05.A.L Benzamides

Pharmacodynamics:

Pharmacological properties:

Sulpiride is an atypical neuroleptic from the group of substituted benzamides.

Pharmacodynamics

Sulpiride has a 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, and affects the neostriatic system insignificantly, it has an antipsychotic effect and causes a small number of side effects. The peripheral action of sulpiride is based on oppression of presynaptic receptors. An increase in the amount of dopamine in the central nervous system is associated with an improvement in mood, with a decrease in the development of symptoms of depression.

Antipsychotic effect of sulpiride is manifested in doses of more than 600 mg per day, in doses up to 600 mg per day, a stimulating and antidepressant effect predominates.

Sulpiride has no significant effect on adrenergic, cholinergic, serotonin, histamine, and gamma-aminobutyric acid receptors (GABA receptors).

In small doses sulpiride can be used as an auxiliary in the treatment of psychosomatic diseases, in particular, it is effective in reversing the negative mental symptoms of peptic ulcer of the stomach and duodenum. With irritable bowel syndrome sulpiride reduces the intensity of abdominal pain and leads to an improvement in the clinical state of the patient. Low doses of sulpiride (50-300 mg per day) are effective in dizziness, regardless of etiology. Sulpiride stimulates the secretion of prolactin and has a central antiemetic effect (oppression of the vomiting center).

Pharmacokinetics:

After oral administration, the maximum plasma concentrations are reached after 3-6 hours. Bioavailability of sulpiride for oral administration is 25 - 35%. The binding of sulpiride to plasma proteins is less than 40%.

Sulpiride in the human body is not metabolized and is excreted almost unchanged through the kidneys (about 95%). The half-life is 6-8 hours. Sulpiride excreted in breast milk.

Indications:

As a monotherapy or in combination with other psychotropic drugs.

- acute and chronic schizophrenia;

- acute delirious states;

- depression of various etiologies;

- neurotic disorders;

- dizziness of various etiologies (vertebro-basilar insufficiency, vestibular neuritis, Meniere's disease, condition after traumatic brain injury, otitis media);

- auxiliary therapy for peptic ulcer of stomach and duodenal ulcer and irritable bowel syndrome.

Contraindications:

- acute poisoning with alcohol, hypnotics, analgesics;

- hypersensitivity to sulpiride or to any of the components of the drug ;,

- pheochromocytoma;

- epilepsy;

- hyperprolactinemia;

- patients in a state of affect and aggression, who are at risk of provoking symptoms;

- the period of breastfeeding;

- children under 14 years.

Carefully:

Precautions should be taken in appointing sulpiride to patients with impaired renal function, since up to 95% of sulpiride is excreted through the kidneys. These patients are recommended to reduce the dose of sulpiride.

Precautions should also be observed when prescribing sulpiride to patients with heart disease, blood vessels, Parkinson's disease,convulsive disorders in the anamnesis and young women with irregular menstrual cycle, patients of advanced age.

Pregnancy and lactation:It is not recommended to prescribe sulpiride to pregnant women, except when the doctor, having estimated the ratio of benefit and risk to the pregnant and fetus, decides that the use of the drug is necessary. During the treatment, the drug should stop breastfeeding.

Dosing and Administration:

Inside. Shake before use!

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

The maximum daily intake for adults is 1600 mg of sulpiride.

Acute and chronic schizophrenia, acute delirious psychosis: the initial doses of sulpiride depend on the clinical picture of the disease and are 600 to 1200 mg of sulpiride 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 conditions the dose can be increased to 300-400 mg per day. 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 one or two doses.

Doses in patients with impaired renal function: due to sulpiride is excreted from the body mainly through the kidneys, it is recommended to reduce the dose of sulpiride and / or increase the interval between the administration of individual doses of the drug.

Doses for the elderly: for the elderly, the initial dose of sulpiride should be 1/4 - 1/2 dose for adults. Doses for children: The standard dose of sulpiride for children older than 14 years is 3-5 mg / kg body weight.

Side effects:

The drug is usually well tolerated. The undesirable phenomena that develop as a result of taking sulpiride are similar to undesirable phenomena caused by other psychotropic drugs, but their frequency of development is, in general, less.

From the endocrine system: it is possible to develop reversible hyperprolactinemia, the most frequent manifestations of which are galactorrhea, menstrual disorders, less often - gynecomastia, impotence and frigidity.

From the gastrointestinal tract: weakening effect or diarrhea due to the presence of maltitol in the drug, dry mouth, heartburn, nausea, vomiting, increased activity of transaminases and alkaline phosphatase in the blood serum.

From the nervous system: sedation, 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 (NZS)!

From the side of the cardiovascular system - tachycardia, it is possible to increase or decrease blood pressure, in rare cases, the development of orthostatic hypotension is possible.

Possible: dizziness, tachycardia, prolongation of the QT-interval, rarely, arrhythmia of the "torsade de pointes" type.

Allergic reactions: possible skin rash, itching, eczema.

During treatment with sulpiride, there may be increased sweating, an increase in body weight.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:When there is an overdose of sulpiride, there are no specific symptoms. In case of an overdose of sulpiride, blurred vision, arterial hypertension, sedative effect, nausea, extrapyramidal symptoms, dry mouth, vomiting, increased sweating and gynecomastia, development of NZS. Due to the lack of a specific antidote, symptomatic and supportive therapy should be used.

Interaction:

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

The combination of sulpiride with alcohol can also enhance the sedative effect of alcohol.

It is necessary to avoid simultaneous administration with levodopa due to the mutual antagonism of levodopa and sulpiride.

With simultaneous administration with lithium preparations, extrapyramidal disorders may develop.

There is an increased risk of orthostatic hypotension with simultaneous administration of sulpiride and antihypertensive drugs.

Sucralfate, antacids containing Mg2 + and / or A13 +, reduce bioavailability by 20-40%.

Special instructions:

In the case of the appearance of hyperthermia, which is one of the elements of malignant neuroleptic syndrome (CNS), the drug must be canceled until the cause of hyperthermia is clarified.

They are used with caution in patients with Parkinsonism, impaired renal function, elderly people, and children.

When prescribing the drug for patients with epilepsy before the start of treatment, a preliminary clinical and electrophysiological examination is necessary, since the drug reduces the threshold of convulsive activity.

Whenever extrapyramidal disorders occur, a dose reduction or antiparkinsonian therapy is necessary. During the treatment period, do not drink alcohol. A sharp discontinuation of the drug may cause withdrawal symptoms. The drug contains maltitol, so it can not be administered to patients with hereditary intolerance to fructose.

Effect on the ability to drive transp. cf. and fur:During the period of treatment, one should refrain from engaging in potentially dangerous activities requiring increased attention and rapid psychomotor reactions.

Form release / dosage:

Solution for oral administration (200 mg / 5 ml).

Packaging:

For 150 ml of the preparation into a bottle of orange glass type 3, sealed with a screw cap of high density polypropylene with a foaming polyethylene gasket, a ring of the first opening and protection of the drug from children.

1 bottle with instructions for use in a cardboard box.

Storage conditions:Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

The drug should not be used after the expiry date indicated on the label of the vial.

After opening, the shelf life is 3 months.

Terms of leave from pharmacies:On prescription

Registration number:PL-000913

Date of registration:18.10.2011

The owner of the registration certificate:Rosemont Pharmaceuticals Ltd.Rosemont Pharmaceuticals Ltd. United Kingdom

Manufacturer: & nbsp

ROSEMONT PHARMACEUTICALS, Ltd. United Kingdom

Representation: & nbspSVYCH LLC SVYCH LLC Russia

Information update date: & nbsp26.08.2015

Illustrated instructions

Instructions

Sulpiride (Sulpirid)