Sulpiride capsules 50mg №30

Packing

Mechanism of action

Sulpiride is an atypical neuroleptic from the group of substituted benzamides.
Sulpiride has moderate neuroleptic activity in combination with stimulating and thymoanleptic (anti-depressive) effects.
Neuroleptic effect is associated with anti-dopaminergic action. In the central nervous system, Sulpiride mainly blocks the dopaminergic receptors of the limbic system, but it has little effect on the non-striated system, it has an antipsychotic effect and causes a small number of side effects.
The peripheral action of sulpiride is based on the inhibition of presynaptic receptors. With an increase in the amount of dopamine in the CNS, an improvement in mood is associated with a decrease in the development of symptoms of depression.

The antipsychotic effect of sulpiride is manifested in doses of more than 600 mg / day, in doses up to 600 mg / day, a stimulating and antidepressant effect prevails.
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 adjunct in the treatment of psychosomatic diseases, in particular, it is effective in relieving negative mental symptoms of gastric ulcer and duodenal ulcer.In irritable bowel syndrome, sulpiride reduces the intensity of abdominal pain and leads to an improvement in the patient's clinical condition.
Low doses of sulpiride (50-300 mg / day) are effective for dizziness, regardless of etiology. Sulpiride stimulates the secretion of prolactin and has a central antiemetic effect (inhibition of the emetic center).

Pharmacokinetics
After oral administration, plasma Cmax is achieved in 1.5–3 h. The bioavailability of sulpiride is 27%. The binding of sulpiride to plasma proteins is less than 40%. The concentration of sulpiride in the CNS is 2-5% of the concentration in plasma. Sulpiride is excreted in breast milk. Sulpiride in the human body is not metabolized and is excreted almost unchanged through the kidneys. T1 / 2 is 6-8 hours. T1 / 2 is significantly increased in patients with moderate and severe renal insufficiency up to 20-26 hours after IV administration. Such patients should reduce the dose of sulpiride and / or increase the interval between taking the drug.

Indications and usage

As 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 a traumatic brain injury, otitis media);
• adjuvant therapy for gastric ulcer and duodenal ulcer and irritable bowel syndrome.

Contraindications

• acute alcohol poisoning, hypnotics, analgesics;
• hypersensitivity to sulpiride; pheochromocytoma;
• epilepsy;
• prolactin-dependent tumors (including breast cancer);
• hyperprolactinemia;
• patients in the state of passion and aggression, in whom there is a danger of provocation of symptoms;
• breastfeeding period;
• children under 14;
• Parkinson's disease;
• galactosemia;
• glucose / galactose malabsorption syndrome or lactase deficiency.

Carefully: Care must be taken when prescribing sulpiride to patients with impaired renal function, as up to 95% of sulpiride is excreted through the kidneys. It is recommended for these patients to reduce the dose of sulpiride; Care should also be taken when prescribing sulpiride to patients with heart disease, blood vessels, angina pectoris, arterial hypertension, liver failure, neuroleptic malignant syndrome in history, epilepsy, glaucoma, prostatic hyperplasia, retention of young women, epilepsy, glaucoma, prostatic hyperplasia, retention of young women, epilepsy, glaucoma, prostatic hyperplasia, retention of young women, epilepsy, glaucoma, hyperplasia of the prostate gland, retention of young women, epilepsy, glaucoma, hyperplasia of the prostate gland, retention of young women, epilepsy, glaucoma, prostatic hyperplasia, retention of urine, women, women, women, women with heart disease, retention age

Pregnancy and Breastfeeding

The prescription of sulpiride to pregnant women is not recommended, unless the doctor, having assessed the ratio of benefits and risks to the pregnant woman and the fetus, decides that the use of the drug is necessary. During the period of drug treatment is necessary to stop breastfeeding.

Special notes

If hyperthermia occurs during treatment with Sulpiride Belupo, it should be discontinued. Hyperemia may be a sign of the development of neuroleptic malignant syndrome (manifested by hyperthermia, dyskinesia, vegetative disorders), described in the treatment with neuroleptics. Although there are no data on the development of the syndrome during treatment with the drug Sulpiride Belupo, caution is necessary, especially when prescribing high doses of the drug.

When prescribing the drug Sulpiride Belupo, patients with epilepsy should be given a preliminary clinical and electrophysiological examination before starting treatment. the drug reduces the threshold of seizure activity.

Influence on ability to drive motor transport and control mechanisms

During the period of treatment it is prohibited to drive vehicles and work with mechanisms that require increased attention, as well as alcohol intake.

Composition

1 capsulecontains:
active substances: sulpiride 50 mg;
Excipients:lactose monohydrate, corn starch, pregelatinized corn starch, Magnesium stearate, titanium dioxide, gelatin.

Dosage and administration

Acute and chronic schizophrenia, acute delirious psychosis: initial doses depend on the clinical picture of the disease and amount to 600–1200 mg per day, divided into several doses; maintenance doses of 300–800 mg per day.

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

Dizziness: 150–200 mg per day; in severe conditions, the dose can be increased to 300–400 mg. The duration of treatment is at least 14 days.

Auxiliary therapy for gastric ulcer and duodenal ulcer, irritable bowel syndrome: 100–300 mg per day, in 1 or 2 doses.

Doses in patients with impaired renal function

Due to the fact that sulpiride is excreted 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 indicators:

Doses for the elderly: the initial dose should be 1 / 4–1 / 2 doses for adults.

Doses for children: The standard dose for children over the age of 14 is 3–5 mg / kg body weight.

Adverse reactions

The undesirable phenomena developing as a result of reception of sulpiride are similar to the undesirable phenomena caused by other psychotropic drugs, but the frequency of their development, generally less.

On the part of the endocrine system: possible development of reversible hyperprolactinemia, the most frequent manifestations of which are galactorrhea, menstrual disorders, less often gynecomastia, impotence and frigidity.

From the digestive system:dry mouth, heartburn, nausea, vomiting, constipation, increased serum transaminase and alkaline phosphatase activity.

From the side of the central nervous system: sedation, drowsiness, dizziness, headache, tremor, rarely - extrapyramidal syndrome, early and late dyskinesias, akathisia, oral automatism, aphasia. When used in small doses, psychomotor agitation, anxiety, irritability, sleep disturbance, visual impairment are possible. With the development of hyperthermia, the drug should be canceled, because an increase in body temperature may indicate the development of neuroleptic malignant syndrome (NZS).

Since the cardiovascular system:tachycardia, possible increase or decrease in blood pressure, in rare cases it is possible the development of orthostatic hypotension, prolongation of the QT interval, rarely, arrhythmia of the "pirouette" type.

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

During treatment with sulpiride, there may be increased sweating, weight gain.

Simultaneous intake of sulpiride and CNS depressant drugs (narcotic analgesics, antihistamines, barbiturates, benzodiazepines, and other anxiolytics) may increase the sedative effect of these drugs.
The combination of sulpiride with alcohol can also increase the sedative effect of alcohol.
Concurrent administration with levodopa due to mutual antagonism between levodopa and sulpiride should be avoided.
There is an increased risk of orthostatic hypotension while taking sulpiride and antihypertensive drugs.
Sucralfate, antacids containing Mg2 + and / or Al3 +, reduce bioavailability by 20-40%.

Antagonism with dopaminergic receptor agonists (amantadine, apomorphine, Bromocriptine , cabergoline, entacapone, lizurid, pergolid, piribedil, pramipexol, kinagolid, ropinirol) and neuroleptics. In extrapyramidal syndrome induced by neuroleptics, dopaminergic receptor agonists are not used, but anticholinergic drugs are used. If it is necessary to treat patients with Parkinson's disease while using dopaminergic receptor agonists, the dose of the latter should be gradually reduced to complete abolition (abrupt cancellation may lead to the development of a neuroleptic malignant syndrome).

The risk of developing ventricular arrhythmias of the "torsade de pointes" type with simultaneous use with: antiarrhythmic drugs of class 1a (quinidine, hydroquinidine, disopyramide) and class III (amiodarone, sotalol, dofetil, ibutilide), some neuroleptics (thioredazine, chlorpromazine, olephromasin, lymphoma, systolol, dyfel, ibutylide), some neuroleptics (tioridazine, chloropromazine, lymphoma, systolol, dofetil, ibutilide) , cyamemazine, amisulpride, Tiapride , Haloperidol , droperidol, pimozide), drugs that cause bradycardia (diltiazem, Verapamil , beta-blockers, clonidine, guanfacine, digitalis preparations, donepeizil, rivastigmine, so Rin, ambenonium chloride, galantamine , pyridostigmine, neostigmine),drugs that cause hypokalemia (potassium diuretics, some laxatives, amphotericin B / c, GCS, tetracosactide) and others (including bepridil, cisapride, diphemanil, intravenous Erythromycin , mizolastine, vincamine in / c, halofantrin, cx, antiphilil, intracellular erythromycin, mizolastine, vincamine in / c, halofanthrin, cristapine, intravenous, mizolastine, vincamine in / c, halofantrin, ct, ciplide, intravenous erythromycin, mizolastine, vincamine, curing, halofanthrin moxifloxacin).