Sulpiride Belupo, 50 mg capsules 30 pcs

Sulpiride is an atypical neuroleptic from the group of substituted benzamides.
Sulpiride has moderate neuroleptic activity in combination with stimulant and thymoanaleptic (antidepressant) effects.

The neuroleptic effect is associated with antidopaminergic action. In CNS, sulpiride blocks mainly dopaminergic receptors of limbic system, and it has little effect on neostriate system, it has antipsychotic effect and causes few side effects.

The peripheral effects of sulpiride are based on inhibition of presynaptic receptors. An increase in dopamine in the CNS is associated with an improvement in mood, and a decrease is associated with the development of symptoms of depression.

The antipsychotic effects of sulpiride are seen in doses greater than 600 mg/day, with stimulant and antidepressant effects predominating in doses less than 600 mg/day.

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

Low doses of sulpiride may be used as adjuvant in the treatment of psychosomatic diseases; in particular, it is effective in relieving negative psychiatric symptoms of gastric and duodenal ulcer disease.

In irritable bowel syndrome, sulpiride reduces the intensity of abdominal pain and leads to improvement of the clinical condition of the patient.

Low doses of sulpiride (50-300 mg/day) are effective for dizziness, regardless of etiology. Sulpiride stimulates prolactin secretion and has a central antiemetic effect (inhibition of the vomiting center).

Indications

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 (vertebrobasilar insufficiency, vestibular neuritis, Meniere’s disease, condition after traumatic brain injury, otitis media);
auxiliary therapy for gastric and duodenal ulcers and irritable bowel syndrome.

Pharmacological effect

Sulpiride is an atypical antipsychotic from the group of substituted benzamides.
Sulpiride has moderate neuroleptic activity in combination with stimulating and thymoanaleptic (antidepressive) effects.

The neuroleptic effect is associated with an antidopaminergic effect. In the central nervous system, sulpiride predominantly blocks dopaminergic receptors of the limbic system, and has a slight effect on the neostriatal system; it has an antipsychotic effect and causes a small number of side effects.

The peripheral effect of sulpiride is based on inhibition of presynaptic receptors. An increase in the amount of dopamine in the central nervous system is associated with an improvement in mood, and a decrease is associated with the development of symptoms of depression.

The antipsychotic effect of sulpiride is manifested in doses of more than 600 mg/day; in doses of up to 600 mg/day, the stimulating and antidepressant effect predominates.

Sulpiride does not have a significant effect on adrenergic, cholinergic, serotonin, histamine and gamma-aminobutyric acid receptors (GABA receptors).

In small doses, sulpiride can be used as an adjuvant in the treatment of psychosomatic diseases; in particular, it is effective in relieving the negative mental symptoms of gastric and duodenal ulcers.

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 (suppression of the vomiting center).

Special instructions

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

When prescribing Sulpiride Belupo to patients with epilepsy, a preliminary clinical and electrophysiological examination must be carried out before starting treatment, since the drug lowers the threshold for seizure activity.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, driving vehicles and operating machinery that require increased attention, as well as drinking alcohol, is prohibited.

Active ingredient

Sulpiride

Composition

1 capsule contains:

active substances:

Contraindications

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

With caution: precautions must be taken when prescribing sulpiride to patients with impaired renal function, since up to 95% of sulpiride is excreted through the kidneys. It is recommended that the dose of sulpiride be reduced in these patients; Precautions should also be observed when prescribing sulpiride to patients with heart disease, blood vessels, angina pectoris, arterial hypertension, liver failure, a history of neuroleptic malignant syndrome, epilepsy, glaucoma, prostatic hyperplasia, urinary retention, young women with irregular menstrual cycles, and elderly patients.

Side Effects

Adverse events that develop as a result of taking sulpiride are similar to those caused by other psychotropic drugs, but the frequency of their development is generally less.

From the endocrine system: the development of reversible hyperprolactinemia is possible, the most common manifestations of which are galactorrhea, menstrual irregularities, and less often – gynecomastia, impotence and frigidity.

From the digestive system: dry mouth, heartburn, nausea, vomiting, constipation, increased activity of transaminases and alkaline phosphatase in the blood serum.

From the side of the central nervous system: sedation, drowsiness, dizziness, headache, tremor, rarely – extrapyramidal syndrome, early and tardive dyskinesia, akathisia, oral automatism, aphasia. When used in small doses, psychomotor agitation, anxiety, irritability, sleep disturbance, and impaired visual acuity are possible. If hyperthermia develops, the drug should be discontinued, because An increase in body temperature may indicate the development of neuroleptic malignant syndrome (NMS).

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

Allergic reactions: possible skin rash, itching, eczema.

During treatment with sulpiride, increased sweating and weight gain may occur.

Interaction

The simultaneous use of sulpiride and drugs that depress the central nervous system (narcotic analgesics, antihistamines, barbiturates, benzodiazepines and other anxiolytics) can 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.

Co-administration with levodopa should be avoided due to the mutual antagonism of levodopa and sulpiride.

There is an increased risk of developing orthostatic hypotension when taking sulpiride and antihypertensive drugs simultaneously.
Sucralfate, antacids containing Mg2+ and/or Al3+ reduce bioavailability by 20-40%.

Antagonism with dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, kinagolide, ropinirole) and antipsychotics.

For extrapyramidal syndrome induced by antipsychotics, 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 until complete withdrawal (abrupt withdrawal can lead to the development of neuroleptic malignant syndrome).

The risk of developing ventricular arrhythmias of the “torsade de pointes” type when used simultaneously with: antiarrhythmic drugs of class 1a (quinidine, hydroquinidine, disopyramide) and class III (amiodarone, sotalol, dofetil, ibutilide), some antipsychotics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, amisulpride, tiapride, haloperidol, droperidol, pimozide), drugs that cause bradycardia (diltiazem, verapamil, beta blockers, clonidine, guanfacine, digitalis preparations, donepizil, rivastigmine, tacrine, ambenonium chloride, galantamine, pyridostigmine, neostigmine), drugs that cause hypokalemia (potassium-sparing diuretics, some laxatives, amphotericin B IV, GCS, tetracosactide) and others (including bepridil, cisapride, difemanil, erythromycin IV, mizolastine, vincamine IV, halofantrine, pentamidine, sparfloxacin, moxifloxacin).

Overdose

Symptoms (common to both dosage forms): dyskinesia (spasm of masticatory muscles, spastic torticollis), extrapyramidal disorders. In some cases – severe parkinsonism, coma.

Treatment: symptomatic. Prescription of centrally acting anticholinergics.

Storage conditions

In a place protected from light, at a temperature not exceeding 20 °C.

Shelf life

4 years.

Manufacturer

Belupo, medicines and cosmetics d.d., Croatia