Sulpiride Belupo, 50mg capsules 30pcs

Composition

1 capsule contains:  active ingredients: sulpiride 50 mg; excipients: lactose monohydrate-29 mg; corn starch-31 mg; pre-gelatinized corn starch-7.2 mg; magnesium stearate-2.8 mg; capsule shell-size 4 (body and lid):  titanium dioxide (E 171) — 2%; gelatin — q. s. up to 100%.

Pharmacological action

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

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

The peripheral effect of sulpiride is based on the inhibition 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.

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

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 agent 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 the etiology. Sulpiride stimulates prolactin secretion and has a central antiemetic effect (inhibition of the emetic center).

Indications

As monotherapy or in combination with other psychotropic drugs.

• acute and chronic schizophrenia;
• acute delirious states;
• depressions 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.

Contraindications

• acute poisoning with alcohol, hypnotics, analgesics;
• hypersensitivity to sulpiride; pheochromocytoma;
• epilepsy;
• prolactinaemia tumors (including breast cancer);
• hyperprolactinemia;
• patients in the heat of passion and aggression, in which there is a danger of provocation of symptoms;
• lactation;
• children up to 14 years;
• Parkinson’s disease;
• galactosemia;
• syndrome of malabsorption of glucose/galactose or lactase deficiency.

With caution:  Precautions should be taken when prescribing sulpiride to patients with impaired renal function, as up to 95% of sulpiride is excreted through the kidneys. These patients are recommended to reduce the dose of sulpiride; precautions should also be taken when prescribing sulpiride to patients with heart disease, blood vessels, angina pectoris, hypertension, liver failure, neuroleptic malignant syndrome in the anamnesis, epilepsy, glaucoma, prostatic hyperplasia, urinary retention, young women with irregular menstrual cycles, elderly patients.

Side effects

The adverse events that develop as a result of taking sulpiride are similar to those caused by other psychotropic drugs, but their frequency is generally lower.

From the endocrine system:  reversible hyperprolactinemia may develop, with the most common manifestations being galactorrhea, menstrual irregularities, and less frequently gynecomastia, impotence, and frigidity.

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

From the central nervous system:  sedation, drowsiness, dizziness, headache, tremor, rarely-extrapyramidal syndrome, early and late dyskinesia, akathisia, oral automatism, aphasia. When used in small doses, psychomotor agitation, anxiety, irritability, sleep disorders, visual acuity disorders are possible. If hyperthermia develops, the drug should be discontinued, since an increase in body temperature may indicate the development of neuroleptic malignant syndrome (NSD).

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

Allergic reactions:  possible skin rash, itching, eczema.

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

Interaction

Concomitant use of sulpiride and drugs that depress the central nervous system (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.

Concomitant use 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 at the same time. 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 neuroleptics.

In neuroleptic-induced extrapyramidal syndrome, 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 may lead to the development of neuroleptic malignant syndrome).

The risk of developing ventricular arrhythmias type “torsade de pointes” when applied simultaneously with: antiarrhythmic drugs 1 and class (quinidine, gedragingen, disopyramide) and class III (amiodarone, sotalol, mofetil, ibutilide), certain antipsychotics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, amisulpride, tiapride, haloperidol, droperidol, pimozide), drugs that cause bradycardia (diltiazem, verapamil, beta-blockers, clonidine, guanfacine, preparations of digitalis, donepezil, rivastigmine, tacrine, amrinone chloride, galantamine, and pyridostigmine, neostigmin), drugs that cause hypokalemia (calivintage diuretics, some laxatives, amphotericin b in/in GCS, tetracosactide) and others (including bepridil, cisapride, was diphemanil, erythromycin intravenously, mizolastine, vincamine has I/, halofantrine, pentamidine, sparfloxacin, moxifloxacin).

How to take, course of use and dosage

Acute and chronic schizophrenia, acute delirious psychosis:  initial doses depend on the clinical picture of the disease and are 600-1200 mg per day, divided into several doses; maintenance doses — 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. Duration of treatment — at least 14 days.

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

Dosage in patients with impaired renal function

Due to the fact that sulpiride is mainly eliminated from the body through the kidneys, it is recommended to reduce the dose and/or increase the interval between the use of individual doses of the drug, depending on the indicators of creatinine clearance:

Doses for the elderly:  the initial dose should be 1/4-1/2 of the adult dose.

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

Overdose

Symptoms (common to both dosage forms): dyskinesia (masticatory muscle spasm, spastic torticollis), extrapyramidal disorders. In some cases-severe Parkinsonism, coma.

Treatment:  symptomatic.Purpose of holinoblokatorov central action.

Special instructions

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

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

Influence on the ability to drive motor vehicles and manage mechanisms

During the treatment period, driving vehicles and working with mechanisms that require increased attention, as well as taking alcohol, are prohibited.

Storage conditions

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

Shelf

life is 4 years.

Active ingredient

Sulpiride

Conditions of release from pharmacies

By prescription

Dosage form

Capsules