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.

Active ingredient

Composition

How to take, the 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 are 300-800 mg per day.

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

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

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

Doses in patients with impaired renal function

Because sulpiride is mainly excreted through the kidneys, it is recommended to decrease the dose and/or increase the interval between doses of the drug depending on creatinine clearance rates:

Doses for the elderly: The starting 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 body weight.

Interaction

Simultaneous use 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 may also increase the sedative effect of alcohol.

Combination with levodopa should be avoided because of mutual antagonism of levodopa and sulpiride.

There is an increased risk of orthostatic hypotension when sulpiride and antihypertensives are taken concomitantly.
Sucralfate, antacids containing Mg2+and/or Al3+ reduce bioavailability by 20-40%.

Antagonism with dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, pyribedil, pramipexole, quinagolide, ropinirole) and neuroleptics.

In extrapyramidal syndrome induced by neuroleptics, dopaminergic receptor agonists are not used but anticholinergic medications are. If it is necessary to treat patients with Parkinson’s disease against the background of using dopaminergic receptor agonists, the dose of the latter should be gradually reduced until complete withdrawal (abrupt withdrawal may lead to the development of malignant neuroleptic syndrome).

The risk of ventricular arrhythmias such as “torsade de pointes” when used simultaneously with: Class 1a (quinidine, hydroquinidine, disopyramide) and Class III (amiodarone, sotalol, dofetil, ibutilide) antiarrhythmic drugs, some neuroleptics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, amisulpride, thiapride, haloperidol, droperidol, pimozide), bradycardia-inducing drugs (diltiazem, verapamil, beta-blockers, clonidine, guanfacine foxglove preparations, donepizil, rivastigmine, tacrine, ambenonium chloride, galantamine, pyridostigmine, neostigmine), drugs causing hypokalemia (potassium withdrawing diuretics, some laxatives, Amphotericin B w/v, GCS, tetracosactide) and others (including bepridil, cisapride, difemanil, erythromycin intravenously, misolastin, vincamine w/v, halofantrine, pentamidine, sparfloxacin, moxifloxacin).

Special Instructions

If hyperemia occurs during treatment with Sulpiride Belupo should be discontinued. Hyperemia may be a sign of malignant neuroleptic syndrome (manifested by hyperthermia, dyskinesia, autonomic disturbances) described during 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 Sulpiride Belupo is prescribed to patients with epilepsy, a prior clinical and electrophysiologic evaluation should be performed before starting treatment, because the drug reduces the seizure threshold.

Impact on driving and operating machinery

During treatment, driving and operating machinery requiring increased attention and drinking alcohol are prohibited.

Contraindications

Side effects

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

Endocrine system disorders: reversible hyperprolactinemia may develop, the most frequent manifestations of which are galactorrhea, menstrual cycle disorders, less frequent – gynecomastia, impotence, and frigidity.

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

CNS disorders: sedative effect, somnolence, dizziness, dizziness, headache, tremor, rarely – extrapyramidal syndrome, early and late dyskinesia, akathisia, oral automatism, aphasia. When used in low doses, psychomotor agitation, anxiety, irritability, sleep disturbance, visual acuity may occur. If hyperthermia develops, the drug should be discontinued, because increased body temperature may indicate the development of neuroleptic malignant syndrome (NMS).

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

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

During treatment with sulpiride increased sweating and weight gain may be noted.

Overdose

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

treatment: symptomatic. Administration of choline blockers of central action.

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