Sulpirid Belupo (Capsules) Instructions for Use

ATC Code

N05AL01 (Sulpiride)

Active Substance

Sulpiride (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antipsychotic drug (neuroleptic)

Pharmacotherapeutic Group

Antipsychotic (neuroleptic) agent

Pharmacological Action

An antipsychotic agent (neuroleptic) from the group of substituted benzamides. It has a moderate antipsychotic effect, as well as an antidepressant effect combined with an activating action.

The mechanism of antipsychotic action is associated with the selective blockade of central dopamine D₂ receptors.

The sedative effect is weak, alpha-adrenergic blocking activity is low, and it practically does not cause antimuscarinic effects.

It rarely causes extrapyramidal disorders, therefore it belongs to the “atypical” neuroleptics.

It promotes the healing of ulcerative lesions of the stomach and duodenum.

Pharmacokinetics

After intramuscular administration of sulpiride at a dose of 100 mg, C_max in plasma is reached after 30 minutes, after oral administration at a dose of 200 mg – after 4.5 hours.

Bioavailability after oral administration is 25-35% and is characterized by significant individual variability.

The plasma concentration of sulpiride is proportional to the dose.

Plasma protein binding is no more than 40%.

Sulpiride rapidly penetrates all tissues of the body, faster into the liver and kidneys, slower into brain tissue (with the main amount accumulating in the pituitary gland).

0.1% of the daily dose of sulpiride is excreted in breast milk.

It is excreted by the kidneys unchanged by glomerular filtration (92%).

The total clearance (usually equal to renal clearance) is 126 ml/min. T_1/2 is about 7 hours.

Indications

Neurotic conditions accompanied by inhibition; psychosomatic disorders, including in gastric and duodenal ulcers, ulcerative colitis; acute and chronic psychoses with a predominance of inhibition, agrammatism, abulia; acute and chronic psychoses accompanied by delirium or confusion, including in schizophrenia.

ICD codes

Dosage Regimen

Administer capsules orally with a sufficient amount of water. Take with or without food, but maintain a consistent daily pattern to ensure stable plasma concentrations.

For adults with neurotic or psychosomatic disorders, the typical oral dosage is 100-300 mg/day, divided into two or three doses. For acute and chronic psychoses, including schizophrenia, higher doses are required; initiate therapy at 400-800 mg/day in divided doses.

The maximum daily dose for oral administration is 1.6 g (1600 mg). Do not exceed this maximum. For severe cases, consider parenteral (intramuscular) administration at a dose of 100-800 mg/day.

For pediatric patients, calculate the dose based on body weight at 5 mg/kg/day. Use with extreme caution and only under specialist supervision.

In geriatric patients or those with renal impairment, initiate treatment at the lower end of the dosage range. For patients with severe renal failure (creatinine clearance below 30 mL/min), a dose reduction of 50-75% or an intermittent dosing schedule is mandatory.

Adjust the dosage gradually based on clinical response and tolerability. Regularly monitor for extrapyramidal symptoms and endocrine disturbances, especially with long-term use at high doses. Abrupt discontinuation is not recommended; taper the dose gradually.

Adverse Reactions

From the central nervous system agitation, dizziness, sleep disorders, oral automatism, aphasia.

From the digestive system dry mouth, heartburn, vomiting, constipation.

From the cardiovascular system increased blood pressure.

From the endocrine system menstrual cycle disorders, decreased sexual activity. With long-term use in high doses – galactorrhea, gynecomastia.

Allergic reactions skin rash, itching.

Contraindications

Pheochromocytoma, arterial hypertension, psychomotor agitation, hypersensitivity to sulpiride.

Use in Pregnancy and Lactation

Use with caution and in minimal effective doses during pregnancy and lactation.

Use in Renal Impairment

In severe renal failure, a dose reduction or intermittent course of treatment is recommended.

Pediatric Use

Use with caution in children.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Use with caution in patients with parkinsonism, elderly patients.

In severe renal failure, a dose reduction or intermittent course of treatment is recommended.

In patients with epilepsy, a preliminary clinical and electrophysiological examination is necessary before starting therapy, because Sulpiride lowers the seizure threshold.

In case of hyperthermia, which is one of the elements of Neuroleptic Malignant Syndrome (NMS), Sulpiride should be discontinued immediately.

Avoid alcohol consumption during treatment.

Use with caution in children.

Effect on the ability to drive vehicles and operate machinery

During treatment, one should refrain from engaging in potentially hazardous activities that require increased attention and rapid psychomotor reactions.

Drug Interactions

With simultaneous use of drugs that depress the central nervous system (opioid analgesics, hypnotics, tranquilizers, clonidine, centrally acting antitussives), the depressant effect on the central nervous system is enhanced.

With simultaneous use with antihypertensive agents, the antihypertensive effect is enhanced and the risk of orthostatic hypotension increases.

With simultaneous use with levodopa, the effectiveness of sulpiride is reduced.

Cases of severe extrapyramidal reactions have been described with the simultaneous use of sulpiride with lithium carbonate.

With simultaneous use with fluoxetine, the development of extrapyramidal symptoms and dystonia is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.