Sulpirid (sulpiride) hard capsules 100 mg. №24

Description

Sulpirid (sulpiride) hard capsules 100 mg. №24

Composition

active substance: sulpiride;

1 capsule contains sulpiride 50 mg or 100 mg;

Excipients: colloidal anhydrous silica, corn starch, lactose monohydrate, magnesium stearate;

hard gelatin capsule for 50 mg: gelatin, titanium dioxide (E 171);

hard gelatin capsule for 100 mg: gelatin, titanium dioxide (E 171), quinoline yellow (E 104), iron oxide red (E 172).

Dosage form

Hard capsules.

Basic physical and chemical properties:

• 50 mg capsules: cylindrical capsules with semicircular edges, number 3, white, filled with white or cream powder;
• 100 mg capsules: cylindrical capsules with semicircular edges, number 3, yellow, filled with white or cream powder.

Pharmacotherapeutic group

Antipsychotics.
ATX code N05A L01

Pharmacological properties

It is an antipsychotic agent. It has moderate neuroleptic activity, as well as thymoleptic and stimulating effect. It is a selective (selective) antagonist of serotonin and dopamine. In addition, it exhibits antiemetic (antiemetic) action.

Indications

Sulpirid capsules is used:

• for short-term symptomatic treatment of anxiety conditions in adults in cases where standard therapeutic measures have not worked;
• with serious behavioral disorders (agitation, stereotypy, self-harm) in children from six years of age, especially in patients with autistic syndromes.

Contraindications

Sulpirid capsules does not apply:

• if you are allergic to sulpiride;
• with intolerance to excipients;
• with pheochromocytoma;
• with acute porphyria;
• with concomitant prolactin-dependent tumors (for example, prolactinoma), breast cancer;
• with concomitant treatment with antiparkinsonian dopamine agonists (rotigotine, cabergoline, kinagolide), levodopa, antiparkinsonian drugs (ropinorol), mechitazine, citalopram, escitalopram.

Application during pregnancy and lactation

Contraindicated.

Method of administration and dosage

For oral use.

The minimum effective dose should always be prescribed.

If the patient’s clinical condition allows, treatment should begin with a low dose, followed by gradual dose titration.

• Adults
  Short-term symptomatic treatment of anxiety in cases where the usual therapeutic measures did not work: the daily dose is 50-150 mg for no more than 4 weeks.
• Children from 6 years old.
  Serious behavioral disorders (agitation, self-harm, stereotype) in children over 6 years of age, especially in patients with autistic syndromes: 5-10 mg / kg body weight per day.

Children

The use of Sulpirid capsules in children under 6 years is contraindicated.

Overdose

Symptoms: dizziness, depression of consciousness of varying severity, arterial hypotension, collapse, extrapyramidal disorders.
Therapeutic measures: gastric lavage, the appointment of sorbents, support of the respiratory and cardiovascular systems, control of electrolyte balance, regulation of the acid-base state.

Side effects:

• Neurological disorders: extrapyramidal disorders (hypertension, tremor, rigidity, hypersalivation, hypokinesia, akathisia, dyskinesia), acute dystonia (oculogyric crisis, spastic torticollis, trismus, etc.), drowsiness, tardive dyskinesia (involuntary movements of the tongue, muscles , insomnia, frigidity, anxiety, agitation, neuroleptic malignant syndrome.
• Digestive disorders: dry mouth, nausea, vomiting, constipation.
• Endocrine disorders: hyperprolactinemia (galactorrhea, amenorrhea, gynecomastia, erectile dysfunction, chest pain).
• Metabolic disorders: weight gain, hyperglycemia.
• Laboratory tests: increasing the level of liver enzymes.
• Immune disorders: allergic manifestations.
• Cardiovascular disorders: bradycardia, arterial hypotension, lengthening of the Q-T interval, ventricular arrhythmias (including torsades de pointes, tachycardia, fibrillation, cardiac arrest), sudden coronary death, venous thromboembolism, PE, deep vein thrombosis.
• Hematological disorders: leukopenia, neutropenia, agranulocytosis.
• Dermatological disorders: angioedema, urticaria.