Sulpiride-DT tablets act on dopaminergic neurotransmission in the brain as a dopaminergic mimetic, thereby activating. In high doses, sulpiride also has an anti-reproductive effect.
Composition
Active ingredient: sulpiride 1 tablet contains sulpiride 50 mg Excipients: celactose 80 (a mixture of lactose monohydrate and powdered cellulose (75:25)), microcrystalline cellulose, corn starch, colloidal silicon dioxide, talc, magnesium stearate.
Contraindication
Hypersensitivity to sulpiride or any of the excipients of the drug. Prolactin-dependent tumors (for example, prolactin-secreting pituitary adenoma (prolactinoma) and breast cancer). Known or suspected diagnosis of pheochromocytoma. Acute porphyria. Combinations with non-antiparkinsonian dopamine agonists (cabergoline, rotigotine and quinagolide), combinations with levodopa or antiparkinsonian drugs (including ropinorole), combinations with mecitazine, citalopram and escitalopram.
Method of application
The minimum effective dose should always be prescribed. If the patient's clinical condition allows, treatment should be initiated at a low dose, followed by gradual dose titration.
Adults
Short-term symptomatic treatment of anxiety states in cases where conventional therapeutic measures have failed: daily dose is 50-150 mg for no more than 4 weeks.
Children aged 6 and over
Serious behavioral disorders (agitation, self-harm, stereotypies), especially in patients with autistic syndromes: 5 mg/kg body weight per day
(If necessary, this dose may be increased to 10 mg/kg body weight per day).
Application features
Children
Since the efficacy and safety of sulpiride in children have not been fully studied, it should be used with caution (see section "Method of administration and dosage"). Due to the effect of the drug on cognitive abilities, it is recommended to conduct an annual clinical examination to assess learning ability. The dose of the drug should be periodically adjusted based on the clinical status of the child.
Pregnancy
Due to limited experience with sulpiride during pregnancy, its use is not recommended. The following adverse reactions have been reported: agitation, hypertonia, hypotension, tremor, drowsiness, respiratory distress and feeding problems. Therefore, the condition of the newborn should be carefully monitored.
Breastfeeding period. Since sulpiride passes into breast milk, breastfeeding during treatment is not recommended.
Overdose
Experience with sulpiride overdose is limited. Dyskinetic manifestations with spasmodic torticollis, tongue protrusion and trismus may occur. Some patients may develop parkinsonism, life-threatening symptoms or even coma.
Sulpiride is partially removed by hemodialysis. There is no specific antidote for sulpiride.
Treatment should be symptomatic, resuscitation with careful monitoring of cardiac activity and respiratory function (risk of QT prolongation and ventricular arrhythmias), which should be continued until the patient recovers completely. In case of severe extrapyramidal syndrome, anticholinergic drugs should be administered.
Side effects
Adverse reactions associated with the use of the drug, observed during clinical studies, are listed below by organ and system classes in order of decreasing frequency of occurrence.
Neurological disorders
Early dyskinesia (spastic torticollis, oculogyric crises, trismus), which decreases with the use of anticholinergic antiparkinsonian drugs.
Extrapyramidal symptoms and related disorders:
parkinsonism and related symptoms: tremor, hypertonia, hypokinesia and hypersalivation akinetic symptoms, with or without hyperkinesia, which are partially reduced by the use of anticholinergic antiparkinsonian agents hyperkinetic-hypertonic, excitable motor activity akathisia
Tardive dyskinesia, which is characterized by involuntary rhythmic movements, particularly of the tongue and/or face, and which can occur during long-term treatment with all neuroleptics; in this case, anticholinergic antiparkinsonian drugs are ineffective and may worsen clinical manifestations.
Sedative effect or drowsiness.
There were reports of insomnia and confusion.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Shelf life - 3 years.
