Sulpiride – composition, action, dosage and side effects of an antipsychotic drug

Proven content

Sulpiride is an organic compound and an active ingredient of antipsychotic drugs with antipsychotic, activating and antidepressant properties. Two preparations containing this ingredient are available on the Polish pharmaceutical market. They are Sulpiryd Teva and Sulpiryd Hasco. What are the indications and contraindications for the use of drugs with sulpiride? How to dose this drug and what to look for when taking the drug? Can the use of drugs with sulpiride in the composition cause side effects in a patient? How much do drugs with sulpiride cost?

Sulpiride – general characteristics of the drug

Sulpiride is a benzamide drug used to treat schizophrenia and other mental illnesses. It is a component of two drugs available on the Polish pharmaceutical market: Sulpirydu Teva and Sulpirydu Hasco.

Sulpiride Teva is available as white, round, biconvex tablets with a smooth surface. The tablets are odorless and have a bitter aftertaste. The tablets are packed in PVC / Al foil blisters. 1 blister may contain 12 or 15 tablets. There are two tablet blisters in a cardboard box.

In the case of Sulpirid Hasco, the form of the drug depends on the dose of the active substance:

1. 50 mg dose – tablets round, biconvex, with bevelled edges, smooth, white. One package of Sulpiryd Hasco 50 mg can contain 24, 30, 60, 120 tablets in a cardboard box; 
2. 100 mg dose – oval, biconvex, smooth, white tablets. One package of Sulpiryd Hasco 100 mg can contain 24, 30, 60, 120 tablets in a cardboard box;
3. 200 mg dose – oval, biconvex tablets, uniform surface on one side and engraved on the other side “HL” (“H” on one side of the scale, “L” on the other side of the scale), plain, white. One package of Sulpiryd Hasco 200 mg can contain 12, 30, 60, 120 tablets in a cardboard box. 

Regardless of the manufacturer of the drug, the active ingredient is sulpiride, which has an antipsychotic and antidepressant effect and belongs to the group of the so-called neuroleptics, benzamide derivatives.

The entities responsible for the production and distribution of drugs with sulpiride are two pharmaceutical concerns: Hasco-Lek and Teva Pharmaceuticals Polska.

Hasco-Lek is a Polish pharmaceutical company based in Wrocław. The company was founded in 1984 by Dr. Stanisław Han. Initially, the company dealt mainly with the production of cosmetics. It was not until 1991 that the first medicinal preparations appeared in the company’s offer. They were syrups composed of natural ingredients. Hasco-Lek is the first company in Poland that in 1999 started the production of gelatin capsules by the method of matrix extrusion. The Hasco-Lek Group also includes the Vratislavia Medica Szpital im. Saint John Paul II.

Teva Pharmaceuticals Polska, a pharmaceutical company, is the world’s largest producer of generic drugs. It is a world leader in the pharmaceutical industry, committed to increasing patient access to high-quality therapies by developing, manufacturing and supplying affordable generics, innovative and specialist drugs and active ingredients. Teva Polska, on the other hand, is among the top three re-creation companies in Poland. It provides access to the widest range of drugs in Poland. Among almost 500 products, there are, among others painkillers, anti-inflammatory drugs, anti-infectives, drugs used in diseases of the cardiovascular system, disorders of the central nervous system, transplantology, as well as in oncology and dermatology. Polish factories produce prescription drugs and OTC drugs (over the counter), such as Aviomarin or Flegamina, and dietary supplements such as Hepatil or Vibovit.

Are Poles satisfied with the activities of Polish pharmaceutical companies? Check: Customer satisfaction from Polish pharmaceutical companies: which is the most convincing?

Sulpiride – composition and action of the drug

Regardless of the drug manufacturer, the basic ingredient of the preparations is sulpiride. First of all, it is an organic chemical compound, a benzamide derivative, used as an antipsychotic drug that acts by selectively blocking D2 dopaminergic receptors in the central nervous system. It works especially within the mesolimbic pathway, reducing dopamine levels. This effect is considered to be an antipsychotic mechanism of action. Sulpiride was authorized in 1976 in Switzerland, and the entity responsible for the registration of the compound was Sanofi-Aventis (Suisse) Sa

This compound works anti-autistic, activating and antidepressant. Sulpiride occupies an important position among antipsychotic drugs due to its rapid effect on hallucinations, thinking disorders, psychomotor inhibition or depressive mood. It is also one of the most powerful anti-drugs drugs. It can be successfully used in the treatment of psychosis with depression and in schizophrenia. It has an antiemetic effect and also improves the patient’s mood.

Orally administered sulpiride is absorbed within about 4,5 hours, and its bioavailability is about 27–34%. Serum concentration is proportional to the dose administered. The biological half-life is approximately 8–9 hours. The compound penetrates the blood-brain barrier to a small extent, and also penetrates into breast milk. It crosses the placenta in trace amounts. 95% of the dose is excreted unchanged in urine and faeces.

Teva Sulpiride is available in two forms, and the excipients used depend on the form chosen:

1. Sulpiride Teva in hard capsules: maize starch, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, gelatin, quinoline yellow (E 104), red iron oxide (E 172) and titanium dioxide (E 171);
2. Teva sulpiride in tablets: maize starch, lactose monohydrate, povidone, microcrystalline cellulose, magnesium stearate.

In the case of Sulpirid Hasco, the following excipients are listed:

1. pregelatinized corn starch;
2. lactose monohydrate;
3. Powidon K 30;
4. microcrystalline cellulose;
5. magnesium stearate.

How to recognize and treat schizophrenia? Read on: Schizophrenia

Sulpiride – indications for use

Sulpiride is a neuroleptic and the indications for its use are:

1. acute and chronic psychosis in schizophrenia, especially with symptoms of impaired activity;
2. chronic alcohol psychoses and psychosomatic disorders;
3. depressive disorders, when treatment with other antidepressants is ineffective or not applicable;
4. migraine and dizziness of various etiologies (including Meniere’s disease);
5. supportive in the treatment of alcohol addiction.

What should you know about the causes, symptoms, and treatment of depression? Read on: Depression – who does it affect and why? How to cure depression? [WE EXPLAIN]

Sulpiride – contraindications to use

The drug sulpiride, despite its effectiveness in the treatment of psychosomatic disorders, cannot be used by every patient struggling with this type of ailments.

Contraindications to the use of drugs with sulpiride are:

1. allergy to the active substance – sulpiride, to other benzamide derivatives or any of the other ingredients of the selected drug;
2. suspicion or confirmation of a phaeochromocytoma in the patient;
3. porphyria oyster;
4. tumors associated with increased secretion of prolactin;
5. simultaneous intake of levodopa;
6. breast-feeding;
7. age of the patient – the drug is not used in children and adolescents under 14 years of age

What should you know about drug hypersensitivity? Check: Drugs are also allergenic

Sulpiride – precautions

Before and during the use of drugs with sulpiride, follow the precautions included in the package leaflet.

Precautions to keep in mind include:

1. Talk to your doctor or pharmacist before using this medicine;
2. in some patients the use of high doses of sulpiride may induce severe motor activity;
3. caution should be exercised in the event of hypomania, including a high mood, characterized by increased energy, less need for sleep, and increased physical and mental efficiency;
4. in aggressive or agitated patients, sulpiride may be administered with a sedative;
5. special care should be taken when administering sulpiride to patients with Parkinson’s disease. Extrapyramidal disorders may occur in a small number of patients;
6. possible occurrence of the so-called neuroleptic malignant syndrome characterized by an increase in body temperature, muscle stiffness, instability of the autonomic system, impaired consciousness, increased concentration of phosphocreatine kinase; 
7. elderly patients may be more prone to developing hypotension, sedation and extrapyramidal symptoms;
8. acute withdrawal symptoms including nausea, vomiting, increased sweating and insomnia may occur when antipsychotics are stopped suddenly;
9. neuroleptics can lower the seizure threshold;
10. when using sulpiride, caution should be exercised in patients with unstable epilepsy, and especially careful monitoring of patients with a history of seizures;
11. caution should be exercised when using sulpiride in patients with renal insufficiency;
12. caution should be exercised when using sulpiride in patients with arrhythmias and cardiovascular disorders;
13. the use of sulpiride with other neuroleptics should be avoided;
14. the use of this type of medication is associated with the risk of blood clots in the veins;
15. sulpiride should not be taken in the late evening hours (after 16.00:XNUMX p.m.) due to the possibility of sleep disturbances;
16. sulpiride should be used with caution in patients at risk of stroke;
17. the medicine should not be used after the expiry date which is stated on the carton. The expiry date refers to the last day of that month;
18. this medicine should not be disposed of via wastewater or household waste. It’s best to ask your pharmacist how to dispose of medicines you no longer use.

What should you know about proper drug storage? Check: Medications that are stored wrongly are poisonous

Sulpiride – proper dosage

Preparations with sulpiride should always be used exactly as described in the package leaflet or according to the doctor’s or pharmacist’s instructions.

The dosage depends on the selected preparation. The starting dose for Sulpiride Teva is for adults patients is 400 mg – 800 mg per day. It is given in two divided doses – in the morning and in the early evening. The maximum dose is 1200 mg of the drug. If you are refractory to treatment, your doctor may decide to increase the dose up to 1600 mg.

In the case of Sulpiryd Hasco, the dosage depends on the condition the patient is struggling with. In For the treatment of schizophrenia, the usual dose is 400-800 mg per day and is given in two divided doses. The maximum daily dose is 1200 mg, but in special cases your doctor may decide to increase the dose to 1600 mg.

Treatment of depressive disorders usually requires the administration of 50-150 mg of the drug per day. This dose may be increased to 150-300 mg daily.

Sulpiride medications can be overdosed. The most commonly reported symptoms of overdose are:

1. excessive sedation;
2. anxiety;
3. confusion (disorientation);
4. disturbances of consciousness;
5. stimulation;
6. extrapyramidal symptoms (e.g. trembling hands, head, sudden muscle contractions, inability to sit or stand in one place, strange, rhythmic uncontrolled movements most often in the face);
7. lowering blood pressure;
8. coma.

How to take medication correctly? Check: How to take medications effectively?

Sulpiride – side effects

The drugs Sulpiryd Teva and Sulpirid Hasco, like any other drug, can cause side effects in patients. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

Common side effects of sulpiride (affects 1 to 10 patients in 100):

1. satisfaction;
2. somnolence.

Rare side effects of sulpiride (affects 1 in 1 patients):

1. extrapyramidal symptoms and acute dyskinesia, tardive dyskinesia (rhythmic involuntary movements primarily of the tongue and / or facial muscles);
2. rotational movements of the eyeball;
3. spastic torticollis;
4. trismus.

Very rare side effects of sulpiride (affects 1 in 10 patients):

1. increase in liver enzymes;
2. maculo-papular rash.

The incidence of side effects after the use of sulpiride is unknown:

1. ventricular tachycardia;
2. hyperprolactinaemia (increased blood prolactin levels);
3. amenorrhea;
4. gynecomastia (male nipple enlargement);
5. sexual frigidity and impotence;
6. orthostatic hypotension;
7. venous clots;
8. excessive salivation;
9. neonatal withdrawal syndrome;
10. prolongation of the QT interval on the ECG;
11. life-threatening neuroleptic malignant syndrome;
12. weight gain.

What is paranoid schizophrenia? Read on: Paranoid Schizophrenia – Learn about the common symptoms

Sulpiride and pregnancy and breastfeeding

The use of any medications or dietary supplements during pregnancy requires consultation with the attending physician. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking sulpiride.

According to the information contained in the leaflet, the use of sulpiride during pregnancy is not recommended. Newborns exposed to antipsychotics during the third trimester of pregnancy are at risk of developing side effects, including so-called extrapyramidal disorders and / or withdrawal symptoms. The intensity of these symptoms may vary depending on the severity of the course and the duration of labor. Agitation, increased or decreased muscle tone, tremors, somnolence, respiratory distress syndrome, or feeding disorders have been observed.

Sulpiride passes into breast milk, therefore you should not breast-feed while taking the drug.

What is worth knowing about proper supplementation during pregnancy? Check: Conscious choices. Diet and supplementation in pregnancy

Sulpiride – food-alcohol interactions

Alcohol is the most popular and used stimulant. However, be aware that consuming it while taking sulpiride can have dangerous and harmful consequences. Alcohol may increase the sedative effect of this medicine.

You should also remember to take the drug at least one hour before or two hours after a meal, as the presence of food reduces the absorption of the drug.

How to deal with mental illness? Read on: You can live normally with a mental illness. Why are we so afraid of them?

Sulpiride – interactions with other drugs

Before starting treatment with sulpiride preparations, inform the treating physician or pharmacist about all medications that he or she has been taking or has recently taken. You should also inform what medications the patient plans to take in the near future.

When using sulpiride, the following should not be used simultaneously:

1. medicines that slow down the heartbeat;
2. drugs that disrupt the electrolyte balance, especially leading to hypokalemia;
3. class Ia and class III antiarrhythmics;
4. other drugs such as: pimozide, sultopride, haloperidol, methadone, imipramine tricyclic antidepressants, halofantrine, lithium, cisapride, bepridil, thioridazine, intravenous vincamine, entamidine, erythromycin, sparfloxacin.

Particular care should be taken, however, with the simultaneous use of sulpiride with:

1. opium derivatives – i.e. painkillers, analgesics, antitussive drugs, substitution treatment; 
2. neuroleptics;
3. barbiturates and drugs that act like barbiturates; 
4. benzodiazepinami;
5. anxiolytics and hypnotics other than benzodiazepines; 
6. sedating antidepressants – i.e. amitriptyline, doxepin, mianserin, mirtazapine, trimipramine, imipramine;
7. hypnotic antihistamines, sedative H1 antagonists; 
8. centrally acting antihypertensive drugs – i.e. baclofen, thalidomide, pizotifen; 
9. antacids and sucralfate; 
10. ropinirolem; 
11. litem;
12. clonidine and clonidine derivatives.

Which drugs should never be combined with each other? Check: Dangerous interactions

Sulpiryd — cena

The price of drugs with sulpiride may differ depending on the city in which the preparation will be purchased or the pharmacy chosen by the patient. The price of the product also depends on the manufacturer responsible for the distribution of the drug and the number of tablets contained in the package.

Sulpiryd Teva leku dinner:

1. 24 capsules 100 mg – about 5-6 zlotys. After the refund, about PLN 2;
2. 24 capsules 50 mg – about 4 zlotys. After the refund, about PLN 2.

This drug is dispensed free of charge up to the limit in indications such as mental illness or mental retardation and additionally also in Tourette’s syndrome.

Cena leku Sulpiryd Hasco:

1. 24 tablets 100 mg – about 5-6 zlotys. After the refund, about PLN 2;
2. 30 tablets of 200 mg – about PLN 9. After reimbursement, the drug is issued free of charge;
3. 24 tablets 50 mg – about 4 zlotys. After the refund, about PLN 2.

How much money does the average Pole spend on treatment? Check: The Pole is not expected to see a doctor