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SULPIRIDE is a brand name for Sulpiride. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Acute and chronic schizophrenia
Verbatim from this product's MHRA label. Tap a section to expand.
Sulpiride has bimodal dose-dependent therapeutic activity; its actions at low dose levels are therefore qualitatively different to those at high dose levels. Adults A starting dose of 400 mg to 800 mg per day, given as two divided doses (morning and early evening), is recommended.
Where positive symptoms predominate (hallucinations, delusions, formal thought disorder, incongruity of affect) these symptoms respond to higher doses and a starting dose of at least 400 mg twice daily is recommended. This can then be increased if necessary up to a maximum daily dose of 2400 mg, taken as two divided doses.
Increasing the dose beyond 1200mg twice daily has not shown to produce further improvement. Where negative symptoms predominate, (anergia, apathy, flattening of affect, poverty of speech) and for depression, doses below 800mg are most effective.
A starting dose of 400 mg twice daily is therefore recommended. Reducing this dose towards 200 mg twice daily will normally increase the alerting effect of sulpiride. Where neither negative or positive symptoms predominate a response is usually seen to a dose of 400 mg to 600 mg twice daily.
5, 2 and 3 respectively. Children under 14 years of age Sulpiride tablets are not recommended for use in children as there is insufficient clinical experience in this age group.
). 5 Interactions with other medicinal products and other forms of interaction). 4 Special warnings and precautions for use Where hypomania is present care should be taken. Increased motor agitation has been reported at high doses. Symptoms may be aggravated in aggressive, agitated or excited phases of the disease process by low doses.
Higher doses may also produce a motor agitation (excitability, irritability anxiety and mood inversion) in a small number of patients. Extrapyramidal reactions, namely tremor and akathisia, have been reported; a reduction in dose or anti-parkinsonian medication may be necessary.
As with other neuroleptic drugs, unexplained hyperthermia, muscle rigidity, autonomic instability, altered consciousness, and elevated CPK levels, could indicate neuroleptic malignant syndrome (NMS). In such cases sulpiride tablets, and any other neuroleptics, should be discontinued.
Avoid concomitant neuroleptics. Elderly patients are more susceptible to sedation, postural hypotension and extrapyramidal effects. An abrupt cessation of treatment in some patients may produce a withdrawal response including nausea, vomiting, insomnia and sweating.
Recurrence of psychotic symptoms can also occur, as can the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia). Therefore gradual withdrawal is advised. 2 Posology and method of administration). Increased Mortality in Elderly people with Dementia Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated.
There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known. Sulpiride is not licensed for the treatment of dementia-related behavioural disturbances. 2 Posology and method of administration).
Where hypomania is present care should be taken. Increased motor agitation has been reported at high doses. Symptoms may be aggravated in aggressive, agitated or excited phases of the disease process by low doses. Higher doses may also produce a motor agitation (excitability, irritability anxiety and mood inversion) in a small number of patients.
Extrapyramidal reactions, namely tremor and akathisia, have been reported; a reduction in dose or anti-parkinsonian medication may be necessary. As with other neuroleptic drugs, unexplained hyperthermia, muscle rigidity, autonomic instability, altered consciousness, and elevated CPK levels, could indicate neuroleptic malignant syndrome (NMS).
In such cases sulpiride tablets, and any other neuroleptics, should be discontinued. Avoid concomitant neuroleptics. Elderly patients are more susceptible to sedation, postural hypotension and extrapyramidal effects. An abrupt cessation of treatment in some patients may produce a withdrawal response including nausea, vomiting, insomnia and sweating.
Recurrence of psychotic symptoms can also occur, as can the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia). Therefore gradual withdrawal is advised. 2 Posology and method of administration). Increased Mortality in Elderly people with Dementia Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated.
There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known. Sulpiride is not licensed for the treatment of dementia-related behavioural disturbances. 2 Posology and method of administration).
Caution should be taken in patients with respiratory disease, myasthenia gravis, prostatic hypertrophy and glaucoma. In patients with Parkinson’s disease, sulpiride can be used when neuroleptic treatment is absolutely necessary, but caution is advisable.
Known hypersensitivity to the active ingredient or to any of the excipients. Phaeochromocytoma. Porphyria. g. 8 Undesirable effects). Association with levodopa (See
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Caution should be taken in patients with respiratory disease, myasthenia gravis, prostatic hypertrophy and glaucoma. In patients with Parkinson’s disease, sulpiride can be used when neuroleptic treatment is absolutely necessary, but caution is advisable.
Patients with unstable epilepsy and those with a history of epilepsy should be more frequently monitored during therapy with sulpiride. Sulpiride is known to induce slight EEG modifications. When patients receiving anti-convulsant therapy require sulpiride treatment, the dose of the anti-convulsant should not be changed.
Cases of convulsions have been reported, sometimes in patients with no previous history. Caution should be exercised in patients with a history of jaundice. In cases of renal insufficiency, the dose should be reduced and titrated in small steps (as with all drugs for which the kidney is a major elimination pathway).
Sulpiride has no significant anticholinergic effect. Caution should be exercised in patients with cardiovascular disease or family history of QT prolongation. Sulpiride may induce a prolongation of the QT interval, which is known to potentiate the risk of serious ventricular arrhythmias such as torsade de pointes.
This effect is enhanced by the pre-existence of bradycardia, hypokalaemia, congenital or acquired long QT interval. It is recommended that factors that could favour the occurrence of this rhythm disorder should be monitored before any administration, if possible according to the patient’s clinical status.
5 Interaction with other medicinal products and other forms of interactions). An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics or other patient populations.
Sulpiride should be used with caution in patients with risk factors for stroke. 3 for further information) a benefit/risk assessment should be undertaken when prescribing neuroleptics to patients with a history of, or with existing mammary neoplasia.
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk for VTE, all possible risk factors for VTE should be identified before and during treatment with Sulpiride and preventive measures undertaken.
5 Interaction with other medicinal products and other forms of interaction Associations contra-indicated Levodopa: reciprocal antagonism of effects between levodopa and neuroleptics. Associations not recommended Alcohol: alcohol enhances the sedative effects of neuroleptics.
Avoid the consumption of alcoholic beverages and dugs containing alcohol. Combination with the following medications which could induce torsades de pointes: • Bradycardia-inducing medications such as beta-blockers, Bradycardia-inducing calcium channel blockers such as diltiazem and verapamil, clonidine; digitalics.
• Medications which induce hypokalaemia: hypokalaemic diuretics, stimulant laxatives, IV amphotericin B, glucocorticoids, tetracosactides. • Class Ia antiarrhythmic agents such as quinidine and disopyramide. • Class III antiarrhythmic agents such as amiodarone and sotalol.
• Other medications such as pimozide, haloperidol, imipramine antidepressants, cisapride, thioridazine, IV erythromycin, pentamide. […]
Patients with unstable epilepsy and those with a history of epilepsy should be more frequently monitored during therapy with sulpiride. Sulpiride is known to induce slight EEG modifications. When patients receiving anti-convulsant therapy require sulpiride treatment, the dose of the anti-convulsant should not be changed.
Cases of convulsions have been reported, sometimes in patients with no previous history. Caution should be exercised in patients with a history of jaundice. In cases of renal insufficiency, the dose should be reduced and titrated in small steps (as with all drugs for which the kidney is a major elimination pathway).
Sulpiride has no significant anticholinergic effect. Caution should be exercised in patients with cardiovascular disease or family history of QT prolongation. Sulpiride may induce a prolongation of the QT interval, which is known to potentiate the risk of serious ventricular arrhythmias such as torsade de pointes.
This effect is enhanced by the pre-existence of bradycardia, hypokalaemia, congenital or acquired long QT interval. It is recommended that factors that could favour the occurrence of this rhythm disorder should be monitored before any administration, if possible according to the patient’s clinical status.
Such factors are: • Bradycardia less than 55 bpm • Hypokalaemia (which should be corrected) • Congenital prolongation of the QT interval • On-going treatment with a medication likely to produce pronounced Bradycardia (<55 bpm), hypokalaemia, decreased intracardiac conduction, or prolongation of the QTc interval (see