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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: Sulpiride is indicated in acute and chronic schizophrenia.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults A starting dose of 400 mg to 800 mg daily, given in two divided doses (morning and early evening) is recommended. Predominantly positive symptoms (formal thought disorder, hallucinations, delusions, incongruity of affect) respond to higher doses, and a starting dose of at least 400 mg twice daily is recommended, increasing if necessary up to a suggested maximum of 1200 mg twice daily.
Increasing the dose beyond this level has not been shown to produce further improvement. Predominantly negative symptoms (flattening of affect, poverty of speech, anergia, apathy), as well as depression, respond to doses below 800 mg daily; therefore, a starting dose of 400 mg twice daily is recommended.
Reducing this dose towards 200 mg twice daily will normally increase the alerting effect of sulpiride. Patients with mixed positive and negative symptoms, with neither predominating, will normally respond to dosage of 400-600 mg twice daily.
Paediatric population Clinical experience in children under 14 years of age is insufficient to permit specific recommendations. Elderly The same dose ranges may be required in the elderly, but should be reduced if there is evidence of renal impairment.
Method of administration For oral administration only.
). 5 Interactions with other medicinal products and other forms of interaction). - Bone marrow suppression. 4 Special warnings and precautions for use Warnings: Increased motor agitation has been reported at high dosage in a small number of patients In aggressive, agitated or excited phases of the disease process, low doses of sulpiride may aggravate symptoms.
Care should be exercised where hypomania is present. If extrapyramidal reactions occur, principally akathisia have been reported in a small number of cases, a reduction in dosage of sulpiride or initiation of antiparkinsonian medication may be necessary.
As with other neuroleptics, neuroleptic malignant syndrome (NMS), a potentially fatal complication, which is characterised by hyperthermia, muscle rigidity, autonomic instability, rhabdomyolisis, altered consciousness and elevated CPK levels, has been reported.
In such an event, or in the event of hyperthermia of undiagnosed origin, which may be considered either as an early sign/symptom of NMS or as an atypical NMS (cases with atypical features, such as hyperthermia without muscle rigidity or hypertonia, have been observed), all antipsychotic drugs, including sulpiride, should be discontinued promptly under medical supervision.
Elderly patients are more susceptible to postural hypotension, sedation and extrapyramidal effects. In patients with aggressive behaviour or agitation with impulsiveness, sulpiride could be given with a sedative. Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs.
Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. Therefore, gradual withdrawal is advisable. Increased Mortality in Elderly people with Dementia Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Warnings:
Increased motor agitation has been reported at high dosage in a small number of patients In aggressive, agitated or excited phases of the disease process, low doses of sulpiride may aggravate symptoms. Care should be exercised where hypomania is present.
If extrapyramidal reactions occur, principally akathisia have been reported in a small number of cases, a reduction in dosage of sulpiride or initiation of antiparkinsonian medication may be necessary. As with other neuroleptics, neuroleptic malignant syndrome (NMS), a potentially fatal complication, which is characterised by hyperthermia, muscle rigidity, autonomic instability, rhabdomyolisis, altered consciousness and elevated CPK levels, has been reported.
In such an event, or in the event of hyperthermia of undiagnosed origin, which may be considered either as an early sign/symptom of NMS or as an atypical NMS (cases with atypical features, such as hyperthermia without muscle rigidity or hypertonia, have been observed), all antipsychotic drugs, including sulpiride, should be discontinued promptly under medical supervision.
Elderly patients are more susceptible to postural hypotension, sedation and extrapyramidal effects. In patients with aggressive behaviour or agitation with impulsiveness, sulpiride could be given with a sedative. Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs.
Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. Therefore, gradual withdrawal is advisable. Increased Mortality in Elderly people with Dementia Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Data from two large observational studies showed that elderly patients with dementia who are treated with antipsychotics are at 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.
1. - Phaeochromocytoma. - Acute porphyria. - Severe renal, haematological or hepatic disease. - Alcoholic intoxication and other disorders which depress CNS function. g. 8 Undesirable effects). - Association with levodopa or antiparkinsonian drugs (including ropinirole) (See
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Data from two large observational studies showed that elderly patients with dementia who are treated with antipsychotics are at 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.
, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.
Sulpiride Oral Solution is not licensed for the treatment of dementia-related behavioural disturbances. Venous thromboembolism Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Sulpiride and preventive measures undertaken.
Patients should be warned against taking alcohol with sulpiride as reaction capacity may be impaired. Breast cancer Sulpiride may increase prolactin levels. Therefore, caution should be exercised and patients with a history or a family history of breast cancer should be closely monitored during sulpiride therapy.
2). In children, efficacy and safety of sulpiride have not been thoroughly investigated. 2). When neuroleptic treatment is absolutely necessary in a patient with Parkinson’s disease, sulpiride can be used, although caution is in order.
Neuroleptics may lower the epileptogenic threshold. Cases of convulsions, sometimes in patients with no previous history, have been reported with sulpiride. Caution is advised in prescribing it for patients with unstable epilepsy, and patients with a history of epilepsy should be closely monitored during therapy with sulpiride.
In patients requiring sulpiride who are receiving anti-convulsant therapy, the dose of the anti-convulsant should not be changed. Cases of convulsions, sometimes in patients with no previous history, have been reported. Initiation of treatment in schizophrenia should only be undertaken by a specialist under whose regular supervision the patients should remain.
As with all drugs for which the kidney is the major elimination pathway, the dose should be reduced and titrated in small steps in cases of renal insufficiency. Sulpiride has an anticholinergic effect and, therefore, should be used with caution in patients with a history of glaucoma, ileus, congenital digestive stenosis, urine retention or hyperplasia of the prostate.
As with all drugs for which the kidney is the major elimination pathway, the dosage should be reduced and titrated in small steps in cases of renal insufficiency. 8). 5). Before any administration, and if possible according to the patient’s clinical status, it is recommended to monitor factors which could favour the occurrence of […]
, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.
Sulpiride Oral Solution is not licensed for the treatment of dementia-related behavioural disturbances. Venous thromboembolism Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Sulpiride and preventive measures undertaken.
Patients should be warned against taking alcohol with sulpiride as reaction capacity may be impaired. Breast cancer Sulpiride may increase prolactin levels. Therefore, caution should be exercised and patients with a history or a family history of breast cancer should be closely monitored during sulpiride therapy.
2). In children, efficacy and safety of sulpiride have not been thoroughly investigated. 2). When neuroleptic treatment is absolutely necessary in a patient with Parkinson’s disease, sulpiride can be used, although caution is in order.
Neuroleptics may lower the epileptogenic threshold. Cases of convulsions, sometimes in patients with no previous history, have been reported with sulpiride. Caution is advised in prescribing it for patients with unstable epilepsy, and patients with a history of epilepsy should be closely monitored during therapy with sulpiride.
In patients requiring sulpiride who are receiving anti-convulsant therapy, the dose of the anti-convulsant should not be changed. Cases of convulsions, sometimes in patients with no previous history, have been reported. Initiation of treatment in schizophrenia should only be undertaken by a specialist under whose regular supervision the patients should remain.
As with all drugs for which the kidney is the major elimination pathway, the dose should be reduced and titrated in small steps in cases of renal insufficiency. Sulpiride has an anticholinergic effect and, therefore, should be used with caution in patients with a history of glaucoma, ileus, congenital digestive stenosis, urine retention or hyperplasia of the prostate.
As with all drugs for which the kidney is the major elimination pathway, the dosage should be reduced and titrated in small steps in cases of renal insufficiency. 8). 5). Before any administration, and if possible according to the patient’s clinical status, it is recommended to monitor factors which could favour the occurrence of this rhythm disorder, for example: • Bradycardia less than 55 bpm • Electrolyte imbalance in particular hypokalaemia • Congenital prolongation of the QT interval • On-going treatment with a medication likely to produce pronounced […]