Chemical formula: C₁₅H₂₃N₃O₄S Molecular mass: 341.426 g/mol PubChem compound: 5355
Sulpiride interacts in the following cases:
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:
Sulpiride should be prescribed with caution in patients presenting with these factors and patients with cardiovascular disorders which may predispose to prolongation of the QT interval.
Combination with the following medications could induce torsades de pointes or prolong the QT interval:
Association with CNS depressants including narcotics, analgesics, sedative H1 antihistamines, barbiturates, benzodiazepines and other anxiolytics, clonidine and derivatives, should be taken into account.
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.
Enhances the sedative effects of neuroleptics. Avoid the consumption of alcoholic beverages and drugs containing alcohol.
The absorption of sulpiride is decreased after co-administration. Therefore, sulpiride should be administered two hours before these drugs.
Antihypertensive effect and possibility of enhanced postural hypotension (additive effect).
Increased risk of extrapyramidal effects. Discontinuation of both drugs is recommended at first signs of neurotoxicity.
Sulpiride should be used with caution in patients with a history of glaucoma, ileus, congenital digestive stenosis, urine retention or hyperplasia of the prostate.
In randomised clinical trials versus placebo performed in a population of elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular events has been observed. The mechanism of such risk increase is not known. An increase in the risk with other antipsychotic drugs or other populations of patients cannot be excluded. Sulpiride should be used with caution in patients with stroke risk factors.
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 mania or hypomania is present.
Sulpiride should be used with caution in hypertensive patients, especially in the elderly population, due to the risk of hypertensive crisis. Patients should be adequately monitored.
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.
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.
When neuroleptic treatment is absolutely necessary in a patient with Parkinson’s disease, sulpiride can be used, although caution is in order.
In patients with aggressive behaviour or agitation with impulsiveness, sulpiride could be given with a sedative.
Neuroleptics may lower the epileptogenic threshold. Caution is advised in prescribing sulpiride for patients with unstable epilepsy, and patients with a history of epilepsy should be closely monitored during therapy with sulpiride.
Population group: only elderly (65 years old or older)
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 licenced for the treatment of dementia-related behavioural disturbances.
There are only very limited data available from the use of sulpiride in pregnant women. The safety of sulpiride during human pregnancy has not been established.
Sulpiride crosses the placenta. Studies in animals are insufficient with respect to reproductive toxicity.
The use of sulpiride is not recommended during pregnancy and in women of child bearing potential not using effective contraception, unless the benefits justify the potential risks.
Neonates exposed to antipsychotics during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
Sulpiride is excreted into breastmilk in rather large amounts, far above the accepted value of 10% of the maternal weight-adjusted dosage in some cases, but blood concentrations in breastfed infants have not been evaluated. There is insufficient information on the effects of sulpiride in newborns/infants.
A decision must be made whether to discontinue breast-feeding or to abstain from sulpiride therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
A decrease in fertility linked to the pharmacological effects of the drug (prolactin mediated effect) was observed in treated animals.
Even used as recommended, sulpiride may cause sedation so that the ability to drive vehicles or operate machinery can be impaired.
The following frequency rating is used, when applicable: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Uncommon: Leukopenia
Not known: Neutropenia, agranulocytosis
Not known: Anaphylactic reactions including urticaria, dyspnoea, hypotension and anaphylactic shock
Common: Hyperprolactinaemia
Common: Insomnia
Not known: Confusion
Common: Sedation or drowsiness, extrapyramidal disorder (these symptoms are generally reversible upon administration of antiparkinsonian medication), Parkinsonism, tremor, akathisia
Uncommon: Hypertonia, dyskinesia, and dystonia
Rare: Oculogyric crisis
Not known: Neuroleptic malignant syndrome, hypokinesia, tardive dyskinesia (have been reported, as with all neuroleptics, after a neuroleptic administration of more than three months. Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms), convulsion.
Not known: hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Rare: Ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia
Not known: electrocardiogram QT prolonged, cardiac arrest, torsade de pointes, sudden death
Uncommon: Orthostatic hypotension
Not known: Venous embolism, pulmonary embolism, deep vein thrombosis
Not known: pneumonia aspiration (mainly in association with other CNS depressants)
Common: constipation
Uncommon: Salivary hypersecretion
Common: Hepatic enzyme increased
Common: Maculo-papular rash
Not known: Torticollis, trismus
Not known: Extrapyramidal symptoms, drug withdrawal syndrome neonatal
Common: Breast pain, galactorrhoea
Uncommon: Breast enlargement, amenorrhoea, orgasm abnormal, erectile dysfunction
Not known: Gynaecomastia
Common: Weight gain
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