Chemical formula: C₁₅H₂₃N₃O₄S Molecular mass: 341.43 g/mol
Levosulpiride interacts in the following cases:
Concomitant administration of neuroleptics with medicines that prolong the QT interval, increases the risk of cardiac arrhythmias.
Simultaneous intake of alcohol must be avoided.
Concomitant therapy with other neuroleptics must be avoided.
In randomized clinical trials versus placebo performed in a population of patients with dementia treated with some atypical antipsychotics, an increase of about three times of the cerebrovascular events risk was observed. The mechanism for this increased risk is not known. An increased risk for other antipsychotics or other patient populations can not be ruled out. Sulvorid should be used with caution in patients with risk factors for stroke.
Levosulpiride should be used with caution in hypertension in patients suspected to be carriers of pheochromocytoma, in patients with signs of heart failure. These conditions do not constitute in fact absolute contraindications.
Levosulpiride should be used with caution in patients with cardiovascular disease or with a family history of QT prolongation.
Levosulpiride should be used with caution in epilepsy, manic states, in the manic phase of manic-depressive disorder.
Do not use in pregnancy and in possible pregnancy. Neonates exposed to conventional or atypical antipsychotics included levosulpiride during the third trimester of pregnancy are at risk for side effects including extrapyramidal symptoms or withdrawal symptoms that may vary by severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder. Therefore, newborns should be carefully monitored.
Do not use during the breastfeeding period.
Levosulpiride has major influence on the ability to drive and use machines. Patients under treatment may experience numbness, dizziness and dyskinesia, therefore they should be advised to avoid driving and operations requiring supervision.
According to MedDRA system, organ classification, frequency categories are defined as follows: 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).
Very rare: allergic reactions
Not known: some disorders such as amenorrhea, gynecomastia, galactorrhea, hyperprolactinemia and changes in libido, observed in special cases, are due to a reversible effect of levosulpiride on the functionality of the hypothalamic-pituitary-gonadal axis, similar to that known for many neuroleptics.
Not known: cases of weight gain have been reported after prolonged treatment.
Very rare: psychomotor agitation, neurovegetative disorders and allergic reactions and extrapyramidal effects such as tremors, parkinsonism and dystonia. All these effects are modest in magnitude and reversible.
The following side effects have been observed with other medicines of the same class:
Rare: cases of QT prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation and cardiac arrest.
Very rare: cases of sudden death.
Not known: there have been reports of venous thromboembolism (VTE), including cases of pulmonary embolism (PE) and deep venous thrombosis (VTE).
Not known: neonatal withdrawal syndrome, extrapyramidal symptoms
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
