Amiabel Special Precautions





United Lab
Full Prescribing Info
Special Precautions
Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., 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. Amisulpride is not licensed for the treatment of dementia-related behavioral disturbances.
Stroke: A three-fold increased risk of cerebrovascular events has been observed in a population of elderly patients with dementia and treated with certain atypical antipsychotic drugs. The mechanism of the increased risk is not known. An increase in the risk with other antipsychotic drugs, or other populations of patients cannot be excluded. Amisulpride should be used with caution in patients with stroke risk factors.
Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal syndrome that has been associated with antipsychotic drugs, including amisulpride. NMS is characterized by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated creatinine phosphokinase (CPK). In case of hyperthermia, particularly with high daily doses, all antipsychotic drugs, including amisulpride should be discontinued.
Seizure: Amisulpride can lower the seizure threshold. Patients with a history of seizures should be closely monitored during amisulpride therapy.
Dystonia: Acute dystonia characterized by spasm torticollis, oculogyric crisis and trismus may appear. This is reversible without amisulpride discontinuation upon treatment with an antiparkinsonian agent.
Extrapyramidal Symptoms: Extrapyramidal symptoms such as tremor, rigidity, hypokinesia, hypersalivation, and akathisia may occur. These symptoms are generally mild at optimal doses and partially reversible without amisulpride discontinuation upon administration of an antiparkinsonian agent. With doses of 50 mg to 300 mg/day, the incidence of extrapyramidal symptoms which is dose-related, remains very low in the treatment of patients with predominantly negative symptoms.
Tardive Dyskinesia: There have been reports of tardive dyskinesia characterized by rhythmic, involuntary movements primarily of the tongue and/or face, usually after long-term administration. Antiparkinsonian drug is ineffective or may aggravate these symptoms.
Hyperglycemia: There have been reports of hyperglycemia in patients treated with some atypical antipsychotic drugs including amisulpride. Therefore, patients with an established diagnosis of diabetes mellitus or with risk factors for diabetes who are on amisulpride therapy should get appropriate glycemic monitoring.
Increased Plasma Prolactin: Amisulpride increases plasma prolactin levels which are reversible after discontinuation of the drug. This may result in galactorrhea, amenorrhea, gynecomastia, breast pain, orgasmic dysfunction, and impotence.
Prolongation of the QT Interval: Amisulpride induces a dose-dependent prolongation of the QT interval. This effect, known to potentiate the risk of serious ventricular arrhythmias such as torsades de pointes, is enhanced by the pre-existence of bradycardia, hypokalemia, congenital or acquired long QT interval.
Hypokalemia should be corrected.
Before amisulpride administration, and if possible according to the patient's clinical status, it is recommended to monitor factors which could favor in the occurrence of this rhythm disorder: Bradycardia less than 55 bpm; Cardiac disease or family history of sudden death or QT prolongation; Electrolyte imbalance, in particular hypokalemia; Congenital prolongation of the QT interval; On-going treatment with drugs likely to produce pronounced bradycardia (<55 bpm), hypokalemia, decreased intracardiac conduction or prolongation of the QT interval.
Baseline ECG is recommended before treatment in all patients particularly in the elderly and patients with a positive personal or family history of cardiac disease or abnormal findings on cardiac clinical examination. During therapy, the need for ECG monitoring (e.g., at dose escalation) should be assessed on an individual patient basis.
Amisulpride dose should be reduced if QT is prolonged and discontinued if QTc is >500 ms.
Periodic electrolyte monitoring is recommended particularly if the patient is taking diuretics or during intercurrent illness.
Concomitant antipsychotic drugs should be avoided.
Venous Thromboembolism (VTE): Cases of venous thromboembolism, sometimes fatal, have been reported with antipsychotic drugs. Amisulpride should be used with caution in patients with risk factors for thromboembolism.
Use in Patients with Concomitant Illness: Like other antidopaminergic agents, caution should be exercised when prescribing amisulpride to patients with Parkinson's disease because it may cause worsening of the disease. Amisulpride should be used only if antipsychotic treatment cannot be avoided.
Amisulpride is eliminated by the renal route. In cases of severe renal insufficiency, the dose should be decreased or intermittent treatment should be considered.
There are limited data on the potential for renally-cleared drugs to interfere with amisulpride clearance. Therefore, amisulpride should be used with caution with other renally-excreted drugs, including lithium.
The impact of hepatic impairment on amisulpride's hepatic metabolism and hepato-biliary excretion has not been studied. Amisulpride should be used with caution in patients with moderate or severe hepatic impairment.
Withdrawal Symptoms: Acute withdrawal symptoms (e.g., nausea, vomiting and insomnia) have been described after abrupt cessation of high doses of antipsychotic drugs. Recurrence of psychotic symptoms may also occur. The emergence of involuntary movement disorders (e.g., akathisia, dystonia and dyskinesia) has been reported with amisulpride. Therefore, gradual withdrawal of the drug is advisable.
Effect on Ability to Drive and Use Machines: Amisulpride may affect reaction time; therefore, ability to drive vehicles or operate machinery can be impaired even when used as recommended.
Use in Children: Amisulpride is not recommended in children less than 15 years because its efficacy and safety have not yet been established in this age group.
Use in Elderly: Caution should be exercised when giving amisulpride to elderly patients because of possible risk of hypotension or sedation.
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