AMISULPRIDE

Posology For acute psychotic episodes Oral doses between 400 mg/day and 800 mg/day are recommended. In individual cases, the daily dose may be increased up to 1200 mg/day. Doses above 1200 mg/day have not been extensively evaluated for safety and therefore should not be used.

No specific titration is required when initiating the treatment with Amisulpride Oral Solution. Doses should be adjusted according to individual response. Maintenance treatment should be established individually with the minimally effective dose.

e. between 400-800 mg/day. Maintenance treatment should be established individually with the minimally effective dose. For patients characterised by predominant negative symptoms Oral doses between 50 mg/day and 300 mg/day are recommended.

Doses should be adjusted individually. Amisulpride Oral Solution can be administered once daily at oral doses up to 300 mg, higher doses should be administered bid.. The minimum effective dose should be used.

Elderly:

The safety of amisulpride has been examined in a limited number of elderly patients. Amisulpride Oral Solution should be used with particular caution because of a possible risk of hypotension or sedation. Reduction in dosage may also be required because of renal insufficiency.

Renal insufficiency:

Amisulpride Oral Solution is eliminated by the renal route. In renal insufficiency, the dose should be reduced to half in patients with creatinine clearance (CRCL) between 30-60 ml/min and to a third in patients with CRCL between 10-30 ml/min.

As there is no experience in patients with severe renal impairment (CRCL <10 ml/min) particular care is recommended in these patients (see

Adverse effects have been ranked under headings of frequency using the following convention : very common (≥1/10); common (≥1/100;<1/10); uncommon (≥1/1,000;<1/100); rare (≥1/10,000;<1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

4). 4). 4). Respiratory, thoracic and mediastinal disorders Uncommon: nasal congestion, pneumonia aspiration (mainly in association with other antipsychotics and CNS depressants). 6).

Common:

Weight gainInvestigations: Uncommon: Elevations of hepatic enzymes, mainly transaminases 1 Amisulpride causes an increase in plasma prolactin levels which is reversible after drug discontinuation. This may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain and erectile dysfunction.

2 These symptoms are generally mild at optimal dosages and partially reversible without discontinuation of amisulpride upon administration of antiparkinsonian medication. The incidence of extrapyramidal symptoms which is dose related, remains very low in the treatment of patients with predominantly negative symptoms with doses of 50-300 mg/day.

3 This is reversible without discontinuation of amisulpride upon treatment with an antiparkinsonian agent 4 These have been reported, usually after long term administration. Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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Hepatic insufficiency:

Since the drug is weakly metabolised a dosage reduction should not be necessary Paediatric population: The efficacy and safety of amisulpride from puberty to the age of 18 years have not been established: There are limited data available on the use of amisulpride in adolescents in schizophrenia.

3).

Method of administration :

The graduations on the dosage syringe measure the millilitres of oral solution. After introducing the measuring syringe into the bottle, draw the plunger of the measuring syringe up to the graduation mark corresponding to the number of millilitres to be administered.

The oral solution should be drunk with a liquid, which does not contain alcohol. 1. 5). 4 Special warnings and precautions for use As with other neuroleptics, Neuroleptic Malignant Syndrome, a potentially fatal complication, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated CPK, may occur.

In the event of hyperthermia, particularly with high daily doses, all antipsychotic drugs including Amisulpride Oral Solution should be discontinued. Hyperglycaemia has been reported in patients treated with some atypical antipsychotic agents, including amisulpride, therefore patients with an established diagnosis of diabetes mellitus or with risk factors for diabetes who are started on amisulpride, should get appropriate glycaemic monitoring.

Amisulpride Oral Solution is eliminated by the renal route. 2). Amisulpride Oral Solution may lower the seizure threshold. Therefore patients with a history of epilepsy should be closely monitored during Amisulpride Oral Solution therapy.

In elderly patients, Amisulpride Oral Solution, like other neuroleptics, should be used with particular caution because of a possible risk of hypotension or sedation. Reduction in dosage may also be required because of renal insufficiency.

As with other antidopaminergic agents, caution should also be exercised when prescribing Amisulpride Oral Solution to patients with Parkinson’s disease since it may cause worsening of the disease. Amisulpride Oral Solution should be used only if neuroleptic treatment cannot be avoided.

Acute Withdrawal symptoms including nausea, vomiting and insomnia have been described after abrupt cessation of high therapeutic doses 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 with amisulpride.

Therefore, gradual withdrawal is advisable.

Prolongation of the QT interval:

Caution should be exercised when amisulpride is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and concomitant use with neuroleptics should be avoided.

Stroke:

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. Amisulpride Oral Solution should be used with caution in patients with stroke risk factors.

Elderly patients with dementia:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. 7 times the risk of death in placebo-treated patients. 6% in the placebo group. g. 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 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 Amisulpride Oral Solution and preventative measures undertaken.

Breast cancer Amisulpride 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 Amisulpride Oral Solution therapy. Benign pituitary tumour Amisulpride may increase prolactin levels.

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