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. Doses should be adjusted according to individual response. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms.

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 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 should be used with particular caution because of a possible risk of hypotension and sedation. Reduction in dosage may also be required because of renal insufficiency.

Children:

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 contraindications).

Renal insufficiency:

Amisulpride 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. 4 special warnings and special precautions for use).

Hepatic insufficiency: since the drug is weakly metabolised a dosage reduction should not be necessary. Method of administration Oral

8 Undesirable effects Adverse effects have been ranked under headings of frequency using the following convention ( ≥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), frequency not known (cannot be estimated from the available data).

4). Rare: agranulocytosis. ● Immune system disorders: Uncommon: allergic reaction ● Endocrine disorders: Common: 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.

4). ● Metabolism and nutrition disorders: Uncommon: hyperglycemia, hypertriglyceridemia and hypercholesterolemia. Rare: hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH). ● Psychiatric disorders: Common: insomnia, anxiety, agitation, orgasmic dysfunction.

Uncommon: confusion. ● Nervous system disorders: Very common: extrapyramidal symptoms may occur: tremor, rigidity, hypokinesia, hypersalivation, akathisia, dyskinesia. 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. Common: acute dystonia (spasm torticollis, oculogyric crisis, trismus) may appear.

This is reversible without discontinuation of amisulpride upon treatment with an antiparkinsonian agent. Somnolence. Uncommon: tardive dyskinesia characterized by rhythmic, involuntary movements primarily of the tongue and/or face have been reported, usually after long term administration.

Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms. Seizures. 4), which is a potentially fatal complication. Not known: restless legs syndrome. ● Eye disorders: Common: blurred vision. ● Cardiac disorders: Uncommon: bradycardia.

4). ● Vascular disorders: Common: hypotension. Uncommon: increase in blood pressure. Rare: venous thromboembolism, including pulmonary embolism, sometimes fatal, and deep vein thrombosis ● Respiratory, thoracic and mediastinal disorders: Uncommon: nasal congestion, aspiration pneumonia (mainly in association with other antipsychotics and CNS depressants).

● Gastrointestinal disorders: Common:constipation, nausea, vomiting, dry mouth. ● Hepatobilary disorders: Uncommon: hepatocellular injury ● Skin and subcutaneous tissue disorders: Rare: angioedema, urticaria. Not known: photosensitivity reaction .

● Musculoskeletal and connective tissue disorders: Uncommon: osteopenia, osteoporosis. 6) ● Injury, poisoning and procedural complications Not Known: Fall as a consequence of adverse reactions compromising body balance ● Investigations: Common: weight gain.

Uncommon: elevations of hepatic enzymes, mainly transaminases. 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.

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As with other neuroleptics, Neuroleptic Malignant Syndrome, a potentially fatal complication, characterized 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 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 glycemic monitoring.

Amisulpride is eliminated by the renal route. 2 Posology and method of administration). Severe liver toxicity has been reported with Amisulpride use. Patients should be instructed to report immediately signs such as asthenia, anorexia, nausea, vomiting, abdominal pain or icterus to a physician.

8) Amisulpride may lower the seizure threshold. Therefore patients with a history of epilepsy should be closely monitored during Amisulpride therapy. In elderly patients, Amisulpride, like other neuroleptics, should be used with particular caution because of a possible risk of hypotension and sedation.

Reduction in dosage may also be required because of renal insufficiency. As with other antidopaminergic agents, caution should be also exercised when prescribing Amisulpride to patients with Parkinson's disease since it may cause worsening of the disease.

Amisulpride should be used only if neuroleptic treatment cannot be avoided. 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 randomized 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 should be used with caution in patients with stroke risk factors.

Withdrawal symptoms including nausea, vomiting and insomnia have very rarely 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 dyskinsia) has been reported with amisulpride.

Therefore, gradual withdrawal of amisulpride is advisable. Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including amisulpride. 8), and requires immediate haematological investigation.

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. , 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 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 and preventative measures undertaken.

Benign pituitary tumour:

Amisulpride may increase prolactin levels. Cases of benign pituitary tumours such as prolactinoma have been observed during amisulpride therapy. In case of very high levels of prolactin or clinical signs of pituitary tumour (such as visual field defect and headache), pituitary imaging should be performed.

If the diagnosis of pituitary tumour is confirmed, the treatment with amisulpride must be stopped.

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 therapy. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

g. 8). Phaeochromocytoma. Children up to puberty. Combination with levodopa (see section