Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**DOSAGE AND ADMINISTRATION** Usually, if the daily dose is ≤ 400 mg, it will be administered as a once-daily intake. If the daily dose exceeds 400 mg, it will be administered as two daily intakes. _Predominantly negative episodes_ The recommended dosage is 50 to 300 mg/day. Dosage should be adjusted on an individual basis. The optimum dosage is about 100 mg/day. _Mixed episodes with positive and negative symptoms_ At the beginning of treatment, the dosage should be that which enables the control of positive symptoms, i.e. 400 to 800 mg/day. The dosage should then be adjusted individually as a function of the patient’s response, so as to obtain the minimum effective dose. _Acute psychotic episodes_ At the beginning of treatment: - it is possible to start via the IM route for a few days, at a maximum dose of 400 mg/day, replaced thereafter with oral treatment, - the recommended dosage via the oral route is 400 to 800 mg; the maximum dosage should never exceed 1200 mg. Thereafter: - the dosage should be maintained or adjusted as a function of the patient’s response. In all cases, the dosage of maintenance therapy should be established individually using the minimum effective dose. _Elderly subjects_ Amisulpride should be used with particular caution in this patient population due to the risk of hypotension and sedation (see SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Renal insufficiency_ Because amisulpride is excreted via the kidneys, the dosage should be reduced by half in patients with renal insufficiency whose creatinine clearance (CrCl) is between 30 and 60 ml/min, and to one third if the creatinine clearance is between 10 and 30 ml/min. In the absence of relevant data on patients with serious renal insufficiency (CrCl < 10 ml/min), amisulpride is contraindicated (see CONTRAINDICATIONS). _Hepatic insufficiency_ Amisulpride is poorly metabolised, so it is not necessary to reduce the dose in patients with hepatic insufficiency.
ORAL
Medical Information
**THERAPEUTIC INDICATIONS** Treatment of schizophrenia, particularly acute or chronic schizophrenic disorders, characterised by positive symptoms (e.g. delirium, hallucinations, thought disorders) and/or negative symptoms (e.g. blunted emotions, emotional and social withdrawal), including when the negative symptoms predominate.
**CONTRAINDICATIONS** This medicinal product MUST NOT BE USED in the following situations: - Hypersensitivity to amisulpride or any of the excipients - Serious hypertensive events have been reported in patients with pheochromocytoma using anti-dopaminergic drugs, including some benzamides. This medicinal product should therefore not be prescribed to known or suspected pheochromocytoma carriers. - Children under 15 years of age, because no clinical data are available - Known or suspected prolactin-dependent tumour, e.g., pituitary gland prolactinomas and breast cancer (see sections Special warnings and special precautions for use and Undesirable effects – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - In combination with: - non-antiparkinsonian dopamine agonists (cabergoline, quinagolide), - citalopram, escitalopram, domperidone, hydroxyzine, piperaquine (see section Interaction with other medicinal products and other forms of interactions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)
N05AL05
amisulpride
Manufacturer Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
DELPHARM DIJON
Active Ingredients
Documents
Package Inserts
Solian Tablet PI.pdf
Approved: August 16, 2022