- Approval Id
- 6b24579f289e9758
- Drug Name
- SOLIAN TABLET 200 mg
- Product Name
- SOLIAN TABLET 200 mg
- Approval Number
- SIN09773P
- Approval Date
- 1998-05-16
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- **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.
- Route Of Administration
- ORAL
- Indication Info
- **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
- **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_)
- Atc Code
- N05AL05
- Atc Item Name
- amisulpride
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/sanofi-aventis-singapore-pte-ltd
