Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Amisulpride 50mg;
Apotex NZ Ltd
Amisulpride 50 mg
50 mg
Tablet
Active: Amisulpride 50mg Excipient: Lactose monohydrate Magnesium stearate Methylcellulose Microcrystalline cellulose Sodium starch glycolate
Blister pack, PVC/Al, 60 tablets
Prescription
Prescription
Cosma SpA
Amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.
Package - Contents - Shelf Life: Blister pack, PVC/Al - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/Al - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/Al - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture
2012-10-30
NEW ZEALAND DATA SHEET APO-AMISULPRIDE AMISULPRIDE 50MG, 100MG & 200MG TABLETS AND 400MG FILM-COATED TABLETS Please refer to Medsafe website ( www.medsafe.govt.nz ) for the most recent datasheet Page 1 of 14 PRESENTATION APO-AMISULPRIDE 50mg are white to off-white, 6.0mm, round, biconvex tablets, with break line on one side. APO-AMISULPRIDE 100mg are white to off-white, 8.0mm, round, flat tablets, with break line on one side. APO-AMISULPRIDE 200mg are white to off-white, 11.0mm, round, flat tablets, with break line on one side. APO-AMISULPRIDE 400mg are white to off-white, 18.0mm long and 8.0mm wide, capsule shaped tablets, with break line on one side. INDICATIONS Apo-Amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterized by predominant negative symptoms. DOSAGE AND ADMINISTRATION For acute psychotic episodes, oral doses between 400mg/day and 800mg/day are recommended. In individual cases, the daily dose may be increased up to 1200mg/day. Doses above 1200mg/day have not been extensively evaluated for safety and therefore should not be used. Doses above 800mg/day have not been shown to be superior to lower doses and may increase the incidence of adverse events. No specific titration is required when initiating the treatment with amisulpride. Doses should be adjusted according to individual response. Doses should preferably be administered before meals. Amisulpride should be administered b.i.d for doses above 400mg. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Mainte Leggi il documento completo