Apo-Amisulpride

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Amisulpride 400mg;  

Available from:

Apotex NZ Ltd

INN (International Name):

Amisulpride 400 mg

Dosage:

400 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Amisulpride 400mg   Excipient: Basic butylated methacrylate copolymer Isopropyl alcohol Lactose monohydrate Macrogol 6000 Magnesium stearate   Methylcellulose Microcrystalline cellulose Purified talc Purified water Sodium starch glycolate Titanium dioxide

Units in package:

Blister pack, PVC/Al, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Laboratorios Espinos Y Bofill SA (LEBSA)

Therapeutic indications:

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.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 10 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/Al - 50 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - 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

Authorization date:

2012-10-30

Summary of Product characteristics

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