Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Amisulpride
Sanofi-Aventis Australia Pty Ltd
Amisulpride
amisulpride-winthrop-ccdsv12-piv14-08aug17 PRODUCT INFORMATION AMISULPRIDE WINTHROP ® TABLETS AND SOLUTION NAME OF THE MEDICINE AMISULPRIDE 50 WINTHROP AMISULPRIDE 100 WINTHROP AMISULPRIDE 200 WINTHROP AMISULPRIDE 400 WINTHROP AMISULPRIDE WINTHROP SOLUTION 100mg/mL AUSTRALIAN APPROVED NAME Amisulpride CHEMICAL STRUCTURE Chemical Name: (R, S)-4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-ethylsulfonyl-2- methoxybenzamide Molecular Weight: 369.48 Molecular Formula: C 17 H 27 N 3 O 4 S CAS NUMBER 71675-85-9 DESCRIPTION Amisulpride is a white to off-white powder, which is practically insoluble in water, sparingly soluble in ethanol, soluble in methanol and freely soluble in dichloromethane. AMISULPRIDE WINTHROP Tablets contain amisulpride (50 mg, 100 mg, 200 mg and 400 mg) and the following excipients: 50, 100 and 200 mg tablets: sodium starch glycollate type A, lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate. 400 mg tablets: sodium starch glycollate type A, lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate, PEG-40 stearate, titanium dioxide. amisulpride-winthrop-ccdsv12-piv14-08aug17 AMISULPRIDE WINTHROP SOLUTION contains amisulpride 100mg/mL and the following excipients: hydrochloric acid, methyl hydroxybenzoate, propyl hydroxybenzoate, potassium sorbate and purified water. and the following proprietary ingredients: Gesweet ® 2023 (ARTG No 10553) and Caramel Flavour E9422058 (ARTG No 10645) PHARMACOLOGY CLASS Neuroleptic of the benzamide class. PHARMACODYNAMICS Amisulpride binds selectively to the human dopaminergic D 2 (Ki 2.8 nM) and D 3 (Ki 3.2 nM) receptor subtypes without any affinity for D 1 , D 4 and D 5 receptor subtypes (Ki > 1 M). Unlike classical and atypical neuroleptics, amisulpride displays low affinity for serotonin, -adrenergic, histamine receptor subtypes, muscarinic receptors and sigma sites. In the rodent, it preferentially blocks post-synaptic D 2 receptors located in the limbic structures as compared to those in the stri Les hele dokumentet