国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
risperidone, Quantity: 2 mg
Arrotex Pharmaceuticals Pty Ltd
Risperidone
Tablet, film coated
Excipient Ingredients: titanium dioxide; microcrystalline cellulose; lactose monohydrate; hypromellose; magnesium stearate; hyprolose; sunset yellow FCF aluminium lake; maize starch; macrogol 8000
Oral
60 tablets
(S4) Prescription Only Medicine
Treatment of schizophrenia and related psychoses. Short-term treatment of acute mania associated with bipolar I disorder. Treatment of behavioural disturbances in dementia. Treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with subaverage intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. Treatment of behavioural disorders associated with autism in children and adolescents.
Visual Identification: Light orange, capsule-shaped, biconvex, film-coated tablets. Engraved "APO" on one side, "RI" score "2" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2007-08-03
Product Information – Australia APO-Risperidone Tablets Page 1 APO-RISPERIDONE TABLETS NAME OF THE MEDICINE Risperidone. Chemical Name: 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2- methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Structural Formula: Molecular Formula: C 23 H 27 FN 4 O 2 Molecular Weight: 410.5 CAS Registry Number: 106266-06-2 DESCRIPTION Risperidone is a novel antipsychotic belonging to a new class of antipsychotic agents, the benzisoxazole derivatives. Risperidone is a white or almost white powder, practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in alcohol. It dissolves in dilute acid solutions. It shows polymorphism. Each tablet contains 0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg of risperidone as the active ingredient. In addition, each tablet contains the following inactive ingredients: lactose, cellulose microcrystalline, maize starch, magnesium stearate, hypromellose, hydroxypropylcellulose, macrogol 8000, titanium dioxide, iron oxide red (0.5 mg), sunset yellow FCF aluminium lake (2 mg), iron oxide yellow (3 mg and 4 mg) and indigo carmine aluminium lake (4 mg). PHARMACOLOGY PHARMACODYNAMICS Risperidone is a selective monoaminergic antagonist with a high affinity for serotoninergic 5HT 2 -receptors and dopaminergic D 2 -receptors. Risperidone binds also to alpha 1 -adrenergic receptors, and with lower affinity, to H 1 -histaminergic and α 2 - adrenergic receptors. Risperidone has no affinity for cholinergic receptors. The antipsychotic activity of risperidone is considered to be attributable to both risperidone and its active metabolite 9-hydroxy-risperidone. Central dopamine D 2 -receptor antagonism is considered to be the mechanism of action by which conventional neuroleptics improve the positive symptoms of schizophrenia, but also induce extrapyramidal symptoms and release of prolactin. Although risperidone antagonises dopamine D 2 -receptors and causes release of prolactin, it is less potent than classical neuroleptics for 完全なドキュメントを読む