国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
risperidone, Quantity: 6 mg
Strides Pharma Science Pty Ltd
Risperidone
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate; quinoline yellow; maize starch; hypromellose; magnesium stearate; titanium dioxide; macrogol 400
Oral
60 tablets
(S4) Prescription Only Medicine
Risperidone is indicated for the treatment of schizophrenia and related psychoses. Risperidone is indicated for the treatment of behavioural disturbances in dementia. Risperidone is indicated for the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent.
Visual Identification: Yellow, film-coated, oblong tablet engraved with "R", a breakline and "6" on one side and a plain face on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2006-06-26
RISPERNIA™ CONSUMER MEDICINE INFORMATION Risperidone 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg & 6 mg film-coated tablets WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about RISPERNIA. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. IF YOU HAVE ANY CONCERNS ABOUT USING RISPERNIA, ASK YOUR DOCTOR OR PHARMACIST. Your doctor and pharmacist have more information. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT RISPERNIA IS USED FOR RISPERNIA is used to treat symptoms of schizophrenia and other types of related psychoses. These are disorders related to thought, feeling and/or action. RISPERNIA may be taken for both sudden (acute) and long-lasting (chronic) schizophrenia. RISPERNIA is also used to treat behavioural problems in patients with a decline in mental ability (dementia). These problems include: Aggression through words or action; Severe suspiciousness; Agitation; or Wandering. RISPERNIA can be used to treat conduct and other disruptive behaviors such as aggression, impulsiveness and self-injury in children (over 5 years old), adolescents and adults who are intellectually disabled. RISPERNIA helps to correct a chemical imbalance in the brain associated with these conditions. RISPERNIA has been approved for the uses mentioned above. However, your doctor may prescribe this medicine for another use. IF YOU WANT MORE INFORMATION, ASK YOUR DOCTOR. RISPERNIA is not addictive. BEFORE YOU USE RISPERNIA _ _ _WHEN YOU MUST NOT USE IT_ DO NOT USE RISPERNIA: If you know you are allergic to any of its ingredients (signs of allergy include skin rash, itching, shortness of breath, and/or swollen face - see the last section of this leaflet for a list of ingredients). If the packaging is torn or shows signs of being tampered with. If the tablets do not look right. To treat any other complaints unless your doctor says it is safe to do so. _BEFORE YOU START TO USE IT _ RISPERNIA sh 完全なドキュメントを読む
Page 1 of 15 PRODUCTION INFORMATION RISPERNIA FILM-COATED TABLETS NAME OF THE MEDICINE Active ingredient: risperidone Chemical structure CAS - 106266-06-2 C 23 H 27 FN 4 O 2 MW 410.49 DESCRIPTION Risperidone is a novel antipsychotic belonging to a new class of antipsychotic agents, the benzisoxazole-derivatives. Risperidone is chemically identified as 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. It 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. The other ingredients in the tablet cores are: lactose, microcrystalline cellulose, maize starch, colloidal anhydrous silica and magnesium stearate. Ingredients in the tablet coating are listed according to different strengths in the table below: Coating ingredients for different strengths of risperidone STRENGTH INGREDIENTS 0.5 mg hypromellose, titanium dioxide, macrogol 400 and iron oxide red. 1 mg hypromellose, titanium dioxide and macrogol 400. 2 mg hypromellose, titanium dioxide, macrogol 400, iron oxide red and quinoline yellow. 3 mg hypromellose, titanium dioxide, macrogol 400 and quinoline yellow. 4 mg hypromellose, titanium dioxide, macrogol 400, indigo carmine and quinoline yellow. 6 mg hypromellose, titanium dioxide, macrogol 400, quinoline yellow. PHARMACOLOGY PHARMACODYNAMICS Risperidone is a selective monoaminergic antagonist with a high affinity for serotoninergic 5-HT 2 and dopaminergic D 2 receptors. Risperidone binds also to alpha 1 -adrenergic receptors, and with lower affinity, to H 1 -histaminergic and alpha 2 -adrenergic receptors. Risperidone has no affinity for Page 2 of 15 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 neu 完全なドキュメントを読む