Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RISPERIDONE
CIPLA MALAYSIA SDN BHD
RISPERIDONE
100Tablet Tablets
CIPLA LTD
_ _ FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A LABORATORY ONLY Risnia 1 mg Tablets Risperidone tablets 1 mg COMPISITION Each film coated tablet contains: Risperidone Ph .Eur………………………………………… 1 mg Colour: Titanium Dioxide DOSAGE FORM Oral Tablets DESCRIPTION White coloured, circular, biconvex film coated tablets, plain on both the sides. CAUTION: THIS PREPARATION MAY BE HABIT FORMING ON PROLONGED USE PHARMACOLOGY PHARMACODYNAMICS Risperidone is a novel antipsychotic belonging to a new class of antipsychotic agents, the benzisoxazole-derivatives. Risperidone is a selective monoaminergic antagonist with a high affinity for both serotonergic 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 cholinergic receptors. Although risperidone is a potent D 2 antagonist, that is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical neuroleptics. Balanced central serotonin and dopamine antagonism may reduce the tendency to cause extrapyramidal side effects, and extend the therapeutic activity to the negative and affective symptoms of schizophrenia. PHARMACOKINETICS Risperidone is completely absorbed after oral administration, reaching peak plasma concentrations within 1 to 2 hours. Food does not affect the absorption of risperidone from the stomach. The effect of food particles in the mouth on absorption has not been studied. The most important route of metabolism of risperidone is hydroxylation by cytochrome CYP 2D6 to 9-hydroxy-risperidone which has a similar pharmacological activity to risperidone. This hydroxylation is subject to debrisoquine-type genetic polymorphism but this does not affect the active antipsychotic fraction since this consists of risperidone and its active metabolite 9-hydroxyrisperidone. After oral Read the complete document