Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
DRL RISPERIDONE SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): DRL RISPERIDONE DRL RISPERIDONE 0.5 (film-coated tablet) DRL RISPERIDONE 1 (film-coated tablet) DRL RISPERIDONE 2 (film-coated tablet) DRL RISPERIDONE 3 (film-coated tablet) DRL RISPERIDONE 4 (film-coated tablet) COMPOSITION: DRL RISPERIDONE 0.5: Each film-coated tablet contains risperidone 0,5 mg DRL RISPERIDONE 1: Each film-coated tablet contains risperidone 1 mg DRL RISPERIDONE 2: Each film-coated tablet contains risperidone 2 mg DRL RISPERIDONE 3: Each film-coated tablet contains risperidone 3 mg DRL RISPERIDONE 4: Each film-coated tablet contains risperidone 4 mg Sugar-free PHARMACOLOGICAL CLASSIFICATION A 2.6.5 Central nervous system depressants. Miscellaneous structures. PHARMACOLOGICAL ACTION Risperidone is an antipsychotic of the benzisoxazol derivatives. It is a selective monoaminergic antagonist. Risperidone has affinity for serotonin-5-HT 2 , dopamine-D 2 , H 1 -histamine, alpha 1 - and alpha 2 -adrenergic receptors. Risperidone has no affinity for cholinergic receptors. It is a dopamine D 2 -antagonist. Pharmacokinetics Risperidone is completely absorbed after oral administration. Peak plasma concentrations are attained within 1 - 2 hours. Food does not affect the absorption of risperidone. Risperidone is metabolized by cytochrome CYP2D6 to 9-hydroxy-risperidone which has a similar pharmacological activity to risperidone. Risperidone and 9-hydroxy-risperidone form the active antipsychotic fraction. After oral administration to psychotic patients the risperidone half-life is about 3 hours. The elimination half-life of 9- hydroxy-risperidone and the active antipsychotic fraction is 24 hours. Bio-equivalence has been proven as a registration requirement. Interchangeability between strengths: tablets may be broken to achieve dosage ti Read the complete document