País: Indonésia
Língua: indonésio
Origem: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PALIPERIDONE
SOHO INDUSTRI PHARMASI - Indonesia
PALIPERIDONE
3 Mg
TABLET PELEPASAN LAMBAT
DUS, 4 BLISTER @ 7 TABLET PELEPASAN LAMBAT
JANSSEN CILAG MANUFACTURING LLC - United States of America
2020-10-29
PRODUCT NAME INVEGA ® Extended-Release Tablets INTERNATIONAL NON-PROPRIETARY NAME Paliperidone DOSAGE FORMS AND STRENGTHS INVEGA ® contains 3, 6, 9 mg of paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9- hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. For excipients, see List of excipient. PHARMACODYNAMIC PROPERTIES PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Antipsychotics, other antipsychotics, ATC code: N05AX13. MECHANISM OF ACTION Paliperidone, the active ingredient in INVEGA®, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives (atypical neuroleptic antipsychotic). INVEGA ® contains a racemic mixture of (+)- and (-)-paliperidone. Paliperidone is a centrally active dopamine D 2 antagonist with predominant serotonergic 5-HT 2A antagonistic activity. Paliperidone is also active as an antagonist at 1 and 2 adrenergic receptors and H 1 histaminergic receptors. Paliperidone has no affinity for cholinergic muscarinic or 1 - and 2 -adrenergic receptors. The pharmacological activity of the (+)– and (-)- paliperidone enantiomers is qualitatively and quantitatively similar. The mechanism of action of paliperidone, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that the drug's therapeutic activity in schizophrenia is mediated through a combination of dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2A ) receptor antagonism. Antagonism at receptors other than D 2 and 5HT 2A may explain some of the other effects of paliperidone. POLYSOMNOGRAPHY Centrally-acting medications through their mechanism of action, drug-release profile, and/or time of dose administration may affect sleep. To evaluate the impact of morning dosing of INVEGA ® on sleep architecture and continuity, a placebo-controlled study was conducted in 36 subjects with schizophrenia in which INVEGA 9 mg or placebo was administered once daily for 14 days. The following obser Leia o documento completo