INVEGA

País: Indonèsia

Idioma: indonesi

Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

ingredients actius:

PALIPERIDONE

Disponible des:

SOHO INDUSTRI PHARMASI - Indonesia

Designació comuna internacional (DCI):

PALIPERIDONE

Dosis:

6 MG

formulario farmacéutico:

TABLET PELEPASAN LAMBAT

Unidades en paquete:

DUS, 4 BLISTER @ 7 TABLET PELEPASAN LAMBAT

Fabricat per:

JANSSEN CILAG FARMACEUTICAL SpA - Italy

Data d'autorització:

2016-03-08

Fitxa tècnica

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