Land: Indonesië
Taal: Indonesisch
Bron: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DULOXETINE HYDROCHLORIDE
PYRIDAM FARMA TBK - Indonesia
DULOXETINE HYDROCHLORIDE
67,3 MG
KAPSUL
DUS, 2 BLISTER @ 7 KAPSUL
LILLY, S.A. - Spain
2021-07-16
Cymbalta-ID-Safety update SAIL 4442-leaflet for doctor-proposedTC-V2 1 X Proposed truth_v2_ X Internal reviewer__DS__ Medical reviewer X Internal creator_MH_ Approval for Submission Marketing reviewer Date ____________ CYMBALTA ® DULOXETINE HYDROCHLORIDE COMPOSITION Each delayed-release formulation contains enteric-coated pellets of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine that are designed to prevent degradation of the drug in the acidic environment of the stomach. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Duloxetine is a serotonin and norephinephrine reuptake inhibitor, and weakly inhibits dopamine uptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors. Duloxetine dose-dependently increased extracellular levels of serotonin and norepinephrine in various brain areas of animals. Neurochemical and behavioral studies in laboratory animals showed an enhancement of both serotonin and norepinephrine neurotransmission in the CNS. Duloxetine also normalized pain thresholds in several preclinical models of neuropathic and inflammatory pain and attenuated pain behavior in a model of persistent pain. The presumed mechanism of action of duloxetine in the treatment of depression is thought to be due to inhibition of neuronal uptake of serotonin and norepinephrine, and a resultant increase in serotonergic and noradrenergic neurotransmission in the CNS. The pain inhibitory action of duloxetine is believed to be a result of potentiation of descending inhibitory pain pathways within the central nervous system. PHARMACOKINETIC PROPERTIES ABSORPTION: ➢ Duloxetine is well absorbed after oral administration with the C max occurring 6 hours post dose. ➢ Food delays the time to reach peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11%). DISTRIBUTION: ➢ Duloxetine is highly protein bound (>90%) primarily to albumin and α 1 -acid glycoprotein but protein binding is not affected by re Lees het volledige document