CYMBALTA

Страна: Индонезия

Език: индонезийски

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

Активна съставка:

DULOXETINE HYDROCHLORIDE

Предлага се от:

PYRIDAM FARMA TBK - Indonesia

INN (Международно Name):

DULOXETINE HYDROCHLORIDE

дозиране:

33,7 MG

Лекарствена форма:

KAPSUL

Броя в опаковка:

DUS, 2 BLISTER @ 7 KAPSUL

Произведено от:

LILLY, S.A. - Spain

Дата Оторизация:

2021-07-09

Данни за продукта

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