Cymbalta

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Compra

Scheda tecnica Scheda tecnica (SPC)
13-11-2009

Principio attivo:

Duloxetine hydrochloride 67.3mg equivalent to duloxetine base 60 mg

Commercializzato da:

Eli Lilly and Company (NZ) Limited

INN (Nome Internazionale):

Duloxetine hydrochloride 67.3 mg (equivalent to duloxetine base 60 mg)

Dosaggio:

60 mg

Forma farmaceutica:

Modified release capsule

Composizione:

Active: Duloxetine hydrochloride 67.3mg equivalent to duloxetine base 60 mg Excipient: Ammonia solution Colour Mixture White DDB8257W Gelatin Hypromellose Hypromellose acetate succinate Indigo carmine Ink Iron oxide yellow Purified talc Sodium laurilsulfate Sucrose Sugar spheres Titanium dioxide Triethyl citrate

Confezione:

Blister pack, PVC/PE/Aclar x 7 caps. sample, 7 capsules

Classe:

Prescription

Tipo di ricetta:

Prescription

Prodotto da:

Evonik Corporation

Dettagli prodotto:

Package - Contents - Shelf Life: Blister pack, PVC/PE/Aclar x 7 caps. sample - 7 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PE/Aclar x 28 capsules - 28 capsules - 36 months from date of manufacture stored at or below 30°C

Data dell'autorizzazione:

2003-07-31

Scheda tecnica

                                Cymbalta NZ Datasheet 
 Version 4.0 May 2011 
DATA SHEET 
CYMBALTA
®
 
Duloxetine capsules, 30 mg and 60 mg. 
PRESENTATION 
CYMBALTA 30 mg capsules have opaque white bodies and
opaque blue caps. 
CYMBALTA 60 mg capsules have opaque green bodies and
opaque blue caps. 
CYMBALTA is a
delayed-release formulation for oral administration.  CYMBALTA 30 mg
and 
60 mg capsules contains enteric-coated pellets of duloxetine
hydrochloride equivalent to 30 
mg and 60 mg of duloxetine, respectively. 
Enteric coating prevents degradation of the 
medicine within the acidic environment of the stomach. 
USES 
_ACTIONS _
Pharmacotherapeutic group: medicines used for the
treatment of depression, anxiety and 
neuropathic pain. 
Duloxetine is a combined serotonin (5-HT) and noradrenaline
(NA) reuptake inhibitor.  It 
weakly inhibits dopamine reuptake with
no significant affinity for histaminergic, 
dopaminergic, cholinergic and adrenergic receptors.  Duloxetine
dose-dependently 
increased extracellular levels of serotonin and noradrenaline in
various brain areas of 
animals. 
_PHARMACODYNAMICS _
Neurochemical and behavioural studies in
laboratory animals showed an enhancement of 
both serotonin and noradrenaline neurotransmission in
the CNS.  Duloxetine also 
normalised pain thresholds in
several preclinical models of neuropathic and inflammatory 
pain and attenuated pain behaviour in
a model of persistent pain.  The presumed 
mechanism of action of duloxetine in the treatment of depression
is thought to be due to its 
inhibition of neuronal uptake of serotonin
and noradrenaline, 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. 
_CLINICAL TRIALS _
Acute t
                                
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