Cymbalta

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Duloxetine hydrochloride 33.7mg equivalent to duloxetine base 30 mg;  

Available from:

Eli Lilly and Company (NZ) Limited

INN (International Name):

Duloxetine hydrochloride 33.7 mg (equivalent to duloxetine base 30 mg)

Dosage:

30 mg

Pharmaceutical form:

Modified release capsule

Composition:

Active: Duloxetine hydrochloride 33.7mg equivalent to duloxetine base 30 mg   Excipient: Ammonia solution Colour mixture White DDB8257W Gelatin Hypromellose Hypromellose acetate succinate Indigo carmine Ink Purified talc Sodium laurilsulfate Sucrose Sugar spheres Titanium dioxide Triethyl citrate

Units in package:

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

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Lilly del Caribe Inc

Product summary:

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

Authorization date:

2003-07-31

Summary of Product characteristics

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