Duloxetine DR-LUPIN Capsule

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
27-05-2024

Viambatanisho vya kazi:

Duloxetine hydrochloride

Inapatikana kutoka:

Lupin Australia Pty Limited

Darasa:

Medicine Registered

Tabia za bidhaa

                                PRODUCT INFORMATION 
1 
 
DULOXETINE DR-LUPIN CAPSULE 
(LUPIN AUSTRALIA PTY.LTD)  
 
NAME OF THE MEDICINE 
Duloxetine (as hydrochloride) 
Duloxetine Hydrochloride is a selective serotonin and
noradrenaline reuptake inhibitor 
(SNRI) for oral administration. 
Chemical Formula: C
18
H
19
NOS.HCl 
Molecular Weight: 333.9 
CAS No: 136434-34-9  
Chemical Structure:  
 
  
DESCRIPTION  
DULOXETINE HYDROCHLORIDE 
It is chemically unrelated to tricyclics, alpha adrenergic receptor
agonists or antimuscarinics. 
Its chemical designation is
(+)-(_S_)-_N_-methyl-γ-(1-naphthalenyloxy)-2-thiophenepropanamine 
hydrochloride. It is a white to cream coloured powder, which
is sparingly soluble in water, 
freely soluble in methanol and practically insoluble in hexane.    
                              
Duloxetine DR Lupin Capsule is a delayed release capsule for oral
administration. Each 
capsule contains enteric-coated mini tablets 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.  
 
EXCIPIENTS   
Inactive ingredients include Lactose, Croscarmellose Sodium,
Pregelatinised maize starch, 
Polysorbate 80, Magnesium stearate, Hypromellose, Hypromellose
phthalate, Purified talc, 
Triethyl citrate.  
                     
                                             
                                             
                               
Duloxetine DR Lupin Capsule 
 
 
2 
Version 03, 08 December 2012    
 
 
Empty Hard Gelatin Capsule: 
The 30 mg capsule is a Size 3 hard gelatin capsule (ARTG No. 108081)
with a dark blue cap 
and a white body and contains Indigo carmine CI73015, Gelatin,
Titanium dioxide and 
Sodium lauryl sulphate. 
_ _
The 60 mg capsule is a Size 1 hard gelatin capsule (ARTG No.
108080) with a dark blue cap 
and a green body and contains I
                                
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