Depodur

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Morphine sulfate

Available from:

Orphan Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

_Consumer Medicine Information_ 

_DepoDur_
_®_

DEPODUR
® 
MORPHINE SULFATE 
10 MG/ML MODIFIED RELEASE 
SUSPENSION FOR INJECTION 

CONSUMER MEDICINE INFORMATION 

WHAT IS THIS LEAFLET? 

This leaflet answers some common 
questions about DepoDur modified 
release suspension for injection.  It does 
not contain all of the available 
information.  It does not take the place 
of talking to your doctor. 

All medicines have risks and benefits.  
Your doctor has weighed the risks of 
you being given DepoDur against the 
benefits they expect it will have for you.  
If you have any concerns about being 
given DepoDur, ask your doctor or the 
medical staff looking after you. 

Keep this leaflet.  You may need to read 
it again. 

WHAT DEPODUR IS USED FOR 

DepoDur modified release suspension 
for injection is used to provide pain 
relief immediately following a surgical 
operation (orthopaedic, abdominal, or 
pelvic). 

The morphine sulfate in DepoDur will 
be released over time to provide pain 
relief for up to 48 hours, decreasing the 
need for other pain medication. 

DepoDur contains the active ingredient, 
morphine sulfate.  Morphine sulfate 
belongs to a group of medicines called 
opioids.  These agents are used to 
relieve pain. 

The inactive ingredients include 
cholesterol, triolein, tricaprylin, 
dioleoylphosphatidylcholine, 
dipalmitoylphosphatidylglycerol, sodium 
chloride, diluted (10%) hydrochloric acid, 
and water for injections. 

Your doctor may have prescribed DepoDur 
for another use.  Ask your doctor if you 
have any questions about why DepoDur 
has been prescribed for you. 

The morphine in DepoDur can be 
addictive.  Patients with a history of opioid 
or other substance abuse would be 
considered to be at greater risk of addiction 
or abuse.  You should discuss this with 
your doctor. 

BEFORE YOU ARE GIVEN DEPODUR 

DepoDur modified release suspension for 
injection is not suitable for everyone.   

Summary of Product characteristics

_Product Information  _
_ _
_DepoDur_
®
_ _
PRODUCT INFORMATION 

DEPODUR
®

10 MG/ML MODIFIED RELEASE SUSPENSION FOR INJECTION 
(FOR EPIDURAL USE ONLY) 

NAME OF DRUG 

Morphine sulfate  
Molecular Formula:   C
34
H
40
N
2
O
10
S
z
5H
2
O 
Molecular Weight:  
758.83 
CAS Registry Number:  6211-15-0 

DESCRIPTION  

DepoDur is an extended-release formulation of morphine sulfate for
epidural injection. 
Morphine sulfate is also known as 7, 8-didehydro-4,
5α-epoxy-17-methylmorphinan-3, 
6 α -diol sulfate (2:1) (salt) pentahydrate.  

DepoDur is a sterile, non-pyrogenic, white to off-white homogeneous
suspension 
presented in a ready-to-use single dose vial, containing 10 mg
of morphine sulfate 
encapsulated in multivesicular lipid-based particles
(DepoFoam™ matrix) as 1 mL in 
normal saline. The median diameter of the lipid-based particles is in
the range of 17 to 
23 
μm. DepoDur also contains cholesterol, triolein, tricaprylin, 
dioleoylphosphatidylcholine, dipalmitoylphosphatidylglycerol, sodium
chloride, diluted 
(10%) hydrochloric acid and water for injections.  

Morphine base has a pKa of 7.9, with an octanol/water partition
coefficient of 1.42 at 
physiologic pH 7.4. At this pH, morphine’s tertiary amino group
is mostly ionized, 
making the molecule water-soluble. The pH of DepoDur is in the range
of 5.0 to 8.0. 

DepoDur contains no antimicrobial agent. DepoDur is for single use in
one patient only. 
Discard any residue. 

PHARMACOLOGY 
PHARMACODYNAMIC PROPERTIES 
Pharmacotherapeutic group: Natural opium alkaloid  
ATC Code: N02A 01 
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_Product Information  _
_ _
_DepoDur_
®
_ _
Epidural administration of morphine sulfate results in analgesia
without attendant loss 
of motor, sensory, or sympathetic function. As compared to systemic
administration of 
morphine at comparable doses, epidurally administered morphine results
in improved 
analgesia with increased duration.  

D