PIL
DEPO-MEDROL
®
_methylprednisolone acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before being treated with DEPO-
MEDROL suspension for injection.
This leaflet answers some common
questions about DEPO-MEDROL. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being treated with
DEPO-MEDROL against the
benefits this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Consider keeping this leaflet even
after treatment with DEPO-
MEDROL is finished. You may need
to read it again.
WHAT DEPO-MEDROL
IS USED FOR
DEPO-MEDROL is used to treat
disorders of many organ systems
such as skin, lung, eye,
gastrointestinal tract, nervous system,
joints and blood. DEPO-MEDROL
works by reducing inflammation and
changing the body's natural ability to
respond when the immune response
is not working properly. It is also
used in certain conditions where the
adrenal gland doesn't function
correctly.
Your doctor may have prescribed
DEPO-MEDROL for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DEPO-
MEDROL HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor's prescription.
BEFORE TREATMENT WITH
DEPO-MEDROL
Some information is provided below.
However, always talk to your doctor
if you have concerns or questions
about your treatment.
_WHEN DEPO-MEDROL MUST_
_NOT BE USED_
DEPO-MEDROL MUST NOT BE
USED:
1. IF YOU HAVE AN ALLERGY TO:
•
methylprednisolone acetate
•
any of the other ingredients listed
under Product Description at the
end of this leaflet.
Symptoms of an allergic reaction
may include skin rash, itching or
difficulty in breathing.
2. IF YOU HAVE A SEVERE FUNGAL
INFECTION
3. IT MUST NOT BE INJECTED INTO THE
SPINAL CORD (INTRATHECALLY OR
EPIDURAL) OR INTO A VEIN
(INTRAVENOUSLY)
4. IF YOU HAVE BEEN GIVEN A VA
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SPC
Version: pfpdepmi10713
Supersedes: pfpdepmi10912
Page 1 of 23
PRODUCT INFORMATION
DEPO-MEDROL
®
SUSPENSION FOR INJECTION
For Intramuscular, Intra-articular, Soft Tissue or Intralesional
Injection Only
NOT FOR INTRAVENOUS, INTRATHECAL OR EPIDURAL USE
NAME OF THE MEDICINE
Australian Approved Name
(AAN): methylprednisolone acetate which is the 6-methyl
derivative of prednisolone.
Chemical structure:
Chemical name:
11
, 17
, 21-trihydroxy-6
-methylpregna-1,4-diene-3,20-dione
acetate
Molecular Formula
C
24
H
32
O
6
Molecular weight:
416.51
CAS registry number:
53-36-1
DESCRIPTION
Methylprednisolone acetate is a white or practically white,
odourless, crystalline powder
which melts at about 215
o
C with some decomposition. It is soluble in dioxane, sparingly
soluble in acetone, in alcohol, in chloroform, and in methanol, and
slightly soluble in ether. It
is practically insoluble in water.
DEPO-MEDROL is an anti-inflammatory glucocorticoid, for intramuscular, intra-articular,
soft tissue or intralesional injection.
It is available in a 40 mg/mL vial.
Version: pfpdepmi10713
Supersedes: pfpdepmi10912
Page 2 of 23
Each mL contains:
Methylprednisolone acetate
40 mg
Macrogol 3350
29 mg
Sodium chloride
8.7 mg
Miripirium chloride
added as preservative.
0.195 mg
When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The pH of
the finished product remains within the USP specified range,
i.e. 3.0 to 7.0.
PHARMACOLOGY
Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining
properties, are used in replacement therapy in adrenocortical deficiency states. Their
synthetic
analogues are used primarily for their potent anti-inflammatory effects in disorders of many
or
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