METHYLPREDNISOLONE ALPHAPHARM methylprednisolone (as sodium succinate) 1 g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methylprednisolone sodium succinate

Available from:

Alphapharm Pty Ltd

INN (International Name):

methylprednisolone sodium succinate

Authorization status:

Registered

Patient Information leaflet

METHYLPREDNISOLONE
ALPHAPHARM
_contains the active ingredient methylprednisolone sodium succinate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Methylprednisolone
Alphapharm.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you being treated with
Methylprednisolone Alphapharm
against the benefits it is expected to
have for you.
Follow the instructions given to you
by your doctor and the advice
contained in this leaflet.
IF YOU HAVE ANY CONCERNS ABOUT
BEING TREATED WITH THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT
METHYLPREDNISOLONE
ALPHAPHARM IS USED
FOR
Your doctor has prescribed
Methylprednisolone Alphapharm for
the treatment of one or more of the
following:
•
skin diseases
•
allergic reactions
•
inflammation of the eyes
•
respiratory diseases and certain
respiratory infections
•
diseases of the gut
(gastrointestinal tract)
•
multiple sclerosis
•
rheumatic disorders
•
diseases of the blood
•
treatment of certain glandular
conditions
Your doctor may have prescribed
Methylprednisolone Alphapharm for
another reason.
_HOW YOUR MEDICINE WORKS_
Methylprednisolone sodium
succinate, the active ingredient in
Methylprednisolone Alphapharm,
belongs to a group of medicines
called corticosteroids.
Methylprednisolone Alphapharm acts
in the body by reducing
inflammation (pain, swelling, redness
and heat), which is one of the body's
reactions to injury, and by reducing
the body's reaction to infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
METHYLPREDNISOLONE ALPHAPHARM
HAS BEEN PRESCRIBED FOR YOU.
Methylprednisolone Alphapharm is
available only with a doctor's
prescription.
There is no evidence that
Methylprednisolone Alphapharm is
addictive.
BEFORE YOU START
TREATMENT WITH
METHYLPREDNISOLONE
ALPHAPHARM
_WHEN METHYLPREDNI

Summary of Product characteristics

METHYLPREDNISOLONE ALPHAPHARM
POWDER FOR INJECTION
_Methylprednisolone (as sodium succinate) _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient
:
Methylprednisolone sodium succinate
Chemical name
:
Pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-
methyl-,monosodium salt,(6α,11β)
Structural formula
:
Molecular formula
:
C
26
H
33
NaO
8
Molecular weight
:
496.53
CAS Registry no.
:
2375-03-3
DESCRIPTION
Methylprednisolone Alphapharm contains methylprednisolone sodium
succinate, a synthetic glucocorticoid. It
occurs as a white or nearly white, odourless, hygroscopic, amorphous
solid. It is very soluble in water and in
alcohol; it is insoluble in chloroform and is very slightly soluble in
acetone.
Methylprednisolone sodium succinate is so extremely soluble in water
that it may be administered in a small
volume of diluent and is especially well suited for intravenous use in
situations in which high blood levels of
methylprednisolone are required rapidly.
Methylprednisolone
Alphapharm
40
mg,
powder
for
injection
(IM-IV)
contains
the
active
ingredient,
methylprednisolone. It also contains the following excipients: sodium
phosphate monobasic anhydrous, sodium
phosphate dibasic anhydrous, sodium hydroxide and lactose anhydrous.
It is intended for intramuscular or
intravenous administration.
Methylprednisolone Alphapharm 500 mg and 1 g, powder for injection
(IV) contain the active ingredient,
methylprednisolone. They also contain the following excipients: sodium
phosphate monobasic anhydrous,
sodium phosphate dibasic anhydrous and sodium hydroxide, and are
indicated for intravenous administration
only.
METHYLPREDNISOLONE ALPHAPHARM – Product Information
2
PHARMACOLOGY
PHARMACODYNAMICS
Methylprednisolone is a potent anti-inflammatory steroid, with greater
anti-inflammatory potency and even less
sodium and water retention inducing tendency than prednisolone.
Methylprednisolone
sodium
succinate
has
the
same
metabolic
and
anti-inflammatory
actions
as
methylprednisolone. When given parente