Skip to Content



PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package Leaflet: Information for the patient
Methylprednisolone sodium succinate
Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you
 Keep this leaflet. You may need to
read it again
 If you have any further questions
please ask your doctor or pharmacist
 This medicine has been prescribed
for you. Do not pass it on to others. It
may harm them even if their signs of
illness are the same as yours
 If you get any side effects, talk to
your doctor or pharmacist. This
includes any side effects not listed in
this leaflet.
What is in this leaflet:
1. What Methylprednisolone is and
what it is used for
2. What you need to know before you
are given Methylprednisolone
3. How Methylprednisolone is given to
4. Possible side effects
5. How to store Methylprednisolone
6. Contents of the pack and other

Methylprednisolone contains
methylprednisolone sodium succinate.
Methylprednisolone belongs to a group
of medicines called corticosteroids
(steroids). Corticosteroids are produced
naturally in your body and are
important for many body functions.
Boosting your body with extra
corticosteroid such as
Methylprednisolone can help following
surgery (e.g. organ transplants), flareups of the symptoms of multiple
sclerosis or other stressful conditions.
These include inflammatory or allergic
conditions affecting the:
 brain caused by a tumour or
 bowel and gut e.g. ‘Crohn’s disease’
and ‘ulcerative colitis’
 lungs caused by asthma, severe
allergy or hypersensitivity,
tuberculosis or breathing in
(aspirating) vomit or stomach
 skin e.g. Stevens-Johnson
Methylprednisolone may be prescribed
to treat conditions other than those
listed above. Ask your doctor if you are
unsure why you have been given this
Do not use Methylprednisolone if:
• you think you have ever suffered an
allergic reaction, or any other type of
reaction after being given
Methylprednisolone, or any other
medicine containing a corticosteroid or
any of the ingredients in this medicine
(section 6 of this leaflet contains a list
of ingredients). An allergic reaction may
cause a skin rash or reddening, swollen
face or lips or shortness of breath.
 you have any fungal infection (such
as thrush), other than on the skin
which is not being treated
 you have recently had, or are about
to have any vaccination
 you are suffering from, or receiving
treatment for malaria
 you are suffering from a head injury
or stroke.
See your doctor immediately if any
of the above applies to you.
Warnings and precautions
You must tell your doctor before you
take this medicine if you have any of
the following conditions.
Your doctor may have to monitor your
treatment more closely, alter your dose
or give you another medicine.
 Chickenpox, measles, shingles or
a herpes eye infection. If you think
you have been in contact with
someone with chickenpox, measles
or shingles and you have not already
had these illnesses, or if you are
unsure if you had them. If you are
not immune or you are a parent of a
child receiving this medicine, avoid
close contact with anyone with these
infections. Seek medical advice if
you think you have been exposed to
one of these infections or if a
member of your household develops
one of them
 Heart failure for which you are being
treated with digoxin
 Worm infestation (e.g. threadworm)
 Severe depression or manic
depression (bipolar disorder). This
includes having had depression
before while taking steroid medicines
like Methylprednisolone, or having a
family history of these illnesses or
problems such as delusions,
hallucinations or disorganised
speech after taking steroids
 Diabetes (or if there is a family
history of diabetes). If you have
diabetes, you should closely monitor
blood sugar while taking
 Epilepsy, fits or seizures
 Glaucoma (increased pressure in
the eye) or if there is a family history
of glaucoma

 You have recently suffered a heart
 Heart problems, including heart
failure or infections
 Hypertension (high blood pressure)
 Hypothyroidism (an under-active
 Joint infection
 Kaposi’s sarcoma (a type of skin
 Kidney or liver disease
 Muscle problems (pain or
weakness) have happened while
taking steroids
 Myasthenia gravis (a condition
causing tired and weak muscles)
 Osteoporosis (brittle bones) or if
you are a women who has gone
through the menopause
 Skin abscess
 Stomach ulcer, diverticulitis
(inflammation of the bowel wall) or
other serious stomach or intestinal
 Thrombophlebitis – vein problems
due to thrombosis (clots in the veins)
resulting in phlebitis (red, swollen
and tender veins)
 Tuberculosis (TB) or if you have
suffered tuberculosis in the past.
 Unusual stress
 Cushing’s disease (condition
caused by an excess of cortisol
hormone in your body)
 Acute pancreatitis (inflammation of
the pancreas).
You must tell your doctor before you
take this medicine if you have any of
the conditions listed above.
Other medicines and
Always tell your doctor or pharmacist if
you are taking any other medicines
(including any you have bought without
a prescription) as taking
Methylprednisolone with other
medicines could be harmful.
You should tell your doctor if you are
taking any of the following medicines
which can affect the way
Methylprednisolone or other medicines
 Acetazolamide – used to treat
glaucoma, epilepsy and water
 Aminoglutethimide or
Cyclophosphamide – used for
treating cancer
 Anticoagulants – used to ‘thin’ the
blood such as acenococoumarol,
phenindione and warfarin
 Anticholinesterases – used to treat
myasthenia gravis (a muscle
condition) such as distigmine and
 Antibiotics (such as erythromycin,
clarithromycin or troleandomycin)
 Antidiabetics – medicines used to
treat high blood sugar. If you have
diabetes, you may need to check
your blood sugar more closely when
using methylprednisolone
 Antihypertensives – medicines
used to treat high blood pressure
 Aprepitant and Fosaprepitant –
used to prevent nausea and vomiting
 Aspirin and non-steroidal antiinflammatory medicines (also called
NSAIDs) such as ibuprofen,
naproxen and diclofenac used to
treat mild to moderate pain
 Barbiturates, carbamazepine,
phenytoin and primidone – used to
treat epilepsy
 Carbenoxolone and cimetidine –
used for heartburn and acid
 Ciclosporin – used to treat
conditions such as severe
rheumatoid arthritis, severe psoriasis
or following an organ or bone
marrow transplant
 Digoxin – used for heart failure
and/or irregular heart beat
 Diltiazem or mibefradil – used for
heart problems or high blood
 Ethinylestradiol and
norethisterone – an oral
 Indinavir and Ritonavir – used to
treat HIV infections
 Isoniazid – used to treat bacterial
 Ketoconazole or itraconazole –
used to treat fungal infections
 Mifepristone – used for the medical
termination of pregnancy
 Pancuronium or vercuronium –
other medicines called
neuromuscular blocking agents
which are used in some surgical
 Potassium depleting agents – such
as diuretics (sometimes called water
tablets), amphotericin B,
xanthenes or beta2 agonists (e.g.
medicines to treat asthma)
 Rifampicin and rifabutin –
antibiotics used to treat tuberculosis
 Tacrolimus – used following an
organ transplant to prevent rejection
of the organ
 Vaccines – tell your doctor or nurse
if you have recently had, or about to
have any vaccination. You should
not have ‘live’ vaccines while using
this medicine.

Other vaccines may be less effective.
If you are taking long term
If you are being treated for diabetes,
high blood pressure or water retention
(oedema) tell your doctor as he/she
may need to adjust the dose of the
medicine used to treat these
Before you have any operation tell
your doctor, dentist or anaesthetist that
you are being treated with
If you require a test to be carried out
by your doctor or in hospital it is
important that you tell the doctor or
nurse that you are taking
Methylprednisolone as this medicine
could affect the test results.
Pregnancy and breast-feeding
You must tell your doctor if you are
pregnant, think you might be pregnant
or are trying to become pregnant as
this medicine could slow the baby’s
Cataracts have been observed in
infants born to mothers undergoing
long-term treatment with corticosteroids
during pregnancy.
Tell your doctor if you are breastfeeding as small amounts of
corticosteroid medicines may get into
breast milk.
Methylprednisolone contains
This medicine contains 1.6 mmol (37.2
mg) of sodium in each 500mg vial of
methylprednisolone and 3.2 mmol
(74.4mg) of sodium in each 1000mg
vial of methylprednisolone. If you are
on a controlled sodium (salt) diet tell
your doctor in case your sodium intake
needs to be adjusted.

Steroid Cards
Remember to always carry a Steroid
Treatment Card. Make sure your
doctor or pharmacist has filled out
the details of your medicine,
including the dose and how long
you will require steroid treatment.
You should show your steroid card to
anyone who gives you treatment (such
as a doctor, nurse or dentist) while you
are taking this medicine, and for 3
months after your last injection.
If you are admitted to hospital for any
reason always tell your doctor or nurse
that you are taking Methylprednisolone.
You can also wear a medic-alert
bracelet or pendant to let medical staff
know that you are taking a steroid if
you have an accident or become
Dosage information
Your doctor will decide on the site of
injection, how many injections you will
receive depending on the condition
being treated and its severity. Your
doctor will inject the lowest dose for the
shortest possible time to get effective
relief of your symptoms.
Methylprednisolone will be given, as an
injection by your doctor or nurse, either
into a vein (intravenous) or into a
muscle (intramuscular). Usually the first
dose is given into a vein, especially in
an emergency. It will be given slowly
over at least 5 minutes. For larger
doses may take 30 minutes or more.
Large doses should normally be used
for only 2 to 3 days. The medicine is
first dissolved in water for injections. If
the medicine is to be given by infusion
(using a pump or drip) it is then mixed
with another suitable fluid. No other
medicines should be mixed with it.
Treatment will normally be the same as
for younger adults. However your
doctor may want to see you more
regularly to check how you are getting
on with this medicine.
Corticosteroids can affect growth in
children so your doctor will prescribe
the lowest dose that will be effective for
your child.
Do not drink grapefruit juice while being
treated with Methylprednisolone.
If you are given more
Methylprednisolone than you should
If you think you have been given too
many injections please speak to your
doctor immediately.
Stopping/reducing the dose of your
Your doctor will decide a suitable time
to stop treatment.
You will need to come off this treatment
slowly if you:
 have had repeated doses of
corticosteroid for more than 3 weeks
 have been given high doses of
Methylprednisolone, over 32 mg
daily, even if it is only for 3 weeks or
 have already had a course of
corticosteroid tablets or injections in
the last year
 already had problems with your
adrenal glands (adrenocortical
insufficiency) before you started this

--------------------------------------------------------------Information for the Healthcare
Methylprednisolone 500mg &
1000mg powder and solvent for
solution for injection/infusion
For full prescribing information please
read the Summary of Product
Presentation: Each vial of powder
contains the equivalent of either 500mg
or 1000mg of methylprednisolone as
the sodium succinate salt. The 500mg
vials come with an ampoule containing
7.8ml of water for injections. The
1000mg vials come with a vial
containing 15.6ml of water for injections
Therapeutic Indications
Treatment of any condition in which
rapid and intense corticosteroid effect
is required.
Dosage and Method of
Methylprednisolone may be
administered i.v. or i.m. For emergency

use the preferred method is i.v.
injection; doses above 250mg should
be given over at least 30 minutes;
doses up to 250mg should be given
over at least 5 minutes. Subsequent
doses may be given i.v. or i.m. at
intervals dictated by the patient's
response and clinical condition.
Corticosteroid therapy is an adjunct to,
and not replacement for, conventional
Undesirable effects may be minimised
by using the lowest effective dose for
the minimum period.
Parenteral drug products should
wherever possible be visually inspected
for particulate matter and discoloration
prior to administration.
Adults: initial dosage will vary from 10
to 500mg depending on the severity of
the condition, up to 1g/day for graft
rejection reactions following

Doses of 500mg to 1000mg should be
limited to 48 to 72 hours until the
patient's condition has stabilised, to
avoid serious side effects. In
anaphylactic reactions adrenaline or
noradrenaline should be administered
first for an immediate haemodynamic
effect, followed by i.v. injection of
methylprednisolone with other
accepted procedures.
In sensitivity reactions
methylprednisolone provides relief
within one half to two hours.
In status asthmaticus, it may be given
at a dose of 40mg i.v., repeated as
dictated by patient response. In some
asthmatic patients administration by
slow i.v. drip over a period of hours is

You will need to come off this medicine
slowly to avoid withdrawal symptoms.
These symptoms may include itchy
skin, fever, muscle and joint pains,
runny nose, sticky eyes, sweating and
weight loss.
If your symptoms seem to return or get
worse as your dose of this medicine is
reduced tell your doctor immediately.
Mental health problems while taking
Mental health problems can happen
while taking steroids like
Methylprednisolone (see also section 4,
Possible Side Effects).
 These illnesses can be serious
 Usually they start within a few days
or weeks of starting the medicine
 They are more likely to happen at
high doses
 Most of these problems go away if
the dose is lowered or the medicine
is stopped. However, if the problems
do happen they might need
Talk to a doctor if you (or someone
using this medicine) show any signs of
mental problems. This is particularly
important if you are depressed, or
might be thinking about suicide. In a
few cases mental problems have
happened when doses are being
lowered or stopped.
If you have any further questions on the
use of this medicine, ask your doctor or
Like all medicines, this medicine can
cause side-effects, although not
everybody gets them. Your doctor will
have given you this medicine for a
condition which if not treated properly
could become serious.
In certain medical conditions
medicines like Methylprednisolone
(steroids) should not be stopped
abruptly. If you suffer from any of
the following symptoms seek
IMMEDIATE medical attention. Your
doctor will then decide whether you
should continue taking your
 Allergic reactions such as skin
rash, swelling of the face or
wheezing and difficulty breathing.
This type of side effect is rare, but
can be serious
 Pancreatitis, stomach pain
spreading to your back, possibly
accompanied by vomiting, shock and
loss of consciousness
 Burst or bleeding ulcers,
symptoms of which are stomach pain
(especially if it seems to spread to
your back), bleeding from the back
passage, black or bloodstained
stools and/or vomiting blood
 Infections. This medicine can hide
or change the signs and symptoms
of some infections, or reduce your
resistance to the infection, so that
they are hard to diagnose at an early
stage. Symptoms might include a
raised temperature and feeling
unwell. Symptoms of a flare up of a
previous TB infection could be
coughing blood or pain in the chest.
Symptoms of a previous malaria
infection could involve chills and
fever. Methylprednisolone may also
make you more likely to develop a
severe infection
 Pulmonary embolus (blood clots in
the lung), symptoms include sudden
sharp chest pain, breathlessness
and coughing up blood
 Raised pressure within the skull of
children (pseudotumor cerebri)
symptoms of which are headaches
with vomiting, lack of energy and
drowsiness. This side-effect usually
occurs after treatment is stopped
 Thrombophlebitis (blood clots or
thrombosis in a leg vein), symptoms
of which include painful swollen, red
and tender veins.
If you experience any of the
following side effects, or notice any
other unusual effects not mentioned
in this leaflet, tell your doctor
straight away.
The side effects may occur with certain
frequencies, which are defined as
 common: affects 1 to 10 users in 100
 not known: frequency cannot be
estimated from the available data.
Blood, heart and circulation
 High blood pressure, symptoms of
which are headaches, or generally
feeling unwell.
not known
 Problems with the pumping of your
heart (heart failure) symptoms of
which are swollen ankles, difficulty in
breathing and palpitations
(awareness of heart beat) or
irregular or very fast or slow pulse
 Low blood pressure symptoms may
include dizziness, fainting, lightheadedness, blurred vision, a rapid,
or irregular heartbeat (palpitations),
general weakness
 Increased numbers of white blood
cells (leucocytisis)
 Increased clotting of the blood.

Body water and salts
 Swelling and high blood pressure,
caused by increased levels of water
and salt content.
not known
 Cramps and spasms, due to the loss
of potassium from your body. In rare
cases this can lead to congestive
heart failure (when the heart cannot
pump properly).
Digestive system
 Ulcers.
not known
 Nausea (feeling sick) or vomiting
(being sick)
 Diarrhoea
 Thrush in the gullet (discomfort when
 Indigestion
 Bloated stomach
 Abdominal pain
 Hiccups.
not known
 A feeling of dizziness or spinning
 Cataracts (indicated by failing
not known
 Glaucoma (raised pressure within
the eye, causing pain in the eyes
and headaches)
 Swollen optic nerve (papillioedema,
indicated by sight disturbances).
 Thinning of the clear part at the front
of the eye (cornea) or of the white
part of the eye (sclera)
 Worsening of viral or fungal eye
 Protruding of the eyeballs
 Disease of the retina and choroid
General disorders
 Poor wound healing.
not known
 Feeling tired or unwell
 Skin reactions at the site of injection.
Hormones and metabolic system
 Slowing of normal growth in infants,
children and adolescents which may
be permanent
 Round or moon-shaped face
(Cushingoid facies).
not known
 Irregular or no periods in women
 Increased appetite and weight gain
 Diabetes or worsening of existing
 Prolonged therapy can lead to lower
levels of some hormones which in
turn can cause low blood pressure
and dizziness. This effect may
persist for months
 The amount of certain chemicals
(enzymes) called transaminase,
aspartate transaminase and alkaline
phosphatase that help the body
digest drugs and other substances in
your body may be raised after
treatment with a corticosteroid. The
change is usually small and the
enzyme levels return to normal after
your medicine has cleared naturally
from your system. You will not notice
any symptoms if this happens, but it
will show up if you have a blood test.
 A disorder causing accumulation of
fat tissue on local parts of the body
Immune system
 Increased susceptibility to infections.
not known
 Suppression of reactions to skin
tests, such as that for tuberculosis.
not known
 Methylprednisolone can damage
your liver, hepatitis and increase of
liver enzymes have been reported.
Muscle and bone issues
 Brittle bones (bones break easily)
 Muscle weakness.
not known
 Muscle wasting
 Broken bones or fractures
 Breakdown of bone due to poor
circulation of blood, this causes pain
in the hip
 Torn muscle tendons causing pain
and/or swelling
 Muscle cramps or spasms.
Nerves and mood issues
Steroids including methylprednisolone
can cause serious health problems.
These are common in both adults and
children. They can affect about 5 in
every 100 people taking medicines like
 Feeling depressed
 Feeling high (mania), or moods that
go up and down
 Feeling anxious, having problems
sleeping, difficulty in thinking or
being confused and losing your
 Feeling, seeing or hearing things
which do not exist. Having strange
and frightening thoughts, changing
how you act or having feelings of
being alone.
 Acne

 Bruising
 Thinning of skin (skin atrophy).
not known
 Stretch marks (skin striae)
 Small purple/red patches on the skin
 Pale or darker patches on your skin,
or raised patches which are unusual
 Excessive growth of bodily and facial
 Rash, itching, hives
 Increased sweating.
Additionally the tearing of heart
muscles has been observed in patients
taking methylprednisolone following a
heart attack.
Withdrawal symptoms
A 'withdrawal syndrome' may occur,
see Section 3 for more information
If you experience any of the side
effects listed above tell your doctor
straight away.
Reporting of side effects
If you get any side effects, talk to your
doctor or nurse. This includes any
possible side effects not listed in this
You can also report side effects directly
(see details below). By reporting side
effects you can help provide more
information on the safety of this
United Kingdom
Report any unwanted side-effects via
the Yellow Card Scheme at:
Reports may be made to HPRA
Pharmacovigilance, Earlsfort Centre,
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971; Fax: +353 1
This medicine must not be used after
the expiry date shown on the
packaging. The expiry date refers to
the last day of the month.
Keep vials/ampoules in the outer carton
to protect from light.
The doctor or pharmacist will keep the
medicine in a safe place where children
cannot reach or see it.
The reconstituted methylprednisolone
solution and water for injections should
be used immediately and any
remainder discarded.
Your doctor or nurse will ensure that
your medicine is used and disposed of

What Methylprednisolone powder
for solution for injection/infusion
This medicine contains
methylprednisolone sodium succinate
as the active ingredient:
Methylprednisolone 500mg powder and
solvent for solution for
Each vial of powder contains 663mg
methylprednisolone sodium succinate
(equivalent to 500mg
Each ampoule of solvent contains
7.8ml of water for injections.
Methylprednisolone 1000mg powder
and solvent for solution for
Each vial of powder contains 1326mg
methylprednisolone sodium succinate
(equivalent to 1000mg
Each vial of solvent contains 15.6ml of
water for injections.
Methylprednisolone powder for solution
for injection/infusion also contains the
inactive ingredient sodium phosphate.
What Methylprednisolone looks like
and contents of the pack:
Methylprednisolone 500mg/1000mg
powder for solution for injection/infusion
is a white powder which comes in a
clear glass vial. Each pack contains
one vial of methylprednisolone
500mg/1000mg powder and one vial or
ampoule of Sterilised Water for
Marketing Authorisation Holder
Beacon Pharmaceuticals Ltd, 85 High
Street, Tunbridge Wells TN1 1YG, UK.
Biomendi, S.A., Polígono Industrial de
Bernedo s/n - 01118 Bernedo, Álava,
This leaflet was last revised in May


+44 (0)1892-600930 FOR

- - - - - - - - - - - - - - - - - - - - - - - - - -- -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - In graft rejection reactions following
transplantation doses of up to 1000mg
per day have been used to suppress
rejection crises, with 500mg to 1000mg
most commonly used for acute
Refer to the Summary of Product
Characteristics for the suggested
dosage schedules for oedemas due to
brain tumour.
In the treatment of acute exacerbations
of multiple sclerosis in adults, the
recommended dose is 1000mg daily for
3 days, given as an i.v. infusion over at
least 30 minutes.
Children: In the treatment of
haematological, rheumatic, renal and
dermatological conditions, 30mg/kg/day
to a maximum of 1 g/day is
recommended. This may be repeated
for three pulses either daily or on
alternate days.

For graft rejection reactions following
transplantation, 10 to 20mg/kg/day for
up to 3 days, to a maximum of 1 g/day,
is recommended.
In the treatment of status asthmaticus,
1 to 4mg/kg/day for 1 to 3 days is
Elderly: Methylprednisolone is
primarily used in acute short term
conditions. Treatment should consider
the more serious consequences of the
common side-effects and close clinical
supervision is required.
Pharmaceutical Information:
Contains sodium phosphate as buffer.
The powder should be reconstituted in
the water for injections supplied. After
reconstitution in water for injections,
each ml of solution contains the
equivalent of 59.6 mg of
Methylprednisolone. The
reconstituted solution may be diluted

with 5% dextrose in water, isotonic
saline solution, or 5% dextrose in
isotonic saline solution. To avoid
compatibility problems with other drugs
the reconstituted solution should be
administered separately, only in the
diluents mentioned.
Storage Precautions: Keep
vials/ampoules in the outer carton to
protect from light. Nature of
Container: Type I glass vials with butyl
rubber stopper and aluminium flip-cap.
Type I glass ampoules. Instructions
for Use and Handling: Please refer to
Dosing instructions. For single use
only. Unused solution must be
discarded immediately.

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.