METHYLPREDNISOLONE 1000 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION

Active substance: METHYLPREDNISOLONE SODIUM SUCCINATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

METHYLPREDNISOLONE 500MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
METHYLPREDNISOLONE 1000MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
Methylprednisolone (as sodium succinate)

Read all of this leaflet carefully
before you are given this medicine
• Keep this leaflet. You may need to
read it again
• If you have any further questions
please ask your doctor or nurse
• If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, tell your doctor or
nurse.
In this leaflet:
1. What Methylprednisolone is and
what it is used for
2. Before you are given
Methylprednisolone
3. How Methylprednisolone will be
given to you
4. Possible side effects
5. How to store Methylprednisolone
6. Further information
1. WHAT METHYLPREDNISOLONE IS AND
WHAT IT IS USED FOR

Methylprednisolone is similar to natural
hormones called corticosteroids
(steroids) which are produced by your
adrenal glands. They work by damping
down inflammation and excessive
activity of the immune system.
Methylprednisolone is used to treat
inflammatory and allergic disorders
such as:
• skin conditions e.g. severe erythema
multiforme (Stevens Johnson
syndrome)
• life threatening allergic conditions
such as bronchial asthma, severe
hay fever, sudden swelling of the
mouth or throat (angioedema)
• gut disorders such as colitis and
Crohn's disease
• severe tuberculosis (TB).
Methylprednisolone may also be
used to reduce the activity of the
immune system in the following
conditions:
• organ rejection reactions after
transplantation surgery
• flare-ups in multiple sclerosis
• brain disorders resulting from a
tumour or meningitis following a TB
infection
• breathing-in (aspiration) the contents
of the stomach into the lungs.
This medicine is sometimes prescribed
for other uses. If so ask your doctor for
more information.
2. BEFORE YOU ARE GIVEN
METHYLPREDNISOLONE
Do not use Methylprednisolone if:
• you could be allergic to
methylprednisolone or any other
corticosteroid or any of the
ingredients (listed in section 6).
• you have a fungal infection, other
than on the skin, which is not being
treated
• you have ever had fever, fits and
loss of consciousness linked with
malaria (cerebral malaria)
• you are suffering from a head injury
or stroke.
Take special care before
Methylprednisolone is given:
Tell your doctor or nurse
immediately if any of the following
apply to you:
• you have not had chicken pox,
measles, shingles or a herpes eye
infection. If you develop them when
taking methylprednisolone they could
make you very ill. 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 immediate 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.
• you are being treated with digoxin
(a medicine for heart failure).
You must tell your doctor before
Methylprednisolone is given if you
suffer from:

• brittle bones (osteoporosis) or if you
are a woman who has gone through
the menopause
• mood disorders, either currently or in
the past, including severe
depression, manic-depression
(bipolar disorder), or problems such
as delusions, hallucinations or
disorganised speech after taking
steroids
• high blood pressure (hypertension)
• weakness of the heart muscle (heart
failure)
• a recent heart attack
• diabetes, either in you or close
family. If you have diabetes, you
should closely monitor blood sugar
while taking methylprednisolone
• tuberculosis, either currently or in the
past
• glaucoma, either in you or close
family
• pain or weakness in the muscles
after treatment with corticosteroid
medicines in the past
• liver problems such as jaundice
• poor kidney function
• epilepsy
• an ulcer in the small intestines
• recent fistula (abnormal connections
inside the intestines)
• ulcerative colitis and diverticulitis
(disorders of the gut)
• inflammation and blood clots of the
leg veins (thrombophlebitis)
• skin abscesses
• myasthenia gravis (a muscle
weakening disease)
• underactive thyroid gland
(hypothyroidism)
• Kaposi’s syndrome (a type of skin
cancer).
Using other medicines
Some medicines could be harmful if
taken with methylprednisolone, or could
affect the way either
methylprednisolone or the other
medicine works. Your doctor may need
to adjust the dose of your medicine if
you are taking other medicines.
Always tell your doctor or pharmacist if
you are taking any other medicines
(including any you have bought without
a prescription).
Tell your doctor or nurse if you are
taking any of the following:
• acetazolamide for glaucoma,
epilepsy and water retention
• aminoglutethimide for Cushing’s
syndrome and breast cancer
• antibiotics such as rifampicin,
rifabutin or erythromycin
• anticoagulants such as warfarin,
acenocoumarol and phenindione
used to thin the blood. Your doctor
may perform blood tests to make
sure that your blood clotting is
normal
• aspirin, sodium salicylate and nonsteroidal anti-inflammatory drugs
such as ibuprofen, naproxen and
diclofenac used to treat mild to
moderate pain
• carbamazepine for epilepsy, pain
and manic depression
• carbenoxolone for stomach ulcers
and heartburn
• ciclosporin to prevent organ rejection
• cimetidine for stomach ulcers and
heartburn
• diltiazem and mibefradil for problems
of the heart and blood circulation
such as high blood pressure and
angina
• diuretics for water retention such as
hydrochlorothiazide, furosemide and
etacrynic acid
• insulin and other drugs such as
metformin for diabetes. If you have
diabetes, you may need to check
your blood sugar more closely when
using methylprednisolone
• ketoconazole and itraconazole for
fungal infections
• medicines for high blood pressure
such as lisinopril and losartan

• pancuronium or other medicines
used for muscle relaxation during
surgery and tooth extractions
• phenobarbital, phenytoin and
primidone for epilepsy
• pyridostigmine and neostigmine for
myasthenia gravis
• vaccinations: tell your doctor before
being immunised with live vaccines
such as for polio if you are taking or
have been taking corticosteroids as
there is a risk of infection and poor
immune response to the vaccine.
Before you have any operation tell
your doctor, anaesthetist or dentist that
you are being treated with
methylprednisolone as your body’s
reaction to stress is reduced.
If you require a test to be carried out
by your general practitioner or hospital
you must tell the doctor that you are
being treated with methylprednisolone
as this medicine could affect the test
results.
Pregnancy and breast feeding
Talk to your doctor before being given
this medicine if you are pregnant,
planning to become pregnant or are
breast-feeding.
Important information about some of
the ingredients of this medicine
This medicine contains 1.6mmol
(37.2mg) of sodium in each 500mg vial
of methylprednisolone and 3.2mmol
(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.
3. HOW METHYLPREDNISOLONE WILL BE
GIVEN TO YOU

Steroid Cards
Your doctor or pharmacist should
give you a Steroid Treatment Card.
Make sure you carry it at all times
for one year after treatment, and
show it to anyone who treats you
such as a doctor, nurse, pharmacist
or dentist.
Treatment information
Treatment with methylprednisolone will
depend on your disease and its
severity. Your doctor will decide on the
dose, how you will be injected, its
duration and number of injections you
will receive. Your doctor will try to give
the lowest dose for the shortest
possible time to treat your illness.
Adults
Methylprednisolone will be given by
your doctor or nurse, as an injection
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. Larger doses
may take 30 minutes or more and are
normally 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.
Elderly
You will normally receive the same
treatment as younger adults although
the doctor may decide to check the
side effects of treatment more closely
(see Section 4 for side-effects).
Children
It is important that the doctor monitors
their growth and development regularly.
Treatment will be limited to 3 days
wherever possible.
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.
Continued overleaf.....

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Information for the Healthcare
Professional
Methylprednisolone 500mg & 1000mg
powder and solvent for solution for
injection/infusion
For full prescribing information please
read the Summary of Product
Characteristics.
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 Administration:
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
therapy.
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 transplantation.
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 recommended.

Stopping/reducing the dose of your
Methylprednisolone
Your doctor will decide a suitable time
to stop treatment.
The dose should be gradually reduced
if:
• you have been treated with
corticosteroid injections for more
than 3 weeks
• it has been less than one year since
you stopped long-term treatment
(months or years) with corticosteroid
tablets
• you suffer from Addison’s disease or
conditions where your adrenal
glands do not produce enough
natural corticosteroids
• you have had a course of more than
32mg of methylprednisolone each
day
• your injections were in the evening.
It is important to reduce the dose
gradually to avoid withdrawal
symptoms.
Withdrawal symptoms may include:
• itchy skin
• sweating
• fever
• muscle and joint pains
• runny nose
• sticky eyes
• weight loss.
If your symptoms return or get
worse as your medicine is reduced
tell your doctor immediately.
Mental health problems while taking
Methylprednisolone
Mental health problems can happen
while taking steroids like
methylprednisolone (see also section
4, Possible Side Effects).
Corticosteroids, especially with high
doses, can alter your mood and
behaviour. Some patients become
confused, irritable and suffer from
delusions and suicidal thoughts early
in treatment. This is particularly the
case if you are already suffering or
susceptible to mental problems.
These effects can also occur when
stopping methylprednisolone. Speak
to a doctor if you or someone close to
you is worried by psychological
changes.
4. POSSIBLE SIDE-EFFECTS
Like all steroids methylprednisolone
can cause side-effects, although not
everybody gets them.
Methylprednisolone is used for
illnesses that could get worse if not
properly treated. Side-effects are more
likely at high doses or during
prolonged treatment. Your doctor will
prescribe the lowest effective dose for
the shortest possible time to minimise
side-effects. Ask your doctor if you
need any further advice.
SERIOUS SIDE EFFECTS
Contact your doctor IMMEDIATELY if
you get any of the following
symptoms:
• sudden life-threatening allergic
reaction (anaphylaxis) with
symptoms such as rash, itching or
hives on the skin, swelling of the
face, lips, tongue or other parts of
the body, shortness of breath,
wheezing or breathing difficulties
• infections, which may be more
frequent and severe, although
symptoms may be less obvious
• stomach ulcers which may lead to
perforation and bleeding.
Symptoms are stomach pain, black
tarry stools or vomiting blood
• acute pancreatitis causing severe
pain in the abdomen and across the
back
• increased pressure in the skull
(pseudotumor cerebri) in children,
usually after stopping
methylprednisolone. Symptoms are
headache with vomiting, lack of
energy and drowsiness
• blood clots in the veins
(thromboembolism), which may
produce pain, tenderness or
swelling in one leg; or of the lungs
with symptoms of sudden sharp

chest pain, breathlessness and
coughing up blood
• failure of the heart to pump blood
properly leading to severe
breathlessness and swollen ankles
(congestive heart failure).
OTHER SIDE EFFECTS
Tell your doctor if any of the
following become serious:
Effects on the digestive system:
• indigestion, bloating, fungal
infections or ulcers of the gullet
• feeling sick, vomiting and bad taste
in the mouth
• raised levels of liver enzymes may
be observed temporarily.
Effects on the immune system:
• increased susceptibility to infections
• some skin tests may give abnormal
results and inactive tuberculosis
could return.
Effects on bones, muscles and
joints:
• weakness of the muscles in the
shoulder and hips
• thinning of the bones (osteoporosis)
and bone fractures especially of the
spine, arms and legs. Bone thinning
usually requires additional treatment
(particularly if you are a woman over
60) in order to prevent breakages
and fractures
• loss of blood supply to the bones in
the joints may lead to pain in the
knee and hip
• torn muscle tendons causing pain or
swelling.
Effects on kidney function:
• retention of sodium and water, loss
of potassium possibly resulting in
abnormal blood alkalinity, which in
rare cases can lead to congestive
heart failure (see serious side
effects).
Effects on the skin:
• development of pale or dark areas
of skin
• slow wound healing, pinhead spots
under the skin and bruising,
redness, thinning of the skin, stretch
marks, acne. Kaposi's sarcoma (a
type of skin cancer). These effects
may get better if the dose of your
medicine is reduced.
Hormonal effects:
• reduced activity of the
hypothalamus, pituitary and adrenal
glands which control reactions to
stress, digestion, the immune
system and emotions
• slow growth in infants and children
• problems with your periods
(menstruation)
• rounded (moon-shaped) face typical
of Cushing’s syndrome
• excessive hairiness
• reduced ability to process sugars
and starches with increased need
for treatment with diabetes
medication
• loss of muscle and bone
• increased appetite and weight gain.
Changes to your mental state:
Steroids including methylprednisolone
can cause serious mental health
problems. These reactions are
common in both adults and children.
About one in twenty adults may be
severely affected.
• mood changes such as irritability,
extreme happiness (euphoria),
depression and sudden mood
swings, withdrawal symptoms
including anxiety
• suicidal thoughts
• delusions, hallucinations, mania,
worsening of schizophrenia
• behavioural disturbances, sleep
disturbances, fits (seizures)
• problems with poor mental function
including confusion and memory
loss.
Effects on the eye:
• raised pressure in the eye,
glaucoma
• swelling of the optic nerve leading to
possible damage
• blurred vision or difficulty seeing
(cataracts), thinning of the cornea
and whites of the eye

• worsening of existing viral or fungal
eye infections.
Effects on the heart, lung and blood
circulation
• tearing of the heart muscles
following a heart attack
• high blood pressure which may give
you headaches, or make you feel
generally unwell
• sudden drop in blood pressure
leading to collapse
• heart attack
• irregular heart beat
• raised levels of white blood cells
• wheezing or coughing.
Other effects
• persistent hiccupping, feeling
unwell.
Withdrawal symptoms
A 'withdrawal syndrome' may occur,
see Section 3 for more information.
If any the side effects listed above
gets serious or you notice any side
effects not described in this leaflet
tell your doctor.
5. HOW TO STORE
METHYLPREDNISOLONE
This medicine must not be used after
the expiry date shown on the
packaging. The expiry date refers to
the last date of the month.
Keep vials in the outer carton to
protect from light.
The reconstituted methylprednisolone
solution and water for injections should
be used immediately and any
remainder discarded.
The doctor or pharmacist will keep the
medicine in a safe place where
children cannot reach or see it.
Your doctor or nurse will ensure that
your medicine is used and disposed of
correctly.
6. FURTHER INFORMATION
What Methylprednisolone powder
for solution for injection/infusion
contains
The active ingredient is
methylprednisolone sodium succinate.
Methylprednisolone 500mg powder
and solvent for solution for
injection/infusion:
Each vial of powder contains 663mg
methylprednisolone sodium succinate
(equivalent to 500mg
methylprednisolone).
Each ampoule of solvent contains
7.8ml of water for injections.
Methylprednisolone 1000mg powder
and solvent for solution for
injection/infusion:
Each vial of powder contains 1326mg
methylprednisolone sodium succinate
(equivalent to 1000mg
methylprednisolone).
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 this medicine looks like:
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 Injections.
Marketing Authorisation Holder
Beacon Pharmaceuticals Ltd, 85 High
Street, Tunbridge Wells TN1 1YG, UK.
Manufacturer
Biomendi, S.A., Polígono Industrial de
Bernedo s/n - 01118 Bernedo, Álava,
Spain.
This leaflet was last approved: May
2013

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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 rejection.
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 1000 mg 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 1g/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 1g/day, is
recommended.
In the treatment of status asthmaticus, 1
to 4mg/kg/day for 1 to 3 days is
recommended.
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 in the
outer carton to protect from light. Nature
of Container: Type I glass vials with
butyl rubber stopper and aluminium flipcap. Type I glass ampoules.
Instructions for Use and Handling:
Please refer to Dosing instructions. For
single use only. Unused solution must be
discarded immediately.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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