Medication Guide App

SOLU-CORTEF 100MG

Active substance: HYDROCORTISONE SODIUM SUCCINATE

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1. What Solu-Cortef is
and what it is used for

PATIENT INFORMATION LEAFLET

Solu-Cortef® 100 mg

Solu-Cortef contains Hydrocortisone Sodium
Succinate.

hydrocortisone sodium succinate

8R2603
26

Read all of this leaflet carefully before you start
taking this medicine
• 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 to others. It may harm them even if their
symptoms are the same as yours
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, tell your doctor
or pharmacist
In this leaflet:
1. What Solu-Cortef is and what it is used for
2. Before you are given Solu-Cortef
3. How Solu-Cortef is given to you
4. Possible side effects
5. How to store Solu-Cortef
6. Further information

PHYSICIAN LEAFLET
INFORMATION FOR DOCTORS AND PHARMACISTS

Solu-Cortef® 100 mg
hydrocortisone sodium succinate

For further information, consult the Summary of Product
Characteristics (SPC).
Posology and method of administration.
Solu-Cortef may be administered by intravenous injection,
by intravenous infusion, or by intramuscular injection, the
preferred method for initial emergency use being
intravenous injection. Following the initial emergency
period, consideration should be given to employing a
longer-acting injectable preparation or an oral
preparation.
Dosage usually ranges from 100 mg to 500 mg
depending on the severity of the condition, administered
by intravenous injection over a period of one to ten
minutes. This dose may be repeated at intervals of 2, 4 or
6 hours as indicated by the patient’s response and
clinical condition.

Hydrocortisone belongs to a group of
medicines called corticosteroids or steroids.
Corticosteroids are produced naturally in your
body and are important for many body
functions.
Boosting your body with extra corticosteroid
such as Solu-Cortef can help when injected
by a doctor or nurse if your body cannot
produce enough corticosteroid due to
problems with your adrenal glands (e.g.
adrenal insufficiency).
Corticosteroids can also help treat shock
following surgery, injuries, hypersensitivity
(anaphylactic) reactions or other stressful
conditions. These include inflammatory or
allergic conditions affecting the:
• bowel and gut e.g. Crohn’s disease
(inflammation of the gut) or ulcerative colitis
(inflammation of the lower bowel)
• lungs e.g. bronchial asthma or
inflammation caused by breathing in
(aspirating) vomit or stomach contents
• skin e.g. Stevens-Johnson syndrome (an
auto-immune disorder in which an immune
system causes the skin to blister and peel),
or systemic lupus erythematosus (lupus).
Solu-Cortef may be prescribed to treat
conditions other than those listed above.
Ask your doctor if you are unsure why you
have been given this medicine.

2. Before you are given
Solu-Cortef
Do not use Solu-Cortef if:

• You think you have ever suffered an
allergic reaction, or any other type of
reaction after being given Solu-Cortef, 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) which is not being treated.

In general high-dose corticosteroid therapy
should be continued only until the patient’s
condition has stabilised - usually not beyond
48 to 72 hours.
If hydrocortisone therapy must be continued
beyond 48 to 72 hours hypernatraemia may
occur, therefore it may be preferable to
replace Solu-Cortef with a corticosteroid such
as methylprednisolone sodium succinate as
little or no sodium retention occurs. Although
adverse effects associated with high dose,
short-term corticoid therapy are uncommon,
peptic ulceration may occur. Prophylactic
antacid therapy may be indicated.
Patients subjected to severe stress following
corticoid therapy should be observed closely
for signs and symptoms of adrenocortical
insufficiency.
Corticosteroid therapy is an adjunct to, and
not a replacement for, conventional therapy.
In patients with liver disease, there may be an
increased effect (see section 4.4 of the SPC)
and reduced dosing may be considered.
Elderly patients:
Solu-Cortef is primarily used in acute
short-term conditions. There is no information
to suggest that a change in dosage is
warranted in the elderly. However, treatment
of elderly patients should be planned bearing
in mind the more serious consequences of

• You must not have ‘live’ vaccines while
using this medicine.
See your doctor immediately if you have
any of the above.

Take special care before taking
Solu-Cortef:

You must tell your doctor before you take this
medicine if you have any of the following
conditions.
Your doctor may also 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 have had them.
• Severe depression or manic depression
(bipolar disorder). This includes having had
depression before while taking steroid
medicines like Solu-Cortef, or having a
family history of these illnesses.
• Diabetes (or if there is a family history of
diabetes).
• Epilepsy.
• Glaucoma (increased pressure in the eye)
or if there is a family history of glaucoma.
• You have recently suffered a heart attack.
• Heart problems, including heart failure or
infections.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Kaposi’s sarcoma (a type of skin cancer).
• Kidney or liver disease.
• Muscle problems (pain or weakness) have
happened while taking steroid medicines in
the past.
• Myasthenia gravis (a condition causing
tired and weak muscles).
• Osteoporosis (brittle bones).
• Skin abscess.
• Stomach ulcer or other serious stomach or
intestinal problems.
• 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.
You must tell your doctor before you take this
medicine if you have any of the conditions
listed above.

the common side-effects of corticosteroids in
old age and close clinical supervision is
required (see Special warnings and special
precautions for use section of the SPC).
Children:
While the dose may be reduced for infants
and children, it is governed more by the
severity of the condition and response of the
patient than by age or body weight, but
should not be less than 25 mg daily (see
Special warnings and precautions for use
section of the SPC).
Preparation of solutions:
For intravenous or intramuscular injection
prepare the solution aseptically by adding not
more than 2 ml of Sterile Water for Injections
to the contents of one vial of Solu-Cortef 100
mg, shake and withdraw for use.
For intravenous infusion, first prepare the
solution by adding not more than 2 ml of
Sterile Water for Injections to the vial; this
solution may then be added to 100 ml 1000 ml (but not less than 100 ml) of 5%
dextrose in water (or isotonic saline solution or
5% dextrose in isotonic saline solution if
patient is not on sodium restriction). When
reconstituted as directed the pH of the
solution will range from 7.0 to 8.0.

Taking other medicines

Always tell your doctor or pharmacist if you
are taking any medicines (including any you
have bought without a prescription) as taking
Solu-Cortef 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 Solu-Cortef or the other
medicine works:
• Acetazolamide - used to treat glaucoma
and epilepsy
• Aminoglutethimide – used for treating
cancer
• Anticoagulants - used to ‘thin’ the blood
such as acenocoumarol, phenindione and
warfarin
• Anticholinesterases - used to treat
myasthenia gravis (a muscle condition)
such as distigmine and neostigmine
• Antibiotics (such as erythromycin)
• Aspirin and non-steroidal antiinflammatory medicines (also called
NSAIDs) such as ibuprofen used to treat
mild to moderate pain
• Barbiturates, carbamazepine, phenytoin
and primidone – used to treat epilepsy
• Carbenoxolone and cimetidine - used for
heartburn and acid indigestion
• 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 an
irregular heart beat
• Diltiazem or mibefradil – used for heart
problems or high blood pressure
• Diuretics – sometimes called water tablets
• Ketoconazole or itraconazole – used to
treat fungal infections
• Pancuronium – or other medicines called
neuromuscular blocking agents which are
used in some surgical procedures
• Rifampicin and rifabutin – antibiotics used
to treat tuberculosis (TB)
• Vaccines - tell your doctor or nurse if you
have recently had, or are about to have any
vaccination. You should not have ‘live’
vaccines while using this medicine. Other
vaccines may be less effective

Shelf-life
The shelf life is printed on labels and cartons.
Do not use Solu-Cortef after this date. After
reconstitution with Water for Injections, use
immediately, discard any remainder.
Storage of the product
Store below 25°C.
Refer to Posology and method of
administration section above.
Reconstituted solutions should be used
immediately. No diluents other than those
referred to are recommended. Parenteral
drug products should be inspected visually
for particulate matter and discoloration prior
to administration.
This leaflet was last revised in July 2012
Ref: SC 6_1

If you are taking long term
medication(s)

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 medicines used to
treat these conditions.
Before you have any operation tell your
doctor, dentist or anesthetist that you are
taking this medicine.
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 Solu-Cortef. This medicine can affect
the results of some tests.

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 growth.
Tell your doctor if you are breast feeding as
small amounts of corticosteroid medicines
may get into breast milk.
If you continue breast-feeding while you are
having treatment, your baby will need extra
checks to make sure he or she is not being
affected by your medicine.

Driving and Using Machines

The effect of this class of medicines on the
ability to drive or use machinery has not
been studied. There are undesirable effects
observed with the use of this medicine such
as syncope (fainting), vertigo (sensation of
rotation or movement of oneself or the
surrounding), and convulsions (seizures). If
you are affected by any of them, you should
not drive or operate machinery.

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 this medicine. 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
unconscious.

Dosage information

Your doctor will decide on the site of
injection, how much of the medicine and
how many injections you will receive
depending on the condition being treated
and its severity. Your doctor will inject you
with the lowest dose for the shortest
possible time to get effective relief of your
symptoms.

Adults

Solu-Cortef 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 a period of
between 1 – 10 minutes. Depending on your
condition a repeat dose may be injected at
intervals of between 2 to 6 hours. Large
doses should normally be used for only two
to three days.
The medicine is first dissolved in Sterile
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

3. How Solu-Cortef is
given to you

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.

Steroid Cards

Children

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

Corticosteroids can affect growth in children
so your doctor will prescribe the lowest
dose (normally not more 25mg a day) that
will be effective for your child.

If you are given more Solu-Cortef
than you should

If you think you have been given too many
injections of this medicine please speak to
your doctor immediately.

Stopping/reducing the dose of your
Solu-Cortef

Your doctor will decide when it is time to
stop your treatment.
You will need to come off this treatment
slowly if you:
• have been given more than 160 mg of
Hydrocortisone, such as Solu-Cortef, for
more than 3 weeks,
• have been given high doses of
corticosteroids, such as Solu-Cortef, over
32 mg (0.8 ml) daily, even if it was only for
3 weeks or less,
• have already had a course of
corticosteroid tablets or injections in the
last year,
• already have problems with your adrenal
glands (adrenocortical insufficiency)
before you started this treatment.
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 problems while taking
Solu-Cortef

Mental health problems can happen while
taking steroids like Solu-Cortef (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 treatment.
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.

4. Possible side effects
Like all steroids 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 Solu-Cortef (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 medicine:
• 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.
• Acute pancreatitis, stomach pain which
may spread through to your back, possibly
accompanied by vomiting, shock and loss
of consciousness.
• Burst or bleeding ulcers, symptoms of
which are severe stomach pain which may
go through to the back and could be
associated with 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. This medicine may also make
you more likely to develop a severe
infection.
• Pulmonary embolus (blood clot in the
lung) symptoms include sudden sharp
chest pain, breathlessness and coughing
up blood.
• Raised pressure within the skull of
children (pseudotumour 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.

Blood, heart and circulation

• 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 beating of the heart, irregular or
very fast or slow pulse.
• Increased numbers of white blood cells
(leucocytosis).

Body water and salts

• Swelling and high blood pressure, caused
by increased levels of water and salt
content.
• 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

• Nausea (feeling sick) or vomiting (being
sick).
• Ulcers or thrush in the gullet (discomfort on
swallowing).
• Indigestion.
• Bloated stomach.
• Persistent hiccups, especially when high
doses are taken.

Eyes

• Glaucoma (raised pressure within the eye,
causing pain in the eyes and headaches).
• Swollen optic nerve (causing a condition
called papilloedema, and which may cause
sight disturbance).
• Damage to the optic nerve or cataracts
(indicated by failing eyesight).
• 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 infections.
• Protruding of the eyeballs (exophthalmos).
• Blurred or double vision.

Hormones and metabolic system

• Slowing of normal growth in infants,
children and adolescents which may be
permanent.
• Irregular or no periods in women.
• Increased hair on the body and face in
women (hirsutism).

• Round or moon-shaped face (Cushingoid
facies).
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes
• 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 alanine 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.

Immune system

• Increased susceptibility to infections which
can hide or change normal reactions to skin
tests, such as that for tuberculosis.

Muscles and bones





Muscle weakness or wasting.
Brittle bones (bones that break easily).
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 Solu-Cortef, can cause
serious mental health problems.
These are common in both adults and
children. They can affect about 5 in every
100 people taking medicines like Solu-Cortef.
• Feeling depressed, including thinking
about suicide.
• Feeling high (mania) or moods that go up
and down.
• Feeling anxious, having problems sleeping,
difficulty in thinking or being confused and
losing your memory.
• Feeling, seeing or hearing things which do
not exist. Having strange and frightening
thoughts, changing how you act or having
feelings of being alone.

• Other nervous system side effects may
include breathing problems, convulsions,
dizziness, drowsiness, difficulty breathing,
sensation of cold, heat or numbness,
tinnitus or unconsciousness.

Skin








Abscess, especially near injection sites.
Acne.
Poor wound healing.
Thinning of skin with stretch marks.
Bruising.
Small purple/red patches on the skin.
Pale or darker patches on your skin, or
raised patches which are an unusual color.
If you experience any of the side effects
listed above tell your doctor straight away.

5. How to store
Solu-Cortef
Solu-Cortef must not be used after the expiry
date ‘EXP’ shown on the container.
The doctor or pharmacist will keep the
medicine in a safe place where children
cannot reach or see it.
This medicine must be stored below 25°C.
Once the medicine has been mixed with
Sterile Water for Injections the solution should
be used straight away. Any unused liquid
should be disposed of safely.
Your doctor will check that the solution
contains no particles and is not discoloured
before using it.

Marketing Authorisation Holder:

The company authorised to sell Solu-Cortef is:
Pharmacia Limited,
Ramsgate Road,
Sandwich,
Kent CT13 9NJ, UK.

Manufacturer

Solu-Cortef is made by:
Pharmacia NV/SA,
Rijksweg 12,
B-2870, Puurs,
Belgium,
and
Laboratoires Pharmacia SAS,
Parc Industriel d’Incarville,
BP 606, 27106 Val De Reuil,
Cedex, France.

Company contact address:

For further information on your medicine contact Medical
Information at the following address:
Pfizer Limited,
Walton Oaks,
Dorking Road,
Tadworth,
Surrey, KT20 7NS.
Tel: 01304 616161.
This leaflet was last revised in July 2012
Ref: SC 6_1

6. Further information
What Solu-Cortef contains:

Each vial of this medicine contains 133.7mg
of Hydrocortisone Sodium Succinate
(equivalent to 100 mg Hydrocortisone) as the
active ingredient.
Solu-Cortef also contains sodium
biphosphate and sodium phosphate.

What a Solu-Cortef looks like:

Solu-Cortef is a white powder which comes
in a clear glass vial fitted with a rubber cap
and metal seal.
Solu-Cortef is available in packs containing
1 or 10 vials.

8R2603

inks on file

structure

2. Before you are given
Solu-Cortef

PATIENT INFORMATION LEAFLET

Solu-Cortef® 100 mg

Do not use Solu-Cortef if:

hydrocortisone sodium succinate

8R2602
615

Read all of this leaflet carefully
before you start taking this medicine
• 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 to others. It may harm
them even if their symptoms are the
same as yours
• If any of the side effects gets serious, or
if you notice any side effects not listed in
this leaflet, tell your doctor or pharmacist
In this leaflet:
1. What Solu-Cortef is and what it is
used for
2. Before you are given Solu-Cortef
3. How Solu-Cortef is given to you
4. Possible side effects
5. How to store Solu-Cortef
6. Further information

1. What Solu-Cortef is
and what it is used
for

Solu-Cortef contains Hydrocortisone
Sodium Succinate.
Hydrocortisone belongs to a group of
medicines called corticosteroids or steroids.
Corticosteroids are produced naturally in
your body and are important for many body
functions.
Boosting your body with extra corticosteroid
such as Solu-Cortef can help when injected
by a doctor or nurse if your body cannot
produce enough corticosteroid due to
problems with your adrenal glands (e.g.
adrenal insufficiency).
Corticosteroids can also help treat shock
following surgery, injuries, hypersensitivity
(anaphylactic) reactions or other stressful
conditions. These include inflammatory or
allergic conditions affecting the:
• bowel and gut e.g. Crohn’s disease
(inflammation of the gut) or ulcerative
colitis (inflammation of the lower bowel)
• lungs e.g. bronchial asthma or
inflammation caused by breathing in
(aspirating) vomit or stomach contents
• skin e.g. Stevens-Johnson syndrome
(an auto-immune disorder in which an
immune system causes the skin to blister
and peel), or systemic lupus
erythematosus (lupus).
Solu-Cortef may be prescribed to treat
conditions other than those listed above.
Ask your doctor if you are unsure why you
have been given this medicine.

PHYSICIAN LEAFLET
INFORMATION FOR DOCTORS AND PHARMACISTS

Solu-Cortef® 100 mg
hydrocortisone sodium succinate
For further information, consult the Summary of Product Characteristics (SPC).
Posology and method of administration.
Solu-Cortef may be administered by intravenous injection, by intravenous infusion, or
by intramuscular injection, the preferred method for initial emergency use being
intravenous injection. Following the initial emergency period, consideration should be
given to employing a longer-acting injectable preparation or an oral preparation.

• You think you have ever suffered an
allergic reaction, or any other type of
reaction after being given Solu-Cortef, 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) which is not being treated.
• You must not have ‘live’ vaccines
while using this medicine.
See your doctor immediately if you
have any of the above.

Take special care before taking
Solu-Cortef:

You must tell your doctor before you take
this medicine if you have any of the
following conditions.
Your doctor may also 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 have had them.
• Severe depression or manic
depression (bipolar disorder). This
includes having had depression before
while taking steroid medicines like
Solu-Cortef, or having a family history of
these illnesses.
• Diabetes (or if there is a family history
of diabetes).
• Epilepsy.
• Glaucoma (increased pressure in the
eye) or if there is a family history of
glaucoma.
• You have recently suffered a heart
attack.
• Heart problems, including heart
failure or infections.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active
thyroid).
• Kaposi’s sarcoma (a type of skin
cancer).
• Kidney or liver disease.
• Muscle problems (pain or weakness)
have happened while taking steroid
medicines in the past.

• Myasthenia gravis (a condition
causing tired and weak muscles).
• Osteoporosis (brittle bones).
• Skin abscess.
• Stomach ulcer or other serious
stomach or intestinal problems.
• 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.
You must tell your doctor before you take
this medicine if you have any of the
conditions listed above.

Taking other medicines

Always tell your doctor or pharmacist if you
are taking any medicines (including any
you have bought without a prescription) as
taking Solu-Cortef 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 Solu-Cortef or the other
medicine works:
• Acetazolamide - used to treat
glaucoma and epilepsy
• Aminoglutethimide – used for
treating cancer
• Anticoagulants - used to ‘thin’ the
blood such as acenocoumarol,
phenindione and warfarin
• Anticholinesterases - used to treat
myasthenia gravis (a muscle condition)
such as distigmine and neostigmine
• Antibiotics (such as erythromycin)
• Aspirin and non-steroidal antiinflammatory medicines (also called
NSAIDs) such as ibuprofen used to treat
mild to moderate pain
• Barbiturates, carbamazepine,
phenytoin and primidone – used to
treat epilepsy
• Carbenoxolone and cimetidine used for heartburn and acid indigestion
• 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
an irregular heart beat
• Diltiazem or mibefradil – used for
heart problems or high blood pressure
• Diuretics – sometimes called water
tablets
• Ketoconazole or itraconazole – used
to treat fungal infections
• Pancuronium – or other medicines
called neuromuscular blocking agents
which are used in some surgical
procedures
• Rifampicin and rifabutin – antibiotics
used to treat tuberculosis (TB)

• Vaccines - tell your doctor or nurse if
you have recently had, or are about to
have any vaccination. You should not
have ‘live’ vaccines while using this
medicine. Other vaccines may be less
effective

3. How Solu-Cortef is
given to you
Steroid Cards

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 medicines used to
treat these conditions.
Before you have any operation tell your
doctor, dentist or anesthetist that you are
taking this medicine.
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 Solu-Cortef. This
medicine can affect the results of some
tests.

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 this medicine. 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
unconscious.

Pregnancy and breast feeding

Dosage information

If you are taking long term
medication(s)

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 growth.
Tell your doctor if you are breast feeding as
small amounts of corticosteroid medicines
may get into breast milk.
If you continue breast-feeding while you are
having treatment, your baby will need extra
checks to make sure he or she is not being
affected by your medicine.

Driving and Using Machines

The effect of this class of medicines on the
ability to drive or use machinery has not
been studied. There are undesirable effects
observed with the use of this medicine
such as syncope (fainting), vertigo
(sensation of rotation or movement of
oneself or the surrounding), and
convulsions (seizures). If you are affected
by any of them, you should not drive or
operate machinery.

Your doctor will decide on the site of
injection, how much of the medicine and
how many injections you will receive
depending on the condition being treated
and its severity. Your doctor will inject you
with the lowest dose for the shortest
possible time to get effective relief of your
symptoms.

Adults

Solu-Cortef 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 a period of
between 1 – 10 minutes. Depending on your
condition a repeat dose may be injected at
intervals of between 2 to 6 hours. Large
doses should normally be used for only two
to three days.
The medicine is first dissolved in Sterile
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

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.

Children

Corticosteroids can affect growth in
children so your doctor will prescribe the
lowest dose (normally not more 25mg a
day) that will be effective for your child.

Dosage usually ranges from 100 mg to 500 mg depending on the severity of the
condition, administered by intravenous injection over a period of one to ten minutes.
This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the
patient’s response and clinical condition.

Corticosteroid therapy is an adjunct to, and not a replacement for, conventional
therapy.
In patients with liver disease, there may be an increased effect (see section 4.4 of the
SPC) and reduced dosing may be considered.

In general high-dose corticosteroid therapy should be continued only until the
patient’s condition has stabilised - usually not beyond 48 to 72 hours.
If hydrocortisone therapy must be continued beyond 48 to 72 hours hypernatraemia
may occur, therefore it may be preferable to replace Solu-Cortef with a corticosteroid
such as methylprednisolone sodium succinate as little or no sodium retention occurs.
Although adverse effects associated with high dose, short-term corticoid therapy are
uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be
indicated.

Elderly patients:
Solu-Cortef is primarily used in acute short-term conditions. There is no information to
suggest that a change in dosage is warranted in the elderly. However, treatment of
elderly patients should be planned bearing in mind the more serious consequences
of the common side-effects of corticosteroids in old age and close clinical
supervision is required (see Special warnings and special precautions for use section
of the SPC).

Patients subjected to severe stress following corticoid therapy should be observed
closely for signs and symptoms of adrenocortical insufficiency.

Children:
While the dose may be reduced for infants and children, it is governed more by the
severity of the condition and response of the patient than by age or body weight, but

If you are given more Solu-Cortef
than you should
If you think you have been given too many
injections of this medicine please speak to
your doctor immediately.

Stopping/reducing the dose of
your Solu-Cortef

Your doctor will decide when it is time to
stop your treatment.
You will need to come off this treatment
slowly if you:
• have been given more than 160 mg of
Hydrocortisone, such as Solu-Cortef, for
more than 3 weeks,
• have been given high doses of
corticosteroids, such as Solu-Cortef,
over 32 mg (0.8 ml) daily, even if it was
only for 3 weeks or less,
• have already had a course of
corticosteroid tablets or injections in the
last year,
• already have problems with your adrenal
glands (adrenocortical insufficiency)
before you started this treatment.
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 problems while taking
Solu-Cortef

Mental health problems can happen while
taking steroids like Solu-Cortef (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 treatment.
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.

4. Possible side effects

Like all steroids 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 Solu-Cortef (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 medicine:
• 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.
• Acute pancreatitis, stomach pain
which may spread through to your back,
possibly accompanied by vomiting,
shock and loss of consciousness.
• Burst or bleeding ulcers, symptoms
of which are severe stomach pain which
may go through to the back and could be
associated with 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. This
medicine may also make you more likely
to develop a severe infection.
• Pulmonary embolus (blood clot in the
lung) symptoms include sudden sharp
chest pain, breathlessness and coughing
up blood.
• Raised pressure within the skull of
children (pseudotumour 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.

should not be less than 25 mg daily (see Special warnings and precautions for use
section of the SPC).
Preparation of solutions:
For intravenous or intramuscular injection prepare the solution aseptically by adding
not more than 2 ml of Sterile Water for Injections to the contents of one vial of
Solu-Cortef 100 mg, shake and withdraw for use.
For intravenous infusion, first prepare the solution by adding not more than 2 ml of
Sterile Water for Injections to the vial; this solution may then be added to 100 ml 1000 ml (but not less than 100 ml) of 5% dextrose in water (or isotonic saline solution
or 5% dextrose in isotonic saline solution if patient is not on sodium restriction). When
reconstituted as directed the pH of the solution will range from 7.0 to 8.0.
Shelf-life
The shelf life is printed on labels and cartons. Do not use Solu-Cortef after this date.
After reconstitution with Water for Injections, use immediately, discard any remainder.

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.

Blood, heart and circulation

• 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 beating of the heart,
irregular or very fast or slow pulse.
• Increased numbers of white blood cells
(leucocytosis).

Body water and salts

• Swelling and high blood pressure,
caused by increased levels of water and
salt content.
• 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

• Nausea (feeling sick) or vomiting (being
sick).
• Ulcers or thrush in the gullet (discomfort
on swallowing).
• Indigestion.
• Bloated stomach.
• Persistent hiccups, especially when high
doses are taken.

Eyes

• Glaucoma (raised pressure within the
eye, causing pain in the eyes and
headaches).
• Swollen optic nerve (causing a condition
called papilloedema, and which may
cause sight disturbance).
• Damage to the optic nerve or cataracts
(indicated by failing eyesight).
• 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
infections.
• Protruding of the eyeballs
(exophthalmos).
• Blurred or double vision.

Hormones and metabolic system
• Slowing of normal growth in infants,
children and adolescents which may be
permanent.
• Irregular or no periods in women.
• Increased hair on the body and face in
women (hirsutism).
• Round or moon-shaped face
(Cushingoid facies).
• Increased appetite and weight gain.
• Diabetes or worsening of existing
diabetes.
• 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 alanine 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.

Immune system

• Increased susceptibility to infections
which can hide or change normal
reactions to skin tests, such as that for
tuberculosis.

Muscles and bones





Muscle weakness or wasting.
Brittle bones (bones that break easily).
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 Solu-Cortef, can cause
serious mental health problems.
These are common in both adults and
children. They can affect about 5 in every
100 people taking medicines like
Solu-Cortef.
• Feeling depressed, including thinking
about suicide.
• Feeling high (mania) or moods that go
up and down.
• Feeling anxious, having problems
sleeping, difficulty in thinking or being
confused and losing your memory.
• Feeling, seeing or hearing things which
do not exist. Having strange and
frightening thoughts, changing how you
act or having feelings of being alone.
• Other nervous system side effects may
include breathing problems,
convulsions, dizziness, drowsiness,
difficulty breathing, sensation of cold,
heat or numbness, tinnitus or
unconsciousness.

Skin








Abscess, especially near injection sites.
Acne.
Poor wound healing.
Thinning of skin with stretch marks.
Bruising.
Small purple/red patches on the skin.
Pale or darker patches on your skin, or
raised patches which are an unusual
color.
If you experience any of the side
effects listed above tell your doctor
straight away.

5. How to store
Solu-Cortef

Solu-Cortef must not be used after the
expiry date ‘EXP’ shown on the container.
The doctor or pharmacist will keep the
medicine in a safe place where children
cannot reach or see it.
This medicine must be stored below 25°C.
Once the medicine has been mixed with
Sterile Water for Injections the solution
should be used straight away. Any unused
liquid should be disposed of safely.
Your doctor will check that the solution
contains no particles and is not discoloured
before using it.

6. Further information
What Solu-Cortef contains:

Each vial of this medicine contains
133.7mg of Hydrocortisone Sodium
Succinate (equivalent to 100mg
Hydrocortisone) as the active ingredient.
Solu-Cortef also contains sodium
biphosphate and sodium phosphate.

What a Solu-Cortef looks like:

Solu-Cortef is a white powder which comes
in a clear glass vial fitted with a rubber cap
and metal seal.
Solu-Cortef is available in packs containing
1 or 10 vials.

Marketing Authorisation Holder:

The company authorised to sell Solu-Cortef
is:
Pharmacia Limited,
Ramsgate Road,
Sandwich,
Kent CT13 9NJ, UK.

Manufacturer

Solu-Cortef is made by:
Pharmacia NV/SA,
Rijksweg 12,
B-2870, Puurs,
Belgium,
and
Laboratoires Pharmacia SAS,
Parc Industriel d’Incarville,
BP 606, 27106 Val De Reuil,
Cedex, France.

Company contact address:

For further information on your medicine
contact Medical Information at the following
address:
Pfizer Limited,
Walton Oaks,
Dorking Road,
Tadworth,
Surrey, KT20 7NS.
Tel: 01304 616161.
This leaflet was last revised in July 2012
Ref: SC 6_1

Storage of the product
Store below 25°C.
Refer to Posology and method of administration section above.
Reconstituted solutions should be used immediately. No diluents other than those
referred to are recommended. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration.
This leaflet was last revised in July 2012
Ref: SC 6_1

8R2602

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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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