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DEXAMETHASONE 3.8 MG/ML SOLUTION FOR INJECTION

Active substance: DEXAMETHASONE SODIUM PHOSPHATE

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Technical Info

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Dexamethasone
3.8 mg/ml solution for
injection
dexamethasone

Information for the patient
Important information about this medicine
• Dexamethasone is a steroid medicine,
prescribed for many different conditions including
serious illnesses
• You need to take it regularly to get the maximum
benefit
• Don’t stop taking this medicine without talking
to your doctor–you may need to reduce the dose
gradually
• Dexamethasone can cause side effects in some
people (read section 4: Possible side effects).
Some problems such as mood changes (feeling
depressed, or ‘high’), or stomach problems can
happen straight away. If you feel unwell, in any
way, keep taking your medicine, but see your
doctor straight away
• Some side effects only happen after weeks or
months. These include weakness of arms and legs,
or developing a rounder face (read Section 4 for
more information)
• If you take it for more than 3 weeks, in the UK,
you will get a blue ‘steroid card’: always keep
it with you and show it to any doctor or nurse
treating you
• Keep away from people who have chicken pox
or shingles, if you have never had them. They
could affect you severely. If you do come into
contact with chicken pox or shingles, see your
doctor straight away
Now read the rest of this leaflet.
It includes other important information on the safe
and effective use of this medicine that might be
especially important for you.
• Read all of this leaflet carefully before you start
using this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor
or your pharmacist
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist
In this leaflet:
1. What Dexamethasone is and what it is used for
2. Before you have Dexamethasone
3. How you have Dexamethasone
4. Possible side effects
5. How to store Dexamethasone
6. Further information
1. What Dexamethasone is and what it is used for
The name of your medicine is Dexamethasone. This
belongs to a group of medicines called corticosteroids.
Corticosteroids are hormones that are found
naturally in your body that help to keep you
healthy and well. Boosting your body with extra
corticosteroid, such as Dexamethasone, is an effective
way to treat various illnesses involving inflammation in
the body. Dexamethasone lowers inflammation, which
could otherwise go on making your condition worse.
You must take this medicine regularly to get maximum
benefit from it.
Dexamethasone can be used to:
• Reduce inflammation
• Treat a number of different diseases of the
immune system
2. Before you have Dexamethasone
Do not have Dexamethasone and tell your doctor if:
• You are allergic (hypersensitive) to dexamethasone
or any other ingredients in this medicine (listed in
section 6)
The signs of an allergic reaction include a rash,
itching or shortness of breath
• You have an infection that affects the whole body
• You have an infection of a joint
• You have unstable joints. This is a condition where
joints, such as the knee, can suddenly give way.
➣ Do not have this medicine if any of the above
apply to you, talk to your doctor or pharmacist
before having Dexamethasone.
Check with your doctor first:
• If you have ever had severe depression or manic
depression (bipolar disorder).
This includes having had depression before while
taking steroid medicines like Dexamethasone
• If any of your close family has had these illnesses
➣ If either of these applies to you, talk to a doctor
before having this medicine.

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Mental problems while having Dexamethasone
Mental health problems can happen while having
steroids like Dexamethasone (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
problems do happen, they might need treatment

➣ Talk to a doctor if you (or someone taking 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.
Take special care with Dexamethasone
➣ Before you have Dexamethasone, tell your doctor if:
• You have a cancer of the blood because you may be at
risk of a very rare, potentially life-threatening condition
resulting from a sudden breakdown of tumour cells.
• You have kidney or liver problems
• You have high blood pressure or heart disease
• You have diabetes or there is a family history of diabetes
• You have thinning of the bones (osteoporosis),
particularly if you are a female who has been through
the menopause
• You have had muscle weakness with this or other
steroids in the past
• You have raised eye pressure (glaucoma) or there is a
family history of glaucoma
• You have a stomach (peptic) ulcer
• You have mental problems or you have had a mental
illness which was made worse by this type of medicine
such as ‘steroid psychosis’
• You have epilepsy
• You have migraines
• You have an infection with parasites
• You have tuberculosis (TB)
• You have stunted growth
• You have ‘Cushing’s syndrome’
• You have had a head injury
• You have had a stroke
➣ If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before having
Dexamethasone.
If a child is having this medicine, it is important that the
doctor monitors their growth and development regularly.
Dexamethasone should not be routinely given to
premature babies with respiratory problems.
More important information about having this kind of
medicine
If you develop an infection while you are having this
medicine, you should talk to your doctor. Please tell
any doctor, dentist or person who may be giving you
treatment that you are currently taking steroids or have
taken them in the past.
If you are living in the UK, you should always carry
a blue ‘steroid card’ which gives clear guidance on
the special care to be taken when you are taking this
medicine. Show this to any doctor, dentist or person who
may be giving you treatment. Even after your treatment
has finished you must tell anyone who is giving you
treatment that you have taken steroids in the past.
Do not use Dexamethasone for the treatment of Acute
Respiratory Distress Syndrome (ARDS; a serious lung
disease) if you have been diagnosed with this condition
for over 2 weeks.
Dexamethasone and viral infections
While you are having this kind of medicine, you should
not come into contact with anyone who has chicken pox,
shingles or measles if you have not had these illnesses.
This is because you may need specialist treatment if
you get these diseases. If you think you may have had
exposure to any of these diseases, you should talk to
your doctor straight away. You should also tell your
doctor if you have ever had infectious diseases such
as measles or chicken pox and if you have had any
vaccinations for these conditions in the past.
➣ Please tell a doctor or anyone giving you treatment,
such as at a hospital, if:
• You have an accident
• You are ill
• You need any surgery. This includes any surgery you
may have at your dentist’s
• You need to have a vaccination
If any of the above apply to you, you should tell your
doctor or the person treating you even if you have
stopped having this medicine.
Taking other medicines
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines you buy without a prescription, including
herbal medicines. Other medicines can affect the way
Dexamethasone works or Dexamethasone can affect the
way they work. In particular:
• Medicines to treat heart and blood problems, such
as warfarin, high blood pressure medicine, and water
tablets (diuretics)
• Antibiotics such as rifampicin and rifabutin
• Medicines to treat epilepsy, such as phenytoin,
carbamazepine, phenobarbitone and primidone
• Medicines that control pain or lower inflammation,
such as aspirin or phenylbutazone
• Medicines used to treat diabetes
• Medicines used to lower potassium levels
• Medicines used to treat myasthenia
• Anti-cancer treatments, such as aminoglutethimide
• Ephedrine used to relieve symptoms of a blocked nose
• Acetazolamide used for glaucoma
• Carbenoxolone sometimes used for ulcers

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Dexamethasone
3.8 mg/ml solution for
injection
dexamethasone

Technical information for the healthcare
professional
NEW FORMULATION
CHANGE IN CONCENTRATION
STORE IN A REFRIGERATOR
The following information is intended for the
healthcare professional only:
This is an extract from the Summary of Product
Characteristics (SmPC) to assist in the administration of
Dexamethasone 3.8 mg/ml solution for injection.
The prescriber should be familiar with the full SmPC in
order to determine the appropriateness of the use of
the product in a particular patient. The full SmPC can be
found on the electronic Medicines Compendium (eMC)
website: http://www.medicines.org.uk/emc/.
The Patient Information Leaflet provided (see the other
half of this leaflet) should be given to the patient.
Dexamethasone 3.8 mg/ml solution for injection
contains dexamethasone base in the form of the salt,
dexamethasone sodium phosphate.
Each vial contains 1 ml of solution. Each 1 ml of solution
contains 3.8 mg dexamethasone base (as sodium
phosphate). This is equivalent to 5.0 mg dexamethasone
sodium phosphate.
Preparation and other handling
instructions
Dexamethasone solution for injection may be diluted
with the following solutions for injection or infusion:
• Sodium Chloride 0.9% infusion, Glucose 5% Infusion,
Compound Sodium Lactate Infusion, Hartmann’s
Solution for Injection, Ringer-Lactate Solution for
Injection, Ringer’s Solution for Injection, Sorbitol 5%
Injection, Invert Sugar 10% Injection and Rheomacrodex
Using the above infusion fluids, Dexamethasone solution
for injection can also be injected into the infusion line
without causing precipitation of the ingredients.
For single use only.
Discard any unused solution after use.
Any unused product or waste material should be
disposed of in accordance with local requirements.
The product should only be used when the solution is
clear and particle free.
DOSAGE AND ADMINISTRATION
Dosage
Note: All dose recommendations stated in this section
are expressed as mg dexamethasone base.
In general, glucocorticoid dosage depends on the
severity of the condition and response of the patient.
Under certain circumstances (e.g. in stress), extra
dosage adjustments may be necessary. If no favourable
response is noted within a couple of days, glucocorticoid
therapy should be discontinued.
Adults and Elderly
Once the disease is under control the dosage should be
reduced or tapered off to the lowest suitable level under
continuous monitoring and observation of the patient.
For acute life-threatening situations (e.g. anaphylaxis,
acute severe asthma) substantially higher dosages may be
needed. Cerebral oedema (adults): initial dose 8 - 16 mg IV
followed by 5 mg IV or IM every 6 hours, until a satisfactory
result has been obtained. In brain surgery these dosages
may be necessary until several days after the operation.
Thereafter, the dosage has to be tapered off gradually.
Increase of intracranial pressure associated with brain
tumours can be counteracted by continuous treatment.
For local treatment, the following dosages can be
recommended:
• intra-articulary:
1.6-3 mg large joints

0.6-0.8 mg small joints
• intrabursally:
1.6-3 mg;
• in tendon sheaths: 0.3-0.8mg
The frequency of these injections may vary from every
3 - 5 days to every 2 - 3 weeks. For rectal drip in cases
of ulcerative colitis: 4 mg diluted in 120 ml saline.
Suggested doses for children
Dosage requirements are variable and may have to be
changed according to individual needs. Usually 0.2 mg/kg
to 0.4 mg/kg of body weight daily.
Please refer to Table 1 for assistance when calculating
any required dosage.
Table 1. Concentration vs. Volume
Desired concentration
Required volume of
(mg dexamethasone base)
product*
(ml)
3.8
1.00
4
1.05
8
2.10
12
3.15
16
4.20
* Dexamethasone 3.8 mg/ml solution for injection

Method of administration
Dexamethasone solution for injection may be
administered intravenously (IV), subcutaneously (SC),
intramuscularly (IM), by local injection or as a rectal drip.

For administration by IV infusion: see section on
‘Preparation and Other Handling Instructions’.
With IV administration high plasma levels can be
obtained rapidly.
Rapid IV injection of massive doses of glucocorticoids
may sometimes cause cardiovascular collapse; the
injection should therefore be given slowly over a
period of several minutes.
Intra-articular injections should be given under
strictly aseptic conditions.
WARNINGS
In post-marketing experience tumour lysis
syndrome (TLS) has been reported very rarely
in patients with haematological malignancies
following the use of dexamethasone alone or in
combination with other chemotherapeutic agents.
Patients at high risk of TLS should be monitored
closely and appropriate precautions taken.
Potentially severe psychiatric adverse reactions
may occur with systemic steroids. Symptoms
typically emerge within a few days or weeks of
starting the treatment. Risks may be higher with
high doses/systemic exposure, although dose
levels do not allow prediction of the onset, type
severity or duration of reactions. Most reactions
recover after either dose reduction or withdrawal,
although specific treatment may be necessary.
Please seek advice if worrying psychological
symptoms develop, especially if depressed mood
or suicidal ideation is suspected. Please also be
alert to possible psychiatric disturbances that
may occur either during or immediately after dose
tapering/withdrawal of systemic steroids, although
such reactions have been reported infrequently.
Take particular care when considering the use of
systemic corticosteroids in patients with existing
or previous history of severe affective disorders
in themselves or in their first degree relatives
(Including depressive or manic-depressive illness
and previous steroid psychosis).
Undesirable effects may be minimised by using
the lowest effective dose for the minimum period,
and by administering the daily requirement as a
single morning dose or whenever possible as a
single morning dose on alternative days. Frequent
patient review is required to appropriately titrate
the dose against disease activity.
After parenteral administration of glucocorticoids
serious anaphylactoid reactions have occasionally
occurred, particularly in patients with a history
of allergy. If such an anaphylactoid reaction
occurs, the following measures are recommended:
immediate slow IV injection of 0.1 - 0.5 ml of
adrenaline (solution of 1:1000: 0.1 - 0.5 mg
adrenaline dependent on body weight), IV
administration of aminophylline and artificial
respiration if necessary.
Corticosteroids should not be used for the
management of head injury or stroke because it
is unlikely to be of any benefit and may even be
harmful.
When treating Acute Respiratory Distress Syndrome
(ARDS), therapy with corticosteroids should start
within the first 2 weeks of onset of ARDS.
Preterm neonates
Available evidence suggests long-term
neurodevelopment adverse events after early
treatment (<96 hours) of premature infants
with chronic lung disease at starting doses of
0.25 mg/kg twice daily.
Dexamethasone withdrawal
Adrenal cortical atrophy develops during
prolonged therapy and may persist for years after
stopping treatment. Withdrawal of corticosteroids
after prolonged therapy must therefore always be
gradual to avoid acute adrenal insufficiency, being
tapered off over weeks or months according to the
dose and duration of treatment.
In patients who have received more than
physiological doses of systemic corticosteroids
(approx. 1 mg dexamethasone) for greater than
3 weeks, withdrawal should not be abrupt. How
dose reduction should be carried out depends
largely on whether the disease is likely to
relapse as the dose of systemic corticosteroids is
reduced. Clinical assessment of disease activity
may be needed during withdrawal. If the disease
is unlikely to relapse on withdrawal of systemic
corticosteroids but there is uncertainty about HPA
suppression, the dose of systemic corticosteroid
may be reduced rapidly to physiological doses.
Once a daily dose of 1 mg dexamethasone is
reached, dose reduction should be slower to allow
the HPA-axis to recover.
Abrupt withdrawal of systemic corticosteroid
treatment, which has continued up to 3 weeks is
appropriate if it is considered that the
disease is unlikely to relapse. Abrupt
withdrawal of doses of up to 6 mg daily

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of dexamethasone for 3 weeks is unlikely to
lead to clinically relevant HPA-axis suppression
in the majority of patients. In the following
patient groups, gradual withdrawal of systemic
corticosteroid therapy should be considered even
after courses lasting 3 weeks or less:
• Patients who have had repeated courses of
systemic corticosteroids, particularly if taken
for greater than 3 weeks.
• When a short course has been prescribed
within one year of cessation of long-term
therapy (months or years).
• Patients who may have reasons for
adrenocortical insufficiency other than
exogenous corticosteroid therapy.
• Patients receiving doses of systemic corticosteroid
greater than 6 mg daily of dexamethasone.
• Patients repeatedly taking doses in the evening.
During prolonged therapy any intercurrent
illness, trauma or surgical procedure will require
a temporary increase in dosage; if corticosteroids
have been stopped following prolonged therapy
they may need to be temporarily re-introduced.
Patients should carry ‘steroid treatment’ cards
which give clear guidance on the precautions to be
taken to minimise risk and which provide details
of prescriber, drug, dosage and the duration of
treatment.
Anti-inflammatory/Immunosuppressive effects and
Infection
Suppression of the inflammatory response and
immune function increases the susceptibility
to infections and their severity. The clinical
presentation may often be atypical, and serious
infections such as septicaemia and tuberculosis
may be masked and may reach an advanced stage
before being recognised.
Appropriate antimicrobial therapy should accompany
glucocorticoid therapy when necessary e.g. in
tuberculosis and viral and fungal infections of the eye.
Chickenpox is of particular concern since
this normally minor illness may be fatal in
immunosuppressed patients.
Patients (or parents of children) without a definite
history of chickenpox should be advised to
avoid close personal contact with chickenpox or
herpes zoster and if exposed they should seek
urgent medical attention. Passive immunisation
with varicella zoster immunoglobulin (VZIG) is
needed by exposed non-immune patients who
are receiving systemic corticosteroids or who
have used them within the previous 3 months;
this should be given within 10 days of exposure
to chickenpox. If a diagnosis of chickenpox is
confirmed, the illness warrants specialist care and
urgent treatment. Corticosteroids should not be
stopped and the dose may need to be increased.
Measles
Patients should be advised to take particular
care to avoid exposure to measles and to
seek immediate medical advice if exposure
occurs; prophylaxis with intramuscular normal
immunoglobin may be needed.
Live vaccines should not be given to individuals with
impaired immune responsiveness. The antibody
response to other vaccines may be diminished.
Special precautions
Particular care is required when considering the
use of systemic corticosteroids in patients with
the following conditions and frequent patient
monitoring is necessary:
a. Osteoporosis (post-menopausal females are
particularly at risk)
b. Hypertension or congestive heart failure

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c. Existing or previous history of severe affective
disorders (especially previous steroid psychosis)
d. Diabetes mellitus (or a family history of diabetes)
e. History of tuberculosis, since glucocorticoids may
induce reactivation
f. Glaucoma (or a family history of glaucoma)
g. Previous corticosteroid-induced myopathy
h. Liver failure
i. Renal insufficiency
j. Epilepsy
k. Gastro-intestinal ulceration
l. Migraine
m. Certain parasitic infestations in particular amoebiasis
n. Incomplete statural growth since glucocorticoids on
prolonged administration may accelerate epiphyseal closure
o. Patients with Cushing’s syndrome
In the treatment of conditions such as tendinitis or
tenosynovitis care should be taken to inject into the
space between the tendon sheath and the tendon as
cases of ruptured tendon have been reported.
Use in children
Corticosteroids cause dose-related growth retardation in
infancy, childhood and adolescence, which may be irreversible.
Dexamethasone has been used ‘off label’ to treat and
prevent chronic lung disease in preterm infants. An
association between the use of dexamethasone in
preterm infants and the development of cerebral palsy
has been suggested. In view of this possible safety
concern, an assessment of the risk:benefit should be
made on an individual patient basis.
Use in the Elderly
The common adverse effects of systemic corticosteroids
may be associated with more serious consequences in
old age. Close clinical supervision is required to avoid
life-threatening reactions.
Please see SmPC section 4.5 for interaction with other
medicinal products and other forms of interaction.
OVERDOSE
It is difficult to define an excessive dose of a
corticosteroid as the therapeutic dose will vary
according to the indication and patient requirements.
Massive IV corticosteroid doses given as a pulse in
emergencies are relatively free from hazardous effects.
Exaggeration of corticosteroid related adverse effects
may occur. Treatment should be asymptomatic and
supportive as necessary.
STORAGE
As packaged for sale
Store in a refrigerator (2°C - 8°C). Do not freeze. Store
in the original package.
Following dilution with infusion fluids (see ‘PREPARATION
AND OTHER HANDLING INSTRUCTIONS’):
Chemical and physical in-use stability of dilutions has
been demonstrated for at least 24 hours, at 25°C
(room temperature)
From a microbiological point of view, the product should
be used immediately.
If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user
and would normally not be longer than 24 hours at
2 to 8°C, unless dilution has taken place in controlled
and validated aseptic conditions.
Marketing Authorisation Holder
Organon Laboratories Limited,
Cambridge Science Park, Milton Road, Cambridge,
CB4 0FL, UK
This leaflet was last revised in December 2013.

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Pregnancy and breast-feeding
Talk to your doctor before having this medicine if you are
pregnant, planning to become pregnant or are breastfeeding.
Driving and using machines
Dexamethasone is not likely to affect you being able to
drive or use any tools or machines.
3. How you have Dexamethasone
Dexamethasone is normally given by a doctor. It will be
given as an injection into a muscle or under your skin.
It can also be given as an injection into a vein. The dose
depends on your illness and how bad it is. The dose in
adults is normally from 0.5 to 24mg daily, and in children
0.2 to 0.4mg/kg daily. Your doctor will decide the dose.
If you have more Dexamethasone than you should
➣ If you think you have been given too much
Dexamethasone, tell your doctor straight away. The
following effects may happen:
• Swelling of the throat
• Skin reaction
• Difficulty breathing
If you stop having Dexamethasone
It can be dangerous to stop having this medicine
suddenly. If you need to stop this treatment, follow your
doctor’s advice. He or she may tell you to lower the
amount of medicine you are having gradually until you
stop having it altogether. If you stop having this medicine
too quickly, your condition may get worse.
You may also feel a ‘withdrawal symptom’. These may
include headache, problems with your vision (including
pain or swelling in the eye), feeling or being sick, fever,
pain in your muscles and joints, swelling in the inside of
your nose, weight loss, itchy skin and conjunctivitis.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Dexamethasone can cause side
effects although not everybody gets them.
Dexamethasone can also cause side effects when you
stop using it.
• See section 3, ‘If you stop having Dexamethasone’
Serious side effects: tell a doctor straight away
Steroids including Dexamethasone 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 Dexamethasone.
These include:
• 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 that do not exist.
Having strange and frightening thoughts, changing
how you act or having feelings of being alone
➣ If you notice any of these problems, talk to a doctor
straight away.
If you have an allergic reaction to Dexamethasone see
a doctor straight away
An allergic reaction may include:
• Any kind of skin rash or itching of the skin
• Difficulty in breathing or collapse.
If you get any of the following side effects see your
doctor as soon as possible:
• Stomach and gut problems: stomach ulcers which
may perforate or bleed, indigestion, having more of an
appetite than usual, diarrhoea, feeling or being sick
• Inflamed pancreas: this may cause severe pain in the
back or tummy
• Problems with salts in your blood such as too much
sodium or low potassium or calcium. You may have
water retention
• Heart and blood problems: high blood pressure,
blood clots
• Bone problems: thinning of the bones (osteoporosis)
with an increased risk of fractures, bone disease,
damaged tendons, damage to the joint where the
injection was given

• Recurring infections that get worse each time
such as chicken pox. Also, thrush
• Skin problems: wounds that heal more slowly,
bruising, acne, sweating more than usual.
Burning, redness and swelling where the injection
was given. This does not last long
• Eye problems: increased pressure in the eye
including glaucoma, eye disorders such as
cataracts, eye infections
• Hormone problems: irregular or missing periods,
stunted growth in children and teenagers, swelling
of the face (called a ‘Cushingoid’ or ‘moon’ face),
it may affect your diabetes and you may notice
you start needing higher doses of the medicine
you take for diabetes, your body may not be
able to respond normally to severe stress such as
accidents, surgery or illness, growth of extra body
hair (particularly in women), increased appetite or
weight gain
• Nervous system problems: fits or epilepsy may
become worse, severe unusual headache with
visual problems, being unable to sleep, feeling
depressed, extreme mood swings, schizophrenia
has become worse, headache or problems with
your vision (including eye pain or swelling)
➣ 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.
5. How to store Dexamethasone
• Keep out of the reach and sight of children
• Do not use Dexamethasone after the expiry date
which is stated on the label and carton after
“EXP”. The expiry date refers to the last day of
that month
• Store in a refrigerator (2°C - 8°C). Do not freeze.
Store in the original package
• After first opening, the product should be used
immediately to avoid microbial contamination.
• When diluted with infusion fluids, chemical and
physical in-use stability of dilutions has been
demonstrated for at least 24 hours, at 25°C (room
temperature). If not used immediately, in-use
storage conditions prior to use are the responsibility
of the user and would normally not be longer than
24 hours at 2 to 8°C, unless dilution has taken
place in controlled and validated aseptic conditions.
• Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment
6. Further information
What Dexamethasone contains
• The active ingredient is dexamethasone (as
sodium phosphate)
• Each 1 ml contains 3.8 mg dexamethasone (as
sodium phosphate) which is equivalent to 5.0 mg
dexamethasone sodium phosphate
• The other ingredients are glycerol, disodium
edetate, water for injections and sodium
hydroxide or phosphoric acid
What Dexamethasone looks like and contents of
the pack
Dexamethasone is a clear, colourless liquid. It
comes in vials containing 1 ml of solution. Vials are
available in packs of 1 or 10. Not all pack sizes may
be marketed.
The Marketing Authorisation Holder is:
Organon Laboratories Ltd, Cambridge Science Park,
Milton Road, Cambridge, CB4 0FL, UK.
The Manufacturer is:
N.V.Organon, PO Box 20, 5340 BH Oss,
The Netherlands.
This leaflet was last revised in December 2013.

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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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