Information for the patient
This leaflet
is designed to help you understand your medicine. If you
have any questions or worries ask your doctor or
pharmacist. At the end of this leaflet you will find
more information about Dexamethasone as well as some
things to remember about your medicine. Please keep this
leaflet until you have finished your medicine, you may
want to read it again.
What
is in Dexamethasone 4 mg/ml Injection and
Dexamethasone 8 mg/2 ml Injection?
Active
Substance
The
active substance in Dexamethasone Injection is
dexamethasone (as the sodium phosphate). Each
millilitre contains 4 mg dexamethasone.
Other
substances in the vial:
The
injection also contains glycerol, disodium edetate,
methylparaben, propylparaben, water for injection
and sodium hydroxide or phosphoric acid.
Other
substances in the ampoule:
The
injection also contains glycerol, disodium edetate,
water for injection and sodium hydroxide or
phosphoric acid.
Appearance
The
injection is a clear colourless liquid and comes in
either 2 ml vials or 1 ml ampoules in packs of 10.
Vials may also be available as single packs.
Ampoules may also be available in packs of 5 and 25.
Therapeutic
Group
Dexamethasone belongs to a group of medicines called
corticosteroids. Corticosteroids work by reducing
inflammation in the body and can be used to treat
many different diseases.
What is
Dexamethasone used for?
Dexamethasone can be used to reduce inflammation or to
treat a number of different diseases of the immune
system.
In general
Dexamethasone can be used in medical emergencies,
whenever its use may be life-saving.
When
should Dexamethasone not be given?
Dexamethasone may not be suitable for you if you suffer
from certain allergies or other medical conditions.
Before Dexamethasone is given to you make sure you tell
your doctor if you suffer or have ever suffered from any
of the following:
-
hypersensitivity to any ingredient in this medicine
- an
infection that affects the whole body
-
joint infections, especially at the injection site
What
precautions should be taken?
While taking
Dexamethasone you may need to be examined by your doctor
more frequently.
Extra
supervision by your doctor may be necessary in some
cases. You must tell your doctor if you have or have
ever had any of the following:
-
Osteoporosis (thinning of the bones)
-
Hypertension (very high blood pressure)
-
Heart disease
-
Diabetes
- TB
(tuberculosis)
-
Glaucoma (raised eye pressure)
-
Serious affective disorders especially steroid
psychosis - (psychiatric illness made worse by
steroids)
-
Muscle disease caused by corticosteroids
-
Liver disease
-
Kidney disease
-
Epilepsy
-
Stomach ulcers
-
Migraine
-
Certain parasitic infections
-
Stunted growth
-
Cushings syndrome
It is
important that you avoid close contact with anybody who
is suffering from measles, chicken-pox or shingles if
you have not previously suffered from these diseases. If
you are in contact with anybody who has one of these
illnesses, or you develop measles or chicken-pox while
taking Dexamethasone tell your doctor immediately.
You should
always carry a 'steroid treatment' card which gives
clear guidance on the special care to be taken when you
are using this medicine. Show this to any doctor,
dentist or nurse 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.
If you are
in an accident or need an operation, tell your doctor
that you are taking dexamethasone.
There may be
an increased risk of premature infants developing
cerebral palsy if they are treated with dexamethasone. A
decision on whether to use dexamethasone needs to be
made, based on the individual case.
Dexamethasone should not be used as part of your
treatment if you have had a head injury or stroke as it
is unlikely to benefit you and may even be harmful.
Are you going
on holiday?
If you think
you may need a vaccination, tell your doctor you are
taking dexamethasone.
What
other medicines are you taking?
Other
medicines may affect how Dexamethasone works or
Dexamethasone may affect how they work. Tell your doctor
if you are using (or intend to use) any other medicines.
Other drugs
that reduce the effect of Dexamethasone are:
-
Antibiotics such as rifampicin, rifabutin.
-
Drugs for epilepsy e.g. carbamazepine, phenytoin,
phenobarbital, primidone, ephedrine, phenylbutazone.
-
Drugs used in the treatment of breast cancer e.g.
aminoglutethimide.
Some
medicines may not work as well when Dexamethasone is
taken at the same time:
The
effectiveness of
-
drugs used to treat diabetes (hypoglycaemic agents)
-
drugs used to treat high blood pressure (anti-hypertensives)
-
diuretics (water pills)
-
drugs which regulate heart beat (cardiac glycosides)
are reduced when dexamethasone is taken.
Dexamethasone affects acetazolamide, loop diuretics,
thiazide diuretics and carbenoxolone, these drugs are
used to lower potassium levels.
The effects
of drugs which prevent blood clotting; (coumarin
anticoagulants e.g. warfarin) may be increased by
Dexamethasone and frequent tests may be required.
Dexamethasone may affect the action of salicylates e.g.
aspirin in patients with low prothrombin levels in the
blood.
Pregnancy
If you are
pregnant, or suspect that you are pregnant or if you are
breastfeeding then you must tell your doctor. Your
doctor will decide if Dexamethasone can be given to you.
Ability
to drive or operate machinery
As far as is
known, Dexamethasone has no effect on alertness or
concentration.
How
should Dexamethasone be given?
How
much:
The dose is
chosen by your doctor and usually depends on how serious
your condition is. The normal dose range is 0.3-4 mg.
The frequency of these injections may vary from every
3-5 days to every 2-3 weeks. Once your condition has
improved the dosage will be reduced or another
corticosteroid such as 'Prednisolone' may be given. For
more serious conditions such as acute asthma, a higher
dose may be necessary.
A dose of
8-16 milligrams followed by 5 milligrams every 6 hours
is usual in the case of brain swelling after brain
surgery until the condition improves. You may need
continuous dosing to reduce pressure within your skull
if you have a brain tumour.
Children:
The dosage
is chosen by the doctor to suit the needs of the
patient. A dose of 0.2-0.4 milligrams per kilogram of
body weight is usual.
How the
injections are given:
Injections
are given slowly into a muscle or under the skin, by
your doctor. Dexamethasone Injections can also be given
intravenously, locally (directly where you need it) or
rectally.
What to
do if someone accidentally takes too much
As your
doctor will be keeping a close eye on you it is unlikely
you will be given too much, however, too high a dose of
Dexamethasone may cause
-
swelling of the throat (glottis oedema)
- skin
allergy (urticaria)
-
difficulty in breathing (bronchospasm)
When
will I stop taking Dexamethasone
Do not stop
taking Dexamethasone just because your complaints seem
to have disappeared. If you stop too early or too
suddenly your condition may worsen, you may get
withdrawal symptoms. Always discuss your treatment with
your doctor who will tell you how to reduce the dose
gradually if treatment can be stopped. Symptoms of
withdrawal include fever, pain in muscle and joint,
inflammation of nose lining (rhinitis), weight loss,
itchy skin, eye inflammation (pink eye -
conjunctivitis).
What
undesirable effects may Dexamethasone cause?
The
occurrence of side effects can be minimised by taking
the lowest possible dose for the shortest possible time.
If you have any of these side effects or any others tell
your doctor. He will review your case and do what is
best for you.
-
lowered resistance or response to stress
-
stunted growth in infants, children and teenagers
-
irregularities in the menstrual cycle (periods) or
complete absence of periods
-
Cushingoid faces (e.g. 'moon' face)
-
hirsutism (excess hair especially in women)
-
weight gain
-
increased sweating
-
reduced carbohydrate tolerance which needs more
antidiabetic therapy
-
increased appetite
- loss
of protein and calcium balance
-
increased chance of picking up infections or mild
infections get worse e.g. chicken pox
-
osteoporosis (thinning of bones)
- bone
disease
-
sodium and water retention and/or potassium loss due
to high carbon dioxide levels (hypokalaemic
alkalosis)
- high
blood pressure
-
extreme mood swings
-
depression
-
inability to sleep (insomnia)
-
schizophrenia may get worse (schizophrenia
aggravation)
-
epilepsy gets worse (more fits)
-
severe unusual headache and visual disturbance
-
increased eye pressure (glaucoma)
- eye
disorders and eye infection
-
indigestion
-
stomach ulcers
- pain
in abdomen and back (pancreatitis)
- skin
disorders such as bruising, acne, slow healing of
wounds
-
hypersensitivity reactions (allergic reactions) e.g.
rash, itch and difficulty in breathing
-
blood clots (thrombosis)
-
brief burning, redness and swelling at the injection
site
-
damage to the joint at the injection site
-
damaged tendons
-
Candidiasis (thrush)
If you
suffer from any of the above side effects or any other
effects that you think may be due to your medicine, tell
your doctor or pharmacist.
How
should you store Dexamethasone?
The hospital
will store Dexamethasone in a fridge or below 25°
C in the dark. Do not freeze Dexamethasone ampoules. As
with all medicines Dexamethasone should be kept in a
safe place out of reach of children. There is a 'use by'
date on the pack. This medicine should not be used after
this date.