WHAT IS IN
DEXAMETHASONE
INJECTION BP 5 MG/ML?

Active Substance
The active substance in Dexamethasone Injection is dexamethasone sodium phosphate, 5mg per millilitre

Other substances in the vial:
Dexamethasone injection also contains glycerol, disodium edetate, methylparaben, propylparaben, water for injection and sodium hydroxide or phosphoric acid

Other substances in the ampoule:
Dexamethasone injection also contains glycerol, disodium edetate. water for injection and sodium hydroxide or phosphoric acid

Appearance
Dexamethasone injection is a clear colourless liquid and comes in either 2ml 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

Product Licence Holder:
Organon Laboratories Ltd .
Cambridge Science Park.
Milton Road, Cambridge. CB4 4FL

Manufactured by:
Ampoules:
Organon Laboratories Ltd,
Newhouse Industrial Estate.
Newhouse, Motherwell, Scotland ML1 5SH

Vials:
N.V. Organon, Oss, The Netherlands
	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 you 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 chicken-pox or shingles if you have not previously suffered from these diseases If you develop 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

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. phenobarbitone, 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
a)	drugs used to treat diabetes (hypoglycaemic agents)
b)	drugs used to treat high blood pressure (anti-hypertensives)
c)	diuretics (water pills)
d)	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 n 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 0.4-5mg
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 10 - 20 milligrams followed by 6 milligrams every 6 hours is usual in the case of brain swelling caused by severe head injury or after brain surgery until the condition improves.

Children:
The dosage is chosen by the doctor to suit the needs of the patient. A dose of 0.25 - 0.5 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 (uticaria)
•	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 he 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 Or 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 anti-diabetic 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. 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

This information was last updated in May 1995

General Things To Remember About Medicines

1.	This medicine has been prescribed for your current medical problems Do not use it for other medical problems.
2.	Do not allow other people to use your medicines and do not use medicines meant for other people.
3.	Tell any doctor treating you what medicines you are taking.
4.	Return unused medicines to the pharmacy for disposal.
5.	Make sure that other people you may live with or who look after you read this information.
6.	Keep medicines out of the reach of children.