Decadron® Injection

(dexamethasone sodium phosphate, MSD)

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS DRUG

Keep this leaflet. You may want to read it again.

What is in your injection?

Active ingredient

The active ingredient in Decadron Injection is Dexamethasone Sodium Phosphate EP.

Decadron Injection is available as a colourless solution containing the equivalent of 3.3 mg dexamethasone per millilitre.

Other ingredients

Creatinine, methyl hydroxybenzoate EP, propyl hydroxybenzoate EP, sodium citrate EP, sodium metabisulphite EP, sodium hydroxide EP, water for injections EP.

Decadron injection is supplied in vials containing 2 ml.

How does your medicine work?

The active ingredient in your medicine is dexamethasone sodium phosphate. This belongs to a group of medicines known as steroids (specifically known as corticosteroids).

Corticosteroids do occur naturally in the body and help to maintain health and well-being. Synthetic steroids such as dexamethasone work by mimicking some of their actions to treat disease.

Who makes your medicine?

Decadron Injection is made by Merck Sharp & Dohme Laboratories-Chibret, Boulevard Etienne, Clementel, Clermont-Ferrand, France, or Merck & Co., Inc., West Point, Pennsylvania, USA, for Merck Sharp & Dohme Limited, Hoddesdon, Hertfordshire, UK, who hold the Product Licence in the UK and the Product Authorisation in Ireland.

Why do you need to take this medicine?

Corticosteroids are given to patients for a variety of conditions where their abilities to reduce inflammation and suppress the immune system are valuable. These conditions may include Crohn's disease, asthma, shock, anaphylaxis, tuberculosis, arthritis, osteoarthritis, and skin disorders including acne. Decadron Injection is usually given to patients unable to take a tablet form of the medicine. Your doctor will be able to explain your condition more fully.

Are there some people who should not be given this medicine?

Yes; you should not be given Decadron Injection if:

  • You are or think you may be pregnant.
  • You are planning to become pregnant.
  • You are breast-feeding.
  • You have an infection, including one which could have been caused by a fungus (e.g. thrush), which is not being treated. However, your doctor may decide to treat you with 'Decadron' under certain circumstances.
  • You have had a bad allergic reaction to this or similar medicines, or to any of the ingredients in the past.
  • You are allergic to sulphites.

If you think any of these apply to you, tell your doctor.

What else should you know about taking Decadron? IMPORTANT: Patients taking Decadron should avoid, if possible, close personal contact with people suffering from chickenpox/shingles or measles. If you think you may have been exposed to either disease, it is vital that you inform your doctor immediately. You should also tell your doctor whether or not you have had common infectious diseases such as measles or chickenpox and of any vaccinations you have had. If

you develop either disease, you will need specialist treatment from your doctor.

Your doctor should use Decadron Injection with care If:

  • You have recently suffered from a heart attack.
  • You have tuberculosis.
  • You suffer from kidney or liver problems, high blood pressure, diabetes, heart problems, osteoporosis (thinning of the bone), glaucoma, myasthenia gravis (a disease causing weak muscles), digestive system or stomach problems.
  • You have suffered from muscle weakness with this or other steroids in the past.
  • You have an eye infection with the herpes virus.

You should see your doctor if you develop any new infections while taking this medicine.

If the patient is a child, it is important that the doctor monitors growth and development at intervals during treatment.

If you have an accident, fall ill, require any surgery (including at the dentist's), or are to have any vaccinations (especially with so-called 'live virus vaccines') during or after treatment with Decadron, you must tell the doctor treating you that you are taking or have taken steroids.

IMPORTANT: All patients taking steroid drugs for more than a few days should carry 'steroid treatment' cards, which are available from your pharmacist. These cards carry details of your medicine and your doctor.

Can Decadron be given with other medicines?

Some other medicines do not mix with Decadron. Your doctor is aware of these and will alter your treatment as necessary. However, it is very important that you tell your doctor about all the medicines you are taking, including those obtained without a doctor’s prescription.

If you are taking any of the following medicines you should talk to your doctor before starting treatment with Decadron Injection:

  • Aspirin or similar medicines.
  • Phenytoin.
  • Ephedrine (a nasal decongestant).
  • Barbiturates.
  • Antibiotics called rifampicin and rifabutin, used to
  • treat tuberculosis.
  • Anticoagulant medicines which thin the blood.
  • Medicines for diabetes.
  • Certain diuretics (water tablets).
  • A medicine called carbamazepine, used to treat
  • epilepsy, pain and manic depression.
  • An anticancer medicine called aminoglutethimide.

How should Decadron Injection be given?

You should have been given, or are about to be given Decadron Injection by a healthcare professional. The medicine will be given as an injection either into a muscle or vein, or may be given as an intravenous infusion. Your doctor will decide what the appropriate dose for your condition is, and may alter your dose depending on how you respond. The usual initial dose ranges from 0.5 mg-20 mg (0.125 ml-5 ml) per day, with repeat dosing depending on your condition.

For some patients the medicine may be given as an injection into the painful area itself, usually once every three to five days or once every 2-3 weeks depending on your response.

IMPORTANT: If you have been treated with Decadron Injection for more than a few days, it is dangerous to have the medicine stopped abruptly, and it should be gradually withdrawn. Withdrawal symptoms after stopping treatment too quickly have included low blood pressure and, in some cases, relapse of the disease for which the treatment was given.

What if you miss a dose or have too much Decadron?

The times at which you are to have your injections will be set by your healthcare professional. Your doctor will monitor your response and condition to

In addition you may experience burning or tingling around the site of injection.