Decadron® Injection

Shock-Pak

(dexamethasone sodium phosphate, MSD)

PLEASE READ ALL OF THIS LEAFLET CAREFULLY

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

What is in your injection?

Active ingredient

The active ingredient in Decadron Injection Shock-Pak is dexamethasone sodium phosphate EP. Decadron Injection Shock-Pak is available as a colourless solution containing dexamethasone sodium phosphate, equivalent to 20 mg dexamethasone per millilitre.

Other ingredients

Creatinine, disodium edetate EP, methyl hydroxybenzoate, propyl hydroxybenzoate EP, sodium citrate EP, sodium metabisulphate EP, sodium hydroxide EP, water for injections EP.

Decadron Injection Shock-Pak is available in vials of 5ml.

How does your medicine work?

The active ingredient in your medicine is dexamethasone sodium phosphate EP. 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 produce beneficial effects in the body in certain illnesses.

Who makes your medicine?

Decadron Injection Shock-Pak 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 this medicine?

Decadron Injection Shock-Pak is used, as well as other treatments, for an emergency condition known as shock. Shock occurs when the blood pressure falls too low to maintain an adequate supply of blood to the tissues of the body. Shock can result from bleeding (internally or externally), dehydration, burns, severe vomiting and diarrhoea. It can also result after a heart attack, a severe allergic reaction or overdose with certain drugs.

Your doctor will explain your condition more fully to you.

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

Yes; you should not be given Decadron Injection Shock-Pak if:

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

If you are confused or unsure, talk to your doctor.

What else should you know about taking Decadron Injection Shock-Pak?

IMPORTANT: Patients taking Decadron Injection Shock-Pak 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.

If you are to receive any vaccination (especially live virus vaccines) after being treated with Decadron Injection Shock-Pak you should make your doctor aware that you have recently received corticosteroids.

Women who are breast-feeding should stop breastfeeding if they are treated with Decadron Injection Shock-Pak.

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 Injection Shock-Pak be given with other medicines?

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

You should talk to your doctor if you are taking any of the following medicines:

  • 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.
  • Certain diuretics (water tablets).
  • An anticancer medicine called aminoglutethimide.
  • A medicine called carbamazepine, used to treat epilepsy, pain and manic depression.

How should Decadron Injection Shock-Pak be given?

You will have been given or are about to be given Decadron Injection Shock-Pak by a healthcare professional. It will be given as a single injection into a vein. The usual dose is 2-6 ml/kg bodyweight. Your doctor will decide the appropriate dose for your condition and what repeat doses (if any) you should have.

Decadron Injection Shock-Pak is an emergency treatment and should be continued only until your condition has stabilised, usually no more than 48-72 hours.

What if you miss a dose or have too much Decadron Injection Shock-Pak?

The times at which you are to have 'Decadron' Injection Shock-Pak will be set by the healthcare professionals treating you. They will monitor your response and condition to determine what doses are needed. However, if you are concerned that you may have missed a dose, or received too much medicine, you should notify your healthcare professional as soon as possible.

What unwanted effects could Decadron Injection Shock-Pak have?

Side effects from short-term treatment with corticosteroids are usually rare. However, stomach pain and burning may be experienced which is associated with a condition called peptic ulceration. Burning and tingling sensations at the site of injection may be experienced.

If you notice either of the above, or have any other unusual feelings or symptoms you should seek medical attention as soon as possible.

How should Decadron Injection Shock-Pak be kept?

Keep the injection out of the reach of children.

Decadron Injection Shock-Pak should be stored below 25°C protected from light. Do not freeze.

The injection should not be used past its expiry date which is clearly marked on the pack.

The leaflet was issued in September 1995.

How can you obtain more information about Decadron Injection Shock-Pak?

This leaflet only gives you some of the most important patient information about 'Decadron' Injection Shock

Pak. If you have any questions after you have read it, ask your doctor or pharmacist, who will give you further information.

® denotes registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.

© Merck Sharp & Dohme Limited, 1995. All rights reserved.