Dexamethasone 3.3mg/Ml Solution For Injection
Package leaflet: Information for the user
Dexamethasone 3.3 mg/ml Solution for Injection
Dexamethasone sodium phosphate
Dexamethasone 3.3 mg/ml Solution for Injection will be referred to as Dexamethasone Solution for Injection throughout the package leaflet.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Dexamethasone Solution for Injection is and what it is used for
2. What you need to know before you use Dexamethasone Solution for Injection
3. How to use Dexamethasone Solution for Injection
4. Possible side effects
5. How to store Dexamethasone Solution for Injection
6. Contents of the pack and other information
1. What Dexamethasone Solution for Injection is and what it is used for
Dexamethasone Solution for injection contains the active substance Dexamethasone Sodium Phosphate.
Dexamethasone Solution for Injection belongs to a group of medicines called Glucocorticoid (steroids). Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as dexamethasone) is an effective way to treat various illnesses involving inflammation in the body. Dexamethasone reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.
It is used in acute conditions in which oral steroid treatment is not possible, such as:
• Shock (e.g. after an accident, after surgery or due to blood poisoning).
• Swelling of the brain because of a brain tumour.
• Diseases of joints and soft tissues, such as rheumatoid arthritis.
• Allergic reactions.
These conditions often require the use of other medicines in addition to corticosteroids.
2. What you need to know before you use Dexamethasone Solution for Injection Do not use Dexamethasone Solution for Injection:
• if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).
• if you have an infection affecting the whole body which is not being treated with antibiotics (dexamethasone treatment may still be used if it is considered to be life saving).
Tell your doctor or pharmacist if either of the above applies to you before this medicine is used.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Dexamethasone Solution for Injection
• 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.
Mental problems while taking dexamethasone
Mental health problems can happen while taking steroids like dexamethasone (see also section 4)
• 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 Solution for Injection and check with your doctor first if you have:
• Liver, kidney or heart problems
• High blood pressure
• Epilepsy
• A history of migraines
• Osteoporosis (thinning of the bones)
• Had tuberculosis in the past
• An under-active thyroid
• Had amoebiasis in the past (infection specific to tropical countries which causes diarrhoea)
• A herpes infection of the eye
• Diabetes (or a family history of diabetes)
• An eye disease called glaucoma (or a family history of glaucoma)
• Stomach ulcers
• Experienced muscle weakness caused by previous steroid treatment.
Children and adolescents
Special care will be taken if Dexamethasone Solution for Injection is to be given to babies or children.
Other medicines and Dexamethasone Solution for Injection
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. You should not be vaccinated with a live vaccine while having steroid therapy. Tell your doctor or pharmacist if you are planning to have a vaccination.
Special care is needed if you are using other medicines as some could interact with dexamethasone, for example:
• Barbiturates (medicines for treating sleep disorders and epilepsy)
• Ephedrine (a medicine that is used as a nasal decongestant or for respiratory conditions)
• Rifampicin and rifabutin (antibiotics that are used for treating tuberculosis)
• Primidone, phenytoin, carbamazepine (medicines to treat epilepsy)
• Aminoglutethimide (an anti-cancer medicine)
• Anticoagulants (medicines used to thin the blood)
• Insulin and other medicines used to used to treat diabetes
• Aspirin and other anti-inflammatory drugs (medicines for treating pain and inflammation)
• Acetozolamide (a medicine for treatment of the eye disorder glaucoma)
• Diuretics (water tablets)
• Carbenoxolone (a medicine for treating stomach ulcers)
• Digoxin and other medicines which regulate heart beat
• Antihypertensives (medicines used to treat high blood pressure)
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you receive dexamethasone often or over a long period of time during pregnancy there may be a risk that the baby’s growth slows down. The baby may need careful observation for a short time after being born.
If you are being given dexamethasone for a long time during breast-feeding then the baby’s growth may slow down and it may have other side effects (see Section 4). Your doctor will discuss this with you and decide whether you should receive dexamethasone.
Driving and using machines
Do not drive or use machines if you experience any side effect which may lessen your ability to do so.
Dexamethasone Solution for Injection contains sodium
This medicine contains 0.26 mmol sodium (6 mg) per 20 mg dose i.e. essentially “sodium-free”.
3. How to use Dexamethasone Solution for Injection
This medicine may be given intravenously (injection into a vein), intramuscularly (injection into a muscle) or directly into a joint or soft tissue. This medicine may also be diluted with dextrose or sodium chloride solution and given as a slow injection via a drip into a vein (infusion).
Dose
The dose of medicine given to you will depend on your age and medical condition and will be carefully adjusted by your doctor.
You are unlikely to need Dexamethasone Solution for Injection for more than a week or two, unless you receive it for treatment of arthritic joints when treatment may carry on for longer. If dexamethasone treatment needs to continue you may be given tablets, rather than an injection. This medicine suppresses your body’s natural ability to make its own corticosteroids. As a result, during prolonged treatment, any new illness, trauma or surgical procedure will require a temporary increase in dosage; if corticosteroids have been recently stopped they may need to be started again.
If you are given too much or too little Dexamethasone Solution for Injection
This medicine will be given to you by a doctor or nurse. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.
If you stop using Dexamethasone Solution for Injection
Do not stop taking this medicine suddenly as this might be dangerous. Your doctor will tell you how the treatment will be gradually reduced. When treatment is stopped, a “withdrawal syndrome” can happen, which includes fever, muscle pain, joint pain, inflammation of the lining of the nose, eye discomfort (conjunctivitis), painful itchy skin lumps and loss of weight. In children raised pressure in the skull may occur: if they complain of a headache, have a fit or are sick then tell a doctor immediately.
In a few cases, mental problems (see section 4) have happened when doses are being lowered or stopped.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If any the following happen, tell your doctor straight away:
• Severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.
• Severe infection and/or fever which makes you feel very ill.
These are very serious side effects. You may need urgent medical attention. All of these very serious side effects are rare.
Serious 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.
• 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 which 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.
Carers of patients using dexamethasone should talk to the doctor straight away if the patient shows any signs of mental problems. This is particularly important if the patient appears to be depressed, or mentions thoughts of suicide.
If any of the following happen, tell your doctor as soon as possible:
• Fits
• Epilepsy or schizophrenia made worse
• Breathlessness
• Severe thirst or passing urine more than usual (may indicate raised blood sugar levels)
• Water retention (swelling) and high blood pressure
• Muscle weakness
• You feel that you or your surroundings are spinning
• Eye disorders including cataracts and glaucoma, infections of the eye may become worse
• Swelling and weight gain of the face and body, excess body hair
• Osteoporosis (thinning of the bones) - the doctor may ask you to have a bone scan to check for this
• Slow growth in children or teenagers (the doctor will check for this)
• You feel you are picking up minor infections too easily
• Irregular periods or absence of periods in woman
• Indigestion, stomach ulcers and pain in stomach and back
• Skin disorders such as slow healing of wounds, increased bruising, broken veins or stretch marks on the skin, increased sweating, rashes, or changes in skin pigmentation, raised itchy coloured lumps on the skin, itchy red rash with flaky white patches (thrush), acne
• Headache
• Pain, redness or swelling at the injection site (if the injection is into a joint)
• Increased appetite
Many of the above side effects only occur after high dose treatment or if treatment continues for a long period of time.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Dexamethasone Solution for Injection
Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date which is stated on the vial label and carton after 'EXP'. The expiry date refers to the last day of that month.
Store below 25°C. Do not freeze. Keep the vials in the outer carton.
Unused portions of opened vials must not be stored for later use.
The in use storage condition and shelf life after dilution of Dexamethasone 3.3 mg/ml solution for injection with 0.9% w/v Saline injection and 5% w/v Dextrose injection at 25°C is stable for 24 hours.
Do not use this medicine unless it is a clear, particle free solution.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Dexamethasone Solution for Injection contains
- The active substance is dexamethasone sodium phosphate. Each ml of Solution for injection contains 4 mg of Dexamethasone Phosphate (as 4.4 mg of dexamethasone sodium phosphate) equivalent to 3.3 mg of Dexamethasone base.
- The other ingredients are sodium citrate, creatinine and Water for Injections.
What Dexamethasone Solution for Injection looks like and contents of the pack
It is a clear colorless solution free from visible particulate matter, filled into a tubular amber colour glass vial with rubber stopper and aluminium seal.
It is available in packs containing 5 vials. Each vial contains 2 ml of solution. Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder
Mylan,
Potters Bar,
Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000 Malta
This leaflet was last revised in 10/2014
The following information is intended for healthcare professionals only:
Dexamethasone Solution for Injection is for intravenous, intramuscular, intraarticular and intralesional use.
The intravenous and intramuscular route of administration of dexamethasone should only be used where acute illness or life-threatening situations exist. Oral therapy should be substituted as soon as possible.
Each ml of Solution for injection contains 4 mg of Dexamethasone Phosphate (as 4.4 mg of dexamethasone sodium phosphate) equivalent to 3.3 mg of Dexamethasone base.
Incompatibilities
Dexamethasone sodium phosphate is physically incompatible with daunorubicin, doxorubicin and vancomycin and should not be admixed with solutions containing these drugs. Also incompatible with doxapram HCl and glycopyrrolate in syringe.
Instructions for use and handling
When dexamethasone (as sodium phosphate) is given by intravenous infusion only 0.9 % w/v Saline Injection or 5 % w/v Dextrose Injection should be used as diluents. The exact concentration of dexamethasone (as sodium phosphate) per infusion container should be determined by the desired dose, patient fluid intake and drip rate required.
The product should only be used when the solution is clear and particle free.
For single use only. Discard any unused contents.
In-use storage precautions
The in use storage condition and shelf life after dilution of Dexamethasone 3.3 mg/ml solution for injection with 0.9% w/v Saline injection and 5% w/v Dextrose injection at 25°C is stable for 24 hours.