Dexamethasone 3.3 mg/ml 4 mg/ml
Solution for Injection
1. What Dexamethasone Solution for Injection is and what it is used for
- Dexamethasone is a steroid medicine, prescribed for many different conditions, including serious illnesses.
- You need to take it regularly to get the maximum benefit.
- Don’t stop taking this medicine without talking to your doctor – you may need to reduce the dose gradually.
Dexamethasone can cause side effects in some people. Some problems such as mood changes (feeling depressed or ‘high’), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away.
Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face .
If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you.
Keep away from people who have chicken pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.
- if swelling of the brain has occurred because of a brain tumour
- to treat diseases of joints and soft tissues such as rheumatoid arthritis
- to treat allergic reactions
2. Before you take Dexamethasone Solution for Injection
Do not take Dexamethasone Solution for Injection:
- if you are allergic (hypersensitive) to dexamethasone or any of the other ingredients of Dexamethasone Solution for Injection.
- if you have an infection that affects the whole body (unless taking antibiotics)
- if you have shown signs of hypersensitivity (severe allergy) to steroids or any of the other ingredients on previous occasions
Check with your doctor first:
- If you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Dexamethasone Solution for Injection.
- If any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor before taking Dexamethasone Solution for Injection.
Take special care with Dexamethasone Solution for Injection
- if you have liver, kidney or heart problems
- if you have high blood pressure
- if you have epilepsy
- if you suffer from migraines
- if you have osteoporosis (thinning of the bones)
- if you have had tuberculosis in the past
- if you have an under-active thyroid gland
- if you have had amoebiasis in the past (a diarrhoea infection specific to tropical countries)
- if you have viral infections of the eye
- if you have diabetes (or a family history of diabetes)
- if you suffer from a mental illness that causes severe changes in mood (especially if you have had a mental illness in the past that is made worse with steroids)
- if you have an eye disease called glaucoma (or a family history of glaucoma)
- if you have stomach ulcers
- if you have previous muscle weakness caused by steroids
- if this medicine is given to premature babies
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, such as:
- 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 (anti-cancer medicine)
- medicines used to thin the blood (anticoagulants)
- medicines used to treat diabetes (including insulin and tablets)
- aspirin and other anti-inflammatory drugs (medicines for treating pain)
- acetozolamide (medicine for treatment of the eye disorder glaucoma)
- water tablets (diuretics)
- carbenoxolone (medicine for treating stomach ulcers)
- medicines which regulate heart beat e.g. digoxin
- medicines used to treat high blood pressure (antihypertensives)
Pregnancy and breast-feeding
If you are pregnant your doctor may still decide to give you dexamethasone. 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.
Driving and using machines
If you experience any effect which may impair your ability to drive or use machines, do not use this product.
3. How to take Dexamethasone Solution for Injection
The dose of medicine given to you will depend on your age and medical condition. This medicine is 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 glucose or sodium chloride solution and given as a slow injection via a drip into a vein (infusion).
As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or pharmacist if you have any concerns.
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.
Growth and development of infants and children on long term treatment with dexamethasone will be carefully monitored.
During treatment with Dexamethasone Solution for Injection
While receiving dexamethasone treatment you should avoid contact with people who have chicken pox. If this happens you should tell your doctor immediately.
You should not be vaccinated with a live vaccine while having steroid therapy.
It is important that you take careful note of the information included in the ‘steroid treatment’ card that your doctor or pharmacist will have given to you.
Mental health problems while taking Dexamethasone Solution for Injection
Mental health problems can happen while taking steroids like dexamethasone (see also section 4 Possible Side Effects).
- 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.
Effects when treatment with Dexamethasone Solution for Injection is stopped:
It can be dangerous to stop taking this medicine suddenly. Your doctor will tell you how the treatment will be 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.
4. Possible side effects
Like all medicines, dexamethasone can cause side effects, although not everybody gets them.
If any of the following happen, tell your doctor immediately:
- 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.
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.
Many of the side effects below will only occur after high dose treatment or if treatment is for a long time. If you experience any of the following tell your doctor as soon as possible:
- severe breathlessness
- swelling and weight gain of the face and body, excess body hair
- stunted growth in infants, children and teenagers
- lowered resistance or response to stress
- irregular or absence of periods in women
- increased appetite
- severe thirst or passing urine more than usual (may indicate raised blood sugar levels)
- water retention (swelling) and high blood pressure
- increased chance of picking up infections
- muscle weakness
- osteoporosis (thinning of the bones)
- 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
- mental disorders including depression, not being able to sleep
- headache, fits or a feeling that you or your surroundings are spinning
- epilepsy or schizophrenia made worse
- eye disorders including cataracts and glaucoma, infections of the eye may become worse
- pain, redness or swelling at the injection site (if the injection is into a joint)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Dexamethasone Solution for Injection
Keep out of the reach and sight of children.
The ampoules should not be stored above 25°C and not allowed to freeze.
The ampoules should be stored in the outer carton (in order to protect from light).
This medicine should not be used after the expiry date printed on the ampoule label and carton.
This medicine should only be used if the solution is clear and no particles can be seen.
6. Further information
What Dexamethasone Solution for Injection contains
The active substance is dexamethasone. Each millilitre (ml) of solution contains 3.3 milligrams (mg) of dexamethasone (as sodium phosphate) which is equivalent to 4 mg dexamethasone phosphate or 4.3 mg dexamethasone sodium phosphate.
The other ingredients are sodium citrate, creatinine, sodium hydroxide, hydrochloric acid and Water for Injections.
What Dexamethasone Solution for Injection looks like and contents of the pack
This medicine is presented in glass containers called ampoules. Each millilitre (ml) of solution contains 3.3 milligrams (mg) of dexamethasone (as sodium phosphate) which is equivalent to 4 mg dexamethasone phosphate or 4.3 mg dexamethasone sodium phosphate. It is available in packs containing 5 ampoules.
The following information is intended for medical or healthcare professionals only:
This is an extract from the Summary of Product Characteristics (SmPC) to assist in the administration of Dexamethasone 3.3 mg/ml Solution for Injection.
When determining appropriateness of use in a particular patient, the prescriber should be familiar with the full SmPC.
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 1 ml of the solution for injection contains 3.3 mg dexamethasone (as sodium phosphate) which is equivalent to 4 mg dexamethasone phosphate or 4.3 mg dexamethasone sodium phosphate.
Dexamethasone sodium phosphate is physically incompatible with daunorubicin, doxorubicin and vancomycin and should not be admixed with solutions containing these drugs. It is also incompatible with doxapram hydrochloride and glycopyrrolate in a syringe.
When dexamethasone sodium phosphate is given by intravenous infusion only Sodium Chloride Injection BP or Glucose Injection BP should be used as diluents. The exact concentration of dexamethasone 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.
Dosage and Administration
N.B. All doses are expressed as mg dexamethasone base.
Intravenous and Intramuscular Administration: IM or IV dosage of dexamethasone is variable, depending on the condition being treated. It usually ranges from 0.4 to 20 mg (0.1 to 6 ml) daily. The duration of therapy is dependent on the clinical response of the patient and as soon as improvement is indicated, the dosage should be adjusted to the minimum required to maintain the desired clinical response. Withdrawal of the drug on completion of therapy should be gradual.
Shock: A single IV injection of 1.67 to 5 mg/kg (0.5 to 1.5 ml/kg) bodyweight which may be repeated in 2-6 hours if shock persists. High-dose therapy should be continued only until the patient’s condition has stabilised and usually for no longer than 48-72 hours. This bolus injection can then be followed by continuous IV infusion of 2.5 mg/kg (0.75 ml/kg) bodyweight per 24 hours.
Cerebral oedema associated with neoplasm: An initial dose of 8.3 mg (2.5 ml) IV followed by 3.3 mg (1.0 ml) IM every 6 hours until the symptoms of oedema subside (usually after 12 to 24 hours). After 2 to 4 days the dosage should be reduced and gradually stopped over a period of 5 to 7 days. In patients with recurrent or inoperable neoplasms, maintenance therapy may be effective at doses of 1.7 mg (0.5 ml) IM or IV 2-3 times daily.
Life-Threatening Cerebral Oedema:
High Dose Schedule (all doses are expressed as mg dexamethasone base):
|Adults||Children > 35 kg||Children < 35 kg|
|Initial dose||41.6 mg (12.5 ml) IV||20.8 mg IV (6.25 ml)||16.7 mg (5.0 ml) IV|
|1st day||6.6 mg (2.0 ml) IV every 2 hrs||3.3 mg (1.0 ml) IV every 2 hrs||3.3 mg (1.0 ml) IV every 3 hrs|
|2nd day||6.6 mg (2.0 ml) IV every 2 hrs||3.3 mg (1.0 ml) IV every 2 hrs||3.3 mg (1.0 ml) IV every 3 hrs|
|3rd day||6.6 mg (2.0 ml) IV every 2 hrs||3.3 mg (1.0 ml) IV every 2 hrs||3.3 mg (1.0 ml) IV every 3 hrs|
|4th day||3.3 mg (1.0 ml) IV every 2 hrs||3.3 mg (1.0 ml) IV every 4 hrs||3.3 mg (1.0 ml) IV every 6 hrs|
|5th-8th day||3.3 mg (1.0 ml) IV every 4 hrs||3.3 mg (1.0 ml) IV every 6 hrs||1.7 mg (0.5 ml) IV every 6 hrs|
|After 8 days||Decrease by daily reduction of 3.3 mg (1.0 ml)||Decrease by daily reduction of 1.7 mg (0.5 ml)||Decrease by daily reduction of 0.8 mg (0.25 ml)|
Intraarticular and Intralesional (Soft Tissue Injections) Administration
Dosage varies with the degree of inflammation and the size and location of the affected area. Injections may be repeated from once every 3-5 days (e.g. for bursae) to once every 2-3 weeks (for joints).
Site of Injection Dosage
|1.||Large Joint||1.7 mg to 3.3 mg (0.5 ml to 1.0 ml)|
|2.||Small Joints||667 micrograms to 0.8 mg (0.2 ml to 0.25 ml)|
|3.||Bursae||1.6 mg to 2.5 mg (0.5 ml to 0.75 ml)|
|4.||Tendon Sheaths||333 micrograms to 0.8 mg (0.1 ml to 0.25 ml)|
|5.||Soft Tissue Infiltration||1.7 mg to 5 mg (0.5 ml to 1.5 ml)|
|6.||Ganglia||0.8 mg to 1.7 mg (0.25 ml to 0.5 ml)|
Dosage requirements are variable and may have to be changed according to individual need. Usually 167 micrograms/kg to 333 micrograms/kg (0.05 ml/kg to 0.1 ml/kg) of body weight daily.
In order to minimise suppression of the hypothalamic-pituitary-adrenal axis and growth retardation, treatment should be limited, where possible, to a single dose on alternate days.
Treatment of elderly patients, particularly long-term, should be planned, bearing in mind the more serious consequences in old age. Close clinical supervision is required to avoid life-threatening reactions.
The lowest effective dose of corticosteroid should be used to control the condition under treatment for the minimum period. Frequent patient review is required to appropriately titrate the dose against disease activity. When dose reduction is possible, it should occur gradually. Too rapid a reduction of dexamethasone dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death.
Severe anaphylactoid reactions have occurred after administration of parenteral corticosteroids, particularly in patients with history of allergy. Appropriate precautions should be taken prior to administration.
The slower rate of absorption after intramuscular injection should be noted.
Intraarticular corticosteroids are associated with a substantially increased risk of an inflammatory response in the joint, particularly a bacterial infection introduced with the injection. Great care is required and all intraarticular corticosteroid injections should be undertaken in an aseptic environment. Charcot like arthropathies have been reported particularly after repeated injections.
Prior to intraarticular injection the joint fluid should be examined to exclude a septic process. A marked increase in pain, accompanied by local swelling, further restriction of joint motion, fever and malaise are suggestive of septic arthritis. If this complication occurs and sepsis is confirmed, appropriate antimicrobial therapy should be commenced.
Extreme caution should be exercised in the treatment of patients with the following conditions and frequent patient monitoring is necessary:
• Liver failure, chronic renal failure, congestive heart failure, hypertension, epilepsy, migraine.
• Osteoporosis, since corticosteroids increase calcium excretion. Post-menopausal women are at particular risk.
• Latent tuberculosis, as corticosteroids can cause reactivation.
• Hypothyroidism or cirrhosis, because such patients often show an exaggerated response to corticosteroids.
• Latent amoebiasis, as corticosteroids may cause reactivation. Prior to treatment, amoebiasis should be ruled out in any patient with unexplained diarrhoea or who has recently spent time in the tropics.
• Ocular herpes simplex, because corticosteroids may cause corneal perforation.
Corticosteroids should also be used with caution in patients with diabetes mellitus (or a family history of diabetes), affective disorders (especially previous steroid psychosis), glaucoma (or a family history of glaucoma), peptic ulceration or previous corticosteroid-induced myopathy.
Treat anaphylaxis with adrenaline and positive pressure ventilation. Other supportive measures aimed to maintain the patient unstressed.
As packaged for sale: Do not store above 25°C. Do not freeze. Keep container in the outer carton.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.