Dexamethasone Injection For Pain
Dexamethasone is a corticosteroid that treats inflammation in your organs. Inflammation occurs when your immune system sends out cells to fight bacteria or heal an injury. A healthcare provider will give you this injection in a hospital or clinic setting.
- 0.1 Does dexamethasone injection help with pain?
- 0.2 How quickly does dexamethasone injection work?
- 1 Why is dexamethasone injection given?
- 2 How long does 4 mg dexamethasone injection stay in your system?
- 3 Is dexamethasone a strong steroid?
- 4 How many times can you inject dexamethasone?
- 5 How often can you get a dexamethasone injection?
- 6 How will dexamethasone make me feel?
- 7 Is 4 mg of dexamethasone a lot?
- 8 Can you drive after taking dexamethasone?
- 9 How long do steroids take to work for inflammation?
- 10 Is a steroid injection a painkiller?
Does dexamethasone injection help with pain?
pronounced as (dex a meth’ a sone) Dexamethasone, a corticosteroid, is similar to a natural hormone produced by your adrenal glands. It often is used to replace this chemical when your body does not make enough of it. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain forms of arthritis; skin, blood, kidney, eye, thyroid, and intestinal disorders (e.g., colitis); severe allergies; and asthma.
- Dexamethasone is also used to treat certain types of cancer.
- This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
- Dexamethasone comes as a tablet and a solution to take by mouth.
- Your doctor will prescribe a dosing schedule that is best for you.
- Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
Take dexamethasone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Do not stop taking dexamethasone without talking to your doctor. Stopping the drug abruptly can cause loss of appetite, upset stomach, vomiting, drowsiness, confusion, headache, fever, joint and muscle pain, peeling skin, and weight loss.
- If you take large doses for a long time, your doctor probably will decrease your dose gradually to allow your body to adjust before stopping the drug completely.
- Watch for these side effects if you are gradually decreasing your dose and after you stop taking the tablets or oral liquid, even if you switch to an inhalation corticosteroid medication.
If these problems occur, call your doctor immediately. You may need to increase your dose of tablets or liquid temporarily or start taking them again.
How long does dexamethasone shot last?
Dexamethasone is considered to be a long acting steroid, meaning that a dose lasts about two or two-and-a-half days.
How quickly does dexamethasone injection work?
6. Response and effectiveness. Peak effects of dexamethasone are reached within 10 to 30 minutes of administration; however, it may take a couple of days before any inflammation is well controlled.
Why is dexamethasone injection given?
pronounced as (dex a meth’ a sone) Dexamethasone injection is used to treat severe allergic reactions. It is used in the management of certain types of edema (fluid retention and swelling; excess fluid held in body tissues,) gastrointestinal disease, and certain types of arthritis.
Dexamethasone injection is also used for diagnostic testing. Dexamethasone injection is also used to treat certain conditions that affect the blood, skin, eyes, thyroid, kidneys, lungs, and nervous system. It is sometimes used in combination with other medications to treat symptoms of low corticosteroid levels (lack of certain substances that are usually produced by the body and are needed for normal body functioning) and in the management of certain types of shock.
Dexamethasone injection is in a class of medications called corticosteroids. It works to treat people with low levels of corticosteroids by replacing steroids that are normally produced naturally by the body. It also works to treat other conditions by reducing swelling and redness and by changing the way the immune system works.
Dexamethasone injection comes as powder to be mixed with liquid to be injected intramuscularly (into a muscle) or intravenously (into a vein). Your personal dosing schedule will depend on your condition and on how you respond to treatment. You may receive dexamethasone injection in a hospital or medical facility, or you may be given the medication to use at home.
If you will be using dexamethasone injection at home, your healthcare provider will show you how to inject the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. Ask your healthcare provider what to do if you have any problems using dexamethasone injection.
Your doctor may change your dose of dexamethasone injection during your treatment to be sure that you are always using the lowest dose that works for you. Your doctor may also need to change your dose if you experience unusual stress on your body such as surgery, illness, or infection. Tell your doctor if your symptoms improve or get worse or if you get sick or have any changes in your health during your treatment.
Dexamethasone injection is also sometimes used to treat nausea and vomiting from certain types of chemotherapy for cancer and to prevent organ transplant rejection. Talk to your doctor about the risks of using this medication for your condition. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How long does 4 mg dexamethasone injection stay in your system?
Dexamethasone is a long-acting corticosteroid with a half-life of 36 to 72 hours.
What to expect after dexamethasone injection?
Stomach upset, heartburn, headache, trouble sleeping, increased appetite, or pain/redness/swelling at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
Is dexamethasone a strong steroid?
Is dexamethasone a strong steroid? Yes, dexamethasone is considered a strong corticosteroid. It is a long-acting corticosteroid that is about 25 times more potent (stronger) than hydrocortisone and 6 times more potent than prednisone.
How many times can you inject dexamethasone?
Usual dosage range: Oral, IV, IM: 4 to 20 mg/day given in a single daily dose or in 2 to 4 divided doses ; High dose: 0.4 to 0.8 mg/kg/day (usually not to exceed 40 mg/day).
How often can you get a dexamethasone injection?
Dexamethasone Injection Dosage and Administration – A. Intravenous or intramuscular administration, The initial dosage of dexamethasone sodium phosphate injection USP may vary from 0.50 mg/day to 9 mg/day depending on the specific disease entity being treated.
- In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required.
- Usually the parenteral dosage ranges are one-third to one-half the oral dose given every 12 hours.
- However, in certain overwhelming, acute, life-threatening situations, administration of dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.
For the treatment of unresponsive shock high pharmacologic doses of this product are currently recommended. Reported regimens range from 1 to 6 mg/kg of body weight as a single intravenous injection to 40 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock persists.
For the treatment of cerebral edema in adults an initial intravenous dose of 10 mg is recommended followed by 4 mg intramuscularly every six hours until maximum response has been noted. This regimen may be continued for several days postoperatively in patients requiring brain surgery. Oral dexamethasone, 1 to 3 mg t.i.d., should be given as soon as possible and dosage tapered off over a period of five to seven days.
Nonoperative cases may require continuous therapy to remain free of symptoms of increased intracranial pressure. The smallest effective dose should be used in children, preferably orally. This may approximate 0.2 mg/kg/24 hours in divided doses. In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day or 4 to 8 mg dexamethasone every other day for 1 month have been shown to be effective.
- The initial dosage should be maintained or adjusted until a satisfactory response is noted.
- If after a reasonable period of time there is a lack of satisfactory clinical response, dexamethasone sodium phosphate injection USP should be discontinued and the patient transferred to other appropriate therapy.
It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.
It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment.
In this later situation it may be necessary to increase the dosage of dexamethasone sodium phosphate injection USP for a period of time consistent with the patient’s condition. If after a long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.B.
Intra-articular, soft tissue or intralesional administration, The dose for instrasynovial administration is usually 2 to 4 mg for large joints and 0.8 to 1 mg for small joints. For soft tissue and bursal injections a dose of 2 to 4 mg is recommended. Ganglia require a dose of 1 to 2 mg. A dose of 0.4 to 1 mg is used for injection into tendon sheaths.
Injection into intervertebral joints should not be attempted at any time and hip joint injection cannot be recommended as an office procedure. Intrasynovial and soft tissue injections should be employed only when affected areas are limited to 1 or 2 sites.
- It should be remembered that corticoids provide palliation only and that other conventional or curative methods of therapy should be employed when indicated.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Frequency of injection usually ranges from once every 3 to 5 days to once every 2 to 3 weeks. Frequent intra-articular injection may cause damage to joint tissue.
How will dexamethasone make me feel?
Dexamethasone is a corticosteroid medication that treats inflammatory health conditions, allergic reactions, and more. Common dexamethasone side effects include difficulty sleeping, stomach upset, and appetite changes. Many of these side effects can be managed with minor lifestyle changes or medication adjustments.
Can you take ibuprofen and dexamethasone together?
Dexamethasone with painkillers – It is safe to take paracetamol, co-codamol and codeine with dexamethasone. Taking of anti-inflammatory painkillers (NSAIDs) like aspirin, ibuprofen or naproxen painkiller with dexamethasone may increase the risk of side effects on the gut, such as stomach ulceration and bleeding.
When is the best time to inject steroids?
How long does a steroid injection take to start working? Patient’s often ask us, This is often when the patient has a significant event such as a marathon coming up. Choosing the best time to have a steroid injection so that it has the best chance of working at the all important can mean the difference between success and failure.
Steroids work differently to many pain killers having a more complex mechanism to reduce pain. Because of this they need time to take effect. Then main mechanism for reducing pain and inflammation is that they reprogram our body’s cells to stop producing inflammation and to produce our own natural anti-inflammatories.
Because this is a more indirect action than most traditional painkillers it does take significantly longer to produce its effect. Most research concludes that steroid injections take between 3-5 days to work. However to be on the safe side we would normally encourage patients to have their injection ideally 7-10 days week before their event.
This gives the maximum chance that the steroid will achieve maximum benefits. Your treating clinician will also be able to give you specific tailored advice with regard to when you will be safe to return to full sporting activities. Our unique one-stop-shop service means that you will be fully assessed by a highly experienced musculoskeletal physiotherapist who will also be able to perform a diagnostic ultrasound scan of the area.
Following this if indicated they will be able to proceed with an ultrasound guided injection directly targeted to the area of pain. Complete Physio provide direct access to private practice ultrasound guided injections. If would like to discuss having a steroid injection or indeed how best to plan the timing before your events please do not hesitate to contact us on or call direct on 02074823875 : How long does a steroid injection take to start working?
What to avoid while on dexamethasone?
Indigestion – take dexamethasone with a meal or snack to reduce the chances of stomach problems. It may also help to avoid rich or spicy food.
Why avoid dexamethasone?
Precautions – Drug information provided by: Merative, Micromedex ® If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be caused by this medicine. Blood or urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 month after your last dose. If you think you have become pregnant while using this medicine, tell your doctor right away. If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress.
Your dose of this medicine might need to be changed for a short time while you have extra stress. Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.
- Using this medicine may increase your risk of cancer, including Kaposi’s sarcoma.
- Talk to your doctor if you have concerns about this risk.
- While you are being treated with dexamethasone, do not have any immunizations (vaccines) without your doctor’s approval.
- Dexamethasone may lower your body’s resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent.
In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella.
Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor. Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly.
This medicine may cause myopathy. Tell your doctor right away if you have new or worsening unexplained muscle pain, tenderness, or weakness. This medicine may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression, mood swings, a false or unusual sense of well-being, trouble sleeping, or personality changes while taking this medicine.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain skin tests. Talk with your doctor before using this medicine if you plan to have children. Some men who use Hemady™ have become infertile (unable to have children).
Where do you inject dexamethasone?
How to Inject –
- Pick an injection site on the thigh(see picture).
- Clean the site with an alcohol wipe.
- Hold syringe like a dart at a 90ºangle to the site.
- With your other hand, hold the muscle firmly at the site.
- Insert the needle straight into the skin with a quick firm motion.
- Slowly push down on plunger until the syringe is empty.
- Remove the needle quickly (at the same angle it was inserted). Apply gentle pressure to site with alcohol wipe, cotton ball, or gauze. The site may bleed a bit.
- Throw out the needle and syringe in a puncture proof container (like a liquid detergent bottle or Sharps container).
Is 4 mg of dexamethasone a lot?
My Account Area – 1. Name of the medicinal product Dexamethasone 4 mg tablets 2. Qualitative and quantitative composition Each 4 mg tablet contains 4 mg dexamethasone. Excipient(s) with known effect Lactose monohydrate 70mg/ tablet For the full list of excipients, see section 6.1.3. Pharmaceutical form Uncoated tablet. Round, biplanar, white to off-white tablets with bevelled edges and single break-mark. Dexamethasone 4 mg is embossed with ‘D | 4’. The tablet can be divided into equal doses.4. Clinical particulars 4.1 Therapeutic indications Neurology Cerebral oedema (only with symptoms of intracranial pressure evidenced by computerised tomography) caused by a brain tumour, neuro-surgical intervention, cerebral abscess. Pulmonary and respiratory diseases Acute asthma exacerbations when use of an oral corticosteroid (OCS) is appropriate, croup. Dermatology Initial treatment of extensive, severe, acute, skin diseases responding to glucocorticoids, e.g. erythroderma, pemphigus vulgaris. Autoimmune disorders/rheumatology Initial treatment of autoimmune disorders like systemic lupus erythematodes. Active phases of systemic vasculitides like panarteritis nodosa (treatment duration should be limited to two weeks in cases of concomitant positive hepatitis B serology). Severe progressive course of active rheumatoid arthritis, e.g. fast proceeding destructive forms and/or extraarticular manifestations. Severe systemic course of juvenile idiopathic arthritis (Still’s disease). Haematological disorder Idiopathic thrombocytopenic purpura in adults. Infectology Tuberculous meningitis only in conjunction with anti-infective therapy. Dexamethasone is indicated in the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) who require supplemental oxygen therapy. Oncology Palliative treatment of neoplastic diseases. Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment. Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma in combination with other medicinal products. Various Prevention and treatment of postoperative vomiting, within antiemetic treatment.4.2 Posology and method of administration Posology Dexamethasone is given in usual doses of 0.5 to 10 mg daily, depending on the disease being treated. In more severe disease conditions doses above 10 mg per day may be required. The dose should be titrated to the individual patient response and disease severity. In order to minimize side effects, the lowest effective possible dose should be used. Unless otherwise prescribed, the following dosage recommendations apply: The below mentioned dosing recommendations are given for guidance only. The initial and daily doses should always be determined based on individual patient response and disease severity. – Cerebral oedema : Initial dose and duration of treatment depending on the cause and severity, 6-16 mg (up to 24 mg) / day orally, divided into 3-4 individual doses. – Acute asthma : Adults: 16 mg / day for two days. Children: 0.6 mg / kg body weight for one or two days. – Croup : Children: 0.15mg/kg-0.6 mg/kg in a single dose. – Acute skin diseases : Depending on the nature and extent of the disease daily doses of 8-40 mg, in some cases up to 100 mg, which should be followed by down titration according to clinical need. – Active phase of rheumatic system disorders: Systemic lupus erythematosus 6-16 mg / day. – Active rheumatoid arthritis with severe progressive course form: running at fast destructive forms 12-16 mg / day, with extra-articular manifestations 6-12 mg / day. – Idiopathic thrombocytopenic purpura : 40 mg for 4 days in cycles. – Tuberculous meningitis : Patients with grade II or III disease received intravenous treatment for four weeks (0.4 mg per kilogram per day for week 1, 0.3 mg per kilogram per day for week 2, 0.2 mg per kilogram per day for week 3, and 0.1 mg per kilogram per day for week 4) and then oral treatment for four weeks, starting at a total of 4 mg per day and decreasing by 1 mg each week. Patients with grade I disease received two weeks of intravenous therapy (0.3 mg per kilogram per day for week 1 and 0.2 mg per kilogram per day for week 2) and then four weeks of oral therapy (0.1 mg per kilogram per day for week 3, then a total of 3 mg per day, decreasing by 1 mg each week). – Palliative treatment of neoplastic diseases : Initial dose and duration of treatment depending on the cause and severity, 3-20 mg / day. Very high doses up to 96 mg may also be used for palliative treatment. – Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment : 8-20 mg dexamethasone prior to chemotherapy treatment, then 4-16 mg/day on day 2 and 3. – Prevention and treatment of postoperative vomiting, within antiemetic treatment : single dose of 8 mg before the surgery. – Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma in combination with other medicinal products: the usual posology is 40 mg or 20 mg once per day. – For the treatment of Covid-19 ▪ Adult patients 6 mg PO, once a day for up to 10 days. ▪ Paediatric population: Paediatric patients (adolescents aged 12 years and older) are recommended to take 6mg/dose PO once a day for up to 10 days. ▪ Duration of treatment should be guided by clinical response and individual patient requirements. ▪ Elderly, renal impairment, hepatic impairment: No dose adjustment is needed. The dose and administration frequency varies with the therapeutic protocol and the associated treatment(s). Dexamethasone administration should follow instructions for dexamethasone administration when described in the Summary of Product Characteristics of the associated treatment(s). If this is not the case, local or international treatment protocols and guidelines should be followed. Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient. Renal impairment Patients undergoing active hemodialysis may show an increased clearance of drug via the dialysate and thus require an adjustment of steroid dose. Hepatic impairment In patients with severe liver disease dose adjustment may be necessary. In patients with a severe liver impairment, the biological effects of dexamethasone may be potentiated due to its slower metabolism (prolonged plasma half-life) and hypoalbuminaemia (increased plasma levels of free drug), which may also cause more side effects. Elderly Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age (osteoporosis, diabetes mellitus, hypertension, reduced immunity, psychological changes). In such patients, the plasma concentrations of dexamethasone may be higher and its excretion slower than in younger patients, therefore its dose should be reduced accordingly. Paediatric population The usual dose is 0.01-0.1 mg/kg of body weight daily. The excretion of dexamethasone is approximately equal in children and adults if dosage is adjusted to their body area. Dosage should be planned bearing in mind possible effects upon growth and development and for signs of adrenal suppression. Long term treatment For the long-term treatment of several conditions, after initial therapy, glucocorticoid treatment should be switched from dexamethasone to prednisone/prednisolone to reduce suppression on the function of the adrenal cortex. Discontinuation of treatment Acute adrenocortical failure may occur after abrupt discontinuation of long-term treatment with large doses of glucocorticoids. Therefore, glucocorticoid doses should be gradually reduced in such cases and treatment should be discontinued gradually. (see section 4.4) Method of administration Dexamethasone should be taken with or after food to minimise irritation to the gastrointestinal tract. Drinks containing alcohol or caffeine should be avoided. Dexamethasone is in the form of tablets 1 mg and 4 mg. The tablets can be divided into equal halves. When alternate-day therapy is not possible, the entire daily dose of glucocorticoid can usually be administered as a single morning dose; however, some patients will require divided daily doses of glucocorticoids.4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Systemic infection unless specific anti-infective therapy is employed. Stomach ulcer or duodenal ulcer. Avoid live vaccines in patients receiving immunosuppressive doses (serum antibody response diminished). In general no contraindications apply in conditions where the use of glucocorticoids may be life saving.4.4 Special warnings and precautions for use In post-marketing experience tumour lysis syndrome (TLS) has been reported in patients with haematological malignancies following the use of dexamethasone alone or in combination with other chemotherapeutic agents. Patients at high risk of TLS such as patients with high proliferative rate, high tumour burden, and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precaution taken. Adrenocortical insufficiency An adrenocortical insufficiency, which is caused by glucocorticoid treatment, can, depending on the dose and length of treatment, remain for many months, and in some cases more than a year, after discontinuation of treatment. During treatment with dexamethasone for specific physical stress conditions (trauma, surgery, childbirth, etc.), a temporary increase in dose may be required. Because of the possible risk in stressful conditions, a corticosteroid ID should be made for patients undergoing long-term treatment. Even in cases of prolonged adrenocortical insufficiency after discontinuation of treatment, the administration of glucocorticoids can be necessary in physically stressful situations. An acute therapy-induced adrenocortical insufficiency can be minimized by slow dose reduction until a planned discontinuation time. Treatment with dexamethasone should only be implemented in the event of the strongest indications and, if necessary, additional targeted anti-infective treatment administered for the following illnesses: – Acute viral infections (Herpes zoster, Herpes simplex, Varicella, herpetic keratitis) – HBsAG-positive chronic active hepatitis – Approx.8 weeks prior through 2 weeks after vaccinations with live vaccines (see section 4.3 and 4.5) – Systemic mycoses and parasitosis (e.g. Nematodes) – Poliomyelitis – Lymphadenitis after BCG vaccination – Acute and chronic bacterial infections – With a history of tuberculosis (reactivation risk) use only under tuberculostatic protection – Known or suspected Strongyloidiasis (threadworm infestation). Treatment with glucocorticoids may lead to lead to Strongyloides hyperinfection and dissemination with widespread larval migration. In addition, treatment with dexamethasone should only be implemented under strong indications and, if necessary, additional specific treatment must be implemented for: – Gastrointestinal ulcers – Severe osteoporosis (as corticosteroids have a negative effect on the calcium balance) – Difficult to regulate high blood pressure – Difficult to regulate diabetes mellitus – Psychiatric disorders (including history) – Angle closure glaucoma and wide-angle glaucoma – Corneal ulcerations and corneal injuries – Severe heart failure Anaphylactic reaction Serious anaphylactic reactions may occur. Tendinitis The risk of tendinitis and tendon rupture is increased in patients treated concomitantly with glucocorticoids and fluoroquinolones. Myasthenia gravis Pre-existing myasthenia gravis may initially deteriorate in the beginning of dexamethasone treatment. Ocular disorders Systemic treatment with glucocorticoids can induce chorioretinopathy which may result in impaired vision including loss of vision. Prolonged use of corticosteroids may cause posterior subcapsular cataracts, glaucoma with possible damage to the optic nerve and can increase the risk of secondary ocular infections due to fungi or viruses. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Intestinal perforation Because of the risk of an intestinal perforation, dexamethasone must only be used under urgent indication and under appropriate monitoring for: – Severe ulcerative colitis with threatened perforation – Diverticulitis – Entero-anastomosis (immediately postoperative) – Signs of peritoneal irritation after gastrointestinal perforation may be absent in patients receiving high doses of glucocorticoids. Diabetes A higher need for insulin, or oral antidiabetics, must be taken into consideration when administering dexamethasone to diabetics. Cardiovascular disorders Regular blood pressure monitoring is necessary during treatment with dexamethasone, particularly during administration of higher doses and with patients with difficult to regulate high blood pressure. Because of the risk of deterioration, patients with severe cardiac insufficiency should be carefully monitored. Bradycardia may occur in patients treated with high doses of dexamethasone. Caution should be exercised when using corticosteroids in patients who have recently suffered myocardial infarction as myocardial rupture has been reported. Infections Treatment with dexamethasone can conceal the symptoms of an existing, or developing infection thereby making a diagnosis more difficult. The prolonged use of even small amounts of dexamethasone leads to an increased risk of infection, even by microorganisms which otherwise rarely cause infections (so-called opportunistic infections). Systemic corticosteroids should not be stopped for patients who are already treated with systemic (oral) corticosteroids for other reasons (e.g. patients with chronic obstructive pulmonary disease) but not requiring supplemental oxygen. Vaccination Vaccinations with inactivated vaccine are always possible. However, it should be noted that the immune reaction and thereby the success of inoculation, can be affected by higher doses of corticoids. Regular checkups with doctors (including vision checkups in three-month intervals) are advised during long-term treatment with dexamethasone. Metabolic disorders At high doses, sufficient calcium intake and sodium restriction, as well as serum potassium levels should be monitored. Depending on the length and dosage of the treatment, a negative influence on calcium metabolism can be expected, so that an osteoporosis prophylaxis is recommended. This applies, above all, to co-existing risk factors like familial disposition, increased age, after menopause, insufficient protein and calcium intake, heavy smoking, excessive alcohol intake, as well as insufficient exercise. Prevention consists of sufficient calcium and vitamin D intake and physical activity. Additional medical treatment should be considered in the event of pre-existing osteoporosis. Corticosteroids should be used cautiously in patients with migraine, as corticosteroids may cause fluid retention. Psychological changes Psychological changes are manifested in various forms, the most common being euphoria. Depression, psychotic reactions and suicidal tendencies may also appear. 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. In a few cases, mental health problems have happened when doses are being lowered or stopped. Cerebral oedema or increased intracranial pressure Corticosteroids should not be used in conjunction with a head injury since they will probably not be of benefit or may even do harm. Discontinuation of treatment Glucocorticoid doses should be gradually reduced. The following risks should be considered upon interruption or discontinuation of long-term glucocorticoid administration: – Exacerbation or recurrence of the underlying disease, acute adrenal insufficiency, corticosteroid withdrawal syndrome (A ‘withdrawal syndrome’ may include fever, muscle and joint pain, inflammation of the nose lining (rhinitis), weight loss, itchy skin and inflammation of the eye (conjunctivitis)). – Certain viral diseases (chickenpox, measles) in patients treated with glucocorticoids, may be very severe. – Children and immunocompromised persons without previous chickenpox or measles infection are particularly at risk. If these people have contact with people infected with measles or chickenpox while undergoing treatment with dexamethasone, a preventative treatment should be introduced if necessary. Other Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation. Paediatric population Corticosteroids cause a dose-dependent inhibition of growth in infancy, childhood, and adolescence since corticosteroids may give rise to early closing of the epiphyses, which may be irreversible. Therefore, during long-term treatment with dexamethasone, the indication should be very strongly presented in children and their growth rate should be checked regularly. Available evidence suggests long-term neurodevelopmental adverse events after early treatment (< 96 hours) of premature infants with chronic lung disease at starting doses of 0.25mg/hg twice daily. Elderly The adverse effects of systemic corticosteroids can have serious consequences especially in old age, mainly osteoporosis, hypertension, hypokalemia, diabetes, susceptibility to infection and skin atrophy. Close clinical monitoring is required to prevent life-threatening reactions. Influence of diagnostic tests Glucocorticoids can suppress skin reaction to allergy testing. They can also affect the nitroblue tetrazolium test for bacterial infections and cause false-negative results. Note on doping The use of doping tests when taking dexamethasone can lead to positive results. Dexamethasone contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction Prior to the use of Dexamethasone in combination with any other medicinal product, reference should be made to the Summary of Product Characteristics of that product. Pharmacodynamic interactions Patients taking NSAIDs should be monitored, as NSAIDs may increase the incidence and/or severity of gastric ulcers. Acetylsalicylic acid should be used carefully in combination with corticosteroids in hypoprothrombinaemia. The renal clearance of salicylates is increased by corticosteroids. Therefore, the dosage of salicylates may be reduced once the steroids are discontinued. Steroid withdrawal may result in salicylate intoxication due to the increase of salicylate concentration in the serum. Corticosteroids reduce the effect of antidiabetic agents such as insulin, sulfonylurea, and metformin. Hyperglycaemia and diabetic ketoacidosis may occur occasionally. Therefore, at the beginning of treatment, diabetics should have more frequent blood and urine tests. The hypokalemic effect of acetazolamide, loop diuretics, thiazide diuretics, kaliuretics, amphotericin B injections (glucomineral)-corticosteroids, tetracosactide and laxatives will increase. Hypokalemia promotes cardiac arrhythmias, especially torsade de pointes, and increases the toxicity of cardiac glycosides. Before the start of corticosteroid treatment, hypokalemia should be corrected and patients should be monitored clinically, for electrolytes and by electrocardiography. Furthermore, there are case reports in which the simultaneous use of amphotericin B and hydrocortisone led to an enlarged heart and heart failure. Antiulcer drugs: Carbenoxolone increases the risk of hypokalemia. Chloroquine, hydroxychloroquine and mefloquine: Increased risk of myopathies and cardiomyopathies. Concomitant administration of ACE inhibitors creates an increased risk of blood disorders. The blood pressure-lowering effects of antihypertensive drugs may be affected by corticosteroids. The dose of the anti-hypertensive treatment may have to be adjusted during the treatment with dexamethasone. Thalidomide: Great care should be taken during co-administration with thalidomide, a there have been reported cases of toxic epidermal necrolysis. The effect of vaccinations may be reduced during treatment with dexamethasone. Vaccination with live vaccines during treatment with large therapeutic doses of dexamethasone (and other corticosteroids) is contraindicated due to the possibility of viral infection. In this case, vaccination should be postponed for at least 3 months after the completion of treatment with corticosteroids. Other types of immunisation during treatment with large therapeutic doses of corticosteroids are dangerous due to the risk of neurological complications and decreased or absent increase in the antibody titers (in comparison with expected values) and therefore a smaller protective effect. However, patients who have received corticosteroids locally (parenteral) or for a short period of time (less than 2 weeks), in smaller doses may be immunised. Cholinesterase inhibitors: Concomitant use of cholinesterase inhibitors and corticosteroids may cause serious muscle weakness in patients with myasthenia gravis. If possible, cholinesterase inhibitors should be discontinued at least 24 hours before the start of corticosteroid therapy. The risk of tendinitis and tendon rupture is increased in patients treated concomitantly with glucocorticoids and fluoroquinolones. Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. Pharmacokinetic interactions Effects of other medicinal products on dexamethasone: Dexamethasone is metabolized via the cytochrome P450 3A4 (CYP3A4). The administration of dexamethasone with inducers of CYP3A4, such as ephedrine, barbiturates, rifabutin, rifampicin, phenytoin, and carbamazepine can lead to reduced plasma concentrations of dexamethasone, so the dose must be increased. Aminoglutethimide can accelerate the reduction of dexamethasone and reduce its efficacy. If necessary, the dexamethasone dosage should be adjusted. Bile acid resins, such as cholestyramine, may decrease the absorption of dexamethasone. Topically applied gastrointestinal drugs, antacids, activated charcoal: Decreased glucocorticoid resorption has been described during co-administration of prednisolone and dexamethasone. Therefore, the administration of glucocorticoids and topically applied gastrointestinal drugs, antacids, activated charcoal should be postponed (with an interval of at least two hours). The administration of dexamethasone with inhibitors of CYP3A4, such as azoleantifungals (e.g. ketoconazole, itraconazole), HIV protease inhibitors (e.g. ritonavir) and macrolide antibiotics (e.g. erythromycin) may lead to increased plasma concentrations and reduced clearance of dexamethasone. If required, the dexamethasone dose should be reduced. Ketoconazole may not only increase the plasma concentration of dexamethasone by inhibition of CYP3A4, but also suppress adrenal corticosteroid synthesis and cause adrenal insufficiency upon discontinuation of corticosteroid treatment. Estrogens, including oral contraceptives, may inhibit the metabolism of certain corticosteroids and thus enhance their effect. Effects of dexamethasone on other medicinal products Dexamethasone is a moderate inducer of CYP3A4. The administration of dexamethasone with substances metabolized by CYP3A4 can lead to increased clearance and decreased plasma concentrations of these substances. Tuberculostatics: A reduction of isoniazid plasma concentrations was observed during concurrent use of prednisolone. Patients taking isoniazid should be monitored closely. Cyclosporine: Concomitant administration of cyclosporine and corticosteroids may lead to an increased effect of both substances. There is an increased risk of cerebral seizures. Praziquantel: Reduced praziquantel plasma concentrations create a risk of treatment failure due to the increased hepatic metabolism of dexamethasone. Oral anticoagulants (coumarin): Concomitant corticosteroid therapy may either potentiate or lead to a weakening of the effect of oral anticoagulants. In case of high doses or of treatment lasting over 10 days there is a risk of bleeding specific to corticosteroid therapies (gastrointestinal mucosa, vascular fragility). Patients who use corticosteroids combined with oral anticoagulants should be closely monitored (controls on day 8, then every two weeks during and after treatment). Atropine and other anticholinergics: Intraocular pressure increases may be noted during co-administration with dexamethasone. Non-depolarizing muscle relaxants: the muscle relaxing effect may last longer. Somatotropin: the effect of the growth hormone can be reduced. Protirelin: Reduced increase in TSH may be noted during administration of protirelin.4.6 Fertility, pregnancy and lactation Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs, however, dexamethasone readily crosses the placenta. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate/lip in man (see also section 5.3). However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential however, patients with normal pregnancies may be treated as though they were in the non-gravid state. Breast-feeding Corticosteroids may pass into breast milk, although no data are available for dexamethasone. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression. A decision on whether to continue/discontinue breast feeding or to continue/discontinue therapy with dexamethasone should be made taking into account the benefit of breast feeding to the child and the benefit of dexamethasone therapy to the woman. Fertility Dexamethasone decreases testosterone biosynthesis and endogenous ACTH secretion which has an effect on the spermatogenesis and the ovarian cycle.4.7 Effects on ability to drive and use machines There have been no studies on the effects on the ability to drive and use machines. Dexamethasone may cause confusional state, hallucinations, dizziness, somnolence, fatigue, syncope and blurred vision (see section 4.8). If affected, patients should be instructed not to drive, use machines or perform hazardous tasks while being treated with dexamethasone.4.8 Undesirable effects Summary of the safety profile The incidence of anticipated adverse effects correlates with the relative potency of the substance, dose, time of day of administration and duration of treatment. During a short-term therapy, in compliance with the dosage recommendations and close monitoring of patients, the risk of side effects is low. The usual side effects of short-term dexamethasone treatment (days/weeks) include weight gain, psychological disorders, glucose intolerance and transitory adrenocortical insufficiency. Long-term dexamethasone treatment (months/years) usually causes central obesity, skin fragility, muscle atrophy, osteoporosis, growth retardation and long-term suprarenal insufficiency. (see also section 4.4 Special warnings and precautions for use) Tabulated list of adverse reactions
|System Organ Class||Frequency Not known (cannot be estimated from the available data)|
|Infections and infestations||Increased susceptibility to, or exacerbation of, (latent) infections* (including septicaemia, tuberculosis, eye infections, chickenpox, measles, fungal and viral infections) with masking of clinical symptoms, opportunistic infections|
|Blood and lymphatic system disorders||Leukocytosis, lymphopenia, eosinopenia, polycythemia, abnormal coagulation|
|Immune system disorders||Hypersensitivity reactions including anaphylaxis, immunosuppression (see also under “Infections and parasitic diseases”)|
|Endocrine disorders||Suppression of the hypothalamic-pituitary-adrenal axis and induction of Cushing’s syndrome (typical symptoms: full-moon face, plethora, truncal obesity), secondary adrenal and pituitary insufficiency* (especially in stress such as trauma or surgery), growth suppression in infancy, childhood and adolescence, menstrual irregularity and amenorrhoea, hirsutism|
|Metabolism and nutrition disorders||Weight gain, negative protein and calcium balance*, increased appetite, sodium and water retention*, potassium loss* (caution: rhythm disorders), hypokalemic alkalosis, manifestation of latent diabetes mellitus, impaired carbohydrate tolerance with increased dose requirements of antidiabetic therapy*, hypercholesterolemia, hypertriglyceridaemia|
|Psychiatric disorders*||Psychological dependence, depression, insomnia, aggravated schizophrenia, mental illness, from euphoria to manifest psychosis|
|Nervous system disorders||Increased intracranial pressure with papilloedema in children (pseudotumor cerebri) usually following discontinuation of treatment; manifestation of latent epilepsy, increased seizures in overt epilepsy, vertigo, headache|
|Eye disorders||Elevated intraocular pressure, glaucoma*, papilloedema, cataract*, mainly with posterior subcapsular opacity, corneal and scleral atrophy, increased ophthalmic viral, fungal and bacterial infections, worsening of symptoms associated with corneal ulcers*, chorioretinopathy|
|Cardiac disorders||Cardiac muscle rupture after recent history of myocardial infarction, congestive heart failure in predisposed patients, cardiac decompensation*|
|Vascular disorders||Hypertension, vasculitis, increased atherosclerosis and risk of thrombosis/thromboembolism (increase in coagulability of blood may lead to thromboembolic complications)|
|Respiratory, thoracic and mediastinal disorders||Hiccough|
|Gastrointestinal disorders||Dyspepsia, abdominal distension*, gastric ulcers with perforation and bleeding, acute pancreatitis, ulcerative esophagitis, oesophageal candidiasis, flatulence, nausea, vomiting|
|Skin and subcutaneous tissue disorders||Hypertrichosis, skin atrophy, telangiectasia, striae, erythema, steroid acne, petechiae, ecchymosis, allergic dermatitis, urticaria, angioneurotic oedema, thinning hair, pigment disorders, increased capillary fragility, perioral dermatitis, hyperhidrosis, tendency to bruise|
|Musculoskeletal and connective tissue disorders||Premature epiphyseal closure, osteoporosis, fractures of the spine and long bones, aseptic necrosis of the femoral and the humeral bones, tendon tears*, proximal myopathy, muscle weakness, loss of muscle mass|
|Reproductive system and breast disorders||Impotence|
|General disorders and administration site conditions||Reduced response to vaccination and skin tests. Delayed wound healing, discomfort, malaise, steroid withdrawal syndrome: a too rapid reduction in corticosteroid dose after prolonged treatment can lead to acute adrenal insufficiency, hypotension, and death. A withdrawal syndrome may present with fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and weight loss.|
see also section 4.4 Special warnings and precautions for use Description of selected adverse reactions Adrenocortical insufficiency An adrenocortical insufficiency, which is caused by glucocorticoid treatment, can, depending on the dose and length of treatment, remain for many months and in some cases more than a year, after discontinuation of treatment. (see section 4.4 Special warnings and precautions for use) Psychological changes Psychological changes are manifested in various forms, the most common being euphoria. Depression, psychotic reactions and suicidal tendencies may also appear. 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. (see section 4.4 Special warnings and precautions for use) Infections Treatment with dexamethasone can conceal the symptoms of an existing, or developing infection thereby making a diagnosis more difficult and can lead to an increased risk of infection. (see section 4.4 Special warnings and precautions for use) Intestinal perforation Corticosteroids can be associated with an increased risk of colonic perforation in severe ulcerative colitis with threatened perforation, diverticulitis and entero-anastomosis (immediately postoperative). Signs of peritoneal irritation after gastrointestinal perforation may be absent in patients receiving high doses of glucocorticoids. (see section 4.4 Special warnings and precautions for use) Cardiovascular disorders Bradycardia, deterioration of severe cardiac insufficiency and difficult to regulate high blood pressure may occur. Caution should be exercised when using corticosteroids in patients who have recently suffered myocardial infarction as myocardial rupture has been reported. (see section 4.4 Special warnings and precautions for use) Paediatric population Corticosteroids cause a dose-dependent inhibition of growth in infancy, childhood, and adolescence since corticosteroids may give rise to early closing of the epiphyses, which may be irreversible. (see section 4.4 Special warnings and precautions for use) Elderly The adverse effects of systemic corticosteroids can have serious consequences especially in old age, mainly osteoporosis, hypertension, hypokalemia, diabetes, susceptibility to infection and skin atrophy. (see section 4.4 Special warnings and precautions for use) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose Symptoms Reports of acute toxicity and/or deaths following overdose with glucocorticoids are rare. Overdose or prolonged use may exaggerate glucocorticoid adverse effects. Management No antidote is available. Treatment should be symptomatic and supportive with the dosage of dexamethasone being reduced or slowly withdrawn where possible. Treatment is probably not indicated for reactions due to chronic poisoning unless the patient has a condition that would render him unusually susceptible to ill effects from corticosteroids. In this case, the stomach should be emptied and symptomatic treatment should be instituted as necessary. Anaphylactic and hypersensitivity reactions may be treated with epinephrine (adrenaline), positive-pressure artificial respiration and aminophylline. The patient should be kept warm and quiet. The biological half-life of dexamethasone in plasma is about 190 minutes.5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: corticosteroids for systemic use, glucocorticoids, ATC code: H02AB02. Mechanism of action Dexamethasone is a highly potent and long-acting glucocorticoid with negligible sodium retaining properties and is therefore, particularly suitable for the use in patients with cardiac failure and hypertension. Its anti-inflammatory potency is 7 times greater than prednisolone and, like other glucocorticoids, dexamethasone also has anti-allergic, antipyretic and immunosuppressive properties. Dexamethasone has a biological half-life of 36 – 54 hours and therefore is suitable in conditions where continuous glucocorticoid action is required. The RECOVERY trial The RECOVERY trial (Randomised Evaluation of COVid-19 thERapY,) 1 is an investigator-initiated, individually randomised, controlled, open-label, adaptive platform trial to evaluate the effects of potential treatments in patients hospitalised with COVID-19. The trial was conducted at 176 hospital organizations in the United Kingdom. There were 6425 Patients randomised to receive either dexamethasone (2104 patients) or usual care alone (4321 patients).89% of the patients had laboratory-confirmed SARS-CoV-2 infection. At randomization, 16% of patients were receiving invasive mechanical ventilation or extracorporeal membrane oxygenation, 60% were receiving oxygen only (with or without non invasive ventilation), and 24% were receiving neither. The mean age of patients was 66.1+/-15.7 years.36% of the patients were female.24% of patients had a history of diabetes, 27% of heart disease and 21% of chronic lung disease. Primary endpoint Mortality at 28 days was significantly lower in the dexamethasone group than in the usual care group, with deaths reported in 482 of 2104 patients (22.9%) and in 1110 of 4321 patients (25.7%), respectively (rate ratio, 0.83; 95% confidence interval, 0.75 to 0.93; P<0.001). In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs.41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and in those receiving supplementary oxygen without invasive mechanical ventilation (23.3% vs.26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94). There was no clear effect of dexamethasone among patients who were not receiving any respiratory support at randomization (17.8% vs.14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55). Secondary endpoints Patients in the dexamethasone group had a shorter duration of hospitalization than those in the usual care group (median, 12 days vs.13 days) and a greater probability of discharge alive within 28 days (rate ratio, 1.10; 95% CI, 1.03 to 1.17). In line with the primary endpoint the greatest effect regarding discharge within 28 days was seen among patients who were receiving invasive mechanical ventilation at randomization (rate ratio 1.48; 95% CI 1.16, 1.90), followed by oxygen only (rate ratio, 1.15 ;95% CI 1.06-1.24) with no beneficial effect in patients not receiving oxygen (rate ratio, 0.96 ; 95% CI 0.85-1.08).
|Outcome||Dexamethasone (N=2104)||Usual Care (N=4321)||Rate or Risk Ratio (95% CI) *|
|no./total no. of patients (%)|
|Mortality at 28 days||482/2104 (22.9)||1110/4321 (25.7)||0.83 (0.75–0.93)|
|Discharged from hospital within 28 days||1413/2104 (67.2)||2745/4321 (63.5)||1.10 (1.03–1.17)|
|Invasive mechanical ventilation or death†||456/1780 (25.6)||994/3638 (27.3)||0.92 (0.84–1.01)|
|Invasive mechanical ventilation||102/1780 (5.7)||285/3638 (7.8)||0.77 (0.62–0.95)|
|Death||387/1780 (21.7)||827/3638 (22.7)||0.93 (0.84–1.03)|
Rate ratios have been adjusted for age with respect to the outcomes of 28-day mortality and hospital discharge. Risk ratios have been adjusted for age with respect to the outcome of receipt of invasive mechanical ventilation or death and its subcomponents.
- Excluded from this category are patients who were receiving invasive mechanical ventilation at randomization.
- Safety There were four serious adverse events (SAEs) related to study treatment: two SAEs of hyperglycaemia, one SAE of steroid-induced psychosis and one SAE of an upper gastrointestinal bleed.
All events resolved. Subgroup analyses Effects of allocation to DEXAMETHASONE on 28−day mortality, by age and respiratory support received at randomisation 2 Effects of allocation to DEXAMETHASONE on 28−day mortality, by respiratory support received at randomisation and history of any chronic disease.3 1 www.recoverytrial.net 2, 3 (source: Horby P. et al., 2020; https://www.medrxiv.org/content/10.1101/2020.06.22.20137273v1; doi: https://doi.org/10.1101/2020.06.22.20137273) 5.2 Pharmacokinetic properties Absorption and Distribution Dexamethasone is well absorbed when given by mouth; peak plasma levels are reached between 1 and 2 hours after ingestion and show wide interindividual variations.
The mean plasma half-life is 3.6 ± 0.9 h. Dexamethasone is bound (to about 77%) to plasma proteins, mainly albumins. Percentage protein binding of dexamethasone, unlike that of cortisol, remains practically unchanged with increasing steroid concentrations. Corticosteroids are rapidly distributed to all body tissues.
They cross the placenta and may be excreted in small amounts in breast milk. Biotransformation Dexamethasone is metabolised mainly in the liver but also in the kidney. Elimination Dexamethasone and its metabolites are excreted in the urine.5.3 Preclinical safety data Studies in animals have shown that glucocorticoids increase the incidence of cleft palate, spontaneous abortions and intrauterine growth retardation.
- In some cases these divergences were combined with defects of the central nervous system and of the heart.
- In non-human primates, minor cranial skeletal abnormalities were observed.
- These effects were observed after use of high doses of dexamethasone.6.
- Pharmaceutical particulars 6.1 List of excipients Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate 6.2 Incompatibilities Not applicable.6.3 Shelf life 36 months 6.4 Special precautions for storage Store below 25°C and in the original pack to protect from light.6.5 Nature and contents of container Thermoformed unit-dose blisters (PVC/PVDC film) sealed with Aluminium lidding foil.
Each unit-dose blister contains 10 tablets.10 x 1, 20 x 1, 30 x 1, 40 x 1, 50 x 1, 60 x 1 and 100 x1, in a box. Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling No special requirements.7. Marketing authorisation holder Mercury Pharmaceuticals Limited Capital House, 85 King William Street, London EC4N 7BL, United Kingdom 8.
Can you drive after taking dexamethasone?
My Account Area – The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. Last updated on emc: 08 Aug 2022 Dexamethasone 2mg Tablets Dexamethasone
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 (read Section 4: Possible side effects). 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 medicine, 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 (read Section 4 for more information) If you take it for more than 3 weeks, in the UK, 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
Now read the rest of this leaflet It includes other important information on the safe and effective use of this medicine that might be especially important for you.
Keep this leaflet. You may need to read it again.If you have any further questions, ask your doctor or pharmacist.This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Dexamethasone is and what it is used for 2. What you need to know before you take Dexamethasone 3. How to take Dexamethasone 4. Possible side effects 5. How to store Dexamethasone 6. Contents of the pack and other information The name of your medicine is Dexamethasone.
Dexamethasone is a synthetic glucocorticoid (adrenocortical hormone) Corticosteroids are hormones that are found naturally in your body that help to keep you healthy and well. Boosting your body with extra corticosteroid, such as Dexamethasone, is an effective way to treat various illnesses involving inflammation in the body.
Dexamethasone lowers inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it. Dexamethasone can be used to:
Reduce inflammationTreat a number of different diseases of the immune system
Dexamethasone is used as a treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) with difficulty breathing and need of oxygen therapy.
If you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include a rash, itching or shortness of breathIf you have an infection that affects the whole bodyIf you need to have a vaccination, particularly with ‘live virus’ vaccines
Do not take this medicine if any of the above apply to you. Treatment with this medicine may cause pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumor of the adrenal glands Crisis can occur with the following symptoms: headaches, sweating, palpitations, and hypertension.
If you have ever had severe depression or manic depression (bipolar disorder).This includes having had depression before while taking steroid medicines like DexamethasoneIf any of your close family has had these illnessesIf you have or are suspected of having pheochromocytoma (a tumor of the adrenal glands).
Mental health problems can happen while taking steroids like Dexamethasone (see also section 4).
These illnesses can be seriousUsually they start within a few days or weeks of starting the medicineThey are more likely to happen at high dosesMost 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. Before you take Dexamethasone, tell your doctor if:
You have a cancer of the blood because you may be at risk of a very rare, potentially life-threatening condition resulting from a sudden breakdown of tumour cells.You have symptoms of tumour lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath, in case you suffer from haematological malignancyYou have kidney or liver problemsYou have high blood pressure or heart diseaseYou have diabetes or there is a family history of diabetesYou have thinning of the bones (osteoporosis), particularly if you are a female who has been through the menopauseYou have had muscle weakness with this or other steroids in the pastYou have raised eye pressure (glaucoma) or there is a family history of glaucomaYou have a stomach (peptic) ulcerYou have mental problems or you have had a mental illness which was made worse by this type of medicine such as ‘steroid psychosis’You have epilepsyYou have migrainesYou have an underactive thyroid glandYou have an infection with parasitesYou have tuberculosis (TB)You have stunted growthContact your doctor if you experience blurred vision or other visual disturbances
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Dexamethasone. If you develop an infection while you are taking this medicine, you should talk to your doctor. Please tell any doctor, dentist or person who may be giving you treatment that you are currently taking steroids or have taken them in the past.
If you are living in the UK, you should always carry a blue ‘steroid card’ which gives clear guidance on the special care to be taken when you are taking this medicine. Show this to any doctor, dentist or person 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 in the past.
Do not use Dexamethasone for the treatment of Acute Respiratory Distress Syndrome (ARDS; a serious lung disease) if you have been diagnosed with this condition for over 2 weeks. While you are taking this kind of medicine, you should not come into contact with anyone who has chicken pox, shingles or measles if you have not had these illnesses.
- This is because you may need specialist treatment if you get these diseases.
- If you think you may have had exposure to any of these diseases, you should talk to your doctor straight away,
- You should also tell your doctor if you have ever had infectious diseases such as measles or chicken pox and if you have had any vaccinations for these conditions in the past.
Please tell a doctor or anyone giving you treatment, such as at a hospital, if:
You have an accidentYou are illYou need any surgery. This includes any surgery you may have at your dentist’sYou need to have a vaccination, particularly with ‘live virus’ vaccines
If any of the above apply to you, you should tell your doctor or the person treating you even if you have stopped taking this medicine. If a child is taking this medicine, it is important that the doctor monitors their growth and development regularly.
Medicines to treat heart and blood problems, such as warfarin, high blood pressure medicine and water tablets (diuretics)Antibiotics such as rifampicin and rifabutinMedicines to treat epilepsy, such as phenytoin, carbamazepine, phenobarbitone and primidoneMedicines to treat stomach problems, such as antacidsCarbenoxolone, sometimes used for ulcersMedicines that control pain or lower inflammation, such as aspirin, ibuprofen or similar non-steroidal anti-inflammatories (NSAIDs)Medicines used to treat diabetesMedicines used to lower potassium levelsMedicines used to treat myastheniaIndinavir or saquinavir used to treat HIVSome medicines may increase the effects of Dexamethasone and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat)Oral contraceptives containing oestrogen and progestogenAnti-cancer treatments, such as aminoglutethimideMethotrexate used for cancer or inflammatory problemsEphedrine used to relieve symptoms of a blocked noseAcetazolamide used for glaucoma
Talk to your doctor, pharmacist or nurse before you take Dexamethasone. General precautions regarding steroid use in specific diseases, masking infection, concomitant medicines etc. in line with current recommendations. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
- Dexamethasone is not likely to affect you being able to drive or use any tools or machines.
- Dexamethasone contains lactose.
- If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
- Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure. Take Dexamethasone as only as prescribed by your doctor. Your doctor will decide how long you should take dexamethasone for. Check with your doctor or pharmacist if you are not sure. For the treatment of Covid-19 Adult patients are recommended to take 6 mg once a day for up to 10 days.
Your doctor will tell you how many tablets to take. This will depend on your illness and how bad it isTake this medicine by mouthSwallow the tablets whole with a drink of waterDo not crush or chew the tablets
The usual dose is 0.5mg to 10mg each dayAs you get better your doctor may then reduce your dose or ask you to take another corticosteroid such as ‘prednisolone’
The usual dose is 0.01 to 0.1 milligrams per kilogram of body weight
If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken. The following effects may happen:
Swelling of the throatSkin reactionDifficulty breathing
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed doseDo not take a double dose to make up for a forgotten dose
It can be dangerous to stop taking this medicine suddenly. If you need to stop this treatment, follow your doctor’s advice. He or she may tell you to lower the amount of medicine you are taking gradually until you stop taking it altogether. If you stop taking this medicine too quickly, your condition may get worse.
- You may also feel a ‘withdrawal symptom’.
- These may include headache, problems with your vision (including pain or swelling in the eye), feeling or being sick, fever, pain in your muscles and joints, swelling in the inside of your nose, weight loss, itchy skin and conjunctivitis.
- If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Dexamethasone can also cause side effects when you stop taking it.
See Section 3: If you stop taking Dexamethasone
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. These include:
Feeling depressed, including thinking about suicideFeeling high (mania) or moods that go up and downFeeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memoryFeeling, seeing or hearing things that 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, If you have an allergic reaction to Dexamethasone see a doctor straight away An allergic reaction may include:
Any kind of skin rash or itching of the skinDifficulty in breathing or collapseSwelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing (angioedema)
Stomach and gut problems: ulcers in the throat, stomach ulcers, which may perforate or bleed, indigestion, feeling sick (nausea) or being sick (vomiting), a swollen stomach, having more of an appetite than usual, hiccups, diarrhoea Inflamed pancreas : this may cause severe pain in the back or tummy Problems with salts in your blood such as too much sodium or low potassium or calcium. You may have water retention Heart and blood problems : high blood pressure, blood clots, problems with the muscles in your heart after a recent heart attack Bone problems : thinning of the bones (osteoporosis) with an increased risk of fractures, bone disease Recurring infections that get worse each time such as thrush and chicken pox Skin problems : wounds that heal more slowly, bruising, acne Eye problems : increased pressure in the eye including glaucoma, eye disorders such as cataracts, eye infections, visual disturbances, loss of vision, blurred vision Hormone problems : irregular or missing periods, stunted growth in children and teenagers, swelling of the face (called ‘Cushingoid’ or ‘moon’ face). It may affect your diabetes and you may notice you start needing higher doses of the medicine you take for diabetes. Your body may not be able to respond normally to severe stress such as accidents, surgery or illness, growth of extra body hair (particularly in women), increased appetite or weight gain Nervous system problems : fits or epilepsy may become worse, severe unusual headache with visual problems, being unable to sleep, feeling depressed, extreme mood swings, schizophrenia may become worse, headache or problems with your vision (including eye pain or swelling) General problems : may make you feel generally unwell or tired
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: By reporting side effects you can help provide more information on the safety of this medicine.
- Eep this medicine out of the sight and reach of children Do not store above 25°C.
- Do not store in the fridge Do not use this medicine after the expiry date which is stated on the carton.
- The expiry date refers to the last day of that month.
- Do not throw away any 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
The active substance is dexamethasone. Dexamethasone Tablets BP 2mg contain 2mg of dexamethasone per tabletThe other ingredients in Dexamethasone Tablets BP 2mg are potato starch, propylene glycol, magnesium stearate and lactose.
Dexamethasone Tablets BP 2mg are round, flat and white. They are marked with XC/8 on one side and plain on the other sideDexamethasone tablets are sold in containers of 100 and 50 tablets. They may also be available in containers of 500 tablets.
Aspen Pharma Trading Limited 3016 Lake Drive Citywest Business Campus Dublin 24 Ireland The Manufacturer is: Aspen Bad Oldesloe GmbH 32-36 Industriestrasse 23843 Bad Oldesloe Germany For any information about this product, please contact the local representative of the Marketing Authorisation Holder: United Kingdom 24 Hour Helpline +441748 823 391 (free phone UK only 0800 0087 392) This leaflet was last revised in February 2022
How long do steroids take to work for inflammation?
Prednisone generally works very quickly — usually within one to four days — if the prescribed dose is adequate to reduce your particular level of inflammation. Some people notice the effects of prednisone hours after taking the first dose.
What should you not do after a steroid shot?
After the cortisone shot – Some people have redness and a feeling of warmth of the chest and face after a cortisone shot. If you have diabetes, a cortisone shot might temporarily increase your blood sugar levels. After your cortisone shot, your doctor might ask that you:
Protect the injection area for a day or two. For instance, if you received a cortisone shot in your shoulder, avoid heavy lifting. If you received a cortisone shot in your knee, stay off your feet when you can. Apply ice to the injection site as needed to relieve pain. Don’t use heating pads. Not use a bathtub, hot tub or whirlpool for two days. It’s OK to shower. Watch for signs of infection, including increasing pain, redness and swelling that last more than 48 hours.
Can dexamethasone be used for back pain?
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Letters to the editor may be sent to, Editor : The title of Dr. Michelle Johnston’s article ( EMN,2021;43:15; https://bit.ly/3ju6o1d ) should be, Does Intravenous, Intramuscular, Oral, or Epidural Dexamethasone Have a Place in Treating Acute Back Pain? My answer is yes, an argument I support with conversations with other emergency physicians who use it to treat acute back pain by anecdotal experience with patients and personal use.
I understand that one of the official back and spine advisory bodies declared that steroids have no place in treating back pain. In this time of caution about prescribing opioids, it would be tragic to lead physicians to believe that an effective medicine doesn’t work and is not worth trying. I find that many seasoned emergency physicians consider it important for treating acute back pain, but other emergency physicians are either unaware of using it therapeutically or, as the columnist indicated, disagree with its use for acute back pain.
All steroids are not created equal, and prednisone and methylprednisolone are not the same as dexamethasone. I think the most obvious example of the differentiation is that dexamethasone is by far the predominant steroid treatment for preventing and ameliorating acute mountain sickness.
My belief is that the dexamethasone is more energizing but produces less anxiety than prednisone. Of course, it also has the advantage of having a longer half-life, which is why it is used more often to treat pediatric asthma. I’ve found it to be effective in treating chronic upper back trigger-point pain, neck muscle spasm, and wry neck.
Unless there’s a contraindication, I always treat low back pain with dexamethasone. I almost always use it orally in the emergency department, and will give 8-12 mg as a loading dose, though even 4 mg can be immensely helpful. In some cases, I will give a prescription for two or four 4 mg dexamethasone tablets to be taken every other day or if the pain goes away and comes back.
I find it paradoxical that epidural steroid injections are widely used and are generally believed to be effective, but other delivery modes are believed to be ineffective. Systemic steroids are used for treating rheumatologic disorders so they can obviously reach inflamed joints in sufficient amounts to provide an anti-inflammatory effect.
Stepping fully into anecdotal territory, my wife is extremely active but had a previous spinal fusion for arthritis produced by spondylolisthesis. She doesn’t take dexamethasone often and only 4 mg at a time when she overexerts her back, but even 4 mg is extremely effective.
The only times I ever missed a shift in my 40-year career were when I broke something and twice when my back blew up. I was essentially cured by an epidural steroid injection most times, and now I will take 4 mg of dexamethasone if I feel my back begin to have a serious spasm, and it almost always heads everything off.
Does this mean that I’m taking dexamethasone all the time? No, only about once or twice a month and rarely more than 4 mg for a single episode, though I have rarely taken 8 mg. A single dose is usually sufficient. James M. Larson, MD San Diego Copyright © 2021 Wolters Kluwer Health, Inc.
Can you lie down after taking dexamethasone?
Nausea and Heartburn – Taking dexamethasone with food or milk is generally enough to prevent nausea and heartburn. If possible, take the medication when you can be upright (not lying down) for a few hours after the dose. Avoid things that worsen the symptoms, and try antacids (milk of magnesia and calcium tablets, like Tums), saltines, or ginger ale to lessen symptoms.
What effect does dexamethasone have on pain?
Pain scores ≤ 4 hour (h) were reduced in patients who received dexamethasone at rest (mean difference (MD), − 0.54, 95% confidence interval (CI) − 0.72 to − 0.35, I 2 = 81%) and on movement (MD − 0.42, 95% CI − 0.62 to − 0.22, I 2 = 35).
Is a steroid injection a painkiller?
How steroid injections work – Steroids closely copy the effects of hormones normally produced by the adrenal glands, 2 small glands found above the kidneys. When injected into a joint or muscle, steroids reduce redness and swelling (inflammation) in the nearby area.
This can help relieve pain and stiffness. When injected into the blood, they can reduce inflammation throughout the body, as well as reduce the activity of the immune system, the body’s natural defence against illness and infection. This can help treat autoimmune conditions, such as multiple sclerosis (MS), which are caused by the immune system mistakenly attacking the body.
Steroid injections are different from the anabolic steroids used illegally by some people to increase their muscle mass. Page last reviewed: 17 April 2023 Next review due: 17 April 2026
What is the action of dexamethasone on pain?
BOTTOM LINE –
Corticosteroids are among the most commonly used medications in palliative care. Their widespread use as analgesic adjuvants for bony, visceral, and neuropathic pain is widely supported by expert opinion. Corticosteroids reduce pain by reducing inflammation and edema associated with tumours and de polarization of damaged nerves. Dexamethasone is the most commonly used corticosteroid owing to its lack of mineralocorticoid effects, long half-life, and higher potency compared with other corticosteroids. Corticosteroids have many potential side effects that require frequent monitoring. Because most of these side effects manifest over the long term, corticosteroids are best used in the short term at the lowest effective dose. Discontinuing corticosteroids used for longer than 2 weeks should involve tapering to reduce the risk of steroid withdrawal. Worsening symptoms in this setting might be caused by steroid withdrawal, rather than progression of underlying disease.
Does dexamethasone help nerve pain?
Abstract – Dexamethasone is currently used for the treatment of peripheral nerve injury, but its mechanisms of action are not completely understood. Inflammation/immune response at the site of nerve lesion is known to be an essential trigger of the pathological changes that have a critical impact on nerve repair and regeneration.
In this study, we observed the effects of various doses of dexamethasone on the functional recovery after sciatic nerve crush injury in a rat model. Motor functional recovery was monitored by walking track analysis and gastrocnemius muscle mass ratio. The myelinated axon number was counted by morphometric analysis.
Rats administered dexamethasone by local intramuscular injection had a higher nerve function index value, increased gastrocnemius muscle mass ratio, reduced Wallerian degeneration severity, and enhanced regenerated myelinated nerve fibers. Immunohistochemical analysis was performed for CD3 expression, which is a marker for T-cell activation, and infiltration in the sciatic nerve.