Instructions Dexamethasone KRKA tablets 4 mg blister No. 30
Composition
active ingredient: dexamethasone;
1 tablet contains 4 mg of dexamethasone:
Excipients: lactose monohydrate, pregelatinized starch, colloidal anhydrous silicon dioxide, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: white or almost white, round tablets with beveled edges and a score on one side; the tablet can be divided into two halves along the score.
Pharmacotherapeutic group
Corticosteroids for systemic use, glucocorticoids.
ATX code H02A B02.
Pharmacological properties
Pharmacodynamics
Mechanism of action
Dexamethasone is a very potent, long-acting glucocorticoid with little sodium retention and is therefore suitable, in particular, for use in patients with heart failure and hypertension.
Its anti-inflammatory effect is 7 times stronger than that of prednisolone. Like other glucocorticoids, dexamethasone has antiallergic, antipyretic and immunosuppressive effects.
The half-life of dexamethasone is 36–54 hours, and therefore it can be used in diseases that require continuous glucocorticoid action.
Pharmacokinetics
Absorption and distribution
Dexamethasone is well absorbed after oral administration; peak plasma levels are reached within 1 to 2 hours after administration and show a wide range of interindividual variability. The mean half-life is 3.6 ± 0.9 hours. Dexamethasone is bound to plasma proteins (about 77%), mainly albumin. The percentage of dexamethasone binding to proteins, unlike cortisol, remains virtually unchanged with increasing steroid concentration. Corticosteroids are rapidly distributed to all body tissues, cross the placenta, and may be excreted in small amounts into breast milk.
Biotransformation
Dexamethasone is metabolized mainly in the liver, but also in the kidneys.
Breeding
Dexamethasone and its metabolites are excreted from the body in the urine.
Indication
Cerebral edema caused by brain tumor, neurosurgery, bacterial meningitis, brain abscess. Severe acute asthma attack. Initial oral treatment of extensive, severe, acute skin diseases responsive to glucocorticoid therapy, e.g. erythroderma, pemphigus vulgaris, acute eczema. Initial oral treatment of autoimmune disorders such as systemic lupus erythematosus (especially its visceral forms). Severe progressive course of active rheumatoid arthritis, e.g. destructive forms and/or extra-articular manifestations. Severe infections with toxic conditions (e.g. tuberculosis, typhus) only with concomitant anti-infective therapy. Palliative treatment of tumors. Prevention and treatment of postoperative vomiting or vomiting induced by cytostatics in combination with antiemetics.
Contraindication
Hypersensitivity to the active substance or to any of the excipients. Systemic infection unless appropriate anti-infective therapy is used. Gastric or duodenal ulcer. Vaccination with a live vaccine during treatment with high therapeutic doses of dexamethasone (and other corticosteroids) due to the possibility of viral infection.
Interaction with other medicinal products and other types of interactions
Before using Dexamethasone KRKA in combination with any other medicine, you should read the instructions for medical use of this medicine.
Pharmacodynamic interactions
Patients taking nonsteroidal anti-inflammatory drugs should be monitored, as NSAIDs may increase the frequency and/or severity of gastric ulcers. Acetylsalicylic acid should be used with caution in combination with corticosteroids in hypoprothrombinemia.
Renal clearance of salicylates is increased by corticosteroids. Thus, the dose of salicylates may be reduced when steroids are discontinued. Discontinuation of steroids may lead to increased salicylate toxicity by increasing serum concentrations.
Corticosteroids reduce the effect of antidiabetic agents such as insulin, sulfonylureas, and metformin. Hyperglycemia and diabetic ketoacidosis may occasionally occur.
Therefore, at the beginning of treatment, diabetic patients should have more frequent blood and urine tests. The hypokalemic effect of acetazolamide injections, loop diuretics, thiazide diuretics, kaliuretics, amphotericin B, glucomineralocorticoids, tetracosactide, and laxatives will be increased. Hypokalemia leads to cardiac arrhythmias, especially torsade de pointes, and increases the toxicity of cardiac glycosides. Before starting treatment with corticosteroids, the patient should have hypokalemia corrected and electrolytes determined, and an ECG performed. In addition, the simultaneous use of amphotericin B and hydrocortisone has been reported to lead to an increase in heart size and heart failure.
Chloroquine, hydroxychloroquine, and mefloquine: Increased risk of myopathy and cardiomyopathy.
Concomitant use with ACE inhibitors increases the risk of hematological disorders. Corticosteroids may interfere with the hypotensive effect of antihypertensive drugs. Doses of antihypertensive drugs may need to be adjusted during treatment with dexamethasone.
Thalidomide: Special attention should be paid to concomitant use with thalidomide, as cases of toxic epidermal necrolysis have been reported.
The effect of vaccination may be reduced during treatment with dexamethasone.
Vaccination with live vaccines during treatment with high 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 end of corticosteroid treatment. Other types of immunization during treatment with high therapeutic doses of corticosteroids are dangerous due to the risk of neurological complications and lower or no increased antibody titers (compared to expected values), and therefore a lower protective effect. However, patients who have received corticosteroids locally or for a short period of time (less than 2 weeks) in lower doses can be vaccinated.
Cholinesterase inhibitors: Concomitant use of cholinesterase inhibitors and corticosteroids may result in severe muscle weakness in patients with myasthenia gravis. If possible, cholinesterase inhibitors should be discontinued at least 24 hours before starting corticosteroid therapy.
There is an increased risk of tendinitis and tendon rupture in patients receiving concomitant glucocorticoids and fluoroquinolones.
Pharmacokinetic interactions
Effects of other drugs on dexamethasone
Dexamethasone is metabolized by cytochrome P450 3A4 (CYP3A4).
Taking dexamethasone with CYP3A4 inducers, such as ephedrine, barbiturates, rifabutin, rifampicin, phenytoin, carbamazepine, may lead to a decrease in the concentration of dexamethasone in the blood plasma, so its dose should be increased.
Aminoglutethimide may accelerate the elimination of dexamethasone and reduce its effectiveness. If necessary, appropriate dose adjustment of dexamethasone should be made.
Bile acid resins, such as cholestyramine, may reduce the absorption of dexamethasone.
Topical gastrointestinal medications, antacids, activated charcoal. Reduced absorption of glucocorticoids has been reported with concomitant use with prednisolone and dexamethasone. Therefore, glucocorticoids and topical gastrointestinal medications, antacids, and activated charcoal should be administered at least two hours apart.
Coadministration of dexamethasone with CYP3A4 inhibitors, such as azole antifungals (e.g. ketoconazole, itraconazole), HIV protease inhibitors (e.g. ritonavir) and macrolides (e.g. erythromycin), may result in increased plasma concentrations and decreased clearance of dexamethasone. If necessary, the dose of dexamethasone should be reduced.
Ketoconazole may not only increase dexamethasone plasma concentrations by inhibiting CYP3A4, but also inhibit adrenal corticosteroid synthesis and cause adrenal insufficiency after discontinuation of corticosteroid treatment.
Estrogens, including oral contraceptives, can inhibit the metabolism of certain corticosteroids and thus enhance their effects.
Effect of dexamethasone on other drugs
Dexamethasone is a moderate inducer of CYP3A4. Taking dexamethasone with drugs that are metabolized by CYP3A4 may lead to increased clearance and decreased plasma concentrations of these substances.
Tuberculosis drugs: Concomitant use of prednisolone has been associated with decreased plasma concentrations of isoniazid. Patients taking isoniazid should be closely monitored.
Cyclosporine: Concomitant administration of cyclosporine and corticosteroids may lead to an increased effect of both substances. There is an increased risk of cerebral convulsions.
Praziquantel: Reduced plasma concentrations of praziquantel lead to a risk of lack of efficacy due to increased hepatic metabolism of dexamethasone.
Oral anticoagulants (coumarin). Concomitant therapy with corticosteroids may potentiate or weaken the effect of oral anticoagulants. In the case of high doses or treatment duration of more than 10 days, there is a risk of bleeding specific to corticosteroid therapy (gastrointestinal mucosa, vascular fragility). Patients receiving corticosteroids in combination with oral anticoagulants should be closely monitored (monitor on day 8, then every two weeks during and after treatment).
Atropine and other anticholinergic drugs. Increased intraocular pressure is possible when taken simultaneously with dexamethasone.
Non-depolarizing muscle relaxants. The muscle relaxing effect may last longer.
Somatotropin. The effect of growth hormone may be reduced.
Concomitant treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic adverse effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid adverse effects, in which case patients should be monitored for systemic corticosteroid effects.
Application features
Adrenal insufficiency
Adrenal insufficiency caused by glucocorticoid treatment, depending on the dosage and duration of treatment, may persist for many months and in some cases more than a year after discontinuation of treatment. During treatment with dexamethasone, in some cases of physical stress (injuries, surgery, childbirth, etc.), a temporary increase in the dose may be necessary. Due to the possible risk under stressful conditions, an initial dose of corticosteroids is necessary in patients undergoing long-term treatment. Even in the case of long-term adrenal insufficiency, glucocorticoid administration may be necessary in patients undergoing severe stress after discontinuation of treatment. Acute adrenal insufficiency caused by therapy can be minimized by slowly reducing the dose until the planned time of discontinuation of the drug.
Treatment with dexamethasone should be carried out only strictly according to indications and, if necessary, additional targeted anti-infective therapy should be carried out in the following diseases and conditions:
acute viral infections (shingles, herpes simplex virus, chickenpox, herpetic keratitis); HBsAg-positive chronic hepatitis in the active phase;
approximately 8 weeks before and 2 weeks after vaccination with a live vaccine (see sections “Contraindications” and “Interaction with other medicinal products and other types of interactions”);
systemic mycoses and parasitosis (e.g. nematodes); poliomyelitis; lymphadenitis after BCG vaccination; acute and chronic bacterial infections; history of tuberculosis (risk of reactivation), only with concomitant use of tuberculostatic drugs; known or suspected strongyloidiasis (nematode invasion). Treatment with glucocorticoids may lead to strongyloidiasis hyperinfection and widespread larval migration.
In addition, dexamethasone treatment should only be prescribed if there are strict indications and, if necessary, additional specific treatment should be carried out for the following diseases:
gastrointestinal ulcers; severe osteoporosis (since corticosteroids negatively affect calcium balance); high blood pressure that is difficult to control; diabetes mellitus that is difficult to control; mental disorders (including a history); angle-closure glaucoma and wide-angle glaucoma; corneal ulcers and corneal injuries; severe heart failure.
Anaphylactic reactions
Serious anaphylactic reactions may occur.
Tendinitis
There is an increased risk of tendinitis and tendon rupture in patients receiving concomitant glucocorticoids and fluoroquinolones.
Myasthenia gravis
Pre-existing myasthenia gravis may worsen at the beginning of treatment with dexamethasone.
Vision impairment
There have been reports of visual disturbances with systemic and topical corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be referred to an ophthalmologist for evaluation of possible causes, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which have been reported following the use of systemic and topical corticosteroids.
Long-term use of corticosteroids may lead to posterior subcapsular cataracts, glaucoma with possible optic nerve damage, and may increase the risk of secondary ocular infections caused by fungi or viruses.
Corticosteroids should be used with caution in patients with ocular herpes due to possible corneal perforation.
Intestinal perforation
Due to the risk of intestinal perforation, dexamethasone should only be used for urgent indications and with adequate control of the following conditions:
severe ulcerative colitis with the threat of perforation; diverticulitis; enteroanastomosis (immediately after surgery).
Signs of abdominal irritation following gastrointestinal perforation may be absent in patients receiving high doses of glucocorticoids.
Diabetes mellitus
The increased need for insulin or oral antidiabetic drugs should be taken into account when taking dexamethasone in diabetic patients.
Cardiovascular system disorders
Regular monitoring of blood pressure is necessary during treatment with dexamethasone, especially at high doses and in patients with high blood pressure that is difficult to control. Due to the risk of deterioration, patients with severe heart failure should be closely monitored.
Bradycardia may occur in patients receiving high doses of dexamethasone.
Corticosteroids should be used with caution in patients who have recently had a myocardial infarction, as cases of myocardial rupture have been reported.
Treatment with dexamethasone may mask the symptoms of an existing or developing infection, making diagnosis difficult. Prolonged use of even low doses of dexamethasone leads to an increased risk of infection, even with microorganisms that otherwise rarely cause infections (so-called opportunistic infections).
Vaccination
Vaccination with an inactivated vaccine is possible. However, it should be noted that higher doses of corticosteroids may negatively affect the immune response and, therefore, the success of the inoculation. With long-term treatment with dexamethasone, regular medical examinations are recommended (including preventive eye examinations at three-month intervals).
Metabolic disorders
At high doses, adequate calcium intake and sodium restriction, as well as serum potassium levels, should be monitored. Depending on the duration and dosage of treatment, negative effects on calcium metabolism can be expected, therefore prevention of osteoporosis is recommended. This applies in particular to concomitant risk factors such as family history, older age, postmenopausal period, insufficient protein and calcium intake, smoking, excessive alcohol consumption, and insufficient physical activity. Prevention consists of adequate calcium and vitamin D intake and physical activity. Additional medical treatment is considered in case of existing osteoporosis.
Corticosteroids should be prescribed with caution in patients with migraine, as the use of corticosteroids may lead to fluid retention.
Psychological changes
Psychological changes manifest in various forms, the most common of which is euphoria. Depression, psychotic reactions, and suicidal tendencies may also occur.
These conditions can be serious. They usually start within a few days or weeks of starting the drug; they are more likely to occur with high doses. Most of these effects go away when the dose is reduced or the drug is stopped. If these effects occur, they are likely to require treatment. In some cases, mental health problems have recurred when the dose is reduced or the drug is stopped.
Brain swelling and increased intracranial pressure
Corticosteroids should not be used for traumatic brain injury as they are unlikely to be of benefit or may even be harmful.
Tumor lysis syndrome
Tumor lysis syndrome (TLS) has been reported in patients with hematological malignancies after the use of dexamethasone alone or in combination with other chemotherapeutic agents. Patients at high risk of TLS, such as those with high proliferation rates, large tumor masses, and high sensitivity to cytotoxic agents, should be closely monitored and appropriate precautions should be taken.
Discontinuation of treatment
Glucocorticoid doses should be gradually reduced.
The following risks should be considered when interrupting or discontinuing long-term use of glucocorticoids:
Exacerbation or relapse of the underlying disease, acute adrenal insufficiency, corticosteroid withdrawal syndrome (withdrawal syndrome may include fever, muscle and joint pain, inflammation of the nasal mucosa (rhinitis), weight loss, itching of the skin and inflammation of the eyes (conjunctivitis). Some viral diseases (chickenpox, measles) in patients receiving glucocorticoids may be severe. Children and immunocompromised individuals who have not had chickenpox or measles are particularly susceptible to adverse effects. If these individuals come into contact with people infected with measles or chickenpox, prophylactic treatment should be given if necessary during treatment with dexamethasone.
Other
Pheochromocytoma crisis, which can be fatal, has been reported following the use of systemic corticosteroids. Corticosteroids should be administered to patients with suspected or established pheochromocytoma only after an appropriate risk/benefit assessment.
Children
Corticosteroids cause dose-dependent growth inhibition in infants, children, and adolescents, as corticosteroids can cause premature epiphyseal closure, which may be irreversible. Therefore, long-term use of dexamethasone in children should be strictly contraindicated, and growth in such patients should be monitored regularly.
Premature infants: Available data suggest long-term neurodevelopmental adverse effects following early treatment (< 96 hours) of premature infants with chronic lung disease at initial doses of 0.25 mg/kg twice daily.
Elderly patients
The side effects of systemic corticosteroids, especially in elderly patients, can have serious consequences. They mainly include osteoporosis, hypertension, hypokalemia, diabetes mellitus, susceptibility to infection, and skin atrophy. Close clinical monitoring is necessary to prevent life-threatening reactions.
Impact on diagnostics
Glucocorticoids may suppress skin reactions in allergy tests. They may also interfere with the nitroblue tetrazolium test for bacterial infections and may lead to false-negative results.
Taking dexamethasone may lead to positive results in a doping test.
Dexamethasone KRKA contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the effects on the ability to drive or use machines have not been conducted.
Dexamethasone may cause confusion, hallucinations, dizziness, drowsiness, fatigue, fainting, and blurred vision. Patients should be advised not to drive, operate machinery, or perform hazardous tasks while receiving dexamethasone.
Use during pregnancy or breastfeeding
Pregnancy
Dexamethasone crosses the placenta. Administration of corticosteroids to pregnant animals can cause fetal malformations, including cleft palate, intrauterine growth retardation, and affect brain growth and development. There is no evidence that corticosteroids increase the incidence of congenital anomalies such as cleft palate/cleft lip in humans. Long-term or repeated corticosteroid therapy during pregnancy increases the risk of intrauterine growth retardation. Neonates exposed to corticosteroids before birth are at increased risk of adrenal insufficiency, which normally resolves spontaneously postnatally, but this is rarely of clinical significance. Dexamethasone should be used during pregnancy, especially in the first trimester, only if the benefits outweigh the risks to the mother and child.
Lactation
Glucocorticoids pass into breast milk. There is insufficient information on the excretion of dexamethasone into breast milk. A risk to the newborn/infants cannot be excluded. Children whose mothers have taken high doses of systemic corticosteroids for a long period may have adrenal suppression.
A decision on whether to continue or discontinue breast-feeding and/or to continue or discontinue dexamethasone therapy should be made taking into account the benefit of breast-feeding for the child and the benefit of dexamethasone therapy for the mother.
Fertility
Dexamethasone reduces testosterone biosynthesis and endogenous ACTH secretion, which affects spermatogenesis and the ovarian cycle.
Method of administration and doses
Dosage
Dexamethasone is usually given in doses of 0.5 to 10 mg per day, depending on the condition being treated. More severe conditions may require doses of more than 10 mg per day. The dose is adjusted according to the individual patient's response and the severity of the condition. Initial doses of dexamethasone should be given until a clinical response is achieved, and then the dose should be gradually reduced to the lowest clinically effective dose. Significantly higher doses are used for the treatment of acute severe conditions than for chronic conditions. In order to minimize side effects, the lowest effective dose should be used.
Unless otherwise specified, the dosage recommendations below apply.
The following dosage recommendations are provided for guidance only. Initial and daily doses should always be determined based on the individual patient's response and the severity of the disease.
Palliative treatment of cancer: the initial dose and duration of treatment depend on the cause and severity of the disease, 3–20 mg/day. Very high doses of up to 96 mg can also be used for palliative treatment. For optimal dosing and to reduce the number of tablets, a combination of low doses (4 and 8 mg) and higher doses (20 mg or 40 mg) can be used.
Prevention and treatment of vomiting caused by cytostatics, emetogenic chemotherapy, in combination with antiemetics: orally 10–20 mg of dexamethasone before the start of chemotherapy, and then, if necessary, 4–8 mg 2–3 times a day for 1–3 days (with moderate emetogenic therapy) and up to 6 days (with intensive emetogenic therapy).
Kidney dysfunction
In patients on active hemodialysis, the clearance of the drug through the dialysate may be increased and, thus, an adjustment of the steroid dose may be required.
Liver dysfunction
Patients with severe liver disease may require dose adjustment. In patients with severe hepatic impairment, the biological effects of dexamethasone may be enhanced due to slower metabolism (prolonged plasma half-life) and hypoalbuminemia (increased free plasma levels), which may also cause more side effects.
Elderly patients
Treatment of elderly patients, especially in the case of long-term treatment, should be selected taking into account the more serious consequences of common side effects of corticosteroids in the elderly (osteoporosis, diabetes mellitus, hypertension, reduced immunity, mental changes). In such patients, plasma concentrations of dexamethasone may be higher, excretion slower than in younger patients, so the dose should be reduced accordingly.
For long-term treatment of a number of diseases, after initial therapy with glucocorticoids, treatment should be changed from dexamethasone to prednisone/prednisolone to reduce suppression of adrenal cortex function.
Discontinuation of treatment
Acute adrenal insufficiency may occur after abrupt discontinuation of long-term high-dose glucocorticoid therapy. Therefore, in such cases, the glucocorticoid dose should be reduced gradually to discontinue treatment (see section 4.4).
Method of application
Dexamethasone should be taken with or immediately after food to minimize gastrointestinal irritation. Drinks containing alcohol or caffeine should be avoided.
Dexamethasone Krka is available in 4 mg, 8 mg, 20 mg and 40 mg tablets. The tablets can be divided into equal parts and provide additional doses of 2 mg and 10 mg to make the tablet easier for the patient to swallow. When alternate-day therapy is not possible, the total daily dose of glucocorticoids can usually be administered as a single morning dose; however, some patients require divided daily doses of glucocorticoids.
Children
The initial dose range for dexamethasone is 0.08-0.3 mg/kg/day or 2.5 mg-10 mg/m2 body surface area/day in 3-4 divided doses. The elimination of dexamethasone is approximately the same in children and adults when the dose is adjusted for body surface area. The dosage should be adjusted taking into account the possible effects on growth and development and the presence of signs of adrenal suppression. Premature infants: There is evidence of prolonged neurological side effects after early treatment (up to 96 hours) of premature infants with chronic lung disease at initial doses of 0.25 mg/kg twice daily.
Overdose
Symptoms
Acute toxicity and/or fatalities following overdose with glucocorticoids have been reported rarely.
Overdose or prolonged use may increase the side effects of glucocorticoids.
Treatment
There is no antidote. Treatment is symptomatic and supportive. Reduction of the dexamethasone dosage or gradual withdrawal, if possible, is recommended. Treatment is probably not indicated for reactions resulting from chronic poisoning, except when the patient's condition may render him or her exceptionally susceptible to the adverse effects of corticosteroids. In such cases, gastric lavage should be performed and symptomatic treatment initiated as necessary. Anaphylactic and hypersensitivity reactions may be treated with epinephrine (adrenaline), positive pressure ventilation, and euphylline. The patient should be kept warm and at rest. The plasma half-life of dexamethasone is approximately 190 minutes.
Adverse reactions
Summary of safety profile
The frequency of expected adverse reactions correlates with the relative activity of the substance, dose, time of administration and duration of treatment. The risk of side effects is low during short-term therapy, provided that dosage recommendations are followed and patients are carefully monitored.
Common side effects of short-term treatment with dexamethasone (days/weeks) include weight gain, psychiatric disorders, impaired glucose tolerance, and transient adrenal insufficiency. Long-term treatment with dexamethasone (months/years) typically causes central obesity, skin fragility, muscle atrophy, osteoporosis, growth retardation, and long-term adrenal insufficiency (see also section 4.4).
Adverse reactions (frequency unknown)
| Organ system classes | |
| Infections and infestations | Increased susceptibility to infections* or their exacerbation (latent), including sepsis, 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, coagulation disorders |
| On the part of the immune system | Allergic reactions, including anaphylaxis, decreased immunity (see also "Infections and invasions"). |
| From the endocrine system | Suppression of the hypothalamic-pituitary-adrenal axis and induction of Cushing's syndrome (typical symptoms: moon face, flushed cheeks (puffiness), obesity), secondary adrenal and pituitary insufficiency (especially with stress such as trauma or surgery), growth suppression in infants, children and adolescents, menstrual irregularities and amenorrhea, hirsutism |
| Metabolism and nutrition | Weight gain, negative protein and calcium balance, increased appetite, sodium and water retention, potassium loss* (caution: arrhythmia), hypokalemic alkalosis, manifestations of latent diabetes mellitus, impaired carbohydrate tolerance with the need to increase the dose of antidiabetic drugs*, hypercholesterolemia, hypertriglyceridemia |
| From the psyche* | Psychological dependence, depression, insomnia, exacerbation of schizophrenia, mental illnesses from euphoria to severe psychosis |
| Increased intracranial pressure with papilloedema in children (idiopathic intracranial hypertension), usually after discontinuation of treatment; manifestations of latent epilepsy, increased number of seizures in existing epilepsy, dizziness, headache |
| From the organs of vision | Increased intraocular pressure, glaucoma, papilloedema, cataract*, mainly with posterior subcapsular opacification, corneal and scleral atrophy, increased incidence of ophthalmic viral, fungal and bacterial infections, worsening of symptoms associated with corneal ulcers*, blurred vision, chorioretinopathy |
| From the heart | Rupture of the heart muscle after a recent myocardial infarction, congestive heart failure in susceptible patients, cardiac decompensation* |
| From the vascular side | Arterial hypertension, vasculitis, increased atherosclerosis and risk of thrombosis/thromboembolism (increased blood clotting can lead to thromboembolic complications) |
| Respiratory, thoracic and mediastinal disorders | Hiccup |
| Gastrointestinal tract | Dyspepsia, abdominal distension*, gastric ulcers with perforation and bleeding, acute pancreatitis, ulcerative esophagitis, esophageal candidiasis, flatulence, nausea, vomiting |
| Skin and subcutaneous tissue disorders | Hypertrichosis, skin atrophy, telangiectasias, striae, erythema, steroid acne, petechiae, ecchymoses, allergic dermatitis, urticaria, angioedema, hair thinning, pigmentation 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 femur and humerus, tendon rupture*, proximal myopathy, muscle weakness, muscle wasting |
| Reproductive system and breast disorders | Impotence |
| General reactions | Decreased response to vaccination and skin tests. Delayed wound healing, discomfort, malaise, corticosteroid withdrawal syndrome: Too rapid a reduction in the dose of corticosteroids after prolonged treatment can lead to acute adrenal insufficiency, hypotension and death. Withdrawal syndrome may manifest as fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful, itchy skin nodules and weight loss. |
*See also the section "Application features".
Description of selected adverse reactions
Adrenal insufficiency
Adrenal insufficiency caused by glucocorticoid treatment may, depending on the dose and duration of treatment, persist for many months, and in some cases for more than a year after discontinuation of treatment (see section "Special warnings and precautions for use").
Mental changes
Mental changes can take many forms, the most common of which is euphoria. Depression, psychotic reactions and suicidal tendencies are also possible. These conditions can be serious. They usually appear within a few days or weeks of starting the drug. They are more likely to occur with high doses. Most of these problems resolve when the dose is reduced or the drug is stopped (see section "Special warnings and precautions for use").
Infections
Treatment with dexamethasone may mask the symptoms of an existing or developing infection. This makes diagnosis difficult and may lead to increased risk of infection.
