Chemical formula: C₂₂H₂₉FO₅ Molecular mass: 392.461 g/mol PubChem compound: 5743
Dexamethasone interacts in the following cases:
Combination of dexamethasone with medicinal products that carry a risk of Torsades de Pointes requires precautions due to increased risk of ventricular arrhythmia. Any hypokalaemia should be corrected and patients should be monitored clinically, for electrolytes and by electrocardiography.
Combination of dexamethasone with non-steroidal anti-inflammatory drugs (NSAIDs) requires precautions due to an increased risk of gastrointestinal ulceration.
Topical gastro-intestinal medicinal products, antacids and activated carbon, as well as cholestyramine, may reduce dexamethasone plasma concentration due to reduction of the intestinal absorption of dexamethasone. The administration of such medicinal products and dexamethasone should be separated by at least two hours.
Combination of dexamethasone with laxatives requires precautions due to increased risk of hypokalaemia. Potassium levels should be monitored and corrected as necessary.
Combination of dexamethasone with hypoglycaemic medicinal products requires precautions as dexamethasone can raise glycaemic levels and diminish glucose tolerance, with a possibility of ketoacidosis. Patients should be made aware of this risk and self-monitoring of blood and urine should be reinforced, especially during the initiation of treatment. The posology of anti-diabetic medicinal products may have to be adjusted during and after the treatment with dexamethasone.
Concomitant administration of dexamethasone with oral anticoagulants could lead to increased clearance and decreased plasma concentrations of oral anticoagulants due to a possible impact of corticosteroids on the metabolism of the oral anticoagulant and on coagulation factors, as well as the haemorrhagic risk (mucosa of the digestive tract, vascular fragility) of dexamethasone therapy itself at high doses or treatment periods above 10 days. It the combination is required, monitoring should be reinforced and coagulation parameters controlled after one week and then every other week of treatment as well as after the end of treatment.
Combination of dexamethasone with anti-hypertensive medicinal products requires precautions due to a reduction of their effect (water and sodium retention). The dose of the anti-hypertensive treatment may have to be adjusted during the treatment with dexamethasone.
Combination of dexamethasone with hypokalemic diuretics requires precautions due to increased risk of hypokalaemia. Potassium levels should be monitored and corrected as necessary.
Estrogens increase the activity of corticosteroids.
Combination of dexamethasone with fluoroquinolones requires precautions due to possibly increased risk of tendonitis and, in exceptional cases, rupture of the affected tendon, particularly after long-term treatment.
Combination of dexamethasone with live attenuated vaccines should be avoided due to risk of vaccine-related illness with risk of death.
Combination of dexamethasone with acetylsalicylic acid should be avoided due to safety concerns, at doses ≥1 g per dose or 3 g per day, due to an increased risk of bleeding. At doses ≥500 mg per dose or <3 g per day, precautions are required due to increased risk of haemorrhage, ulcerations and gastro-intestinal perforation. However, antithrombotic prophylaxis with low-dose acetylsalicylic acid is possible.
Aminogluthetimide may reduces dexamethasone plasma concentration due to a reduction of the efficacy of dexamethasone through an increase of its hepatic metabolism.
Combination of dexamethasone with intravenous amphotericin B requires precautions due to increased risk of hypokalaemia. Potassium levels should be monitored and corrected as necessary. In addition, amphotericin B carries a risk of cardiac enlargement and cardiac failure with concurrent use.
Aprepitant and fosaprepitant may increase dexamethasone plasma concentration by a reduction of its hepatic metabolism.
Anticonvulsants that are hepatic enzyme inducers: carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone may reduce dexamethasone plasma concentration and hence its efficacy.
Concomitant administration of dexamethasone with ciclosporin could lead to increased clearance and decreased plasma concentrations of ciclosporin due to a reduction of ciclosporin bioavailability and plasma levels. Ciclosporin may also increase the intracellular uptake of dexamethasone. In addition, convulsions have been reported with concurrent use of dexamethasone and ciclosporin. Concomitant use of dexamethasone and ciclosporine should be avoided.
Clarithromycin, erythromycin, telithromycin, itraconazole, ketoconazole, posaconazole, voriconazole, nelfinavir, ritonavir may increase dexamethasone plasma concentration due to reduction of its hepatic metabolism.
Combination of dexamethasone with digitalis requires precautions as hypokalaemia enhances the toxic effects of digitalis. Any hypokalaemia should be corrected and patients should be monitored clinically, for electrolytes and by electrocardiograpy.
Concomitant administration of dexamethasone with docetaxel and cyclophosphamide could lead to increased clearance and decreased plasma concentrations of docetaxel and cyclophosphamide due to reduction of their plasma levels by induction of CYP3A and P-gp.
Ephedrine may reduces dexamethasone plasma concentration by increased metabolic clearance.
Concomitant administration of dexamethasone with erythromycin could lead to increased clearance and decreased plasma concentrations of erythromycin due to increased metabolism of erythromycin in non-carriers of the CYP3A5*1 allele after dexamethasone treatment.
Concomitant administration of dexamethasone with indinavir could lead to increased clearance and decreased plasma concentrations of indinavir by intestinal CYP3A4 induction.
Concomitant administration of dexamethasone with isoniazid could lead to increased clearance and decreased plasma concentrations of isoniazid probably due to a stimulation of hepatic metabolism of isoniazid and a reduction of glucocorticoid metabolism.
Concomitant administration of dexamethasone with ivermectin could lead to increased clearance and decreased plasma concentrations of ivermectin. Parasite eradication must be successfully terminated before dexamethasone use.
Concomitant administration of dexamethasone with lapatinib could lead to increased clearance and decreased plasma concentrations of lapatinib due to increased hepatotoxicity of lapatinib likely due to induction of CYP3A4 metabolism.
The combination of dexamethasone with lenalidomide in multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients compared with 0.6% in placebo/dexamethasone-treated patients). Grade 4 febrile neutropenia episodes were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 0.0% in placebo/dexamethasone treated patients). Neutropenia was the most frequently reported Grade 3 or 4 haematological adverse reaction in patients with relapsed/refractory multiple myeloma treated with the combination of dexamethasone with pomalidomide. Patients should be monitored for haematological adverse reactions, especially neutropenia. Patients should be advised to promptly report febrile episodes. A dose reduction of lenalidomide or pomalidomide may be required. In case of neutropenia, the physician should consider the use of growth factors in patient management.
The combination of dexamethasone with lenalidomide in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients). Thrombocytopenia was also reported very commonly by patients with relapsed/refractory multiple myeloma treated with the combination of dexamethasone with pomalidomide. Patients and physicians are advised to be observant for signs and symptoms of bleeding, including petechiae and epistaxes, especially in case of concomitant treatment susceptible to induce bleeding. A dose reduction of lenalidomide or pomalidomide may be required.
A complete blood cell count, including white blood cell count with differential count, platelet count, haemoglobin, and haematocrit should be performed at baseline, every week for the first 8 weeks of dexamethasone/lenalidomide treatment and monthly thereafter to monitor for cytopenias.
Combination of dexamethasone with methotrexate requires precautions due to an increased risk of haematological toxicity.
Concomitant administration of dexamethasone with midazolam could lead to increased clearance and decreased plasma concentrations of midazolam by CYP3A4 induction. The efficacy of midazolam may be reduced.
Concomitant administration of dexamethasone with praziquantel could lead to increased clearance and decreased plasma concentrations of praziquantel due to an increase of its hepatic metabolism by dexamethasone, with a risk of failure of treatment. The treatments with the two medicinal products should be separated by at least one week.
Concomitant administration of dexamethasone with rifabutin could lead to increased clearance and decreased plasma concentrations of rifabutin by induction of intestinal and hepatic CYP3A4.
Rifampicin may reduces dexamethasone plasma concentration and efficacy by an increase of its hepatic metabolism.
Combination of dexamethasone with tetracosactide requires precautions due to increased risk of hypokalaemia. Potassium levels should be monitored and corrected as necessary.
Treatment for active gastric or duodenal ulceration should be commenced prior to initiation of corticosteroids. Appropriate prophylaxis should be considered for patients with a previous history of, or risk factors for, gastric or duodenal ulceration, haemorrhage or perforation. Patients should be monitored clinically, including by endoscopy.
Systemic treatment with glucocorticoids can induce chorioretinopathy which may result in impaired vision including loss of vision.
Corticosteroids can favour the development of tendonitis and, in exceptional cases, rupture of the affected tendon. This risk is increased by concomitant use of fluoroquinolones and in patients undergoing dialysis with secondary hyperparathyroidism or after renal transplantation.
Prolonged use of corticosteroids may produce subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Particular care is needed when treating patients with glaucoma (or family history of glaucoma) as well as when treating patients with ocular herpes simplex, because of possible corneal perforation.
Treatment with high-dose dexamethasone increases the risk of developing serious infections, in particular due to bacteria, yeasts and/or parasites. Such infections can also be caused by microorganisms that rarely cause disease under normal circumstances (opportunistic infections). Signs of a developing infection may be masked by dexamethasone therapy.
Before the start of treatment, any source of infection, especially tuberculosis, should be removed. During treatment, patients should be closely monitored for the appearance of infections. In particular, pneumonia occurs commonly. Patients should be informed of the signs and symptoms of pneumonia and be advised to seek medical attention in case of their appearance. In case of active infectious disease, appropriate anti- infective treatment must be added to the treatment with dexamethasone.
In cases of prior tuberculosis with major radiological sequelae or if it is not certain that a full 6-month rifampicin treatment course has been followed, a prophylactic anti-tuberculosis treatment is required.
There is a risk of severe strongyloidiasis. Patients from endemic areas (tropical and sub-tropical regions, southern Europe) should have a stool examination and if required an eradication of the parasite before initiating dexamethasone treatment.
Certain viral diseases (varicella, measles) can be aggravated in patients receiving glucocorticoid treatment or who have received glucocorticoid treatment within the previous 3 months. Patients must avoid contact with subjects with chickenpox or measles. Immunocompromised patients who have not previously had chickenpox or measles are particularly at risk. If such patients have been in contact with people with chickenpox or measles, a preventive treatment with intravenous normal immunoglobulin or passive immunisation with varicella zoster immunoglobulin (VZIG) must be started as appropriate. Exposed patients should be advised to seek medical attention without delay.
Dexamethasone should not be used with live attenuated vaccines. Vaccinations with inactivated vaccines are usually possible. However, the immune response and hence the effect of the vaccination can be diminished by high glucocorticoid doses.
Dexamethasone can suppress skin reaction to allergy testing. It can also affect the nitro blue tetrazolium (NBT) test for bacterial infections and cause false-negative results.
Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids. Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses, although dose levels do not allow prediction of the onset, type severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during, or immediately after, dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychoses.
Insomnia may be minimised by administering dexamethasone in the morning.
Based on human experience, dexamethasone is suggested to cause congenital malformations, particularly intra-uterine growth retardation and rarely neonatal adrenal insufficiency, when administered during pregnancy.
Studies in animals have shown reproductive toxicity.
Dexamethasone should not be used during pregnancy unless the clinical condition of the woman requires treatment with dexamethasone.
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 foetal 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.
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.
There are no or limited amount of data from the use of dexamethasone eye drops in pregnant women. Studies in animals have shown that topically applied steroids can be absorbed systemically and can cause abnormalities of foetal development in pregnant animals. Although the relevance of these findings to human beings has not been established, the use of dexamethasone eye drops during pregnancy should be avoided.
Studies in animals have shown teratogenic effects following topical ophthalmic administration. There are no adequate data from the use of intravitreally administered dexamethasone in pregnant women. Long-term systemic treatment with glucocorticoids during pregnancy increases the risk for intra-uterine growth retardation and adrenal insufficiency of the newborn child. Therefore, although the systemic exposure of dexamethasone would be expected to be very low after local, intraocular treatment, dexamethasone is not recommended during pregnancy unless the potential benefit justifies the potential risk to the foetus.
Glucocorticoids are excreted in human milk and effects have been shown in breastfed newborns/infants of treated women. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from dexamethasone therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
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.
Systemically administered corticosteroids appear in human milk in quantities that could affect the child being breastfed. However, when instilled topically, systemic exposure is low. It is unknown whether dexamethasone is excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from dexamethasone therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Dexamethasone is excreted in breast milk. No effects on the child are anticipated due to the route of administration and the resulting systemic levels. However dexamethasone is not recommended during breast feeding unless clearly necessary.
Women should avoid pregnancy during dexamethasone treatment. Dexamethasone may cause congenital malformations. Dexamethasone may be used with known teratogens (e.g. thalidomide, lenalidomide, pomalidomide, plerixafor), or with cytotoxic substances which are contraindicated in pregnancy. Patients receiving dexamethasone in combination with products containing thalidomide, lenalidomide or pomalidomide should adhere to the pregnancy prevention programmes of those products.
Women of childbearing potential and their male partners should take appropriate contraceptive measures. In particular, the requirements of the pregnancy prevention programme for combination treatment with thalidomide or its analogues must be followed. The efficacy of oral contraceptives may be reduced during dexamethasone treatment.
There are no fertility data available.
Dexamethasone has moderate influence on the ability to drive and use machines. Dexamethasone may cause confusional state, hallucinations, dizziness, somnolence, fatigue, syncope and blurred vision. If affected, patients should be instructed not to drive, use machines or perform hazardous tasks while being treated with dexamethasone.
Not relevant.
Dexamethasone eye drops have no or negligible influence on the ability to drive and use machines; however, instillation of eye drops may cause transient blurring of vision. Warn patients not to drive or operate hazardous machinery until vision is clear.
Dexamethasone may have a moderate influence on the ability to drive and use machines. Patients may experience temporarily reduced vision after receiving OZURDEX by intravitreal injection. They should not drive or use machines until this has resolved.
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