dexamethasone
Regulatory sources consulted
Approved indications
- Pemphigus, myositis, adult immune thrombocytopenic purpura, metastatic spinal cord compression, prevention or treatment of chemotherapy-induced emesis, and selected hematologic cancers in combination.
Contraindications
Absolute
- Systemic infection without specific treatment; gastric or duodenal ulcer; live vaccines during high therapeutic doses.
- Hypersensitivity to dexamethasone or excipients.
Clinical warnings
- Major warning · Use the lowest effective dose and taper gradually after prolonged treatment; abrupt withdrawal can precipitate adrenal insufficiency. — CIMA/AEMPS, ficha técnica 86125
- Major warning · It may increase susceptibility to infection, reactivate latent infections, and mask their signs. Avoid live vaccines at immunosuppressive doses. — CIMA/AEMPS, ficha técnica 86125
- Major warning · Monitor glucose, blood pressure, electrolytes, bone health, psychiatric symptoms, and ocular and gastrointestinal complications during systemic treatment. — CIMA/AEMPS, ficha técnica 86125
Drug interactions
- ModerateCYP3A4 inhibitors or inducers
Mechanism: They may increase or decrease systemic glucocorticoid exposure.
Recommendation: Monitor efficacy and toxicity and adjust only under clinical supervision.
CIMA/AEMPS, ficha técnica 86125
- HighLive vaccines
Mechanism: Immunosuppression may promote disseminated infection and reduce vaccine response.
Recommendation: Avoid live vaccines during immunosuppressive treatment; plan vaccination with the treating team.
CIMA/AEMPS, ficha técnica 86125
- ModerateAntidiabetic drugs, diuretics, and NSAIDs
Mechanism: Glucocorticoids may oppose glycemic control, worsen potassium loss, and increase gastrointestinal risk.
Recommendation: Monitor glucose and electrolytes and consider gastroprotection or alternatives according to risk.
CIMA/AEMPS, ficha técnica 86125
Adverse events
Rare but serious
Adrenal insufficiency, opportunistic infection, gastrointestinal bleeding, psychosis, and osteonecrosis
Pregnancy and lactation
During pregnancy, use only if the expected benefit outweighs the risk and monitor the newborn after high or prolonged doses. During breastfeeding, individualize according to dose and duration.
Recent literature (PubMed)
Glucocorticoids are the mainstay for the treatment of croup. The existing evidence demonstrates that glucocorticoids are effective in the treatment of croup in children. However, updating the evidence on their clinical relevance in croup is imperative. This is an update to a review first published in 1999, and updated in 2004, 2011, and 2018. To investigate the effects and safety of glucocorticoids in the treatment of croup in children aged 18 years and below. We searched the Cochrane Library, which includes the Cochrane Central Register of Controlled Trials (CENTRAL; 2022 Issue 9), Ovid MEDLINE Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Ovid MEDLINE (1946 to 4 March 2022), Embase (Ovid) (1974 to 4 March 2022). We also searched the WHO ICTRP and ClinicalTrials.gov on 4 March 2022. We included randomised controlled trials (RCTs) in children (aged 18 years and below) with croup. We assessed the effect of glucocorticoids compared to the following: placebo, any other pharmacologic agents, any other glucocorticoids, any combination of other glucocorticoids, given by different modes of administration, or given in different doses. The included studies must have assessed at least one of our primary outcomes (defined as the change in croup score or return visits, (re)admissions to the hospital or both) or secondary outcomes (defined as the length of stay in hospital or emergency departments, patient improvement, use of additional treatments, or adverse events). Review authors independently extracted data, with another review author verified. We entered the data into Review Manager 5 for meta-analysis. Two review authors independently assessed studies for risk of bias using the Cochrane risk of bias tool. Two review authors assessed the certainty of the evidence for the primary outcomes using the GRADE approach. This updated review includes 45 RCTs with a total of 5888 children, an increase of two RCTs with 1323 children since the last update. We also i
Amivantamab, an EGFR-MET bispecific antibody, is approved for multiple indications in EGFR-mutated advanced NSCLC as monotherapy or combined with other agents. Intravenous amivantamab is associated with a 67% infusion-related reaction (IRR) rate. The phase 2 SKIPPirr study (NCT05663866) enrolled participants with EGFR-mutated (exon 19 deletion or exon 21 L858R) advanced NSCLC after progression on osimertinib and platinum-based chemotherapy who received intravenous amivantamab plus oral lazertinib (amivantamab-lazertinib), a third-generation tyrosine kinase inhibitor. Aiming to mitigate IRRs, four independent prophylactic approaches were evaluated using Simon's two-stage design with an expansion stage if a cohort passed both stages: oral dexamethasone 4 mg twice daily given on cycle (C) 1 day (D) -1 (two doses); oral dexamethasone 8 mg twice daily given on C1D-2, C1D-1, and the morning of C1D1 (five doses); oral montelukast 10 mg once daily given on C1D-4, C1D-3, C1D-2, C1D-1, and C1D1 (five doses); subcutaneous methotrexate 25 mg (one dose) given anytime between C1D-7 and C1D-3. The primary end point was C1D1 IRR incidence. As of June 24, 2024, 68 participants were treated across all cohorts. The dexamethasone 8 mg cohort passed stages 1 and 2 proceeding to the expansion stage, with 24 additional participants treated. At C1D1, nine of 40 participants (22.5%) experienced IRRs, resulting in an approximately threefold decrease versus historical data (67.4%). By the end of C3, 10 of 41 participants (24.4%) in the dexamethasone 8 mg cohort experienced IRRs (grades 1-2, except one grade 3 on C2D1). Amivantamab-lazertinib's safety and efficacy were consistent with previous reports. Prophylaxis with 8 mg oral dexamethasone meaningfully reduced IRRs and can be readily implemented in clinical practice.
- Systemic Postnatal Corticosteroids, Bronchopulmonary Dysplasia, and Survival Free of Cerebral Palsy.
Systemic postnatal corticosteroids have been shown to reduce rates of bronchopulmonary dysplasia (BPD) in infants born preterm, but both corticosteroids and BPD are associated with cerebral palsy. To describe how the association between systemic postnatal corticosteroids and survival free of cerebral palsy varies with the risk of BPD in infants born preterm, and if the association differs between dexamethasone and hydrocortisone, or with age at starting treatment. This comparative effectiveness research used weighted meta-regression analysis of eligible randomized clinical trials (RCTs) of systemic postnatal corticosteroids reported from June 1989 through March 2022 that included rates of all of BPD, mortality, and cerebral palsy in neonatal intensive care units in 10 countries. Infants born preterm at risk of BPD were included. Data were analyzed from April and July 2024. Systemic dexamethasone or hydrocortisone. Type and timing of corticosteroid, control group rate of BPD, and risk difference in survival free of cerebral palsy between corticosteroid and control arms. Twenty-six RCTs with data on 3700 randomized infants were eligible; 18 (69%) investigated dexamethasone and 8 (31%) hydrocortisone; 12 (46%) started treatment in the first week after birth. There was evidence for a differential association of the type of corticosteroid with the effect of systemic dexamethasone on survival free of cerebral palsy and the risk of BPD in control groups (interaction coefficient, 0.54; 95% CI, 0.25-0.82; P = .001). For dexamethasone, for every 10-percentage point increase in the risk of BPD, the risk difference for survival free of cerebral palsy increased by 3.74% (95% CI, 1.54 to 5.93; P = .002). Dexamethasone was associated with improved survival free of cerebral palsy at a risk of BPD greater than 70%. Conversely, dexamethasone was associated with harm at a risk of BPD less than 30%. There was some evidence for a negative association with hydrocortisone, with possible b
The prophylaxis and treatment of postoperative pain to enhance patient comfort has been a primary goal of anesthesiologists for the last decades; however, avoiding postoperative nausea and vomiting (PONV) is, from a patient's perspective, a highly relevant and equally important goal of anesthesia. Recent consensus-based guidelines suggest the assessment of risk factors including female gender, postoperative opioid administration, non-smoking status, a history of PONV or motion sickness, young patient age, longer duration of anesthesia, volatile anesthetics and the type of surgery and reducing the patient's baseline risk (e.g. through the use of regional anesthesia and administration of non-opioid analgesics as part of a multimodal approach). In general, a liberal PONV prophylaxis is encouraged for adult patients and children, which should also be administered when no risk assessment is made. The basis for every adult patient should be a standard prophylaxis with two antiemetics, such as dexamethasone in combination with a 5-HT3 receptor antagonist. In patients at high risk, this should be supplemented by a third and potentially a fourth antiemetic prophylaxis with a different mechanism of action. A recently published comprehensive Cochrane meta-analysis comparing available antiemetic prophylaxes reported the highest effectiveness to prevent PONV for the NK1 receptor antagonist aprepitant (relative risk, RR 0.26), followed by ramosetron (RR 0.44), granisetron (RR 0.45), dexamethasone (RR 0.51) and ondansetron (RR 0.55), thereby revising the dogma that every antiemetic is equally effective. Adverse events of antiemetics were generally rare and reported in less than half of the included studies, yielding a low quality of evidence for these end points. In general, combinations of different antiemetics were more effective than single prophylaxes. In children above 3 years of age, the same principles should be applied as in adults. For these patients, there is a high degr
Synthetic glucocorticoids are widely used to treat patients with a broad range of diseases. While efficacious, glucocorticoids can be accompanied by neuropsychiatric adverse effects. This systematic review and meta-analysis assesses and quantifies the proportion of different neuropsychiatric adverse effects in patients using synthetic glucocorticoids. Six electronic databases were searched to identify potentially relevant studies. Randomized controlled trials, cohort studies, and cross-sectional studies assessing psychiatric side effects of glucocorticoids measured with validated questionnaires were eligible. Risk of bias was assessed with RoB 2, ROBINS-I, and AXIS appraisal tool. For proportions of neuropsychiatric outcomes, we pooled proportions, and when possible, differences in questionnaire scores between glucocorticoid users and nonusers were expressed as standardized mean differences (SMD). Data were pooled in a random-effects logistic regression model. We included 49 studies with heterogeneity in study populations, type, dose, and duration of glucocorticoids. For glucocorticoid users, meta-analysis showed a proportion of 22% for depression (95% CI, 14%-33%), 11% for mania (2%-46%), 8% for anxiety (2%-25%), 16% for delirium (6%-36%), and 52% for behavioral changes (42%-61%). Questionnaire scores for depression (SMD of 0.80 [95% CI 0.35-1.26]), and mania (0.78 [0.14-1.42]) were higher than in controls, indicating more depressive and manic symptoms following glucocorticoid use. The heterogeneity of glucocorticoid use is reflected in the available studies. Despite this heterogeneity, the proportion of neuropsychiatric adverse effects in glucocorticoid users is high. The most substantial associations with glucocorticoid use were found for depression and mania. Upon starting glucocorticoid treatment, awareness of possible psychiatric side effects is essential. More structured studies on incidence and potential pathways of neuropsychiatric side effects of prescribe