Abbreviated Prescribing Information: DEXOL 2mg/5ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A colourless to faint yellow oral solution with an odour of mint containing 2mg Dexamethasone as dexamethasone sodium phosphate. Therapeutic Indications: Dexamethasone is a corticosteroid indicated for use in certain endocrine and non- endocrine disorders, cerebral oedema, and diagnostic testing of adrenocortical hyperfunction. It is used in endocrine exophthalmos and a wide range of corticosteroid-responsive non-endocrine conditions including anaphylaxis; arteritis and collagen disorders such as polymyalgia rheumatica and polyarteritis nodosa; haematological conditions like haemolytic anaemia, leukaemia, myeloma, and idiopathic thrombocytopenic purpura; gastrointestinal diseases including ulcerative colitis (rectal only), Crohn’s disease, and certain hepatitis forms; polymyositis; neurological conditions such as raised intracranial pressure due to cerebral tumours and acute multiple sclerosis exacerbations; ocular inflammations including uveitis, optic neuritis, and orbital pseudotumour; nephrotic syndrome; pulmonary conditions such as asthma, COPD, aspiration pneumonitis, sarcoidosis, allergic pulmonary diseases, Löffler’s syndrome, and fibrosing alveolitis; rheumatic diseases including rheumatoid arthritis (and juvenile forms), lupus erythematosus, and temporal arteritis; severe dermatological conditions like pemphigus vulgaris, Stevens-Johnson syndrome, and mycosis fungoides; oncological uses including lymphatic leukaemia, malignant lymphoma, metastasised breast cancer, and hypercalcaemia due to bone metastases or Kahler’s disease. It is also used in severe allergic reactions, as an immunosuppressant in organ transplantation, and as an adjuvant in managing emetogenic cancer therapies. In paediatrics, it is indicated for croup syndromes, and in infectious disease, for treating COVID-19 in adults and adolescents (≥12 years, ≥40 kg) requiring supplemental oxygen therapy. Posology and Method of Administration: Dexamethasone dosing in adults should be tailored to the individual’s condition and response, with the lowest effective dose used to minimise side effects. Initial doses typically range from 0.5–9 mg daily, with higher doses for severe conditions, and maintenance doses should ideally not exceed 1.5 mg/day. Dosage may need adjustment during stress (e.g. surgery, infection), and gradual withdrawal is advised after prolonged use. For acute allergic conditions, a combined schedule of intramuscular injection followed by tapering oral doses over eight days is recommended. In cerebral oedema, initial treatment is via injection, transitioning to oral maintenance (e.g. 2 mg two to three times daily). For diagnostic suppression tests in Cushing’s syndrome, specific oral dosing protocols are used over 1–2 days with cortisol and urine assessments. In COVID-19, adults should receive 6 mg orally once daily for up to 10 days. No dose adjustment is needed for elderly or those with renal/hepatic impairment, though long-term treatment in the elderly should be approached cautiously due to increased risk of side effects. Paediatric population: In children, dexamethasone should be used with caution due to the risk of growth retardation. Dosing should be determined individually, with preference for alternate-day single dosing to minimise hypothalamo-pituitary-adrenal axis suppression. For childhood croup, a single dose of 0.15 mg/kg oral solution is recommended, with a second dose after 12 hours if needed, not exceeding a total of 10 mg. In COVID-19, adolescents aged 12 years and older weighing at least 40 kg should receive 6 mg orally once daily for up to 10 days. Oral administration is standard, but nasogastric or PEG tube routes are also suitable. Contraindications: Hypersensitivity to dexamethasone or any of the excipients. Systemic infection unless specific anti-infective therapy is employed. Systemic fungal infections. Stomach or duodenal ulcer. Infection with tropical worms. Parasitic infection. Avoid live vaccines in patient receiving immunosuppressive doses. In general, no contraindications apply in conditions where the use of glucocorticoids may be life-saving. Special Warnings and Precautions for use: Dexamethasone should be used with caution, and patients must be provided with a steroid treatment card and patient information leaflet. The lowest effective dose for the shortest duration should be used, with gradual tapering to avoid adrenal insufficiency. Corticosteroids may mask infections, exacerbate systemic fungal infections, and reduce vaccine efficacy. Serious infections such as tuberculosis, chickenpox, and measles may be more severe in immunosuppressed patients, requiring prophylactic or urgent treatment. Use in cerebral malaria, ocular herpes simplex, and glaucoma requires particular care. Electrolyte disturbances, hypertension, and fluid retention may occur, especially in patients with renal or cardiac conditions. Psychiatric reactions, including mood changes and psychosis, may arise and require monitoring. Visual disturbances and rare conditions like central serous chorioretinopathy have been reported. Use in children may cause growth retardation and epiphyseal closure; in preterm neonates, early treatment (within 96 hours) at doses of 0.25 mg/kg twice daily has been associated with long-term neurodevelopmental adverse events. In the elderly, side effects may be more severe. Corticosteroids may activate latent infections and should be avoided in patients with pheochromocytoma unless benefits outweigh risks. Tumour lysis syndrome has been reported in haematological malignancies. Close monitoring is essential in patients with comorbidities such as diabetes, osteoporosis, peptic ulcer, liver or renal impairment, and those with a history of severe affective disorders or hypersensitivity reactions. Any warning from the MC, CHM CSM or MHRA: No. Black Triangle notice: Not applicable. The reported adverse reactions are: Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis, severe Varicella zoster virus infection. Decreased resistance to infection, decreased responsiveness to vaccination and skin tests, leucocytosis, hypersensitivity including anaphylaxis, menstrual irregularities and amenorrhoea, suppression of the hypothalamic-pituitary-adrenal axis, premature epiphyseal closure, development of Cushingoid state, hirsutism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness), negative protein and calcium balance, sodium retention, fluid retention, potassium loss, hypokalaemic alkalosis, increased calcium excretion, lipoprotein deficiency, increased appetite, impaired carbohydrate tolerance with increased requirement for anti-diabetic therapy, in post-marketing experience tumour lysis syndrome(TLS) has been reported very rarely. Convulsions and aggravation of epilepsy, vertigo, headache, increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal, psychological dependence, depression, insomnia, aggravation of schizophrenia and psychic disturbances ranging from euphoria to frank psychotic manifestations, a wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances and cognitive dysfunction including confusion and amnesia, psychological effects have been reported on withdrawal of corticosteroids, posterior subcapsular cataracts, increased intra-ocular pressure, glaucoma, papilloedema, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases, exophthalmos, vision blurred, chorioretinopathy, congestive heart failure in susceptible patients, myocardial rupture following recent myocardial infarction, thromboembolism, hypertension. Dyspepsia, peptic ulceration with perforation and haemorrhage, acute pancreatitis, candidiasis, abdominal distension and vomiting, ulcerative oesophagitis, perforation of the small and large bowel, nausea, hiccups, impaired wound healing, thin fragile skin, petechiae and ecchymoses, erythema, striae, telangiectasia, acne, increased sweating, suppressed reaction to skin tests, allergic dermatitis, urticaria, angioneurotic oedema, thinning scalp hair, osteoporosis, vertebral and long bone fractures, avascular necrosis, tendon rupture, proximal myopathy, muscle weakness, aseptic necrosis of femoral and humeral heads, loss of muscle mass, growth suppression in infants, children and adolescents, malaise, oedema, abnormal fat deposits, increased or decreased motility and spermatozoa, and weight gain. Please consult the SmPC for full details of other adverse reactions. Pack Size and NHS Price: 75ml £21.15, 150ml £42.30. Marketing Authorisation Number: UK: PL 00427/0137. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE. Legal Category Prescription only medicine. Date of Preparation 20 August 2025