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Dexamethasone Abbreviated Prescribing Information

Abbreviated Prescribing Information: DEXSOL 2mg/5ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A colourless to faint yellow solution with an odour of mint containing 2mg Dexamethasone as dexamethasone sodium phosphate in each 5ml. Therapeutic Indications: Dexamethasone is a corticosteroid. It is designed for use in certain cases of cerebral oedema and certain endocrine and non-endocrine disorders; Allergy and anaphylaxis; Arteritis collagenosis; Haemotological disorders; Gastroenterological disorders; Muscular disorders; Neurological disorders; Ocular disorders; Renal disorders; Pulmonary disorders; Rheumatic disorders; Skin disorders; Oncological disorders; Intense allergic reactions; as immunosuppressant in organ transplantation; as an adjuvant in the prevention of nausea and vomiting and in the treatment of cancer with oncolytics that have a serious emetic effect; Heterogeneous group of illnesses affecting the larynx, trachea and bronchi, and  Covid-19: in adult and adolescent patients who require supplemental oxygen therapy. Posology and Method of Administration: Adults: The dosage should be titrated to the individual response and the nature of the disease. The lowest effective possible dosage should be used. The initial dosage varies from 0.5 – 9mg a day. In more severe diseases, doses higher than 9mg may be required. If satisfactory response does not occur after a reasonable time, discontinue treatment and transfer the patient to another therapy. Chronic dosage should preferably not exceed 1.5mg daily. If the drug is to be stopped after more than a few days of treatment, it should be withdrawn gradually. If a dose less then 5ml is required, an oral dosing device should be employed. Paediatric: Dosage should be limited to a single dose on alternate days. Childhood Croup: A single dose of 0.15mg/kg is recommended. A second dose may be administered after 12 hours, if considered necessary by the treating physician. However, no more than a maximum of 10mg is recommended. Elderly: Care should be takenFor the treatment of Covid-19, 6 mg orally, once a day for up to 10 days are recommended for adults and paediatric patients (adolescents aged 12 years and older with body weight at least 40kg). Oral use, suitable for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy tubes (PEG). 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. Avoid live vaccines in patients receiving immuno suppressive doses. In general, no contraindications apply in conditions where the use of glucocorticoids may be lifesaving. Special Warnings and Precautions for use: Corticosteroids should only be used in systemic fungal infections to control drug reactions due to amphotericin. Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may be atypical. Appropriate anti-microbial therapy should accompany glucocorticoid therapy when necessary. There may be decreased resistance and inability to localise infection in patients on corticosteroids. Treatment of acute respiratory distress syndrome with corticosteroids should be initiated within the first two weeks of onset.  Chickenpox and measles are of particular concern. Exposed patients should be advised to seek medical advice without delay. Corticosteroids may activate latent infections or exacerbate active disease due to pathogen. Should not be used in cerebral malaria. Prolonged use 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. Salt restriction and potassium supplementation may be necessary. Calcium excretion will be increased. Adrenal cortical atrophy develops during prolonged therapy. Withdrawal after prolonged therapy must always be gradual. During prolonged therapy, any intercurrent illness, trauma, stress or surgical procedure will require a temporary increase in dosage; if corticosteroids have been stopped following prolonged therapy they may need to be temporarily re-introduced. Patients under stress may require increased doses prior, during and after the period of stressful situation. Stopping corticosteroids after prolonged therapy may cause withdrawal symptoms including fever, myalgia, arthralgia and malaise. There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis. Particular care is required with the following conditions: renal insufficiency, hypertension or congestive heart failure, diabetes mellitus (or a family history of diabetes), osteoporosis, previous corticosteroid-induced myopathy, glaucoma (or family  history of glaucoma), myasthenia gravis, non-specific ulcerative colitis, diverticulitis or fresh intestinal anastomosis, peptic ulceration, existing or previous history of severe affective disorders (especially previous steroid psychosis), liver failure, epilepsy, migraine, history of allergy to corticosteroids, tuberculosis, herpes simplex, psychiatric disorders. Fat embolism has been reported as a possible complication of hypercortisonism. Large doses may mask the symptoms of gastro-intestinal perforation.  Use with great caution after recent myocardial infarction. Decrease or withdrawal could reveal underlying diseases that are accompanied by eosinophilia in patients with asthma. Potentially severe psychiatric adverse reactions may occur. Seek medical advice if worrying psychological symptoms develop. Particular care is required in patients with or having close relatives with existing history of severe affective disorders. Children on prolonged therapy should be carefully monitored for growth retardation. Preterm neonates: Evidence of long-term neurodevelopmental adverse events after early treatment (<96 hours) in chronic lung disease. Tumour lysis syndrome (TLS) has been reported in patients with haematological malignancies. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation. Visual disturbance may be reported with systemic and topical corticosteroid use. Any warning from the MC, CHM CSM or MHRA: No. Black Triangle notice: Not applicable. Legal Category: POM. The reported adverse reactions are: Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis, 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, Negative protein and calcium balance, Sodium retention, Fluid retention, Potassium loss, Hypokalaemic alkalosis, Increased calcium excretion, Increased appetite, Impaired carbohydrate tolerance with increased requirement for anti-diabetic therapy, 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, Affective disorders, Psychotic reactions, Behavioural disturbances, Irritability, Anxiety, Sleep disturbances and cognitive dysfunction including confusion and amnesia, 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, Abnormal fat deposits, Increased or decreased motility and spermatozoa, and  Weight gain. Pack Size and NHS Price: 75ml – -£21.15 and 150ml-£42.30. Marketing Authorisation Number: UK: PL 00427/0137 and IE: PA23081/006/001. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE. Date of Preparation: April 2023.

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400