Drosone® For Healthcare Professionals

Drosone® contains hydrocortisone as its active substance, the active form of naturally produced cortisol. Cortisol is synthesised in the adrenal cortex from cortisone, which is inactive until it is converted to the active hydrocortisone. Hydrocortisone belongs to the short-acting glucocorticoids, with an average duration of action of 8-12 hours. It is included in the  World Health Organization’s List of Essential Medicines, where the most effective and safest medicines needed in a health system are listed.

Drosone® soluble tablets are indicated for replacement therapy in congenital adrenal hyperplasia in children.

Drosone® soluble tablets are also used for the emergency treatment of severe bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema and anaphylaxis in adults and children.

Dosage

Replacement therapy

Paediatric population: 10-30mg in divided doses is the usual daily requirement.

In patients who need replacement therapy, the daily dose should be given, where possible, in two doses. The first dose, taken in the morning, should be larger than the second dose, taken in the evening, thereby mimicking the normal daily rhythm of cortisol secretion.

Acute emergency situations

60-80mg every 4-6 hours for 24 hours, followed by gradual dose reduction over a few days.

Elderly

Steroids should be used with caution in the elderly, because adverse reactions are intensified in patients of advanced age.

When long-term treatment is to be discontinued, the dose should be reduced gradually over a period of several weeks or months, depending on the dose and duration of treatment (see section 4.4). Adverse reactions can be minimised by using the lowest effective dose for the shortest possible period, and by administering the daily requirement as a single morning dose or, when possible, as a single morning dose every other day. Frequent examination of patients is required to titrate the dose against disease activity.

Method of administration

Drosone® soluble tablets must be dissolved in (at least 50ml of) water before use. After dissolving, take it immediately.

Blood and lymphatic system disorders: Leukocytosis

Immune system disorders: Hypersensitivity.

Endocrine disorders: Increase or decrease in motility and number of spermatozoa, menstrual irregularities, amenorrhoea, development of a condition resembling Cushing’s syndrome, suppression of growth in children, secondary absence of adrenocortical and pituitary responsiveness (particularly in stressful situations, such as trauma, surgery or illness), decreased carbohydrate tolerance, manifestation of latent diabetes mellitus, hyperglycaemia, increased requirement for insulin or oral hypoglycaemic agents in diabetes, hirsutism.

Metabolism and nutrition disorders: Sodium retention, fluid retention, potassium loss, hypokalaemic alkalosis, increased calcium excretion, negative nitrogen balance due to protein catabolism, weight gain, increased appetite.

Psychiatric disorders: mental disorders, psychological dependence, insomnia. A wide range of psychiatric reactions has been reported, including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delirium, hallucinations and exacerbation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances and cognitive dysfunction, including confusion and amnesia. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated at 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; however, the frequency is unknown.

Nervous system disorders: Convulsions, increased intracranial pressure with papilloedema (pseudotumour cerebri), usually after treatment, vertigo, headache, malaise.

Eye disorders: posterior subcapsular cataract, increased intraocular pressure, papilloedema, thinning of the cornea or sclera, exacerbation of viral eye infections, glaucoma, exophthalmos, blurred vision (frequency not known).

Gastrointestinal disorders: Peptic ulcer with possible perforation and haemorrhage, perforation of the small and large bowel, particularly in patients with inflammatory bowel disease, pancreatitis, abdominal distension, ulcerative oesophagitis, dyspepsia, oesophageal candidiasis, nausea.

Skin and subcutaneous tissue disorders: Delayed wound healing, thin fragile skin, petechiae and ecchymoses, erythema, striae, telangiectasia, acne and increased sweating may suppress reactions to skin tests, other skin reactions such as allergic dermatitis, urticaria, angioneurotic oedema.

Musculoskeletal, connective tissue and bone disorders: Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis (particularly in postmenopausal women), vertebral compression fractures, aseptic necrosis of the femoral and humeral head, pathological fractures of long bones, tendon rupture.

Cardiac disorders: Myocardial rupture following recent myocardial infarction, congestive heart failure in susceptible patients. Hypertrophic cardiomyopathy in premature neonates, frequency not known.

Vascular disorders: thromboembolism, hypertension.

Respiratory, thoracic and mediastinal disorders: Hiccups.

Other: Hypersensitivity, leukocytosis, weight gain, increased appetite, nausea, malaise.

Investigations: Weight gain, frequency not known.

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Endocrine Society: Primary Adrenal Insufficiency Guideline Resources