Choose the IR hydrocortisone that can be used to treat adrenal insuffi ciency in all ages


●


The only immediate release hydrocortisone tablet licensed for use in adults with primary, secondary or acute adrenal insuffi ciency¹


● Also licensed for use in children in chronic adrenocortical insuffi ciency¹ ● Tablets can be halved and quartered for ease of dose adjustment¹


Actavis hydrocortisone – licensed for use in all ages


Prescribing Information Hydrocortisone Auden Please refer to the Summary of Product Characteristics (SPC) before prescribing. Presentation: Tablet of 10mg, 20mg hydrocortisone. Indications: Replacement therapy in primary, secondary, or acute adrenocortical insuffi ciency. Pre-operatively and during serious trauma or illness in patients with known adrenal insuffi ciency or doubtful adrenocortical reserve. Dosage and Administration: Individualise dosage according to response. Use lowest possible dosage in multiples of 10mg. Observe closely for signs that might require dosage adjustment. It may be necessary to withdraw the drug gradually. In chronic adrenocortical insuffi ciency, a dosage of 20 to 30mg a day is usually recommended. When immediate support


is mandatory, parenteral administration of a soluble


adrenocortical hormone preparation can be life-saving. Use in children: In chronic adrenocortical insuffi ciency, approximately 0.4 to 0.8mg/kg/day in two or three divided doses. Use in the elderly: Plan treatment bearing in mind the common side eff ects of corticosteroids in old age. Pre-operative use: Inform anaesthetist if the patient is taking or has taken corticosteroids. Contraindications: Hypersensitivity. Systemic fungal infections. Warnings and Precautions: Patients should carry ‘steroid treatment’ cards. Lowest possible dosage should be used and any reduction should be gradual. Severe psychiatric adverse reactions may occur. Care is required in patients with existing or previous history of severe aff ective disorders. Chickenpox may be fatal in immunosuppressed patients. Passive immunisation with Varicella zoster immunoglobulin (VZIG) may be needed. Hydrocortisone should not be used in systemic fungal infections unless needed to control life-threatening drug reactions due to amphotericin. Caution in patients with left ventricular free wall rupture after a recent myocardial infarction. Can cause elevation of blood pressure, salt and water retention, and increase excretion of potassium. Caution in cerebral malaria, latent tuberculosis or tuberculin reactivity. Use in active tuberculosis only in fulminating or disseminated tuberculosis. Caution in renal insuffi ciency, hypertension, diabetes or family history of diabetes, congestive heart failure, thrombophlebitis, exanthematous disease, chronic nephritis, acute glomerulonephritis, metastatic carcinoma, osteoporosis, severe aff ective disorders, epilepsy, previous steroid myopathy, glaucoma (or family history of glaucoma), myasthenia gravis, non-specifi c ulcerative colitis, diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer. Signs of gastro-intestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent. Enhanced eff ect in patients with hypothyroidism and in those with cirrhosis. Prolonged courses increase susceptibility to infections and their severity. May mask signs of infection and aff ect the nitrobluetetrazolium test for bacterial infection. May activate latent amoebiasis or strongyloidiasis


or exacerbate active disease. Prolonged use may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and secondary ocular infections due to fungi or viruses. Caution in patients with ocular herpes simplex. May aff ect motility and number of spermatozoa. May aggravate or precipitate diabetes. Menstrual irregularities may occur. Anaphylactoid reactions have occurred. Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia. Withdrawal: Reduce dosage gradually. Stopping corticosteroid after prolonged therapy may cause withdrawal symptoms. Children: Limit treatment to the minimum dosage. Monitor growth and development of infants and children on prolonged therapy. Contains lactose. May cause vertigo, visual fi eld loss and muscle wasting and weakness. If aff ected, patients should not drive or operate machinery. Fertility, Pregnancy & Lactation: Hydrocortisone readily crosses the placenta. Should only be prescribed when the benefi ts to the mother and child outweigh the risks. Corticosteroids are excreted in breast milk. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression. Undesirable Eff ects: Blood and Lymphatic System Disorders: Leucocytosis. Immune System Disorders: Hypersensitivity. Endocrine Disorders: Increased or decreased motility and number of spermatozoa, menstrual irregularities, amenorrhoea, development of Cushingoid state, suppression of growth in children, secondary adrenocortical


and pituitary unresponsiveness, decreased carbohydrate


tolerance, manifestations of latent diabetes mellitus, hyperglycemia, increased requirements for insulin or oral hypoglycaemic agents in diabetes, hirsutism. Metabolism & Nutrition Disorders: Sodium retention, fl uid retention, potassium loss, hypokalaemic alkalosis, increased calcium excretion, negative nitrogen balance due to protein catabolism, weight gain, increased appetite. Psychiatric Disorders: psychic disturbances, psychological dependence, insomnia. A wide range of psychiatric reactions including aff ective disorders, psychotic reactions, behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions have been estimated to be 5-6%. Psychological eff ects have been reported on withdrawal of corticosteroids; 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 cataracts, increased intra-ocular pressure, papilloedema, corneal or scleral thinning, exacerbation of ophthalmic viral disease, glaucoma, exophthalmos. Gastro-intestinal Disorders: Peptic ulcer with


possible perforation and haemorrhage, perforation of the small and large bowel particularly in patients with infl ammatory bowel disease, pancreatitis, abdominal distension, ulcerative oesophagitis, dyspepsia, oesophageal candidiasis, nausea. Skin and Subcutaneous Tissue Disorders: Impaired wound healing, thin fragile skin, petechiae, and ecchymoses, erythema, striae, telangiectasia, acne, increased sweating, may suppress reactions to skin tests, other cutaneous reactions such as allergic dermatitis, urticaria, angioneurotic oedema. Musculoskeletal, Connective Tissue & Bone Disorders: Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathological fracture of long bones, tendon rupture. Cardiac Disorders: Myocardial rupture following recent myocardial infarction, congestive heart failure in susceptible patients. Vascular Disorders: thrombo- embolism, hypertension. Respiratory, Thoracic & Mediastinal Disorders: Hiccups. See SPC for details of other adverse events. Pack Size and NHS Price (Generics): 10mg x 30 £87.85 and 20mg x 30 £93.99. Legal Category: POM. Further information is available from Actavis UK Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS. Marketing Authorisation Numbers: PL 17507/0246, PL 17507/0248. Date of PI Preparation: February 2016. UK/HYD/0004/03-16


Adverse events should be reported.


Reporting forms and information can be found at www.mhra.gov.uk/yellowcard


Adverse events should also be reported to Actavis on 01271 385257.


Reference: 1. Hydrocortisone Tablets Summary of Product Characteristics January 2016. PL 17507/0246 & PL 17507/0248


Actavis hydrocortisone 10mg & 20mg tablets are licensed for use: • As replacement therapy in primary, secondary or acute adrenocortical insuffi ciency • Pre-operatively, and during serious trauma or illness in patients with known adrenal insuffi ciency or doubtful adrenocortical reserve


UK/HYD/0009/03-16 Date of Preparation: April 2016


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