DELTALONE

Posology Adults and the elderly The lowest effective dose should be used for the minimum period. Children Prednisolone should only be used when specifically indicated, at the lowest dose possible and for the shortest possible time. The initial dosage of Prednisolone may vary from 5mg to 60mg daily depending on the disorder being treated.

Divided daily dosage may be used. Administration as a once daily dose in the morning or on alternate days can reduce the risk of adrenocortical suppression (see Section

Apart from substitution therapy, corticosteroid treatment always involves an overdose compared to the physiological state. Side effects mainly occur with long-term treatment, but also depend on dose size and individual sensitivity. The following side effects have been observed and reported during treatment with Prednisolone at the following frequencies: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).

, tuberculosis) Blood and lymphatic system Leukocytosis (due to redistribution of intravascular granulocytes) Immune system disorders Drug hypersensitivity Anaphylactic reaction Anaphylactoid reaction Endocrine disorders Inhibition of the hypothalamic- pituitary- adrenal (HPA) axis, Cushing- like symptoms.

4) Exophthalmos Cardiac disorders Heart failure (in sensitive patients) Bradycardia** Vascular disorders Oedema hypertension Thromboembolic events Respiratory, thoracic and mediastinal disorders Hiccup Gastrointestinal disorders Peptic wound (possibly with perforation and bleeding) Intestinal perforation pancreatitis Ulcerative esophagitis abdominal distention Abdominal pain Diarrhoea Dyspepsia Nausea Skin and subcutaneous tissue disorders Skin atrophy Impaired wound healing Angioedema Hirsutism Petechiae Ecchymosis Erythema hyperhidrosis Stretch marks Itching Urticaria Acne Musculoskeletal and connective tissue disorders Muscular Atrophy Aspetic bone necrosis Tendon rupture Muscle weakness Myalgia Myopathy Pathological fracture Neuropathic arthropathy Arthralgia Renal and urinary disorders Acute renal crisis (Scleroderma renal crisis) * Reproductive system and breast disorders Irregular menstruation General disorders and administration Fatigue Malaise site conditions Investigations Increased calcium levels in the urine Elevated alanine aminotransferase Elevated aspartate aminotransferase Increased blood alkaline phosphatase Elevated blood urea Suppression of skin test reactions1 1 Not MedDRA term.

). g. patients with rheumatoid arthritis with pronounced morning stiffness where an evening dose may need to be given. The following therapeutic guidelines should be kept in mind for all therapy with corticosteroids: The lowest dose to produce an acceptable result should be given; Initial dosage should be adjusted until the desired clinical response has been achieved.

The dose should be gradually reduced until the lowest dose which will maintain an adequate clinical response is reached. 5 – 5 mg every second to fifth day (more rapidly at the higher initial dose levels) until the lowest possible maintenance dose is reached.

Preferably this should not exceed 10 mg per day. Use of the lowest effective dose will tend to minimise side-effects. 4 'Special warnings and special precautions for use'). 5 mg prednisolone daily or equivalent for more than 3 weeks, owing to a greater risk of suppression of the hypothalamic-pituitary-adrenal (HPA) axis in these patients.

The speed with which dose can be reduced is also dependent on risk of relapse of the disease being treated. 5 mg (regarded as “equivalent” to physiological levels of glucocorticoids) should be conducted particularly cautiously. More rapid withdrawal of systemic corticosteroid treatment that has been given forless than 3 weeks is appropriate if it is considered that the disease is unlikely to relapse.

Withdrawal of doses of up to 40 mg daily of prednisolone, or equivalent that have been administered for less than 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of patients. In the following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less: • Patients who have had repeated courses of systemic corticosteroids, particularly if taken for greater than 3 weeks, • When a short course has been prescribed within one year of cessation of long-term therapy (months or years), • Patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroids therapy, • Patients receiving doses of systemic corticosteroid greater than 40 mg daily of prednisolone (or equivalent), • Patients repeatedly taking doses in the evening.

i. 1. ii. Systemic yeast infection iii. Administration of live vaccines is contraindicated in patients receiving corticosteroids in immunosuppressive doses. iv. In those conditions when treatment with prednisolone can save lives, none of the contraindications generally apply.