PREDSONE

What it is

PREDSONE is a prednisone tablet containing 1 mg of the active ingredient prednisone. Prednisone is a synthetic corticosteroid with glucocorticoid and anti-inflammatory effects. Prednisone is readily absorbed from the gastrointestinal tract and must be converted in the liver to its active metabolite, prednisolone.

Approved indications

PREDSONE is indicated wherever corticosteroid therapy is indicated, including: — Pemphigus vulgaris — Allergic dermatitis — Eczema — Exfoliative dermatitis — Dermatitis herpetiformis — Dermatitis medicamentosa — Erythema multiforme — Disseminated lupus erythematosus — Dermatomyositis — Polyarteritis nodosa — Severe bronchial asthma and status asthmaticus — Emphysema — Pulmonary fibrosis — Adrenal hyperplasia (adrenogenital syndrome) — Idiopathic thrombocytopenic purpura — Acquired haemolytic anaemia — Acute leukaemia — Nephrotic syndrome — Iridochoroiditis — Ulcerative colitis — Rheumatoid arthritis — Ankylosing spondylitis — Rheumatic fever — Gout — Periarthritis of the shoulder

Dosing overview

The severity, prognosis, expected duration of the disease, and the patient's reaction to medication are primary factors in determining dosage. For adults, the initial dosage may range from 20 to 40 mg daily, but can be 60 to 80 mg daily if necessary, depending on the disease being treated, with usual maintenance dosage of 5 to 20 mg daily. In long-term therapy, the ideal dosage should not be greater than 40 mg per day so as to minimise side-effects. It is usually administered in 2–4 divided doses or as a single daily dose after breakfast or on alternate days. Alternate-day therapy is the dosage regimen of choice for long-term oral glucocorticoid treatment of most conditions, with a single dose administered every other morning, providing relief of symptoms while minimizing adrenal suppression, protein catabolism, and other adverse effects. For elderly patients, the dose should be the minimum necessary to achieve the desired therapeutic effect. For children, the initial dosage is 0.5 mg/kg daily in three or four divided doses after food, which can be doubled or trebled if necessary, with maintenance dosage of 0.125 to 0.25 mg/kg daily.

Key safety warnings

Caution is required in patients with systemic sclerosis because of an increased incidence of (possibly fatal) scleroderma renal crisis with hypertension and decreased urinary output observed with a daily dose of 15 mg or more prednisone or prednisolone. Blood pressure and renal function should therefore be routinely checked. During prolonged corticosteroid therapy, adrenal suppression and atrophy may occur, and withdrawal of corticosteroids should always be gradual. Abrupt withdrawal of corticosteroid therapy may precipitate acute adrenal insufficiency. Corticosteroids may mask some signs of infection and new infections may appear during their use, and there may be decreased resistance and inability to localise infection when corticosteroids are used. Patients should not be vaccinated with live vaccines while on corticosteroid therapy. Patients with active or doubtfully quiescent tuberculosis should not be given PREDSONE except as adjuncts to treatment with tuberculostatic drugs as reactivation of the disease may occur, and chemoprophylaxis is indicated during prolonged corticosteroid therapy. Visual disturbance may be reported with systemic and topical corticosteroid use, and if a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy.

Contraindications

PREDSONE is contraindicated in uncontrolled infections and in patients with known hypersensitivity to prednisone, prednisolone, or any of the excipients in the tablet.

PBS listing

PREDSONE 1 mg tablets are listed on the PBS with 2 items under a restricted listing, at an ex-manufacturer price of A$2.83.

Regulatory history

PREDSONE prednisone 1 mg tablet (ARTG 99792) was first registered on 23 February 2004.