SOLONE

What it is

SOLONE contains prednisolone. SOLONE tablets are available in 1 mg, 5 mg or 25 mg strengths. Prednisolone is a synthetic corticosteroid with glucocorticoid and anti-inflammatory effects, approximately three times more potent on a weight basis than hydrocortisone but considerably less active in mineralocorticoid activity.

Approved indications

SOLONE 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

Dosage is determined by the severity, prognosis, expected duration of the disease, and the patient's reaction to medication. Initial adult dosage may range from 20 to 40 mg daily, or 60 to 80 mg daily if necessary depending on the disease being treated, with maintenance dosage usually 5 to 20 mg daily. In long term therapy the ideal dosage should not be greater than 40 mg per day 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, in which a single dose is administered every other morning, is the dosage regimen of choice for long-term oral glucocorticoid treatment of most conditions, providing relief of symptoms while minimising adrenal suppression and other adverse effects. In elderly patients, the dose should be the minimum necessary to achieve the desired therapeutic effect, as in adults. In children, 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 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 prednisolone, and blood pressure and renal function should be routinely checked. During prolonged corticosteroid therapy, adrenal suppression and atrophy may occur; duration of treatment and dosage are important factors in determining suppression of the pituitary-adrenal axis; therefore, withdrawal of corticosteroids should always be gradual. Abrupt withdrawal of corticosteroid therapy may precipitate acute adrenal insufficiency, and in some cases withdrawal symptoms may simulate a clinical relapse of the disease for which the patient has been under treatment. Corticosteroids may mask some signs of infection and new infections may appear during their use, with decreased resistance and inability to localise infection. Patients should not be vaccinated with live vaccines while on corticosteroid therapy, and other immunisation procedures should not be undertaken in patients on corticosteroid therapy, especially on high doses. Patients with active or doubtfully quiescent tuberculosis should not be given SOLONE except as adjuncts to treatment with tuberculostatic drugs, and chemoprophylaxis is indicated during prolonged corticosteroid therapy. Visual disturbance may be reported with systemic corticosteroid use; patients presenting with symptoms such as blurred vision or other visual disturbances should be considered for referral to an ophthalmologist to evaluate for possible causes including cataract, glaucoma or central serous chorioretinopathy.

Contraindications

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

Regulatory history

SOLONE prednisolone tablets (5 mg and 25 mg strengths) were first listed on the Australian Register of Therapeutic Goods on 30 August 1991.