PANAFCORTELONE

What it is

PANAFCORTELONE is a prednisolone tablet . It is available in strengths of 1 mg, 5 mg or 25 mg . Prednisolone is a synthetic corticosteroid with glucocorticoid and anti-inflammatory effects . Prednisolone exceeds hydrocortisone in glucocorticoid and anti-inflammatory activity, being about three times more potent on a weight basis than the parent hormone, but is considerably less active than hydrocortisone in mineralocorticoid activity .

Approved indications

PANAFCORTELONE 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 initial adult 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 . Maintenance dosage is usually 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; in this regimen, a single dose is administered every other morning and provides relief of symptoms while minimising adrenal suppression, protein catabolism, and other adverse effects . For children, initial dosage is 0.5 mg/kg daily in three or four divided doses after food, 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 prednisolone; blood pressure and renal function should therefore be routinely checked . During prolonged corticosteroid therapy, adrenal suppression and atrophy may occur; withdrawal of corticosteroids should always be gradual, as abrupt withdrawal may precipitate acute adrenal insufficiency . Corticosteroids may mask some signs of infection such as fever and inflammation, and new infections may appear during their use; 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 PANAFCORTELONE except as adjuncts to treatment with tuberculostatic drugs as reactivation of the disease may occur; chemoprophylaxis is indicated during prolonged corticosteroid therapy . Visual disturbance may be reported with systemic corticosteroid use; 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

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

PBS listing

The 25 mg tablet is listed on the PBS as a single unrestricted item with an ex-manufacturer price of A$3.98 . The 5 mg tablet is listed on the PBS as two items: one unrestricted and one with restrictions, with an ex-manufacturer price of A$3.29 .

Regulatory history

PANAFCORTELONE was first registered on the ARTG on 21 October 1991, with all three strengths (1 mg, 5 mg and 25 mg) listed on that date .