Product Dossier
PANAFCORT
Product Dossier for PANAFCORT (prednisone, Aspen Pharmacare). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Aspen Pharmacare
- Active ingredient: prednisone
- Therapeutic area: Immunology
- Related brand: PREDSONE
- Related brand: SONE
- Same area: COSENTYX
- Same area: HYRIMOZ
What it is
PANAFCORT is a prednisone tablet medicine. PANAFCORT tablets are available in strengths of 1 mg, 5 mg or 25 mg. The tablets contain lactose monohydrate as an excipient with known effects.
Approved indications
PANAFCORT 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 maintenance dosage 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, where a single dose is administered every other morning, providing relief of symptoms while minimising 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, with maintenance dosage of 0.125 to 0.25 mg/kg daily.
Key safety warnings
Dosage should be decreased or discontinued gradually when the drug has been administered for more than a few days to avoid the risk of relative adrenal insufficiency. Continued supervision of the patient after cessation of corticosteroids is essential, since there may be a reappearance of severe manifestations of the disease for which the patient was treated. In patients on long term corticosteroid therapy subjected to stress from trauma or infection, steroid dosage should generally be increased to cover the stressful period.
PBS listing
The 5 mg tablet is listed on the PBS with 2 items; one item is restricted and one is unrestricted, with an ex-manufacturer price of A$3.21. The 25 mg tablet is listed on the PBS with 1 unrestricted item and an ex-manufacturer price of A$2.77.
Regulatory history
The 5 mg and 25 mg tablet strengths of PANAFCORT were first registered on the ARTG on 21 October 1991, and the 1 mg strength was registered on 26 May 1992.