SONE

What it is

Sone is a tablet containing 5 mg or 25 mg prednisone as the active ingredient. Prednisone is a synthetic corticosteroid with glucocorticoid and anti-inflammatory effects. Prednisone is readily absorbed from the gastrointestinal tract, but must be converted in the liver to its active metabolite, prednisolone.

Approved indications

— Wherever corticosteroid therapy is indicated.

Dosing overview

For adults, the dose is 10 to 100 mg daily in divided doses. For children aged 1 to 5 years, the dose is 2.5 to 10 mg twice daily, and for children aged 6 to 12 years, 5 to 20 mg twice daily.

Key safety warnings

Corticosteroids may mask some signs of infection, and new infections may appear during their use. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. These infections may be mild, but can be severe and at times fatal. 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 (s-creatinine) should therefore be routinely checked. During prolonged treatment with corticosteroids, adrenal suppression and atrophy may occur and secretion of corticotrophin may be suppressed. Sudden withdrawal of the hormone treatment may then precipitate acute adrenal insufficiency with muscle weakness, hypotension, hypoglycaemia, headache, nausea, vomiting, restlessness and muscle and joint pain. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Contraindications

Sone is contraindicated in systemic fungal infections and known hypersensitivity to prednisone or any of the excipients. It is also contraindicated in peptic ulcer, osteoporosis, psychoses or severe psychoneuroses. Patients with active or doubtfully quiescent tuberculosis should not be given these hormones except as adjuncts to treatment with tuberculostatic drugs.

Regulatory history

The 25 mg tablet strength (ARTG 13470) was first listed on 30 August 1991, and the 5 mg tablet strength (ARTG 56129) was first listed on 4 July 1996. The product information was revised on 11 June 2021.