PREDSOL

What it is

PREDSOL contains prednisolone sodium phosphate . The oral liquid formulation contains prednisolone sodium phosphate 6.72 mg per 1 mL, which is equivalent to prednisolone 5 mg per 1 mL . Prednisolone is a synthetic glucocorticoid that 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

— Wherever corticosteroid therapy is indicated .

Dosing overview

The severity, prognosis, expected duration of the disease, and the patient's reaction to medication are primary factors in determining dosage .

**Adults:** 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 . It is usually administered in 2–4 divided doses or as a single daily dose after breakfast or on alternate days, with alternate-day therapy being the dosage regimen of choice for long-term oral glucocorticoid treatment of most conditions, administered as a single dose every other morning .

**Elderly:** Dosing is as for adults, though the dose should be the minimum necessary to achieve the desired therapeutic effect .

**Children:** Initial dosage is 0.5 mg/kg daily in three or four divided doses after food as in adults . Maintenance dosage is 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 and withdrawal of corticosteroids should always be gradual, as abrupt withdrawal may precipitate acute adrenal insufficiency . 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 . Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation, and prolonged use 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 . Corticosteroids may mask some signs of infection and new infections may appear during their use, with decreased resistance and inability to localise infection when corticosteroids are used . 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 . The majority of adverse reactions from corticosteroids are those resulting from withdrawal or from prolonged use of high doses .

Contraindications

Contraindications include uncontrolled infections, systemic fungal infections, and known hypersensitivity to prednisone or prednisolone or any of the excipients in the liquid .

PBS listing

PREDSOL is listed on the PBS in two formulations: retention enema 20 mg (as sodium phosphate) in 100 mL with an ex-manufacturer price of A$38.54, and suppositories 5 mg (as sodium phosphate) in packs of 10 with an ex-manufacturer price of A$8.46 . Both formulations are restricted PBS items .

Regulatory history

PREDSOL was first approved on 11 March 1998 . The ARTG registration includes a retention enema formulation first listed on 13 August 1991 and a suppository formulation first listed on 17 September 1996 .