REDIPRED

What it is

REDIPRED is prednisolone sodium phosphate. REDIPRED contains prednisolone sodium phosphate 6.72 mg per 1 mL, which is equivalent to prednisolone 5 mg per 1 mL. REDIPRED is a raspberry flavoured, clear, colourless to slightly yellow solution. 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 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 to 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 which a single dose is administered every other morning. For children, initial dosage is 0.5 mg per kg daily in three or four divided doses after food, with maintenance dosage of 0.125 to 0.25 mg per kg daily. For elderly patients, dosing is as for adults though the dose should be the minimum necessary to achieve the desired therapeutic effect.

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. Abrupt withdrawal of corticosteroid therapy may precipitate acute adrenal insufficiency. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. 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. 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. The risk of gastrointestinal ulceration or haemorrhage is increased when alcohol is used concurrently with glucocorticoids.

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

REDIPRED oral solution 5 mg per mL (as sodium phosphate) in 30 mL bottles is listed on the PBS with 2 items at unrestricted and restricted access levels, with an ex-manufacturer price of A$7.87.

Regulatory history

REDIPRED prednisolone 25 mg per 5 mL oral liquid was first listed on the ARTG on 11 March 1998.