REDIPRED Oral solution Ref.[50299] Active ingredients: Prednisolone

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

Children

Acute asthma requiring oral steroids

2 mg/kg at once, up to a maximum of 40 mg. Thereafter dose at 2 mg/kg once daily up to a maximum of 40 mg per day, and for up to a total of five days. Redipred should be taken in the morning after food. No gradual decrease of the dose is required.

Other indications

Initial dosage: 0.5 mg/kg/day in three or four divided doses after food. This dosage can be doubled or trebled if necessary.

Maintenance dosage: 0.125 to 0.25 mg/kg/day.

Dosage for infants and children should be governed by the same considerations as adults rather than by strict adherence to the ratio indicated by age or body weight. 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 Redipred – Data Sheet Page 2 of 11 essential, since there may be a reappearance of severe manifestations of the disease for which the patient was treated.

In general, initial dosage should be maintained or adjusted until the anticipated response is observed. The dose should then be gradually reduced until the lowest dose which will maintain an adequate clinical response is reached.

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: 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.

Elderly

As for adults – though the dose should be the minimum necessary to achieve the desired therapeutic effect.

Alternate-day therapy

Alternate-day therapy is the dosage regimen of choice for long-term oral glucocorticoid treatment of most conditions. In alternate-day therapy, a single dose is administered every other morning. This regimen provides relief of symptoms while minimising adrenal suppression, protein catabolism, and other adverse effects. However, some patients may require daily glucocorticoid therapy because symptoms of the underlying disease cannot be controlled by alternate-day therapy.

Stress and intercurrent illness

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. For mild infections without fever, no increase is necessary. For more serious infections, the dose of prednisone/prednisolone should be doubled (to a maximum of 20 mg daily, if the usual dosage was below this).

Adrenocortical insufficiency

Drug induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimised by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy may need to be reinstituted. If the patient is receiving steroids already, dosage may have to be increased.

Treatment is symptomatic with the dosage being reduced or the drug withdrawn.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

18 months.

Once opened, Redipred is stable for 4 weeks. Product should not be used beyond the expiry date printed on the bottle.

Store at or below 30°C.

30 mL & 100 mL PET bottles.

Not all pack sizes may be marketed.

No special requirements for disposal.