Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
ASPELONE is indicated for the relief of symptoms associated with inflammatory conditions, where a steroid is indicated.
DOSING REQUIREMENT MAY VARY DEPENDING ON THE SPECIFIC DISEASE, ITS SEVERITY AND THE RESPONSE OF THE PATIENT. DOSAGES SHOULD THEREFORE BE MODIFIED TO SUIT EACH PATIENT.
The usual dose of ASPELONE is about 3 mg to 60 mg daily in divided doses and it varies according to the disease being treated.
ASPELONE may be given daily as a single dose after breakfast or as a double dose on alternate days.
Some patients may require higher initial doses, where low doses should be sufficient in less severe situations.
Careful adjustment of the initial dose may be required to obtain a satisfactory response and this dose should be maintained thereafter.
Gradually discontinue the treatment if spontaneous remission occurs in a chronic condition.
When prescribing doses for infants and children, one should not only adhere to ratios indicated by age or body weight but should also consider the guidelines followed when prescribing doses in adults.
For oral administration.
For symptoms of overdosage please see section 4.8.
Treatment is symptomatic and supportive. Treatment is unlikely to be needed in cases of acute overdosage. Serum electrolytes should be monitored.
High systemic doses of corticosteroids, such as prednisolone, as in ASPELONE, caused by chronic use have been associated with adverse events such as neuropsychiatric disorders (psychosis, depression, hallucinations), cardiac dysrhythmias and Cushing’s syndrome.
24 months.
Store at or below 25°C.
Protect from light.
Shake the bottle before use and keep well closed.
100 ml is packed in a round amber glass bottle sealed with a white, tamper evident, expanded polyethylene lined polypropylene screw cap. The bottle is placed in a cardboard unit carton with a leaflet.
50 ml is packed in a round amber glass bottle sealed with a white, tamper evident, expanded polyethylene lined polypropylene screw cap. The bottle is placed in a cardboard unit carton with a leaflet.
Not all pack sizes may be marketed.
No special requirements.
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