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

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2021  Publisher: Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland, New Zealand, Telephone: (09) 918 5100, Email: aspen@aspenpharma.co.nz

5.1. Pharmacodynamic properties

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Prednisolone is a synthetic glucocorticoid with the general properties of the corticosteroids. Prednisolone 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.

Prednisolone, like hydrocortisone, is a potent therapeutic agent influencing the biochemical behaviour of most tissues of the body. The mechanism of action of corticosteroids is thought to be by control of protein synthesis. Corticosteroids react with receptor proteins in the cytoplasm of sensitive cells in many tissues to form a steroid-receptor complex.

Corticosteroids are palliative symptomatic treatment of virtue of their anti- inflammatory effects; they are never curative.

5.2. Pharmacokinetic properties

Prednisolone is rapidly and well absorbed from the gastrointestinal tract following oral administration. REDIPRED Oral Solution produces a 20% higher peak plasma level of prednisolone which occurs approximately 15 minutes earlier than the peak seen with tablet formulations. Prednisolone is 90-95% protein-bound, less so at higher doses. The apparent volume of distribution for unbound prednisolone is 1.5 ± 0.2 L/kg. Prednisolone is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolised mainly in the liver and excreted in the urine as sulphate and glucuronide conjugates.

5.3. Preclinical safety data

Not relevant.

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