2.1 Recommended Dosing
Dosage of prednisolone sodium phosphate orally disintegrating tablets should be individualized according to the severity of the disease and the response of the patient. For pediatric patients, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight.
Do not break or use partial prednisolone sodium phosphate orally disintegrating tablets. Use an appropriate formulation of prednisolone if indicated dose cannot be obtained using prednisolone sodium phosphate orally disintegrating tablets. This may become important in the treatment of conditions that require tapering doses that cannot be adequately accommodated by prednisolone sodium phosphate orally disintegrating tablets, e.g., tapering the dose below 10 mg.
The initial dose of prednisolone sodium phosphate orally disintegrating tablets may vary from 10 mg to 60 mg (prednisolone base) per day, depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time, there is a lack of satisfactory clinical response, prednisolone sodium phosphate orally disintegrating tablets should be discontinued and the patient placed on other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of prednisolone sodium phosphate orally disintegrating tablets for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Prednisolone sodium phosphate orally disintegrating tablets are packaged in a bottle. For patients dispensed a bottle, they should be instructed not to remove the tablet from the bottle until just prior to dosing. The bottle should then be opened, and the orally disintegrating tablet placed on the tongue, where tablets may be swallowed whole as any conventional tablet, or allowed to dissolve in the mouth, with or without the assistance of water. Orally disintegrating tablet dosage forms are friable and are not intended to be cut, split or broken.
Multiple Sclerosis
In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for one month have been shown to be effective.
Pediatric
In pediatric patients, the initial dose of prednisolone sodium phosphate orally disintegrating tablets may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m2bsa/day).
Nephrotic Syndrome
The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m2/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m2/day.
Asthma
The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, prednisolone or methylprednisolone in children whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1 to 2 mg/kg/day in single or divided doses.
It is further recommended that short course, or “burst” therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.
2.2 Recommended Monitoring
Blood pressure, body weight, routine laboratory studies, including serum potassium and fasting blood glucose, should be obtained at regular intervals during prolonged therapy. Appropriate diagnostic studies should be performed in patients with known or suspected peptic ulcer disease and in patients at risk for reactivation of latent tuberculosis infections.
2.3 Corticosteroid Comparison Chart
For the purpose of comparison, one 10 mg prednisolone sodium phosphate orally disintegrating tablet (13.4 mg prednisolone sodium phosphate) is equivalent to the following milligram dosage of the various glucocorticoids:
Betamethasone 1.75 mg
Paramethasone 4 mg
Cortisone 50 mg
Prednisolone 10 mg
Dexamethasone 1.75 mg
Prednisone 10 mg
Hydrocortisone 40 mg
Triamcinolone 8 mg
Methylprednisolone 8 mg
These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
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