Prednisolone Oral Solution 25mg/5ml Generic Name & Formulations
Legal Class
Rx
General Description
Prednisolone (as sodium phosphate) 25mg/5mL; grape flavored.
Pharmacological Class
Glucocorticoid.
See Also
How Supplied
Soln (25mg/5mL)—8oz; 15mg/5mL—contact supplier
Manufacturer
Prednisolone Oral Solution 25mg/5ml Indications
Indications
Corticosteroid-responsive disorders.
Prednisolone Oral Solution 25mg/5ml Dosage and Administration
Adult
See full labeling. Initially 5–60mg daily.
Children
See full labeling. Initially 0.14–2mg/kg/day in 3 or 4 divided doses.
Prednisolone Oral Solution 25mg/5ml Contraindications
Contraindications
Systemic fungal infections. Live vaccines.
Prednisolone Oral Solution 25mg/5ml Boxed Warnings
Not Applicable
Prednisolone Oral Solution 25mg/5ml Warnings/Precautions
Warnings/Precautions
Systemic fungal infections, cerebral malaria, optic neuritis: not recommended. Tuberculosis. Latent amebiasis. Strongyloides infestation. Ocular herpes simplex. May increase risk and mask signs of infection. If exposed to chickenpox or measles, consider prophylactic passive immune therapy. HPA axis suppression. Cushing’s syndrome. Hyperglycemia. Thyroid disorders. Hypertension. CHF. Renal insufficiency. Recent MI. Risk of GI perforation. Peptic ulcer. Diverticulitis. Intestinal anastomoses. Myasthenia gravis. Osteoporosis. Kaposi’s sarcoma. May cause electrolyte imbalances or psychotic manifestations. Avoid abrupt cessation. Monitor weight, growth, BP, IOP, fluid and electrolyte balance. Elderly. Pregnancy (Cat.D). Nursing mothers.
Prednisolone Oral Solution 25mg/5ml Pharmacokinetics
See Literature
Prednisolone Oral Solution 25mg/5ml Interactions
Interactions
See Contraindications. Potentiated by CYP3A4 inhibitors (eg, ketoconazole, macrolides), cyclosporine, estrogens. Antagonized by CYP3A4 inducers (eg, barbiturates, phenytoin, carbama-zepine, rifampin), cholestyramine, aminoglutethimide. May potentiate cyclosporine. May antagonize anticoagulants (monitor), isoniazid. Increased risk of arrhythmias with digitalis. May need to adjust dose of antidiabetic agents. Increased GI effects with aspirin or NSAIDs. Caution with aspirin in hypoprothrombinemia. Monitor for hypokalemia with potassium-depleting drugs. Withdraw anticholinesterase agents at least 24hrs before initiating therapy. May suppress reactions to skin tests.
Prednisolone Oral Solution 25mg/5ml Adverse Reactions
Adverse Reactions
HPA axis suppression, increased susceptibility to infection, glaucoma, cataracts, secondary infections, hypokalemia, hypocalcemia, hypernatremia, hypertension, CHF, psychic disorders, myopathy, osteoporosis, peptic ulcer, dermal atrophy, increased intracranial pressure, carbohydrate intolerance.
Prednisolone Oral Solution 25mg/5ml Clinical Trials
See Literature
Prednisolone Oral Solution 25mg/5ml Note
Not Applicable
Prednisolone Oral Solution 25mg/5ml Patient Counseling
See Literature
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