INDICATIONS AND USAGE
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (15 mg Prednisolone
per 5 mL) is indicated in the following conditions:
1. Allergic StatesControl of severe or incapacitating allergic conditions
intractable to adequate trials of conventional treatment in adult and pediatric
populations with: seasonal or perennial allergic rhinitis; asthma; contact
dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity
reactions.
2. Dermatologic DiseasesPemphigus; bullous dermatitis herpetiformis; severe erythema
multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis
fungoides.
3. Edematous StatesTo induce diuresis or remission of proteinuria in nephrotic
syndrome in adults with lupus erythematosus and in adults and pediatric
populations, with idiopathic nephritic syndrome, without uremia.
4. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone
or cortisone is the first choice; synthetic analogs may be used in conjunction
with mineralocorticoids where applicable; in infancy mineralocorticoid
supplementation is of particular importance); congenital adrenal hyperplasia;
hypercalcemia associated with cancer; nonsuppurative thyroiditis.
5. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:
ulcerative colitis; regional enteritis.
6. Hematologic DisordersIdiopathic thrombocytopenic purpura in adults; selected cases of
secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red
cell aplasia; Diamond-Blackfan anemia.
7. Neoplastic DiseasesFor the treatment of acute leukemia and aggressive lymphomas in
adults and children.
8. Nervous SystemAcute exacerbations of multiple sclerosis.
9. Ophthalmic DiseasesUveitis and ocular inflammatory conditions unresponsive to
topical corticosteroids; temporal arteritis; sympathetic ophthalmia.
10. Respiratory DiseasesSymptomatic sarcoidosis; idiopathic eosinophilic pneumonias;
fulminating or disseminated pulmonary tuberculosis when used concurrently with
appropriate antituberculous chemotherapy; asthma (as distinct from allergic
asthma listed above under "Allergic States"), hypersensitivity pneumonitis,
idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive
pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated
with hypoxemia occurring in an HIV (+) individual who is also under treatment
with appropriate anti-PCP antibiotics. Studies support the efficacy of systemic
corticosteroids for the treatment of these conditions: allergic bronchopulmonary
aspergillosis, idiopathic bronchiolitis obliterans with organizing
pneumonia.
11. Rheumatic DisordersAs adjunctive therapy for short term administration (to tide the
patient over an acute episode or exacerbation) in: psoriatic arthritis;
rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases
may require low dose maintenance therapy); ankylosing spondylitis; acute and
subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis;
epicondylitis. For the treatment of systemic lupus erythematosus,
dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren's syndrome,
relapsing polychondritis, and certain cases of vasculitis.
12. MiscellaneousTuberculous meningitis with subarachnoid block or impending
block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory
difficulty, and tuberculosis with pleural or pericardial effusion (appropriate
antituberculous chemotherapy must be used concurrently when treating any
tuberculosis complications); trichinosis with neurologic or myocardial
involvement; acute or chronic solid organ rejection (with or without other
agents).