Product Description.:
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (15 mg Prednisolone per 5 mL) is a dye free, pale to light yellow solution. Each 5 mL (teaspoonful) of PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION contains 20.2 mg prednisolone sodium phosphate (15 mg prednisolone base) in a palatable, aqueous vehicle.
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (15 mg Prednisolone per 5 mL) also contains anti-bitter mask, corn syrup, edetate disodium, glycerin, grape flavor, hydroxyethylcellulose, methylparaben, potassium phosphate dibasic, potassium phosphate monobasic, purified water, and sodium saccharin.
Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water soluble in methanol slightly soluble in alcohol and in chloroform and very slightly soluble in acetone and in dioxane.
INDICATIONS AND USAGE
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (15 mg Prednisolone per 5 mL) is indicated in the following conditions:
1. Allergic States
Control 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 Diseases
Pemphigus bullous dermatitis herpetiformis severe erythema multiforme (Stevens-Johnson syndrome) exfoliative erythroderma mycosis fungoides.
3. Edematous States
To 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 Disorders
Primary 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 Diseases
To tide the patient over a critical period of the disease in: ulcerative colitis regional enteritis.
6. Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults selected cases of secondary thrombocytopenia acquired (autoimmune) hemolytic anemia pure red cell aplasia Diamond-Blackfan anemia.
7. Neoplastic Diseases
For the treatment of acute leukemia and aggressive lymphomas in adults and children.
8. Nervous System
Acute exacerbations of multiple sclerosis.
9. Ophthalmic Diseases
Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids temporal arteritis sympathetic ophthalmia.
10. Respiratory Diseases
Symptomatic 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 Disorders
As 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. Miscellaneous
Tuberculous 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).
CONTRAINDICATIONS
Systemic fungal infections. Hypersensitivity to the drug or any of its components.
WARNINGS
General
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated.
