Orapred Odt Recall
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FDA Labeling Changes
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Orapred ODT (prednisolone sodium phosphate orally disintegrating tablet) is indicated in the treatment of the following diseases or conditions:
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with:
- Atopic dermatitis
- Drug hypersensitivity reactions
- Seasonal or perennial allergic rhinitis
- Serum sickness
- Bullous dermatitis herpetiformis
- Contact dermatitis
- Exfoliative erythroderma
- Mycosis fungoides
- Severe erythema multiforme (Stevens-Johnson syndrome)
- Congenital adrenal hyperplasia
- Hypercalcemia of malignancy
- Nonsuppurative thyroiditis
- Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable.
During acute episodes in:
- Crohn's Disease
- Ulcerative colitis
- Acquired (autoimmune) hemolytic anemia
- Diamond-Blackfan anemia
- Idiopathic thrombocytopenic purpura in adults
- Pure red cell aplasia
- Secondary thrombocytopenia in adults
For the treatment of:
- Acute leukemia
- Aggressive lymphomas
- Acute exacerbations of multiple sclerosis
- Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury
- Sympathetic ophthalmia
- Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids
- Acute or chronic solid organ rejection
- Acute exacerbations of chronic obstructive pulmonary disease (COPD)
- Allergic bronchopulmonary aspergillosis
- Aspiration pneumonitis
- Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy
- Hypersensitivity pneumonitis
- Idiopathic bronchiolitis obliterans with organizing pneumonia
- Idiopathic eosinophilia pneumonias
- Idiopathic pulmonary fibrosis Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics
- Symptomatic sarcoidosis
To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus
As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in:
- Acute gouty arthritis
During an exacerbation or as maintenance therapy in selected cases of:
- Ankylosing spondylitis
- Dermatomyositis /polymyositis
- Polymyalgia rheumatica/temporal arteritis
- Psoriatic arthritis
- Relapsing polychondritis
- Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy)
- Sjogren's syndrome
- Systemic lupus erythematosus
- Trichinosis with neurologic or myocardial involvement
- Tuberculous meningitis with subarachnoid block or impending block, (used concurrently with appropriate antituberculous chemotherapy
There is currently no drug history available for this drug.
Orapred ODT (prednisolone sodium phosphate disintegrating tablets) is a sodium salt of the phosphoester of the glucocorticoid prednisolone. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.
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.
The chemical name of prednisolone sodium phosphate is pregna-1,4-diene-3, 20-dione, 11, 17-dihydroxy-21 -(phosphonooxy)-, disodium salt, (1113)-.
The empirical formula is C21H27Na2OsP; the molecular weight is 484.39. Its chemical structure is:
Each orally disintegrating tablet also contains the following inactive ingredients: citric acid, colloidal silicon dioxide, crospovidone, grape flavor, hypromellose, magnesium stearate, mannitol, methacrylate copolymer, microcrystalline cellulose, sodium bicarbonate, sucralose, and sucrose.