1 INDICATIONS AND USAGE
Orapred ODT (prednisolone sodium phosphate orally disintegrating tablet) is indicated in the treatment of the following diseases or conditions:
Orapred ODT is a corticosteroid indicated
as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation (1)
for the treatment of certain endocrine conditions (1)
for palliation of certain neoplastic conditions (1)
1.1 Allergic 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
1.2 Dermatologic Diseases
Bullous dermatitis herpetiformis
Contact dermatitis
Exfoliative erythroderma
Mycosis fungoides
Pemphigus
Severe erythema multiforme (Stevens-Johnson syndrome)
1.3 Endocrine Conditions
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.
1.4 Gastrointestinal Diseases
During acute episodes in:
Crohn's Disease
Ulcerative colitis
1.5 Hematologic Diseases
Acquired (autoimmune) hemolytic anemia
Diamond-Blackfan anemia
Idiopathic thrombocytopenic purpura in adults
Pure red cell aplasia
Secondary thrombocytopenia in adults
1.6 Neoplastic Conditions
For the treatment of:
Acute leukemia
Aggressive lymphomas
1.7 Nervous System Conditions
Acute exacerbations of multiple sclerosis
Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury
1.8 Ophthalmic Conditions
Sympathetic ophthalmia
Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids
1.9 Conditions Related to Organ Transplantation
Acute or chronic solid organ rejection
1.10 Pulmonary Diseases
Acute exacerbations of chronic obstructive pulmonary disease (COPD)
Allergic bronchopulmonary aspergillosis
Aspiration pneumonitis
Asthma
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate
chemotherapy
Hypersensitivity pneumonitis
Idiopathic bronchiolitis obliterans with organizing pneumonia
Idiopathic eosinophilic 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
1.11 Renal Conditions
To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus
1.12 Rheumatologic Conditions
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
Vasculitis
1.13 Specific Infectious Diseases
Trichinosis with neurologic or myocardial involvement
Tuberculous meningitis with subarachnoid block or impending block, used concurrently with appropriate antituberculous chemotherapy