prednisolone 10 MG Disintegrating Oral Tablet

1 INDICATIONS AND USAGE Prednisolone sodium phosphate orally disintegrating tablets are indicated in the treatment of the following diseases or conditions: Prednisolone sodium phosphate orally disintegrating tablets are 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)

mylan pharmaceuticals inc.

FDA Reported Adverse Reactions
[1] alopecia    [2] drug ineffective    [3] nausea    [4] diarrhoea    [5] fatigue    [6] off label use    [7] dyspnoea    [8] pain    [9] headache    [10] adverse drug reaction