U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
This repository is under review for potential modification in compliance with Administration directives.

Details

Stereochemistry ABSOLUTE
Molecular Formula C23H30O6
Molecular Weight 402.4807
Optical Activity UNSPECIFIED
Defined Stereocenters 7 / 7
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of PREDNISOLONE ACETATE

SMILES

CC(=O)OCC(=O)[C@@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@]12C

InChI

InChIKey=LRJOMUJRLNCICJ-JZYPGELDSA-N
InChI=1S/C23H30O6/c1-13(24)29-12-19(27)23(28)9-7-17-16-5-4-14-10-15(25)6-8-21(14,2)20(16)18(26)11-22(17,23)3/h6,8,10,16-18,20,26,28H,4-5,7,9,11-12H2,1-3H3/t16-,17-,18-,20+,21-,22-,23-/m0/s1

HIDE SMILES / InChI

Molecular Formula C23H30O6
Molecular Weight 402.4807
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 7 / 7
E/Z Centers 0
Optical Activity UNSPECIFIED

Prednisolone hemisuccinate is a prodrug of a glucocorticoid agonist prednisolone, which is marketed under trade name Prednisolut in Germany and Austria. Prednisolone hemisuccinate is used in emergency medicine to treate shock due to allergic reaction, insect and snake bites, in neurology to treat brain edema and meningitis, in transplantation medicine to reduce risk of organ refection after kidney transplane, in pneumology to treat acute asthma attack, pulmonary edema, in severe or life-threatening situation in rheumatic diseases.

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Prednisolone

Approved Use

Prednisolone Sodium Phosphate Oral Solution (10 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 nephrotic 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).

Launch Date

1955
Primary
Prednisolone

Approved Use

Prednisolone Sodium Phosphate Oral Solution (10 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 nephrotic 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).

Launch Date

1955
Primary
Prednisolone

Approved Use

Prednisolone Sodium Phosphate Oral Solution (10 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 nephrotic 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).

Launch Date

1955
Primary
Prednisolone

Approved Use

Prednisolone Sodium Phosphate Oral Solution (10 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 nephrotic 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).

Launch Date

1955
Primary
Prednisolone

Approved Use

Prednisolone Sodium Phosphate Oral Solution (10 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 nephrotic 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).

Launch Date

1955
Primary
Prednisolone

Approved Use

Prednisolone Sodium Phosphate Oral Solution (10 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 nephrotic 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).

Launch Date

1955
Primary
Prednisolone

Approved Use

Prednisolone Sodium Phosphate Oral Solution (10 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 nephrotic 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).

Launch Date

1955
Primary
Prednisolone

Approved Use

Prednisolone Sodium Phosphate Oral Solution (10 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 nephrotic 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).

Launch Date

1955
Primary
Prednisolone

Approved Use

Prednisolone Sodium Phosphate Oral Solution (10 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 nephrotic 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).

Launch Date

1955
Palliative
Sixtysix-20

Approved Use

Antiinflammatory agent
Palliative
RAYOS

Approved Use

RAYOS 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; for the treatment of certain endocrine conditions; for palliation of certain neoplastic conditions

Launch Date

2012
Palliative
RAYOS

Approved Use

RAYOS 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; for the treatment of certain endocrine conditions; for palliation of certain neoplastic conditions

Launch Date

2012
Palliative
RAYOS

Approved Use

RAYOS 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; for the treatment of certain endocrine conditions; for palliation of certain neoplastic conditions

Launch Date

2012
Palliative
RAYOS

Approved Use

RAYOS 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; for the treatment of certain endocrine conditions; for palliation of certain neoplastic conditions

Launch Date

2012
Palliative
RAYOS

Approved Use

RAYOS 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; for the treatment of certain endocrine conditions; for palliation of certain neoplastic conditions

Launch Date

2012
Palliative
RAYOS

Approved Use

RAYOS 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; for the treatment of certain endocrine conditions; for palliation of certain neoplastic conditions

Launch Date

2012
Primary
OMNIPRED

Approved Use

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

Launch Date

1973
Primary
OMNIPRED

Approved Use

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

Launch Date

1973
Primary
OMNIPRED

Approved Use

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

Launch Date

1973
Primary
OMNIPRED

Approved Use

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

Launch Date

1973
Primary
OMNIPRED

Approved Use

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

Launch Date

1973
Curative
Prednisolut

Approved Use

Prednisolut is indicated in shock and emergency medicine: Shock due to a severe allergic reaction (anaphylactic shock), after previous treatment with epinephrine, progressive forms of allergic reactions in insect bites and snake bites
Primary
Prednisolut

Approved Use

Brain swelling (brain edema), triggered by brain tumor, neurosurgery, brain abscess, bacterial meningitis (meningitis).
Primary
Prednisolut

Approved Use

Prednisolut is indicated to treat acute asthma attack, pulmonary edema by inhalation of toxic substances such as chlorga's, isocyanates, hydrogen sulphide, phosgene, nitrose gas, ozone, also nitrogen oxide, by gastric juice aspiration, and by drown.
Primary
Prednisolut

Approved Use

Prednisolut is indicated to treat acute asthma attack, pulmonary edema by inhalation of toxic substances such as chlorga's, isocyanates, hydrogen sulphide, phosgene, nitrose gas, ozone, also nitrogen oxide, by gastric juice aspiration, and by drown.
Primary
Prednisolut

Approved Use

Prednisolut is indicated for treatment of severe / life-threatening situations in the following rheumatic diseases: rheumatoid arthritis and still syndrome, felty syndrome, polymyalgia rheumatica, systemic juvenile idiopathic arthritis (eg breast disease, seropositive polyarthritis), collagenoses, vasculitides, rheumatic fever.
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
0.054 mg/L
60 mg single, enteral
dose: 60 mg
route of administration: Enteral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
33.2 ng/mL
30 mg single, oral
dose: 30 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
41.8 ng/mL
40 mg single, oral
dose: 40 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
43.9 ng/mL
40 mg single, oral
dose: 40 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
15.4 μg/L
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FED
420.91 ng/mL
30 mg single, oral
dose: 30 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISOLONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: FASTED
14.43 ng/mL
40 mg single, intramuscular
dose: 40 mg
route of administration: Intramuscular
experiment type: SINGLE
co-administered:
PREDNISOLONE blood
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
86 μg/dL
20 mg single, intramuscular
dose: 20 mg
route of administration: Intramuscular
experiment type: SINGLE
co-administered:
PREDNISOLONE HEMISUCCINATE serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
36 μg/dL
20 mg single, intramuscular
dose: 20 mg
route of administration: Intramuscular
experiment type: SINGLE
co-administered:
PREDNISOLONE serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
0.484 mg × h/L
60 mg single, enteral
dose: 60 mg
route of administration: Enteral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
298 ng × h/mL
30 mg single, oral
dose: 30 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
358 ng × h/mL
40 mg single, oral
dose: 40 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
387 ng × h/mL
40 mg single, oral
dose: 40 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
97 μg × h/L
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FED
2408.1 ng × h/mL
30 mg single, oral
dose: 30 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISOLONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: FASTED
0.025 μg × h/mL
1200 mg single, intravenous
dose: 1200 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PREDNISOLONE HEMISUCCINATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
0.0173 μg × h/mL
75 mg single, intravenous
dose: 75 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PREDNISOLONE HEMISUCCINATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
0.085 μg × h/mL
1200 mg single, intravenous
dose: 1200 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PREDNISOLONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
0.0601 μg × h/mL
75 mg single, intravenous
dose: 75 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PREDNISOLONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
5.11 h
60 mg single, enteral
dose: 60 mg
route of administration: Enteral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
3.3 h
40 mg single, oral
dose: 40 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
3.6 h
40 mg single, oral
dose: 40 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
3.85 h
20 mg single, oral
dose: 20 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FED
2.6 h
30 mg single, oral
dose: 30 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISOLONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: FASTED
4 h
PREDNISOLONE plasma
Homo sapiens
30 min
20 mg single, intramuscular
dose: 20 mg
route of administration: Intramuscular
experiment type: SINGLE
co-administered:
PREDNISOLONE HEMISUCCINATE serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
25 min
1200 mg single, intravenous
dose: 1200 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PREDNISOLONE HEMISUCCINATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
18 min
75 mg single, intravenous
dose: 75 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PREDNISOLONE HEMISUCCINATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
3.7 h
1200 mg single, intravenous
dose: 1200 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PREDNISOLONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
3.5 h
75 mg single, intravenous
dose: 75 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PREDNISOLONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
50%
PREDNISONE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
20%
30 mg single, oral
dose: 30 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PREDNISOLONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: FASTED
10%
PREDNISOLONE plasma
Homo sapiens
23%
75 mg single, intravenous
dose: 75 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PREDNISOLONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
100 mg 1 times / day multiple, oral
Highest studied dose
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
unhealthy, adult
5 mg 1 times / day steady, oral
Recommended
Dose: 5 mg, 1 times / day
Route: oral
Route: steady
Dose: 5 mg, 1 times / day
Sources:
unhealthy, adult
Disc. AE: Vertigo, Abdominal pain upper...
AEs leading to
discontinuation/dose reduction:
Vertigo (1%)
Abdominal pain upper (1%)
Gastroesophageal reflux disease (1%)
Intestinal functional disorder (1%)
Nausea (1%)
Dizziness (1%)
Aphasia (1%)
Headache (1%)
Renal pain (1%)
Sources:
1 % 4 times / day multiple, ophthalmic
Recommended
Dose: 1 %, 4 times / day
Route: ophthalmic
Route: multiple
Dose: 1 %, 4 times / day
Sources:
unhealthy, ADULT
Health Status: unhealthy
Age Group: ADULT
Sex: M+F
Food Status: UNKNOWN
Sources:
AEs

AEs

AESignificanceDosePopulation
Abdominal pain upper 1%
Disc. AE
5 mg 1 times / day steady, oral
Recommended
Dose: 5 mg, 1 times / day
Route: oral
Route: steady
Dose: 5 mg, 1 times / day
Sources:
unhealthy, adult
Aphasia 1%
Disc. AE
5 mg 1 times / day steady, oral
Recommended
Dose: 5 mg, 1 times / day
Route: oral
Route: steady
Dose: 5 mg, 1 times / day
Sources:
unhealthy, adult
Dizziness 1%
Disc. AE
5 mg 1 times / day steady, oral
Recommended
Dose: 5 mg, 1 times / day
Route: oral
Route: steady
Dose: 5 mg, 1 times / day
Sources:
unhealthy, adult
Gastroesophageal reflux disease 1%
Disc. AE
5 mg 1 times / day steady, oral
Recommended
Dose: 5 mg, 1 times / day
Route: oral
Route: steady
Dose: 5 mg, 1 times / day
Sources:
unhealthy, adult
Headache 1%
Disc. AE
5 mg 1 times / day steady, oral
Recommended
Dose: 5 mg, 1 times / day
Route: oral
Route: steady
Dose: 5 mg, 1 times / day
Sources:
unhealthy, adult
Intestinal functional disorder 1%
Disc. AE
5 mg 1 times / day steady, oral
Recommended
Dose: 5 mg, 1 times / day
Route: oral
Route: steady
Dose: 5 mg, 1 times / day
Sources:
unhealthy, adult
Nausea 1%
Disc. AE
5 mg 1 times / day steady, oral
Recommended
Dose: 5 mg, 1 times / day
Route: oral
Route: steady
Dose: 5 mg, 1 times / day
Sources:
unhealthy, adult
Renal pain 1%
Disc. AE
5 mg 1 times / day steady, oral
Recommended
Dose: 5 mg, 1 times / day
Route: oral
Route: steady
Dose: 5 mg, 1 times / day
Sources:
unhealthy, adult
Vertigo 1%
Disc. AE
5 mg 1 times / day steady, oral
Recommended
Dose: 5 mg, 1 times / day
Route: oral
Route: steady
Dose: 5 mg, 1 times / day
Sources:
unhealthy, adult
Sourcing

Sourcing

Vendor/AggregatorIDURL
PubMed

PubMed

TitleDatePubMed
Comparative study of availability of prednisolone after intestinal infusion of prednisolone metasulfobenzoate and prednisone.
1993
Prednisone is more effective than prednisolone metasulfobenzoate in the treatment of bullous pemphigoid.
1999 Jan
Pulmonary mucosa-associated lymphoid tissue lymphoma in a patient with common variable immunodeficiency syndrome.
2001
Bilateral empyema caused by adult-onset Still's disease.
2001
Choroidal granulomas in systemic sarcoidosis.
2001
Cyclophosphamide and antithymocyte globulin to condition patients with aplastic anemia for allogeneic marrow transplantations: the experience in four centers.
2001
Hodgkin's disease: clinical presentation and treatment.
2001
Current status of cytotoxic chemotherapy in hormone refractory prostate cancer.
2001 Feb
Cyclophosphamide-based, seven-drug hybrid and low-dose involved field radiation for the treatment of childhood and adolescent Hodgkin disease.
2001 Feb
Primary central nervous system lymphoma in childhood presenting as progressive panhypopituitarism.
2001 Feb
Hepatic dysfunction as the presenting feature of acute lymphoblastic leukemia.
2001 Feb
Bone marrow involvement by nasal NK cell lymphoma at diagnosis is uncommon.
2001 Feb
The usefulness of quantitative orbital magnetic resonance imaging in Graves' ophthalmopathy.
2001 Feb
Mycophenolic acid plasma concentrations: influence of comedication.
2001 Feb
Interstitial nephritis in patients with inflammatory bowel disease treated with mesalamine.
2001 Feb
Prednisone withdrawal followed by interferon alpha for treatment of chronic hepatitis C infection: results of a randomized controlled trial.
2001 Feb
Recalcitrant allergic contact dermatitis from azathioprine tablets.
2001 Feb
Circulating CD8+ T cells in polymyalgia rheumatica and giant cell arteritis: a review.
2001 Feb
[Can 67Ga citrate predict the efficacy of chemotherapy early in Hodgkin's lymphoma?].
2001 Feb
Idiopathic leukonychia totalis and partialis in a 12-year-old patient.
2001 Feb
Post-transplant diabetes mellitus: increasing incidence in renal allograft recipients transplanted in recent years.
2001 Feb
Familial nephropathy differing from minimal change nephropathy and focal glomerulosclerosis.
2001 Feb
Idiopathic IgA nephropathy with segmental necrotizing lesions of the capillary wall.
2001 Feb
Fistulation of the auditory tube diverticulum (guttural pouch) with a neodymium:yttrium-aluminum-garnet laser for treatment of chronic empyema in two horses.
2001 Feb 1
Adult Gaucher disease in association with primary malignant bone tumors.
2001 Feb 1
Improved response with higher corticosteroid dose in children with acute lymphoblastic leukemia.
2001 Feb 15
Sample size calculations for the two-sample problem using the multiplicative intensity model.
2001 Feb 28
Remission of precapillary pulmonary hypertension in systemic lupus erythematosus.
2001 Jan
Pyodera gangrenosum after aortic valve replacement.
2001 Jan
Two-year effects of alendronate on bone mineral density and vertebral fracture in patients receiving glucocorticoids: a randomized, double-blind, placebo-controlled extension trial.
2001 Jan
Gingival overgrowth as the initial paraneoplastic manifestation of Hodgkin's lymphoma in a child. A case report.
2001 Jan
Lupus-like syndrome with submassive hepatic necrosis associated with hepatitis A.
2001 Jan
Macrohematuria with electron-dense deposits in a 14-year-old boy with minimal change nephrotic syndrome.
2001 Jan
Fatal cytomegalovirus disease in a high-risk renal transplant recipient.
2001 Jan
Nocardia pleural empyema complicating anti-Jo1 positive polymyositis during immunoglobulin and steroid therapy.
2001 Jan
Systemic vasculitis in patients with hepatitis C.
2001 Jan
Factors associated with low bone mineral density in female patients with systemic lupus erythematosus.
2001 Jan
A rationale for adjuvant surgical intervention in pyoderma gangrenosum.
2001 Jan
Effective steroid-sparing treatment for peripheral ulcerative keratitis and pyoderma gangrenosum.
2001 Jan
Plasmapheresis as an effective treatment for opsoclonus-myoclonus syndrome.
2001 Jan
Multiple myeloma in elderly patients: presenting features and outcome.
2001 Jan
Tacrolimus monotherapy in adult cardiac transplant recipients: intermediate-term results.
2001 Jan
What have we learned about cognition in myasthenia gravis?: a review of methods and results.
2001 Jan
Phase II study of rituximab in combination with chop chemotherapy in patients with previously untreated, aggressive non-Hodgkin's lymphoma.
2001 Jan 15
Ethnic differences in clinical response to corticosteroid treatment of acute renal allograft rejection.
2001 Jan 27
Autologous hematopoietic stem-cell transplantation for Behçet's disease with pulmonary involvement.
2001 Jan 4
[Life threatening hypercalcemia in a young man with ALL].
2001 Jan 5
Retinopathy due to juvenile polymyositis.
2001 Jan-Feb
[Acceptability and tolerance of prednisolone metasulfobenzoate in orally dispersing tablets in 2 to 12-years-old children].
2004 Sep
Clinical trial: oral prednisolone metasulfobenzoate (Predocol) vs. oral prednisolone for active ulcerative colitis.
2008 Feb 1
Patents

Sample Use Guides

In Vivo Use Guide
Unknown
Route of Administration: Unknown
In Vitro Use Guide
Unknown
Substance Class Chemical
Created
by admin
on Mon Mar 31 17:48:28 GMT 2025
Edited
by admin
on Mon Mar 31 17:48:28 GMT 2025
Record UNII
8B2807733D
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
PREDNISOLONE ACETATE
EP   GREEN BOOK   MART.   ORANGE BOOK   USP   USP-RS   VANDF   WHO-DD   WHO-IP  
Common Name English
PREDNISOLONE 21-ACETATE
MI  
Preferred Name English
METHYLPREDNISOLONE ACETATE IMPURITY E [EP IMPURITY]
Common Name English
PRED-G COMPONENT PREDNISOLONE ACETATE
Common Name English
PREGNA-1,4-DIENE-3,20-DIONE, 21-(ACETYLOXY)-11,17-DIHYDROXY-, (11.BETA.)-
Systematic Name English
FLO-PRED
Brand Name English
METIMYD COMPONENT PREDNISOLONE ACETATE
Common Name English
PREDNISOLONE ACETATE [USP IMPURITY]
Common Name English
NSC-10966
Code English
CETAPRED COMPONENT PREDNISOLONE ACETATE
Common Name English
PREDNISOLONE ACETATE [VANDF]
Common Name English
HYDROCORTISONE ACETATE IMPURITY C [EP IMPURITY]
Common Name English
PREDAMIDE COMPONENT PREDNISOLONE ACETATE
Common Name English
Prednisolone acetate [WHO-DD]
Common Name English
METICORTELONE
Brand Name English
PREDSULFAIR COMPONENT PREDNISOLONE ACETATE
Common Name English
PREDNISOLONE IMPURITY C [EP IMPURITY]
Common Name English
11?,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-acetate
Systematic Name English
OMNIPRED
Brand Name English
ECONOPRED
Brand Name English
BLEPHAMIDE S.O.P. COMPONENT PREDNISOLONE ACETATE
Common Name English
PRED FORTE
Brand Name English
NEO-DELTA-CORTEF COMPONENT PREDNISOLONE ACETATE
Common Name English
PREDNISOLONE ACETATE [JAN]
Common Name English
PREDNISOLONE ACETATE [GREEN BOOK]
Common Name English
PREDNISOLONE 21-ACETATE [MI]
Common Name English
PREDNISOLONE ACETATE [USP-RS]
Common Name English
BLEPHAMIDE COMPONENT PREDNISOLONE ACETATE
Common Name English
PREDNISOLONE ACETATE [WHO-IP]
Common Name English
ISOPTO CETAPRED COMPONENT PREDNISOLONE ACETATE
Common Name English
11.BETA.,17-DIHYDROXY-3,20-DIOXOPREGNA-1,4-DIEN-21-YL ACETATE
Systematic Name English
PREDNISOLONE ACETATE [ORANGE BOOK]
Common Name English
PREDNISONE IMPURITY L [EP]
Common Name English
PREDNISOLONI ACETAS [WHO-IP LATIN]
Common Name English
PREDNISOLONE ACETATE [USP MONOGRAPH]
Common Name English
PREDNISOLONE ACETATE [MART.]
Common Name English
POLY-PRED COMPONENT PREDNISOLONE ACETATE
Common Name English
SULPHRIN COMPONENT PREDNISOLONE ACETATE
Common Name English
PREDNISOLONE ACETATE [EP MONOGRAPH]
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C521
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
CFR 21 CFR 522.1881
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
Code System Code Type Description
FDA UNII
8B2807733D
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
EPA CompTox
DTXSID3023502
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
MERCK INDEX
m9111
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY Merck Index
EVMPD
SUB04014MIG
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
DRUG BANK
DB15566
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
DAILYMED
8B2807733D
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
RXCUI
34372
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY RxNorm
RS_ITEM_NUM
1556008
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
WHO INTERNATIONAL PHARMACOPEIA
PREDNISOLONE ACETATE
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY Description: A white or almost white, crystalline powder; odourless. Solubility: Practically insoluble in water; slightly soluble in ethanol (~750 g/l) TS and acetone R. Category: Adrenal hormone.Storage: Prednisolone acetate should be kept in a well-closed container, protected from light. Additional information: Prednisolone acetate has a melting temperature of about 235?C with decomposition.Definition: Prednisolone acetate contains not less than 96.0% and not more than 104.0% of C23H30O6, calculated with referenceto the dried substance.
SMS_ID
100000090168
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
MESH
C009935
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
NCI_THESAURUS
C1202
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
WIKIPEDIA
Prednisolone acetate
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
CAS
52-21-1
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
ChEMBL
CHEMBL1152
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
NSC
10966
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
PUBCHEM
5834
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
DRUG CENTRAL
2247
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
ECHA (EC/EINECS)
200-134-1
Created by admin on Mon Mar 31 17:48:28 GMT 2025 , Edited by admin on Mon Mar 31 17:48:28 GMT 2025
PRIMARY
Related Record Type Details
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
PARENT -> IMPURITY
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
PARENT -> IMPURITY
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
PARENT -> IMPURITY
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
Related Record Type Details
ACTIVE MOIETY