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prednisone tablet prednisone solution prednisone intensol solution concentrate

INDICATIONS Prednisone tablets and solutions are indicated in the following conditions: 1. 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 2. 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 Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Nervous System Acute exacerbations of multiple sclerosis 13. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement

west-ward pharmaceuticals corp.


5 years ago ROUND WHITE 54 760 prednisone tablet prednisone solution prednisone intensol solution concentrate

ROUND WHITE 54 760

5 years ago ROUND WHITE 54 760 prednisone tablet prednisone solution prednisone intensol solution concentrate

54 760 ROUND WHITE

HOW SUPPLIED

PREDNISONE Tablets, USP 1 mg – white to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 092” debossed on the other side. NDC 0054-8739-25: 10x10 Unit-Dose NDC 0054-4741-25: Bottle of 100 Tablets NDC 0054-4741-31: Bottle of 1,000 Tablets 2.5 mg – white to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 339” debossed on the other side. NDC 0054-8740-25: 10x10 Unit-Dose NDC 0054-4742-25: Bottle of 100 Tablets 5 mg – white to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 612” debossed on the other side. NDC 0054-8724-25: 10x10 Unit-Dose NDC 0054-4728-25: Bottle of 100 Tablets NDC 0054-4728-31: Bottle of 1,000 Tablets 10 mg – white to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 899” debossed on the other side. NDC 0054-0017-20: 10x10 Unit-Dose NDC 0054-0017-25: Bottle of 100 Tablets NDC 0054-0017-29: Bottle of 500 Tablets 20 mg – white to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 760” debossed on the other side. NDC 0054-0018-20: 10x10 Unit-Dose NDC 0054-0018-25: Bottle of 100 Tablets NDC 0054-0018-29: Bottle of 500 Tablets 50 mg – white to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 343” debossed on the other side. NDC 0054-0019-20: 10x10 Unit-Dose NDC 0054-0019-25: Bottle of 100 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, child-resistant container as defined in the USP/NF. PROTECT FROM MOISTURE.

PREDNISONE Oral Solution USP, 5 mg per 5 mL Clear, colorless, slightly viscous solution. NDC 0054-3722-50: Bottle of 120 mL NDC 0054-3722-63: Bottle of 500 mL Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF.

PREDNISONE Intensol™ Oral Solution (Concentrate), 5 mg per mL Clear, colorless, slightly viscous solution. NDC 0054-3721-44: Bottle of 30 mL with calibrated oral syringe (graduations of 0.25 mL [1.25 mg] to 1 mL [5 mg] on the syringe) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense only in the bottle and only with the calibrated oral syringe provided. Discard opened bottle after 90 days. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000278/04 Revised February 2024


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