prednisone 5 MG Oral Tablet
INDICATIONS AND USAGE Prednisone tablets and solutions are indicated in the following conditions: 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. 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. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. 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. 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. 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. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic Diseases For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. 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. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.
Aphena Pharma Solutions - Tennessee, Inc.
ROUND WHITE 54 612
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HOW SUPPLIED Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. PredniSONE Tablets USP 1 mg, round, white, scored tablets (Identified 54 092) NDC 0054-8739-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4741-25: Bottles of 100 tablets. NDC 0054-4741-31: Bottles of 1000 tablets. 2.5 mg, round, white, scored tablets (Identified 54 339) NDC 0054-8740-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4742-25: Bottles of 100 tablets. 5 mg, round, white, scored tablets (Identified 54 612) NDC 0054-8724-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4728-25: Bottles of 100 tablets. NDC 0054-4728-31: Bottles of 1000 tablets. 10 mg, round, white, scored tablets (Identified 54 899) NDC 0054-0017-20: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-0017-25: Bottles of 100 tablets. NDC 0054-0017-29: Bottles of 500 tablets. 20 mg, round, white, scored tablets (Identified 54 760) NDC 0054-0018-20: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-0018-25: Bottles of 100 tablets. NDC 0054-0018-29: Bottles of 500 tablets. 50 mg, round, white, scored tablets (Identified 54 343) NDC 0054-0019-20: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-0019-25: Bottles of 100 tablets. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight container, as defined in the USP/NF. PROTECT FROM MOISTURE. PredniSONE Oral Solution USP, 5 mg per 5 mL Clear, colorless solution NDC 0054-8722-16: Unit dose Patient Cup™ filled to deliver 5 mL (5 mg Prednisone), ten 5 mL Patient Cups™ per shelf pack, 4 shelf packs per shipper. NDC 0054-3722-50: Bottles of 120 mL. NDC 0054-3722-63: Bottles of 500 mL. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight 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: Bottles of 30 mL with calibrated dropper (graduations of 0.25 mL [1.25 mg] to 1.0 mL [5 mg] on the dropper). Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.
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