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INDICATIONS AND USAGE Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases For the palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
west-ward pharmaceuticals corp.
ROUND TURQUOISE 54 769
54 769 ROUND TURQUOISE
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HOW SUPPLIED Dexamethasone Tablets, USP 0.5 mg tablets are supplied as a light yellow, flat tablet with beveled edges, scored on one side and product identification “54 299” debossed on the other side. NDC 0054-8179-25: 10x10 Unit-Dose NDC 0054-4179-25: Bottle of 100 Tablets 0.75 mg tablets are supplied as a pale blue, flat tablet with beveled edges, scored on one side and product identification “54 960” debossed on the other side. NDC 0054-8180-25: 10x10 Unit-Dose NDC 0054-4180-25: Bottle of 100 Tablets 1 mg tablets are supplied as a yellow, flat tablet with beveled edges, scored on one side and product identification “54 489” debossed on the other side. NDC 0054-8174-25: 10x10 Unit-Dose NDC 0054-4181-25: Bottle of 100 Tablets 1.5 mg tablets are supplied as a pink, flat tablet with beveled edges, scored on one side and product identification “54 943” debossed on the other side. NDC 0054-8181-25: 10x10 Unit-Dose NDC 0054-4182-25: Bottle of 100 Tablets 2 mg tablets are supplied as a white, flat tablet with beveled edges, scored on one side and product identification “54 662” debossed on the other side. NDC 0054-8176-25: 10x10 Unit-Dose NDC 0054-4183-25: Bottle of 100 Tablets 4 mg tablets are supplied as a green, flat tablet with beveled edges, scored on one side and product identification “54 892” debossed on the other side. NDC 0054-8175-25: 10x10 Unit-Dose NDC 0054-4184-25: Bottle of 100 Tablets 6 mg tablets are supplied as an aqua, flat tablet with beveled edges, scored on one side and product identification “54 769” debossed on the other side. NDC 0054-8183-25: 10x10 Unit-Dose NDC 0054-4186-25: Bottle of 100 Tablets Store and Dispense 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. Dexamethasone Oral Solution, USP 0.5 mg per 5 mL oral solution is supplied as a (cherry brandy flavored) clear colorless solution. NDC 0054-3177-57: Bottle of 240 mL NDC 0054-3177-63: Bottle of 500 mL Store and Dispense 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. Dexamethasone Oral Solution, USP Intensol ™ (Concentrate) 1 mg per mL oral solution is supplied as a clear colorless solution. NDC 0054-3176-44: Bottle of 30 mL with calibrated oral syringe [graduation of 0.25 mL (0.25 mg), 0.5 mL (0.5 mg), 0.75 mL (0.75 mg) and 1 mL (1 mg) on the oral syringe]. Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze. Do not use if solution contains a precipitate. Dispense only in this 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 C5000comb/02/k01 Revised February 2024
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