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Hydrocortisone Tablets, USP

Brand and Other Names: Cortef
Mechanism of Action:
Indications:

•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 Non-suppurative thyroiditis Hypercalcemia associated with cancer.
•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 and, Epicondylitis. See package insert for complete information.

Route: Oral
Dose:
The initial dosage of CORTEF Tablets may vary from 20 mg to 240 mg of hydrocortisone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time, there is a lack of satisfactory clinical response, CORTEF should be discontinued and the patient transferred to other appropriate therapy. See package insert for complete information.
Adverse Reactions:

• Fluid and Electrolyte Disturbances: Sodium retention, Fluid retention, Congestive heart failure in susceptible patients, Potassium loss, Hypokalemic alkalosis, and, Hypertension.
• Musculoskeletal: Muscle weakness, Steroid myopathy, Loss of muscle mass, Osteoporosis, Tendon rupture, particularly of the Achilles tendon, Vertebral compression fractures, Aseptic necrosis of femoral and humeral heads, and Pathologic fracture of long bones. See package insert for complete information.

Contraindication:
Systemic fungal infections and known hypersensitivity to components.
Warnings and Precautions:
Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. See package insert for complete information.
See package insert for full prescribing information.