Cortef Generic Name & Formulations
Legal Class
Rx
General Description
Hydrocortisone 5mg, 10mg, 20mg; tabs.
Pharmacological Class
Gluco/mineralocorticoid.
See Also
How Supplied
Tabs 5mg—50; 10mg, 20mg—100; Solu-Cortef 100mg (2mL)—1, 25; 250mg (2mL)—1, 25; 500mg (4mL), 1g (8mL)—1
Manufacturer
Cortef Indications
Indications
Steroid-responsive disorders.
Cortef Dosage and Administration
Adult
See full labeling. Oral: initially 20–240mg daily. Parenteral: initially 100–500mg.
Children
See full labeling. Oral: in single or divided doses. Replacement: 0.56mg/kg/day. Other indications: 2–8mg/kg/day. Parenteral: initially 0.56–8mg/kg/day in 3 or 4 divided doses.
Cortef Contraindications
Contraindications
Systemic mycoses. Live vaccination. Solu-Cortef: also premature infants (benzyl alcohol content), intrathecal administration, idiopathic thrombocytopenic purpura (IM preparations).
Cortef Boxed Warnings
Not Applicable
Cortef Warnings/Precautions
Warnings/Precautions
Not for epidural use; serious neurologic events may occur. Concomitant systemic fungal infections, active ocular herpes simplex, cerebral malaria: not recommended. Latent or active amebiasis. Strongyloides infection. Tuberculosis. If exposed to chickenpox or measles, consider prophylactic passive immune therapy. Renal insufficiency. Recent MI. CHF. Hypertension. Thyroid disorder. Peptic ulcers. Diverticulitis. Intestinal anastomoses. Ulcerative colitis. Cirrhosis. Postmenopausal women (osteoporosis risk). Diabetes. Supplement with additional steroids in physiologic stress. Emotional instability. Psychotic tendencies. Myasthenia gravis. Avoid abrupt cessation. Alternate, intermittent or single-daily doses at 8AM minimize adrenal suppression. Monitor thyroid, weight, growth, fluid, electrolyte balance and intraocular pressure (w. therapy >6weeks). Pregnancy (Cat.C). Nursing mothers.
Cortef Pharmacokinetics
See Literature
Cortef Interactions
Interactions
Potentiated by ketoconazole, macrolides, cyclosporine, estrogens. Antagonized by CYP3A4 inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin), cholestyramine. May potentiate cyclosporine (seizure risk). May antagonize anticoagulants (monitor), isoniazid. Increased risk of arrhythmias with digitalis. May need to adjust dose of antidiabetic agents. Increased GI effects with aspirin, other NSAIDs. Caution with aspirin in hypoprothrombinemia. Monitor for hypokalemia with potassium-depleting drugs (eg, amphotericin B, diuretics). Concomitant neuromuscular blocking agents; increased risk of myopathy. Withdraw anticholinesterase agents at least 24hrs before initiating corticosteroid therapy. Aminoglutethimide may lead to loss of corticosteroid-induced adrenal suppression. May suppress reactions to skin tests.
Cortef Adverse Reactions
Adverse Reactions
HPA axis suppression, masks infection, increased susceptibility to infection, glaucoma, cataracts, secondary infections, hypokalemia, hypocalcemia, hypernatremia, hypertension, psychic disorders, myopathy, osteoporosis, peptic ulcer, dermal atrophy, increased intracranial pressure, carbohydrate intolerance, Kaposi's sarcoma, pheochromocytoma crisis.
Cortef Clinical Trials
See Literature
Cortef Note
Not Applicable
Cortef Patient Counseling
See Literature