SOLU-CORTEF INJECTION Dosage & Rx Info

Solu-cortef Injection Generic Name & Formulations

Legal Class

General Description

Hydrocortisone (as sodium succinate) 100mg, 250mg, 500mg, 1g; for IV or IM inj; preservative (benzyl alcohol) and preservative-free.

Pharmacological Class

Gluco/mineralocorticoid.

How Supplied

Tabs 5mg—50; 10mg, 20mg—100; Solu-Cortef 100mg (2mL)—1, 25; 250mg (2mL)—1, 25; 500mg (4mL), 1g (8mL)—1

Manufacturer

Pfizer Inc.

Mechanism of Action

Hydrocortisone sodium succinate has the same metabolic and anti-inflammatory actions as hydrocortisone. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

Solu-cortef Injection Indications

Indications

Steroid-responsive disorders when oral therapy not feasible.

Solu-cortef Injection 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.

Solu-cortef Injection Contraindications

Contraindications

Systemic mycoses. Live vaccination. Solu-Cortef: also premature infants (benzyl alcohol content), intrathecal administration, idiopathic thrombocytopenic purpura (IM preparations).

Solu-cortef Injection Boxed Warnings

Not Applicable

Solu-cortef Injection 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. High tumor proliferative rate, high tumor burden, or sensitivity to cytotoxic agents; monitor closely. 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. Nursing mothers.

Solu-cortef Injection Pharmacokinetics

Metabolism

Hepatic.

Elimination

Renal.

Solu-cortef Injection 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.

Solu-cortef Injection 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, tumor lysis syndrome.

Solu-cortef Injection Clinical Trials

See Literature

Solu-cortef Injection Note