Deflazacort

May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully.

Rare cases of anaphylaxis have occurred in patients receiving corticosteroids.

Prolonged use of corticosteroids may increase the incidence of secondary infection, cause activation of latent infections, mask acute infection (including fungal infections), prolong or exacerbate existing infections, or limit response to killed or inactivated vaccines. Exposure to chickenpox or measles should be avoided. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only in conjunction with antituberculosis treatment). Avoid use in patients with active ocular herpes simplex. Hepatitis B reactivation can occur in patients who are hepatitis B carriers. Amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiation of corticosteroids. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination and fatalities have occurred.

Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

Acute myopathy has been reported with high dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles; monitor creatinine kinase; recovery may be delayed.

Prolonged use may cause posterior subcapsular cataracts, glaucoma (with possible nerve damage), and increased intraocular pressure. Consider routine eye exams in chronic users.

Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

Toxic epidermal necrolysis has been reported within 8 weeks of starting treatment; discontinue at first sign of rash, unless rash is clearly not drug-related.

Higher cumulative doses of corticosteroids have been associated with an increased risk of thromboembolism. Use caution in patients with a history of or at increased risk for thromboembolic disorders. Disease-related concerns:

Use with caution in patients with heart failure and/or hypertension; use has been associated with fluid retention, electrolyte disturbances, and hypertension. Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.

Use with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

Use with caution in patients with GI diseases (diverticulitis, fresh intestinal anastomoses, ulcerative colitis, active or latent peptic ulcer, abscess or other pyogenic infections) due to perforation risk. Avoid use if there is a probability of impending perforation, abscess, or other pyogenic infection.

Use with caution in patients with severe hepatic impairment.

Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred especially during initial treatment with corticosteroids.

Use with caution in patients with or who are at risk for osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss, osteoporotic fractures, and avascular necrosis.

Use with caution in patients with pheochromocytoma; cases of pheochromocytoma crisis, which can be fatal, have been reported with corticosteroids.

Use with caution in renal impairment; fluid retention may occur.

Use with caution in patients with a history of seizure disorder.

Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

May affect growth velocity; growth should be routinely monitored in pediatric patients. Dosage form specific issues:

Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP 1997; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling. Other warnings/precautions:

Withdraw therapy with gradual tapering of dose.

Patients may require higher doses when subject to stress (ie, trauma, surgery, severe infection).