Iodoquinol and hydrocortisone: Drug information

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Anaphylactoid reactions: Rare cases of anaphylactoid reactions have been observed in patients receiving corticosteroids.

• Contact dermatitis: Allergic contact dermatitis can occur and is usually diagnosed by failure to heal rather than clinical exacerbation; discontinue use if irritation occurs and treat appropriately.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Exposure to chickenpox or measles should be avoided; corticosteroids should not be used to treat ocular herpes simplex. Corticosteroids should not be used for cerebral malaria, fungal infections, or viral hepatitis. Close observation is required in patients with tuberculosis (TB) infection (latent TB) and/or TB reactivity; restrict use in TB disease (active TB) (only fulminating or disseminated TB in conjunction with antituberculosis treatment). Amebiasis should be ruled out in any patient with recent travel to tropical climates or unexplained diarrhea prior to initiation of corticosteroids.

• Kaposi sarcoma: 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)

• Myopathy: 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.

• Optic atrophy/neuritis: Prolonged use of high doses of iodoquinol may result in optic neuritis and optic atrophy; avoid long-term therapy.

• Peripheral neuropathy: Prolonged use of high doses of iodoquinol may result in peripheral neuropathy; avoid long-term therapy.

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

• Sensitization: Topical use has been associated with local sensitization (redness, irritation); discontinue if sensitization is noted.

• Superinfection: Prolonged use may result in the overgrowth of nonsusceptible organisms.

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with heart failure and/or hypertension.

• Diabetes: Use with caution in patients with diabetes mellitus.

• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, intestinal anastomoses, peptic ulcer, nonspecific ulcerative colitis).

• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis.

• Myocardial infarction: Use with caution following acute myocardial infarction (MI); corticosteroids have been associated with myocardial rupture.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use.

• Osteoporosis: Use with caution in patients with osteoporosis.

• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.

• Thyroid disease: Use with caution in patients with thyroid abnormalities; wait one month after discontinuing therapy before performing thyroid tests.

• Ulcerative colitis: With severe ulcerative colitis, it may be hazardous to delay surgery while waiting for response to treatment.

Special populations:

• Older adult: Because of the risk of adverse effects associated with systemic absorption, topical corticosteroids should be used cautiously in elderly patients in the smallest possible effective dose for the shortest duration.

• Pediatric: Children may absorb proportionally larger amounts of corticosteroids after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Benzyl alcohol and derivatives: 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:

• Appropriate use: For external use only; avoid contact with eyes, lips, and mucous membranes. Staining of the skin, hair and fabrics may occur. Not recommended for use under occlusive dressings, tight fitting garments, or diapered areas. If occlusive dressings are used, general caution should be observed; adverse effects may be increased.

• Discontinuation of therapy: After long-term use, withdraw therapy with gradual tapering of dose.

• Stress: May require higher doses when subject to stress (ie, trauma, surgery, severe infection).