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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Ketoconazole foam, 2% may result in contact sensitization, including photoallergenicity ( 5.1 , 6.2 ). • The contents of ketoconazole foam, 2% are flammable. Avoid fire, flame, or smoking during and immediately following application. ( 5.2 ). 5.1 Contact Sensitization Ketoconazole foam, 2% may result in contact sensitization, including photoallergenicity [see Adverse Reactions (6.2) ] . 5.2 Flammable Contents The contents of ketoconazole foam, 2% include alcohol and propane/butane, which are flammable. Avoid fire, flame and/or smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C). 5.3 Systemic Effects Hepatitis has been seen with orally administered ketoconazole (1:10,000 reported incidence). Lowered testosterone and ACTH–induced corticosteroid serum levels have been seen with high doses of orally administered ketoconazole. These effects have not been seen with topical ketoconazole.
6 ADVERSE REACTIONS The most common adverse reactions observed in clinical studies (incidence >1%) were application site burning and application site reaction ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates. The safety data presented in Table 1 reflect exposure to ketoconazole foam, 2% in 672 subjects, 12 years and older with seborrheic dermatitis. Subjects applied ketoconazole foam, 2% or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. Adverse reactions occurring in > 1% of subjects are presented in Table 1. Table 1: Adverse Reactions Reported by > 1% Subjects in Clinical Trials Adverse Reactions Ketoconazole Foam, 2% N = 672 n (%) Vehicle Foam N = 497 n (%) Subjects with an Adverse Reaction 188 (28%) 122 (25%) Application site burning 67 (10%) 49 (10%) Application site reaction 41 (6%) 24 (5%) Application site reactions that were reported in <1% of subjects were dryness, erythema, irritation, paresthesia, pruritus, rash and warmth. 6.2 Dermal Safety Studies In a photoallergenicity study, 9 of 53 subjects (17%) had reactions during the challenge period at both the irradiated and non-irradiated sites treated with ketoconazole foam, 2%. Ketoconazole foam, 2% may cause contact sensitization. 6.3 Postmarketing Experience The following adverse events have been identified during postmarketing use of ketoconazole foam, 2%: Gastrointestinal disorders: Cheilitis General disorders and administration site conditions: Application site pain and application site burn Skin and subcutaneous tissue disorders: Skin burning sensation and erythema Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.