ketoconazole
Generic: KETOCONAZOLE
Basic Information
Manufacturer
Bryant Ranch Prepack
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
a878a39d-6d26-4ede-9667-b3e201ffc337
Indications & Usage
1 INDICATIONS AND USAGE Ketoconazole foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.
Limitations of Use Safety and efficacy of ketoconazole foam, 2% for treatment of fungal infections have not been established.
Ketoconazole foam, 2% is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older ( 1 ).
Limitations of Use Safety and efficacy of ketoconazole foam, 2% for treatment of fungal infections have not been established.
Limitations of Use Safety and efficacy of ketoconazole foam, 2% for treatment of fungal infections have not been established.
Ketoconazole foam, 2% is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older ( 1 ).
Limitations of Use Safety and efficacy of ketoconazole foam, 2% for treatment of fungal infections have not been established.
Adverse Reactions
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.
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.