Ketoconazole Foam
FDA Drug Information • Also known as: Ketoconazole
- Brand Names
- Ketoconazole
- Drug Class
- Azole Antifungal [EPC]
- Route
- TOPICAL
- Dosage Form
- AEROSOL, FOAM
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION Ketoconazole foam, 2% contains 2% ketoconazole USP, an antifungal agent, in a thermolabile hydroethanolic foam for topical application. The chemical name for ketoconazole is piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl) -2-(1 H -imidazol-l-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, cis - with the molecular formula C 26 H 28 Cl 2 N 4 O 4 and a molecular weight of 531.43. The following is the chemical structure: Ketoconazole foam, 2% contains 20 mg of ketoconazole per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (denatured with tert -butyl alcohol and brucine sulfate) 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Ketoconazole Structural Formula
What Is Ketoconazole Foam Used For?
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 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 for treatment of fungal infections have not been established.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Ketoconazole foam, 2% should be applied to the affected area(s) twice daily for four weeks. Hold the container upright, and dispense ketoconazole foam, 2% into the cap of the can or other cool surface in an amount sufficient to cover the affected area(s). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of ketoconazole foam, 2% with the fingertips, and gently massage into the affected area(s) until the foam disappears. For hair-bearing areas, part the hair, so that ketoconazole foam, 2% may be applied directly to the skin (rather than on the hair). Avoid contact with the eyes and other mucous membranes. Ketoconazole foam, 2% is not for ophthalmic, oral or intravaginal use.
Side Effects (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 Xiromed, LLC at 844-XIROMED (844-947-6633) 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.
Contraindications
4 CONTRAINDICATIONS None. None.
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary There are no available data on ketoconazole foam, 2% use in pregnant women to identify a drug‑associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. No reproductive studies in animals have been performed with ketoconazole foam, 2%. In animal reproduction studies with pregnant mice, rats and rabbits both embryotoxic and developmental effects (structural abnormalities) were observed following oral dosing of ketoconazole during organogenesis. Assuming equivalent systemic absorption of topical and oral ketoconazole doses and an ketoconazole foam, 2% maximum recommended human dose (MRHD) of 8 grams (equivalent to 160 mg ketoconazole), embryotoxic effects were observed at 0.8 to 2.4 times the MRHD and developmental effects were observed at 4.8 times the MRHD [see Data ] . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data The animal multiples of human exposure calculations are based on body surface area (BSA) comparisons of oral doses administered to animals and an ketoconazole foam, 2% maximum recommended human dose (MRHD) of 8 grams (equivalent to 2.67 mg ketoconazole/kg/day for a 60 kg individual or 98.8 mg ketoconazole/m 2 /day). Embryofetal development studies have been conducted in mice, rats and rabbits with orally administered ketoconazole. When orally administered to mice on gestational days 6 through 18 (covering the period of organogenesis), ketoconazole was embryotoxic (25 mg/kg and higher; 0.8 times the MRHD based on BSA comparisons) with a high incidence of resorptions, increased number of stillbirths and delayed parturition. Delays in maturation were also observed....
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Ketoconazole foam, 2% contains 20 mg of ketoconazole, USP per gram. The thermolabile hydroethanolic foam is available as follows: NDC 70700-160-19 50 g aluminum can NDC 70700-160-20 100 g aluminum can Store at 20 ° to 25 ° C (68 ° to 77 ° F). [See USP Controlled Room Temperature.] Do not store under refrigerated conditions. Contents are flammable. Do not expose containers to heat and/or store at temperatures above 49°C (120°F). Do not store in direct sunlight. Contents under pressure. Do not puncture and/or incinerate container. Keep out of reach of children.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.