Ketodan
Ketoconazole · Aerosol, Foam · Topical
Uses
1. INDICATIONS AND USAGE Ketodan ® Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Ketodan ® 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 Ketodan ® Foam, 2% for treatment of fungal infections have not been established. Limitations of Use Safety and efficacy of Ketodan ® Foam, 2% for treatment of fungal infections have not been established.
Dosage and administration
2. DOSAGE AND ADMINISTRATION Ketodan ® Foam, 2% should be applied to the affected area(s) twice daily for four weeks. Hold the container upright, and dispense Ketodan ® 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 Ketodan ® 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 Ketodan ® Foam, 2% may be applied directly to the skin (rather than on the hair). Avoid contact with the eyes and other mucous membranes. Ketodan ® Foam, 2% is not for ophthalmic, oral or intravaginal use. Ketodan ® Foam, 2% should be applied to the affected area(s) twice daily for four weeks ( 2 ). Ketodan ® Foam, 2% is not for ophthalmic, oral, or intravaginal use ( 2 ).
Dosage forms and strengths
3. DOSAGE FORMS AND STRENGTHS Ketodan ® Foam, 2% contains 20 mg of ketoconazole, USP per gram, supplied in 100 g containers. Foam: 2% ketoconazole in 100 g containers ( 3 ).
Contraindications
4. CONTRAINDICATIONS None. None.
Warnings and precautions
5. WARNINGS AND PRECAUTIONS Ketodan ® Foam, 2% may result in contact sensitization, including photoallergenicity ( 5.1 , 6.2 ). The contents of Ketodan ® Foam, 2% are flammable. Avoid fire, flame, or smoking during and immediately following application. ( 5.2 ). 5.1 Contact Sensitization Ketodan ® Foam, 2% may result in contact sensitization, including photoallergenicity [see Adverse Reactions (6.2) ]. 5.2 Flammable Contents The contents of Ketodan ® 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.
Side effects
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 Medimetriks at 1-973-882-7512 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%. Ketodan ® 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.
Use in specific populations
8. USE IN SPECIFIC POPULATIONS 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 a 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 a 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. There was no evidence of maternal toxicity or malformations at up to 50 mg/kg (1.5 times the MRHD based on BSA comparisons). No treatment related developmental effects were observed at 10 mg/kg (0.3 times the MRHD based on BSA comparisons). In the presence of maternal toxicity in rats, orally administered ketoconazole was both embryotoxic (40 mg/kg and higher; 2.4 times the MRHD based on BSA comparisons), including increased resorbed fetuses and stillbirths, and teratogenic (80 mg/kg and higher; 4.8 times the MRHD based on BSA comparisons), including syndactylia, oligodactylia, waved ribs and cleft palate. Additionally, 100 mg/kg (6 times the MRHD based on BSA comparisons) ketoconazole orally administered on a single day during gestation (gestational days 9 through 12) was embryotoxic (increased resorptions). This same oral dose given on gestation day 12, 13, 14 or 15 induced external malformations including cleft palate, micromelia and digital anomalies (brachydactyly, ectrodactyly, syndactyly). In pregnant rabbits orally administered ketoconazole, evidence of embryotoxicity (increased resorptions) was observed at 10 mg/kg (1.2 times the MRHD based on BSA comparisons) and higher and an increased incidence of skeletal abnormalities was observed at 40 mg/kg (4.8 times the MRHD based on BSA comparisons). 8.2 Lactation Risk Summary There is no information available on the presence of ketoconazole in human milk, or the effects on the breastfed child, or the effects on milk production after topical application of ketoconazole foam, 2% to women who are breastfeeding. In animal studies ketoconazole was found in milk following oral administration. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Ketodan ® Foam, 2% and any potential adverse effects on the breastfed infant from Ketodan ® Foam, 2% or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential Infertility In animal fertility studies in rats and dogs, administration of oral doses of ketoconazole between 3-day and 3-month periods resulted in infertility that was reversible [see Nonclinical Toxicology (13.1) ] . 8.4 Pediatric Use The safety and effectiveness of ketoconazole foam, 2% in pediatric patients less than 12 years of age have not been established. Of the 672 subjects treated with ketoconazole foam, 2% in the clinical trials, 44 (7%) were from 12 to 17 years of age. [See Clinical Studies (14) ]. 8.5 Geriatric Use Of the 672 subjects treated with ketoconazole foam, 2% in the clinical trials, 107 (16%) were 65 years and over. Clinical trials of ketoconazole foam, 2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects.
Pregnancy
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 a 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 a 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. There was no evidence of maternal toxicity or malformations at up to 50 mg/kg (1.5 times the MRHD based on BSA comparisons). No treatment related developmental effects were observed at 10 mg/kg (0.3 times the MRHD based on BSA comparisons). In the presence of maternal toxicity in rats, orally administered ketoconazole was both embryotoxic (40 mg/kg and higher; 2.4 times the MRHD based on BSA comparisons), including increased resorbed fetuses and stillbirths, and teratogenic (80 mg/kg and higher; 4.8 times the MRHD based on BSA comparisons), including syndactylia, oligodactylia, waved ribs and cleft palate. Additionally, 100 mg/kg (6 times the MRHD based on BSA comparisons) ketoconazole orally administered on a single day during gestation (gestational days 9 through 12) was embryotoxic (increased resorptions). This same oral dose given on gestation day 12, 13, 14 or 15 induced external malformations including cleft palate, micromelia and digital anomalies (brachydactyly, ectrodactyly, syndactyly). In pregnant rabbits orally administered ketoconazole, evidence of embryotoxicity (increased resorptions) was observed at 10 mg/kg (1.2 times the MRHD based on BSA comparisons) and higher and an increased incidence of skeletal abnormalities was observed at 40 mg/kg (4.8 times the MRHD based on BSA comparisons).
Pediatric use
8.4 Pediatric Use The safety and effectiveness of ketoconazole foam, 2% in pediatric patients less than 12 years of age have not been established. Of the 672 subjects treated with ketoconazole foam, 2% in the clinical trials, 44 (7%) were from 12 to 17 years of age. [See Clinical Studies (14) ].
Geriatric use
8.5 Geriatric Use Of the 672 subjects treated with ketoconazole foam, 2% in the clinical trials, 107 (16%) were 65 years and over. Clinical trials of ketoconazole foam, 2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects.
Description
11. DESCRIPTION Ketodan ® 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-1-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: Ketodan ® Foam, 2% contains 20 mg ketoconazole per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Chemical Structure
Mechanism of action
12.1 Mechanism of Action The mechanism of action of ketoconazole in the treatment of seborrheic dermatitis is not known.
How supplied
16. HOW SUPPLIED/STORAGE AND HANDLING Ketodan ® Foam, 2% contains 20 mg of ketoconazole, USP per gram. The thermolabile hydroethanolic foam is available as follows: NDC 43538-530-10 100 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.
Storage
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.
Patient information
17. PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Patient Package Insert ). Instruct patients on a proper use of Ketodan ® Foam, 2% Avoid fire, flame and/or smoking during and immediately following application. Do not apply Ketodan ® Foam, 2% directly to hands. Dispense onto a cool surface, and apply to the affected areas using the fingertips. Wash their hands after application Ketodan ® Foam, 2% may cause skin irritation (application site burning and/or reactions) Instruct a patient to contact a health care provider if the area of application shows signs of increased irritation and report any signs of adverse reactions.
Label text from the FDA structured product label by Medimetriks Pharmaceuticals, Inc. (revised Dec 5, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Ketoconazole in 1 product
Ketodan NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 43538-530 | Ketoconazole 20 mg/g Aerosol, Foam | Medimetriks Pharmaceuticals, Inc. | ANDA |
Frequently asked questions
What is Ketodan used for?
1. INDICATIONS AND USAGE Ketodan ® Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Ketodan ® 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 Ketodan ® Foam, 2% for treatment of fungal infections…
What are the side effects of Ketodan?
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 Medimetriks at 1-973-882-7512 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,… See the full label for the complete list.
Who makes Ketodan?
Ketodan is listed by 1 labeler in the FDA NDC directory, including Medimetriks Pharmaceuticals, Inc..