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Ketoconazole - Prescription Drug Labeling

Product NDC Code 63629-8676
Drug Name

Ketoconazole

Type Generic
Pharm Class Azole Antifungal [EPC],
Azoles [CS],
Cytochrome P450 3A4 Inhibitors [MoA],
Cytochrome P450 3A5 Inhibitors [MoA],
P-Glycoprotein Inhibitors [MoA]
Active Ingredients
Ketoconazole 2 g/100g
Route TOPICAL
Dosage Form AEROSOL, FOAM
RxCUI drug identifier 728550
Application Number ANDA091550
Labeler Name Bryant Ranch Prepack
Packages
Package NDC Code Description
63629-8676-1 1 canister in 1 carton (63629-8676-1) > 50 g in 1 canister

Adverse reactions

Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.
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 Perrigo at 1-866-634-9120 or www.perrigo.com and 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.
Adverse ReactionsKetoconazole Foam, 2%N=672n (%)Vehicle FoamN=497n (%)
Subjects with an Adverse Reaction188 (28%)122 (25%)
Application site burning67 (10%)49 (10%)
Application site reaction41 (6%)24 (5%)

Clinical pharmacology

Information about the clinical pharmacology and actions of the drug in humans.
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mechanism of action of ketoconazole in the treatment of seborrheic dermatitis is not known. 12.2 Pharmacodynamics The pharmacodynamics of Ketoconazole Foam, 2% has not been established. 12.3 Pharmacokinetics In a bioavailability study, 12 subjects with moderate to severe seborrheic dermatitis applied 3 g of ketoconazole foam, 2% twice daily for 4 weeks. Circulating plasma levels of ketoconazole were < 6 ng/mL for a majority of subjects (75%), with a maximum level of 11 ng/mL observed in one subject. 12.4 Microbiology Ketoconazole is an antifungal agent which inhibits the in vitro synthesis of ergosterol, a key sterol in the cell membrane of Malassezia furfur . The clinical significance of antifungal activity in the treatment of seborrheic dermatitis is not known.

Mechanism of action

Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.
12.1 Mechanism of Action The mechanism of action of ketoconazole in the treatment of seborrheic dermatitis is not known.

Pharmacodynamics

Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.
12.2 Pharmacodynamics The pharmacodynamics of Ketoconazole Foam, 2% has not been established.

Pharmacokinetics

Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.
12.3 Pharmacokinetics In a bioavailability study, 12 subjects with moderate to severe seborrheic dermatitis applied 3 g of ketoconazole foam, 2% twice daily for 4 weeks. Circulating plasma levels of ketoconazole were < 6 ng/mL for a majority of subjects (75%), with a maximum level of 11 ng/mL observed in one subject.

Contraindications

Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.
4 CONTRAINDICATIONS None. None.

Description

General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
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-1-ylmethyl)-1, 3-dioxolan-4-yl]methoxy]phenyl]-, cis - with the molecular formula C 26 H 28 CI 2 N 4 O 4 and a molecular weight of 531.43. The following is the chemical structure: Ketoconazole Foam, 2% contains 20 mg 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.

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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. • Ketoconazole Foam, 2% should be applied to the affected area(s) twice daily for four weeks (2). • Ketoconazole Foam, 2% is not for ophthalmic, oral, or intravaginal use (2).

Dosage forms and strengths

Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.
3 DOSAGE FORMS AND STRENGTHS Ketoconazole Foam, 2% contains 20 mg of ketoconazole, USP per gram, supplied in 50 g and 100 g containers. Foam: 2% ketoconazole in 50 g and 100 g containers.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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. Limitations of Use Safety and efficacy of Ketoconazole Foam, 2% for treatment of fungal infections have not been established.

Spl product data elements

Usually a list of ingredients in a drug product.
ketoconazole ketoconazole KETOCONAZOLE KETOCONAZOLE CETYL ALCOHOL CITRIC ACID MONOHYDRATE TERT-BUTYL ALCOHOL ALCOHOL BRUCINE SULFATE POLYSORBATE 60 POTASSIUM CITRATE PROPYLENE GLYCOL WATER STEARYL ALCOHOL BUTANE PROPANE chemical structure step-1.jpg step-2.jpg step-2.1.jpg step-3.jpg step-3.1.jpg step-4.jpg

Carcinogenesis and mutagenesis and impairment of fertility

Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic or photo-carcinogenic potential of ketoconazole foam, 2%. In oral carcinogenicity studies in mice (18-months) and rats (24-months) at dose levels of 5, 20 and 80 mg/kg/day ketoconazole was not carcinogenic. The high dose in these studies was approximately 2.4 to 4.8 times the MRHD based on BSA comparisons. In a bacterial reverse mutation assay, ketoconazole did not express any mutagenic potential. In three in vivo assays (sister chromatid exchange in humans, dominant lethal and micronucleus tests in mice), ketoconazole did not exhibit any genotoxic potential. In animal fertility studies, oral ketoconazole impaired both male and female fertility in rats in a dose and duration dependent manner. In females, oral doses up to 40 mg/kg (2.4 times the MRHD based on BSA comparisons) had no effect on fertility, while doses of 75 mg/kg (4.5 times the MRHD based on BSA comparisons) and higher decreased the pregnancy rate and number of implantation sites. In male rats, oral dosing at 200 mg/kg/day (12 times the MRHD based on BSA comparisons) for three days decreased fertility and 400 mg/kg/day (24 times the MRHD based on BSA comparisons) for three days resulted in a complete loss of fertility. When administered for longer durations (up to 3 months), decreased fertility in male rats was observed at doses as low as 24 mg/kg/day (1.4 times the MRHD based on BSA comparisons). In male beagle dogs, an oral dose of 25 mg/kg/day ketoconazole for up to 4 weeks (5.2 times the MRHD based on BSA comparisons) resulted in decreased sperm motility, decreased sperm count, increased abnormal sperm and atrophy of the testes. These effects were reversed subsequent to withdrawal of treatment.

Nonclinical toxicology

Information about toxicology in non-human subjects.
13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic or photo-carcinogenic potential of ketoconazole foam, 2%. In oral carcinogenicity studies in mice (18-months) and rats (24-months) at dose levels of 5, 20 and 80 mg/kg/day ketoconazole was not carcinogenic. The high dose in these studies was approximately 2.4 to 4.8 times the MRHD based on BSA comparisons. In a bacterial reverse mutation assay, ketoconazole did not express any mutagenic potential. In three in vivo assays (sister chromatid exchange in humans, dominant lethal and micronucleus tests in mice), ketoconazole did not exhibit any genotoxic potential. In animal fertility studies, oral ketoconazole impaired both male and female fertility in rats in a dose and duration dependent manner. In females, oral doses up to 40 mg/kg (2.4 times the MRHD based on BSA comparisons) had no effect on fertility, while doses of 75 mg/kg (4.5 times the MRHD based on BSA comparisons) and higher decreased the pregnancy rate and number of implantation sites. In male rats, oral dosing at 200 mg/kg/day (12 times the MRHD based on BSA comparisons) for three days decreased fertility and 400 mg/kg/day (24 times the MRHD based on BSA comparisons) for three days resulted in a complete loss of fertility. When administered for longer durations (up to 3 months), decreased fertility in male rats was observed at doses as low as 24 mg/kg/day (1.4 times the MRHD based on BSA comparisons). In male beagle dogs, an oral dose of 25 mg/kg/day ketoconazole for up to 4 weeks (5.2 times the MRHD based on BSA comparisons) resulted in decreased sperm motility, decreased sperm count, increased abnormal sperm and atrophy of the testes. These effects were reversed subsequent to withdrawal of treatment.

Microbiology

Microbiology
12.4 Microbiology Ketoconazole is an antifungal agent which inhibits the in vitro synthesis of ergosterol, a key sterol in the cell membrane of Malassezia furfur . The clinical significance of antifungal activity in the treatment of seborrheic dermatitis is not known.

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Ketoconazole 2%, Foam, #50 Label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Made in Israel Manufactured By Perrigo Yeruham, Israel Distributed By Perrigo® Allegan, MI 49010 www.perrigo.com Rev 08-18 5K200RCJ3

ketoconazole: Information for patients

Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Package Insert). Instruct patients on a proper use of Ketoconazole Foam, 2%. • Avoid fire, flame and/or smoking during and immediately following application. • Do not apply Ketoconazole Foam, 2% directly to hands. Dispense onto a cool surface, and apply to the affected areas using the fingertips. • Wash their hands after application • Ketoconazole 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.

Instructions for use

Information about safe handling and use of the drug product.
Instructions for Use Ketoconazole Foam, 2% Important Information: Ketoconazole Foam, 2% is for use on the skin only. Do not use Ketoconazole Foam, 2% in your eyes, mouth or vagina. Step 1: Remove the clear cap from the Ketoconazole Foam, 2% can. Step 2: Hold the can upright and firmly press the nozzle to dispense Ketoconazole Foam, 2% into the clear cap. • Dispense enough Ketoconazole Foam, 2% to cover the entire affected area(s). • If the can seems warm or the foam seems runny, run the can under cold water. Step 3: Pick up small amounts of Ketoconazole Foam, 2% with your fingertips and gently rub the foam into the affected area(s) until the foam disappears. • If you are treating areas such as your scalp, part the hair so that Ketoconazole Foam, 2% may be applied directly to the skin. Step 4: Wash your hands after applying Ketoconazole Foam, 2%. • Throw away any of the unused medicine that is left in the cap. How should I store Ketoconazole Foam, 2%? • Store Ketoconazole Foam, 2% at room temperature between 68°F to 77°F (20°C to 25°C). • Do not store the Ketoconazole Foam, 2% can in the refrigerator or freezer. • Keep Ketoconazole Foam, 2% away from heat. Never throw the can into a fire, even if the can is empty. • Do not store Ketoconazole Foam, 2% at temperatures above 120°F (49°C). • Do not break through (puncture) the Ketoconazole Foam, 2% can. Keep Ketoconazole Foam, 2% and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Rx Only Made in Israel Manufactured By Perrigo Yeruham, Israel Distributed By Perrigo® Allegan, MI 49010 www.perrigo.com Rev 08-18

Spl patient package insert

Information necessary for patients to use the drug safely and effectively.
PATIENT INFORMATION Ketoconazole Foam, 2% Important Information: Ketoconazole Foam, 2% is for use on the skin only. Do not use Ketoconazole Foam, 2% in your eyes, mouth or vagina. What is Ketoconazole Foam, 2%? Ketoconazole Foam, 2% is a prescription medicine used on the skin (topical) to treat seborrheic dermatitis in people 12 years of age and older with a normal immune system. It is not known if Ketoconazole Foam, 2% is safe and effective when used to treat fungal infections. It is not known if Ketoconazole Foam, 2% is safe and effective in children less than 12 years of age. Before using Ketoconazole Foam, 2%, tell your healthcare provider about all of your medical conditions, including if you: • are pregnant or plan to become pregnant. It is not known if Ketoconazole Foam, 2% will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if Ketoconazole Foam, 2% passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Ketoconazole Foam, 2%. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use Ketoconazole Foam, 2%? • Use Ketoconazole Foam, 2% exactly as your healthcare provider tells you to use it. See the detailed “Instructions for Use” at the end of this leaflet for directions about how to apply Ketoconazole Foam, 2% the right way. • Apply Ketoconazole Foam, 2% to the affected skin area(s) 2 times each day for 4 weeks. You should apply enough Ketoconazole Foam, 2% to cover the entire affected area(s). • Talk to your healthcare provider if your skin does not improve after 4 weeks of treatment with Ketoconazole Foam, 2%. • Dispense Ketoconazole Foam, 2% directly into the cap. Do not dispense Ketoconazole Foam, 2% directly onto your hands, because the foam will begin to melt on contact with warm skin. • Wash your hands after applying Ketoconazole Foam, 2%. What should I avoid while using Ketoconazole Foam, 2%? • Ketoconazole Foam, 2% is flammable. Avoid fire, flames, or smoking during and right after you apply Ketoconazole Foam, 2% to your skin. • Avoid getting Ketoconazole Foam, 2% in or near your eyes, mouth, lips or vagina. If you get Ketoconazole Foam, 2% on your lips or in your eyes, mouth or vagina, rinse well with water. What are the possible side effects of Ketoconazole Foam, 2%? Ketoconazole Foam, 2% may cause serious side effects, including: • Skin irritation at the application area(s), including skin reactions caused by exposure to light. Tell your healthcare provider if you develop skin irritation during treatment with Ketoconazole Foam, 2%. The most common side effects of Ketoconazole Foam, 2% include, burning, dryness, redness, irritation, numbness, itching, rash and warmth at the application site. These are not all of the possible side effects of Ketoconazole Foam, 2%. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Ketoconazole Foam, 2%? • Store Ketoconazole Foam, 2% at room temperature between 68°F to 77°F (20°C to 25°C). • Do not store the Ketoconazole Foam, 2% can in the refrigerator or freezer. • Keep Ketoconazole Foam, 2% away from heat. Never throw the Ketoconazole Foam, 2% can into a fire, even if the can is empty. • Do not store Ketoconazole Foam, 2% at temperatures above 120°F (49°C). • Do not break through (puncture) the Ketoconazole Foam, 2% can. Keep Ketoconazole Foam, 2% and all medicines out of the reach of children. General information about the safe and effective use of Ketoconazole Foam, 2%. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Ketoconazole Foam, 2% for a condition for which it was not prescribed. Do not give Ketoconazole Foam, 2% to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Ketoconazole Foam, 2% that is written for health professionals. What are the ingredients in Ketoconazole Foam, 2%? Active ingredient: ketoconazole Inactive Ingredients: 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 For more information, call Perrigo at 1-866-634-9120 This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.

Clinical studies

This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.
14 CLINICAL STUDIES The safety and efficacy of ketoconazole foam, 2% were evaluated in a randomized, double-blind, vehicle-controlled trial in subjects 12 years and older with mild to severe seborrheic dermatitis. In the trial, 427 subjects received ketoconazole foam, 2% and 420 subjects received vehicle foam. Subjects applied ketoconazole foam, 2% or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. The overall disease severity in terms of erythema, scaling, and induration was assessed at Baseline and week 4 on a 5-point Investigator’s Static Global Assessment (ISGA) scale. Treatment success was defined as achieving a Week 4 (end of treatment) ISGA score of 0 (clear) or 1 (majority of lesions have individual scores for scaling, erythema, and induration that averages 1 [minimal or faint]) and at least two grades of improvement from baseline. The results are presented in Table 2. The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups. Table 2: Efficacy Results Number of Subjects Ketoconazole Foam, 2% N = 427 n (%) Vehicle Foam N = 420 n (%) Subjects Achieving Treatment Success 239 (56%) 176 (42%)
Number of SubjectsKetoconazole Foam, 2%N = 427n (%)Vehicle FoamN = 420n (%)
Subjects Achieving Treatment Success239 (56%)176 (42%)

Geriatric use

Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.
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.

Nursing mothers

Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.
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)] .

Pediatric use

Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.
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) ].

Pregnancy

Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)
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).

Use in specific populations

Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.
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 Ketoconazole Foam, 2% and any potential adverse effects on the breastfed infant from Ketoconazole 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.

How supplied

Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.
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 63629-8676-1 50 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.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API