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Xolegel - Prescription Drug Labeling

Product NDC Code 16110-080
Drug Name

Xolegel

Type Brand
Pharm Class Azole Antifungal [EPC],
Azoles [CS],
Cytochrome P450 3A4 Inhibitors [MoA],
Cytochrome P450 3A5 Inhibitors [MoA],
P-Glycoprotein Inhibitors [MoA]
Active Ingredients
Ketoconazole 20 mg/g
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 647253,
664961
Application Number NDA021946
Labeler Name Almirall, LLC
Packages
Package NDC Code Description
16110-080-45 1 tube in 1 carton (16110-080-45) > 45 g in 1 tube

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 treatment-related adverse reaction was application site burning (4%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Almirall at 1-866-665-2782 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 clinical practice. In the 3 safety and efficacy trials, 65 of 933 subjects (7%) experienced at least one treatment-related adverse event. The most common treatment-related adverse reaction was application site burning (4%). Treatment-related application site reactions that were reported in < 1% of subjects were: dermatitis, discharge, dryness, erythema, irritation, pain, pruritus, and pustules. Other treatment-related adverse reactions that were reported in < 1% of subjects were: eye irritation, eye swelling, keratoconjunctivitis sicca, impetigo, pyogenic granuloma, dizziness, headache, paresthesia, acne, nail discoloration, facial swelling.

Xolegel Drug Interactions

Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.
7 DRUG INTERACTIONS Formal drug interaction studies with XOLEGEL have not been performed. Coadministration of oral ketoconazole with CYP3A4 metabolized HMG-CoA reductase inhibitors such as simvastatin, lovastatin and atorvastatin, may increase the risk of skeletal muscle toxicity, including rhabdomyolysis. These effects have not been observed with topically administered ketoconazole.

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 unknown. 12.2 Pharmacodynamics Pharmacodynamic markers for seborrheic dermatitis have not been identified. 12.3 Pharmacokinetics In a pharmacokinetic absorption trial, eighteen subjects, both males and females, with severe seborrheic dermatitis (range 1-14% of body surface area) applied XOLEGEL once daily for 2 weeks. The median total amount of gel applied was 4.6 g (range 1.65–46.3 g). Daily doses ranged from 0.05 to 3.47 g. Mean (± standard deviation [SD]) peak plasma levels were 1.35 (± 3.18) ng/mL on Day 7 (range from <0.1 ng/mL, to 13.9 ng/mL), and 0.80 (± 1.22) ng/mL on Day 14 (range from <0.1 ng/mL to 5.4 ng/mL). Median T max was 8 hours on Day 7 and 7 hours on Day 14. Mean (± SD) AUC 0-24 values were 20.8 (± 44.7) ng∙h/mL and 15.6 (± 26.4) ng∙h/mL on Day 7 and 14, respectively. The plasma levels from an oral dose of 200 mg ketoconazole taken with a meal are approximately 250 times higher than the resulting plasma levels of ketoconazole following topical application of XOLEGEL.

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 unknown.

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 Pharmacodynamic markers for seborrheic dermatitis have not been identified.

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 pharmacokinetic absorption trial, eighteen subjects, both males and females, with severe seborrheic dermatitis (range 1-14% of body surface area) applied XOLEGEL once daily for 2 weeks. The median total amount of gel applied was 4.6 g (range 1.65–46.3 g). Daily doses ranged from 0.05 to 3.47 g. Mean (± standard deviation [SD]) peak plasma levels were 1.35 (± 3.18) ng/mL on Day 7 (range from <0.1 ng/mL, to 13.9 ng/mL), and 0.80 (± 1.22) ng/mL on Day 14 (range from <0.1 ng/mL to 5.4 ng/mL). Median T max was 8 hours on Day 7 and 7 hours on Day 14. Mean (± SD) AUC 0-24 values were 20.8 (± 44.7) ng∙h/mL and 15.6 (± 26.4) ng∙h/mL on Day 7 and 14, respectively. The plasma levels from an oral dose of 200 mg ketoconazole taken with a meal are approximately 250 times higher than the resulting plasma levels of ketoconazole following topical application of XOLEGEL.

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 XOLEGEL contains the antifungal agent ketoconazole USP at 2% in a topical anhydrous gel vehicle for topical administration. Chemically, ketoconazole is (±)-cis-1-Acetyl-4-[p-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine, with the molecular formula C 26 H 28 Cl 2 N 4 O 4 and a molecular weight of 531.43. Figure 1 Each gram contains: 20 mg ketoconazole USP, dehydrated alcohol (34%), ascorbic acid, butylated hydroxytoluene, citric acid monohydrate, glycerin, hydroxypropyl cellulose, polyethylene glycol 400, PPG-15 stearyl ether, propylene glycol, FD&C yellow No. 6, and FD&C yellow No. 10. XOLEGEL is a smooth, translucent to clear, amber gel. Chemical Structure

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 XOLEGEL is for topical use only, and not for oral, ophthalmic, or intravaginal use. XOLEGEL should be applied once daily to the affected area for 2 weeks. XOLEGEL is for topical use only, and not for oral, ophthalmic, or intravaginal use. ( 2 ) XOLEGEL should be applied once daily to the affected area for 2 weeks. ( 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 XOLEGEL is a translucent to clear amber colored gel containing 2% ketoconazole. Gel containing 2% ketoconazole. ( 3 )

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 XOLEGEL is indicated for the topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older. Safety and efficacy of XOLEGEL for treatment of fungal infections have not been established. XOLEGEL is an azole antifungal indicated for topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older. ( 1 , 12.1 ) Safety and efficacy of XOLEGEL for treatment of fungal infections have not been established. ( 1 )

Spl product data elements

Usually a list of ingredients in a drug product.
Xolegel ketoconazole KETOCONAZOLE KETOCONAZOLE ALCOHOL ASCORBIC ACID BUTYLATED HYDROXYTOLUENE CITRIC ACID MONOHYDRATE GLYCERIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) POLYETHYLENE GLYCOL 400 PPG-15 STEARYL ETHER PROPYLENE GLYCOL FD&C YELLOW NO. 6 D&C YELLOW NO. 10

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 A 2-year dermal carcinogenicity study conducted in mice with topical administration of ketoconazole gel at doses up to 80 mg ketoconazole/kg/day exhibited no evidence of carcinogenic activity. A long-term feeding study in mice and in rats showed no evidence of carcinogenic activity. Ketoconazole produced no evidence of mutagenicity in the dominant lethal mutation test in male and female mice at single oral doses up to 80 mg/kg. When tested in the Ames assay, ketoconazole was not mutagenic to Salmonella typhimurium in the presence or absence of metabolic activation. Ketoconazole, in combination with another drug, gave equivocal results in the mouse micronucleus test. At oral doses of 75 mg/kg/day, ketoconazole impaired the reproductive performance in female (decreased pregnancy and implantation rates) and male (increased abnormal sperm and decreased sperm motility) rats.

Nonclinical toxicology

Information about toxicology in non-human subjects.
13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year dermal carcinogenicity study conducted in mice with topical administration of ketoconazole gel at doses up to 80 mg ketoconazole/kg/day exhibited no evidence of carcinogenic activity. A long-term feeding study in mice and in rats showed no evidence of carcinogenic activity. Ketoconazole produced no evidence of mutagenicity in the dominant lethal mutation test in male and female mice at single oral doses up to 80 mg/kg. When tested in the Ames assay, ketoconazole was not mutagenic to Salmonella typhimurium in the presence or absence of metabolic activation. Ketoconazole, in combination with another drug, gave equivocal results in the mouse micronucleus test. At oral doses of 75 mg/kg/day, ketoconazole impaired the reproductive performance in female (decreased pregnancy and implantation rates) and male (increased abnormal sperm and decreased sperm motility) rats.

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.
PRINCIPAL DISPLAY PANEL - 45 g Carton NDC 16110-080-45 Xolegel ® (ketoconazole) Gel, 2% AQUA PHARMACEUTICALS 45 grams Rx only. For topical use only. PRINCIPAL DISPLAY PANEL - 45 g Carton PRINCIPAL DISPLAY PANEL - 45 g Carton NDC 16110-080-45 Xolegel ® (ketoconazole) Gel, 2% AQUA PHARMACEUTICALS 45 grams Rx only. For topical use only. PRINCIPAL DISPLAY PANEL - 45 g Tube

Xolegel: 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 Information )] This medication is to be used as directed by the health care provider. It is for external use only. XOLEGEL may be irritating to mucus membranes. Contact with the eyes, nostrils, and mouth should be avoided. As with any topical medication, patients should wash their hands after application. Advise breastfeeding women not to apply XOLEGEL directly to the nipple and areola to avoid direct infant exposure. This medication should not be used for any disorder other than that for which it has been prescribed. Patients should report any signs of adverse reactions to their health care provider.

Spl patient package insert

Information necessary for patients to use the drug safely and effectively.
PATIENT INFORMATION XOLEGEL ® (Xol-a-gel) (ketoconazole) Gel, 2% Read the Patient Information that comes with XOLEGEL carefully before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your health care provider. If you have any questions about XOLEGEL, ask your health care provider. What is XOLEGEL? XOLEGEL is a prescription medicine used on the skin to treat a skin condition called seborrheic dermatitis. Patients with seborrheic dermatitis can have areas of dry, flaky skin on the scalp, face, ears, chest, or upper back. XOLEGEL is only to be used in adults and in children older than 12 years of age who have a normal (healthy) immune system. XOLEGEL has not been studied in children below the age of 12. It is not known whether XOLEGEL can be used to treat fungal infections. XOLEGEL is a translucent to clear, amber colored gel. What should I tell my health care provider before using XOLEGEL? Tell your health care provider about all of your medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding or planning to breastfeed. XOLEGEL should be used during pregnancy and breastfeeding only if needed. Tell your health care provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Keep a list of your medicines and show it to your health care provider and pharmacist. Tell your health care provider and pharmacist when you get a new medicine. It is not known if XOLEGEL and other medicines can interact with each other. How should I use XOLEGEL? Use XOLEGEL exactly as prescribed. Talk to your health care provider if your condition gets worse or does not get better by the end of your treatment. Wash your hands before and after applying XOLEGEL. Spread a thin layer of XOLEGEL evenly on the affected skin with your fingertips. Be sure to cover all affected areas. Do not wash the areas where you applied XOLEGEL for at least 3 hours after you apply it. Wait at least 20 minutes after you spread XOLEGEL on your skin before you put makeup or sunscreens on the affected areas. Use XOLEGEL once daily for 2 weeks. What should I avoid while using XOLEGEL? XOLEGEL is only to be used on the skin. It is not for eye, mouth, or vaginal use. Do not touch your eyes, nose, or mouth while you are applying XOLEGEL. Wash your hands well after you apply it. Irritation may occur if you get XOLEGEL in your eyes, nose, or mouth. If used during breastfeeding and XOLEGEL is applied on the chest, take care to avoid accidental ingestion of XOLEGEL by the baby. XOLEGEL is flammable (it can catch fire). Stay away from heat, flame, or smoking while you are applying XOLEGEL and right after you apply it. This medication should not be used for any disorder other than that for which it has been prescribed. What are the possible side effects of XOLEGEL? The effects of XOLEGEL during pregnancy, including whether XOLEGEL can harm your unborn baby, are not known. It is not known if XOLEGEL can pass into your breastmilk or if it can harm your breastfed baby. Stop using XOLEGEL and talk to your health care provider if you develop itching, a rash, or any skin irritation after using XOLEGEL. Stop using XOLEGEL and talk to your health care provider if your skin condition (seborrheic dermatitis) gets worse. The most common side effect is a burning feeling where XOLEGEL is applied. Report any side effects to your health care provider to receive immediate medical attention. You can also report suspected side effects by calling the US Food and Drug Administration at 1-800-FDA-1088, or reporting via the internet at www.fda.gov/medwatch. These are not all of the side effects of XOLEGEL. For more information, ask your health care provider or pharmacist. How should I store XOLEGEL? Store XOLEGEL at 59°F to 86°F (15° to 30°C). Keep XOLEGEL and all medicines out of the reach of children. Contents are flammable. Avoid storing XOLEGEL near heat or flame. General information about XOLEGEL Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use XOLEGEL for a condition for which it was not prescribed. Do not give XOLEGEL to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about XOLEGEL. If you would like more information, talk with your health care provider. You can also ask your pharmacist or health care provider for information about XOLEGEL that is written for health professionals. What are the ingredients in XOLEGEL? Active ingredient: ketoconazole, USP Inactive ingredients: dehydrated alcohol, ascorbic acid, butylated hydroxytoluene, citric acid monohydrate, glycerin, hydroxypropyl cellulose, polyethylene glycol 400, PPG-15 stearyl ether, propylene glycol, FD&C yellow No. 6, and FD&C Yellow No. 10. This Patient Information leaflet has been approved by the U.S. Food and Drug Administration. The Patient Information leaflet was last revised: May 2012. Manufactured for Almirall, LLC 101 Lindenwood Drive, Suite 400, Malvern, PA 19355 Revised 12/2019 XOLEGEL is a registered trademark of Almirall, LLC. © 2019 Almirall, LLC Almirall, LLC

Clinical studies

This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.
14 CLINICAL STUDIES Study 1 was a multicenter, double-blind, randomized, vehicle-controlled trial which enrolled 459 subjects 12 years of age and older with moderate to severe seborrheic dermatitis. A total of 229 subjects were treated with XOLEGEL, and 230 subjects were treated with vehicle. All subjects were treated once daily for 14 days, and efficacy was assessed at Day 28 (i.e., 2 weeks after end of treatment). Effective Treatment was defined as: an Investigator's Global Assessment score of ≤ 1 (completely clear or almost clear) and erythema and scaling scores of 0 (none) if the baseline score was 2, or 1 (mild) if the baseline score was 3. The proportion of subjects effectively treated is shown in Table 1 . Table 1: Trial Results XOLEGEL N=229 Vehicle N=230 Number and proportion of subjects effectively treated 58 (25.3%) 32 (13.9%) Two additional double-blind, randomized, vehicle-controlled, parallel, and multicenter trials that included a total of 316 subjects treated with XOLEGEL provided supportive evidence of the efficacy of XOLEGEL for treatment of seborrheic dermatitis. Subjects applied either XOLEGEL or vehicle study treatment to the affected area(s) once daily for 14 days and were followed through Day 28. Efficacy was assessed by the proportion of subjects who were completely clear at Day 28. The contribution to efficacy of individual components of the vehicle has not been established.
Table 1: Trial Results
XOLEGEL N=229Vehicle N=230
Number and proportion of subjects effectively treated58 (25.3%)32 (13.9%)

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 933 subjects in the three safety and efficacy trials, 193 (20.7%) were 65 and older, while 61 (6.5%) were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects but greater sensitivity of some older individuals cannot be ruled out.

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 Safety and effectiveness in pediatric subjects below the age of 12 have not been established.

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 XOLEGEL use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies with pregnant rats, structural abnormalities (syndactylia and oligodactylia) were observed following oral doses of ketoconazole during organogenesis ( see Data ). The available data do not allow calculation of relevant comparisons between the systemic exposure of ketoconazole observed in animal studies to the systemic exposure observed in humans after topical use of XOLEGEL. The estimated 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%-4% and 15%-20%, respectively. Data Animal Data Oral administration of ketoconazole at 80 mg/kg/day to pregnant rats during organogenesis was associated with structural abnormalities (syndactylia and oligodactylia) . However, these effects may be related to maternal toxicity, which was also seen at this and higher dose levels. In oral peri- and postnatal development studies in rats, maternal toxicity, prolonged gestation, embryolethality and fetotoxicity were observed at ketoconazole doses of 40 mg/kg/day and higher.

Teratogenic effects

Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).
Risk Summary There are no available data on XOLEGEL use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies with pregnant rats, structural abnormalities (syndactylia and oligodactylia) were observed following oral doses of ketoconazole during organogenesis ( see Data ). The available data do not allow calculation of relevant comparisons between the systemic exposure of ketoconazole observed in animal studies to the systemic exposure observed in humans after topical use of XOLEGEL. The estimated 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%-4% and 15%-20%, respectively. Data Animal Data Oral administration of ketoconazole at 80 mg/kg/day to pregnant rats during organogenesis was associated with structural abnormalities (syndactylia and oligodactylia) . However, these effects may be related to maternal toxicity, which was also seen at this and higher dose levels. In oral peri- and postnatal development studies in rats, maternal toxicity, prolonged gestation, embryolethality and fetotoxicity were observed at ketoconazole doses of 40 mg/kg/day and higher.

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 XOLEGEL use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies with pregnant rats, structural abnormalities (syndactylia and oligodactylia) were observed following oral doses of ketoconazole during organogenesis ( see Data ). The available data do not allow calculation of relevant comparisons between the systemic exposure of ketoconazole observed in animal studies to the systemic exposure observed in humans after topical use of XOLEGEL. The estimated 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%-4% and 15%-20%, respectively. Data Animal Data Oral administration of ketoconazole at 80 mg/kg/day to pregnant rats during organogenesis was associated with structural abnormalities (syndactylia and oligodactylia) . However, these effects may be related to maternal toxicity, which was also seen at this and higher dose levels. In oral peri- and postnatal development studies in rats, maternal toxicity, prolonged gestation, embryolethality and fetotoxicity were observed at ketoconazole doses of 40 mg/kg/day and higher. 8.2 Lactation Risk Summary There are no data available on the presence of ketoconazole in human milk, its effects on the breastfed infant, or its effects on milk production. After topical application, ketoconazole concentrations in plasma are low and therefore concentrations in human breast milk are likely to be low [see Clinical Pharmacology ( 12.3 )]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XOLEGEL and any potential adverse effects on the breastfed infant from XOLEGEL or from the underlying maternal condition. Clinical Considerations Advise breastfeeding women not to apply XOLEGEL directly to the nipple and areola to avoid direct infant exposure. 8.4 Pediatric Use Safety and effectiveness in pediatric subjects below the age of 12 have not been established. 8.5 Geriatric Use Of the 933 subjects in the three safety and efficacy trials, 193 (20.7%) were 65 and older, while 61 (6.5%) were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects but greater sensitivity of some older individuals cannot be ruled out.

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 16.1 How Supplied XOLEGEL ® (ketoconazole) Gel, 2% is supplied in 45-gram (NDC 16110-080-45) white-coated aluminum tubes with white caps, and is dispensed with FDA-Approved Patient Labeling. 16.2 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). Contents are flammable. Keep out of reach of children.

Storage and handling

Information about safe storage and handling of the drug product.
16.2 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). Contents are flammable. 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