Ketodan (Page 2 of 3)

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.

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-(1H -imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, cis — with the molecular formula C26 H28 Cl2 N4 O4 and a molecular weight of 531.43. The following is the chemical structure:

Chemical Structure
(click image for full-size original)

Ketodan® 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.

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 Ketodan® 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.

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.

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 = 427n (%) Vehicle FoamN = 420n (%)
Subjects Achieving Treatment Success 239 (56%) 176 (42%)

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.

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.

Manufactured for: Medimetriks Pharmaceuticals, Inc.383 Route 46 West, Fairfield, NJ 07004-2402 www.medimetriks.com

Manufactured by: Perrigo, Yeruham, Israel

Made in Israel

Rev. Date: 06/19

IP031-R3

5K200 EK J5

PATIENT INFORMATIONKetodan® Foam, 2%
Important Information: Ketodan® Foam, 2% is for use on the skin only. Do not use Ketodan® Foam, 2% in your eyes, mouth or vagina.
What is Ketodan® Foam, 2%?Ketodan® 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 Ketodan® Foam, 2% is safe and effective when used to treat fungal infections.It is not known if Ketodan® Foam, 2% is safe and effective in children less than 12 years of age.
Before using Ketodan® 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 Ketodan® Foam, 2% will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Ketodan® Foam, 2% passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Ketodan® 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 Ketodan® Foam, 2%?
  • Use Ketodan® 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 Ketodan® Foam, 2% the right way.
  • Apply Ketodan® Foam, 2% to the affected skin area(s) 2 times each day for 4 weeks. You should apply enough Ketodan® 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 Ketodan® Foam, 2%.
  • Dispense Ketodan® Foam, 2% directly into the cap. Do not dispense Ketodan® Foam, 2% directly onto your hands, because the foam will begin to melt on contact with warm skin.
  • Wash your hands after applying Ketodan® Foam, 2%.
What should I avoid while using Ketodan® Foam, 2%?
  • Ketodan® Foam, 2% is flammable. Avoid fire, flames, or smoking during and right after you apply Ketodan® Foam, 2% to your skin.
  • Avoid getting Ketodan® Foam, 2% in or near your eyes, mouth, lips or vagina. If you get Ketodan® Foam, 2% on your lips or in your eyes, mouth or vagina, rinse well with water.
What are the possible side effects of Ketodan® Foam, 2%? Ketodan® 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 Ketodan® Foam, 2%.

The most common side effects of Ketodan® 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 Ketodan® 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 Ketodan® Foam, 2%?
  • Store Ketodan® Foam, 2% at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not store the Ketodan® Foam, 2% can in the refrigerator or freezer.
  • Keep Ketodan® Foam, 2% away from heat. Never throw the Ketodan® Foam, 2% can into a fire, even if the can is empty.
  • Do not store Ketodan® Foam, 2% at temperatures above 120°F (49°C).
  • Do not break through (puncture) the Ketodan® Foam, 2% can.

Keep Ketodan® Foam, 2% and all medicines out of the reach of children.

General information about the safe and effective use of Ketodan® Foam, 2%.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Ketodan® Foam, 2% for a condition for which it was not prescribed. Do not give Ketodan® 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 Ketodan® Foam, 2% that is written for health professionals.
What are the ingredients in Ketodan® Foam, 2%?Active ingredient: ketoconazoleInactive 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) propellantFor more information, call Medimetriks at 1-973-882-7512This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.

Instructions for Use Ketodan® Foam, 2%

Important Information: Ketodan® Foam, 2% is for use on the skin only. Do not use Ketodan® Foam, 2% in your eyes, mouth or vagina.

Step 1: Remove the clear cap from the Ketodan® Foam, 2% can.Image
Step 2: Hold the can upright and firmly press the nozzle to dispense Ketodan® Foam, 2% into the clear cap.
  • Dispense enough Ketodan® Foam, 2% to cover the entire affected area(s).
Image
  • If the can seems warm or the foam seems runny, run the can under cold water.
Image
Step 3: Pick up small amounts of Ketodan® Foam, 2% with your fingertips and gently rub the foam into the affected area(s) until the foam disappears.ImageImage
  • If you are treating areas such as your scalp, part the hair so that Ketodan® Foam, 2% may be applied directly to the skin.
Image
Step 4: Wash your hands after applying Ketodan® Foam, 2%.
  • Throw away any of the unused medicine that is left in the cap.
How should I store Ketodan® Foam, 2%?
  • Store Ketodan® Foam, 2% at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not store the Ketodan® Foam, 2% can in the refrigerator or freezer.
  • Keep Ketodan® Foam, 2% away from heat. Never throw the can into a fire, even if the can is empty.
  • Do not store Ketodan® Foam, 2% at temperatures above 120°F (49°C).
  • Do not break through (puncture) the Ketodan® Foam, 2% can.

Keep Ketodan® 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.

Image

Rx Only
Made in Israel

Manufactured by:
Perrigo, Yeruham, Israel

Manufactured for:
Medimetriks Pharmaceuticals, Inc.
383 Route 46 West, Fairfield, NJ 07004-2402
www.medimetriks.com

IP031-R3
Rev. Date: 06/19

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.