KETOCONAZOLE aerosol, foam

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)

זמין מ:

Bryant Ranch Prepack

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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. None. 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/m2 /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). 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. 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)] . 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)]. 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. 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. How should I store Ketoconazole Foam, 2%? 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

leaflet_short:

Ketoconazole Foam, 2% contains 20 mg of ketoconazole, USP per gram. The thermolabile hydroethanolic foam is available as follows: NDC 63629-9421-01 50 g aluminum can Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

KETOCONAZOLE- KETOCONAZOLE AEROSOL, FOAM
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KETOCONAZOLE FOAM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
KETOCONAZOLE FOAM.
KETOCONAZOLE FOAM, 2%
FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
Ketoconazole Foam, 2% is indicated for topical treatment of seborrheic
dermatitis in immunocompetent
patients 12 years of age and older. (1)
Limitations of Use (1)
Safety and efficacy of Ketoconazole Foam, 2% for treatment of fungal
infections have not been
established. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Foam: 2% ketoconazole in 50 g and 100 g containers. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
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.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 1/2024
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Contact Sensitization
5.2 Flammable Contents
5.3 Systemic Effects
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
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).
Ketoconazole Foam, 2% may result in contact sensitization, including
photoallergenicity (5.1, 6.2).
The contents of Ketoconazole Foam, 2% are flammable. Avoid fire,
flame, or smoking during and
immediately following application. (5.2).
6.2 Dermal Safety Studies
6.3 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males