e in the rat at this dose would be equivalent to 5 timesthe MRHD (based on AUC comparison).
8.2 Lactation
Risk Summary
There are no data on the presence of tazarotene, halobetasol propionate or its metabolites in human milk, the effects on the breastfedinfant, or the effects on milk production after treatment with DUOBRII Lotion.
After single topical doses of a 14C-tazarotene gel formulation to the skin of lactating rats, radioactivity was detected in rat milk.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectablequantities in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DUOBRIILotion and any potential adverse effects on the breastfed child from DUOBRII Lotion.
Clinical Considerations
Advise breastfeeding women not to apply DUOBRII Lotion directly to the nipple and areola to avoid direct infant exposure.
8.3 Females and Males of Reproductive PotentialPregnancy Testing
DUOBRII Lotion is contraindicated in women who are pregnant. Females of reproductive potential should be warned of the potentialrisk and use adequate birth-control measures during treatment with DUOBRII Lotion.
The possibility that a female of reproductivepotential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy should be obtainedwithin 2 weeks prior to DUOBRII Lotion therapy, which should begin during menstruation.
Contraception
Based on animal studies, DUOBRII Lotion may cause fetal harm when administered to a pregnant female [see Use in SpecificPopulations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment with DUOBRII Lotion.
8.4 Pediatric Use
Safety and effectiveness of DUOBRII Lotion in pediatric patients under the age of 18 years have not been eva luated.
Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression andCushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiencyduring or after withdrawal of treatment. Adverse reactions including striae have been reported with use of topical corticosteroids ininfants and children [see Warnings and Precautions (5.2)].
HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been
reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol
levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles,headaches, and bilateral papilledema [see Warnings and Precautions (5.2)].
8.5 Geriatric Use
Of the 270 subjects exposed to DUOBRII Lotion in clinical trials, 39 subjects were 65 years or older. Clinical trials of DUOBRIILotion did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently fromyounger subjects.
11 DESCRIPTION
DUOBRII Lotion is a combination product with halobetasol propionate and tazarotene as the active ingredients in a white to off-whitelotion formulation intended for topical use.
Halobetasol propionate is a synthetic corticosteroid. Th |
