5.5 Ophthalmic Adverse Reactions
5.6 Concomitant Skin Infections
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are notlisted.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
DUOBRII™ (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis inadults.
2 DOSAGE AND ADMINISTRATION
Apply a thin layer of DUOBRII Lotion once daily to cover only affected areas and rub in gently. If a bath or shower is taken prior toapplication, the skin should be dry before applying the lotion.
The total dosage should not exceed approximately 50 g per week because of the potential for the drug to suppress the hypothalamicpituitary-adrenal(HPA) axis [see Warnings and Precautions (5.2)]. Do not use with occlusive dressings unless directed by aphysician. Discontinue treatment when control is achieved. Avoid application of DUOBRII Lotion on the face, groin, or in theaxillae.
DUOBRII Lotion is not for oral, ophthalmic, or intravaginal use.
3 DOSAGE FORMS AND STRENGTHS
Lotion, 0.01%/0.045%
Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene in a white to offwhitelotion.
4 CONTRAINDICATIONS
4.1 Pregnancy
DUOBRII Lotion is contraindicated in pregnancy [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].].
5 WARNINGS AND PRECAUTIONS
5.1 Embryofetal Risk
Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, DUOBRII Lotionmay cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Tazarotene is teratogenic, andit is not known what level of exposure is required for teratogenicity in humans [see Contraindications (4), Clinical Pharmacology(12.3)]. Tazarotene elicits teratogenic and developmental effects associated with retinoids after topical or systemic administration inrats and rabbits [see Use in Specific Populations (8.1)].
Advise pregnant females of the potential risk to a fetus. Obtain a pregnancy test within 2 weeks prior to DUOBRII Lotion therapy.
Initiate DUOBRII Lotion therapy during a menstrual period. Advise females of reproductive potential to use effective contraceptionduring treatment with DUOBRII Lotion therapy [see Use in Specific Populations (8.1 and 8.3)].
5.2 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted SystemicGlucocorticoid Effects
DUOBRII Lotion contains halobetasol propionate, a corticosteroid, and has been shown to suppress the hypothalamic-pituitaryadrenal(HPA) axis.
Systemic effects of topical corticosteroids may include reversible HPA axis suppression with the potential for glucocorticosteroidinsufficiency. This may occur during treatment or upon wit |
