halobetasol/tazarotene (Rx)

Brand and Other Names:Duobrii
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Dosing & Uses

AdultPediatric

Dosage Forms and Strengths

halobetasol/tazarotene

topical lotion

  • 0.01%/0.045%

Plaque Psoriasis

Indicated for topical treatment of plaque psoriasis in adults

Apply a thin layer of lotion to affected areas qDay

Not to exceed ~50 gram/week owing to potential for suppressing the hypothalamic-pituitary-adrenal (HPA) axis

Discontinue when control is achieved

Safety and efficacy not established

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Interactions

Interaction Checker

and halobetasol/tazarotene

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            Adverse Effects

            1-10%

            Contact dermatitis (7%)

            Application site pain (3%)

            Folliculitis (2%)

            Skin atrophy (2%)

            Excoriation (2%)

            Rash (1%)

            Skin abrasion (1%)

            Skin exfoliation (1%)

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            Warnings

            Contraindications

            Pregnancy

            Cautions

            Based on animal reproduction studies, retinoid pharmacology, and potential for systemic absorption, may cause fetal harm when administered to females of reproductive potential and is contraindicated during pregnancy (see Pregnancy)

            Local adverse reactions may include atrophy, striae, telangiectasias, folliculitis, and contact dermatitis; if these adverse reactions occur, discontinue treatment at least until integrity of skin is restored; do not resume treatment if allergic contact dermatitis is identified

            Avoid use on eczematous skin; may cause severe irritation

            Posterior subcapsular cataracts and glaucoma reported postmarketing with topical corticosteroid use

            Use appropriate antimicrobial agent if skin infection is present or develops; if favorable response does not occur promptly, discontinue until infection adequately treated

            Photosensitivity and risk for sunburn

            • Heightens sunburn susceptibility; avoid exposure to sunlight (eg, sunlamps); if medically necessary, minimize exposure during treatment; instruct patients to use sunscreens and protective clothing
            • Avoid use in patients with sunburn until fully recovered; exercise caution in patients with considerable sun exposure or with inherent sensitivity to sunlight
            • Caution if coadministered with drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides)

            HPA axis suppression and other unwanted systemic glucocorticoid effects

            • Halobetasol propionate has been shown to suppress of hypothalamic-pituitary-adrenal (HPA) axis
            • Because of the potential for systemic absorption, use of topical corticosteroids, may require evaluating patients periodically for evidence of HPA axis suppression
            • Consider a corticotropin stimulation test to help evaluate patients for HPA axis suppression
            • If HPA axis suppression is documented, attempt to gradually withdraw drug or reduce frequency of application
            • Systemic effects of topical corticosteroids may also include Cushing syndrome, hyperglycemia, and glucosuria
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            Pregnancy

            Pregnancy

            Contraindicated in women who are pregnant

            Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, fetal harm may occur when administered to a pregnant female

            Safety in pregnant females has not been established

            Consider potential risks to the fetus outweighs the potential benefit to the mother from topical lotion during pregnancy; discontinue lotion as soon as pregnancy is recognized

            Observational studies suggest an increased risk of low birthweight in infants with the maternal use of potent or very potent topical corticosteroids

            Pregnancy testing

            • Obtain a negative result for pregnancy within 2 weeks prior to therapy, which should begin during menstruation

            Contraception

            • Advise females of reproductive potential to use effective contraception during treatment

            Tazarotene

            • Teratogenic; unknown what level of exposure is required for teratogenicity in humans
            • Elicits teratogenic and developmental effects associated with retinoids after topical or systemic administration in rats and rabbits

            Lactation

            No data available on the presence of tazarotene, halobetasol propionate, or its metabolites in human milk, effects on the breastfed infant, or effects on milk production after treatment

            After single topical doses of a 14C-tazarotene gel formulation to the skin of lactating rats, radioactivity was detected in rat milk

            Unknown whether topical corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk

            Advise breastfeeding women not to apply directly to nipple and areola to avoid direct infant exposure

            Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Precise mechanism of action in plaque psoriasis is unknown

            Halobetasol: Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation

            Tazarotene: A retinoid prodrug converts to its active form, tazarotenic acid, the carboxylic acid of tazarotene, by deesterification; tazarotenic acid binds to members of the retinoic acid receptor family

            Absorption

            Peak plasma concentration: 101.9 pg/mL (halobetasol); 24.6 pg/mL (tazarotene); 23.4 pg/mL (tazarotenic acid)

            AUC: 1300 pg·hr/mL (halobetasol); 273 pg·hr/mL (tazarotene); 9954 pg·hr/mL (tazarotenic acid)

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            Administration

            Topical Administration

            Apply thin layer to affected areas and rub gently

            Do not use with occlusive dressings unless directed by a physician

            Avoid application on the face, groin, or in the axillae

            Not for oral, ophthalmic, or intravaginal use

            Storage

            Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F); protect from freezing

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.