halobetasol topical/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

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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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                    Images

                    No images available for this drug.
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                    Patient Handout

                    A Patient Handout is not currently available for this monograph.
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                    Formulary

                    FormularyPatient Discounts

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                    The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                    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.
                    6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    NC NOT COVERED – Drugs that are not covered by the plan.
                    Code Definition
                    PA Prior Authorization
                    Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                    QL Quantity Limits
                    Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                    ST Step Therapy
                    Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                    OR Other Restrictions
                    Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.