Version May 2024
Plaque psoriasis: Topical: Lotion: Apply a thin layer to affected areas once daily; total dosage should not exceed 50 g/week. Discontinue therapy when control is achieved.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. See individual agents.
1% to 10%:
Dermatologic: Contact dermatitis (7%), excoriation of skin (2%), folliculitis (2%), skin atrophy (2%), exfoliation of skin (1%), skin rash (1%)
Local: Application site pain (3%)
Frequency not defined:
Dermatologic: Atrophic striae, skin photosensitivity, telangiectasia
Endocrine & metabolic: HPA-axis suppression
Pregnancy.
Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to halobetasol, tazarotene, corticosteroids, retinoic compounds, or any component of the formulation; bacterial or fungal skin infections; eruptions following vaccinations; parasitic infections; seborrheic dermatitis; syphilis or tuberculosis skin manifestations; viral (eg, herpes simplex, vaccinia, varicella) lesions of the skin; women who may become pregnant.
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
• Local effects: Local adverse reactions may occur (eg, skin atrophy, striae, telangiectasias, folliculitis, contact dermatitis); may be irreversible. Local adverse reactions are more likely to occur with use of higher potency corticosteroids, occlusive dressings and/or prolonged use. If local adverse reactions develop, discontinue use and institute appropriate therapy until skin integrity is restored. Do not restart if allergic contact dermatitis is identified. Avoid use on eczema.
• Ocular effects: Topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Monitor for ocular symptoms. Avoid contact with eyes.
• Photosensitivity: May cause photosensitivity; exposure to ultraviolet rays (including sunlight/sunlamps) should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized. Risk may be increased by concurrent therapy with known photosensitizers (thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides); use with caution. Daily sunscreen use and other protective measures recommended. Patients with sunburn should discontinue use until sunburn has healed.
• Skin infections: Use appropriate antibacterial or antifungal agents to treat concomitant skin infections; discontinue treatment if infection does not resolve promptly.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Lotion, External:
Duobrii: Halobetasol propionate 0.01% and tazarotene 0.045% (100 g) [contains edetate (edta) disodium dihydrate, methylparaben, propylparaben]
No
Lotion (Duobrii External)
0.01-0.045% (per gram): $12.47
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Lotion, External:
Duobrii: Halobetasol propionate 0.01% and tazarotene 0.045% (100 g) [contains edetate (edta) disodium dihydrate, methylparaben, propylparaben]
Topical: For external use only; not for ophthalmic, oral, or intravaginal use; do not apply to the face, groin, or axillae. Use of occlusive dressings is not recommended unless directed by a health care provider. Ensure affected areas are dry prior to application. Apply thin film to affected areas and rub in gently. Wash hands after application (unless treating hands).
Plaque psoriasis: Treatment of plaque psoriasis in adults.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).
None known.
There are no known significant interactions.
Evaluate pregnancy status prior to use in females of reproductive potential. A negative pregnancy test should be obtained within 2 weeks prior to treatment; treatment should begin during a normal menstrual period. Adequate contraception should be used in females of reproductive potential.
Based on the tazarotene component, use in pregnancy is contraindicated.
Refer to individual monographs for additional information.
It is not known if tazarotene is present in breast milk; systemic corticosteroids are present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Do not apply directly to the breast to avoid direct infant exposure.
Refer to individual monographs for additional information.
Signs/symptoms of HPA axis suppression/adrenal insufficiency; bacterial or fungal skin infection; disease severity in plaque psoriasis during therapy (reduction in erythema, scaling, induration); clinical response and skin tolerance; pregnancy test within 2 weeks prior to treatment in females of reproductive potential.
Halobetasol is a high range potency topical corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid.
Tazarotene is a synthetic, acetylenic retinoid which modulates differentiation and proliferation of epithelial tissue and exerts some degree of anti-inflammatory and immunological activity.
See individual agents.
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