Dosing & Uses
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
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (0)
Minor (0)
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%)
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
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.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)
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
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