halobetasol topical/tazarotene (Rx)

1-10%

Contact dermatitis (7%)

Application site pain (3%)

Folliculitis (2%)

Skin atrophy (2%)

Excoriation (2%)

Rash (1%)

Skin abrasion (1%)

Skin exfoliation (1%)

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

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.

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)

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