Duobrii (halobetasol propionate/tazarotene)

Application of tazarotene cream or gel may cause a transient feeling of pruritus, burning, or stinging. (See Cautions: Precautions and Contraindications.) If irritation is excessive, tazarotene should be discontinued temporarily until the integrity of the skin is restored, or dosing of the drug should be reduced to a lower concentration (in patients with psoriasis) or to an interval the patient can tolerate; tazarotene therapy may be resumed, or the drug concentration or frequency of application increased, as therapy with the drug becomes more tolerable. Frequency of dosing, therapeutic response, and skin tolerance should be monitored carefully during tazarotene therapy. The efficacy of reduced dosing frequencies (i.e., less than once daily) has not been established.

Safe use of tazarotene gel over more than 20% of body surface area has not been established.

For dermatologic use, topical corticosteroids are available in various dosage forms including creams, dressings (tape), foams, gels, lotions, ointments, solutions, and aerosols (suspensions). The choice of a dosage form depends on the location of the lesion and the condition being treated. Lotions are probably best for the treatment of weeping eruptions, especially in areas subject to chafing such as the axilla, foot, and groin. Lotions, gels, and aerosols may be used on hairy areas, particularly the scalp. Creams are suitable for most dermatoses, but ointments, which may also provide some occlusion, are usually used for the treatment of dry, scaly lesions. Because certain areas of the body may be more susceptible to atrophic changes than others following treatment with corticosteroids, certain topical corticosteroid preparations (e.g., betamethasone dipropionate 0.05% gel; clobetasol propionate 0.05% cream, foam, gel, lotion, solution, or shampoo; hydrocortisone valerate 0.2% cream; mometasone furoate 0.1% cream, lotion, or ointment) should not be applied to the face or intertriginous areas (e.g., axilla, groin).

Because the formulation of dermatologic corticosteroid products affects percutaneous penetration and subsequent activity of the drug, extemporaneous preparation or dilution of most commercially available products with another vehicle may result in decreased effectiveness.

The area of skin to be treated may be thoroughly cleansed before topical application of corticosteroids to reduce the risk of infection. However, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating. Topical corticosteroids are generally applied sparingly in thin films and rubbed gently into the affected area 1-4 times daily. When a favorable response is achieved, the frequency of application or concentration of the corticosteroid is reduced to the minimum necessary to maintain control and avoid relapse and, if possible, the drug should be discontinued.

For occlusive dressing therapy, the affected area is soaked or washed to remove scales and a corticosteroid cream, lotion, or ointment is applied in a thin film or is rubbed gently into the lesion and another thin film applied. After applying the corticosteroid, the affected area is covered with a thin, pliable plastic film which is sealed to adjacent normal skin with adhesive tape or held in place by a gauze or elastic bandage. If the affected area is moist, the edges of the plastic film may be incompletely sealed or the film may be punctured to allow excess moisture to escape. For added moisture in dry lesions, the corticosteroid may be covered with a dampened cloth before the plastic film is applied or the affected area may be briefly soaked in water before application of the drug and plastic film. Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion. Flurandrenolide tape may be used alone as an occlusive dressing for small areas.

The frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of the corticosteroid are essential at each dressing change. The occlusive dressing is usually left in place for 12-24 hours and therapy is repeated as needed. Some manufacturers state that the occlusive dressing may be left in place for 3-4 days at a time in resistant conditions, because theoretically the longer the occlusive dressing is left in place at one time, the more rapidly the dermatoses respond to topical corticosteroid therapy. However, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience. For example, the corticosteroid and an occlusive dressing may be used at night, and the topical corticosteroid or a bland emollient may be used without an occlusive dressing during the day. In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion.

Tazarotene is applied topically to the skin as a 0.05 or 0.1% cream or gel. Patients should be instructed carefully regarding proper use of the drug. (See Cautions: Precautions and Contraindications.)

Occlusive dressings or wrappings should not be used with tazarotene cream or gel, and hands should be washed after applying the drug (unless the hands are being treated for psoriasis). Patients should be advised not to use tazarotene cream or gel in amounts larger than instructed or more often than instructed, since such use of the drug will not lead to more rapid or better results but may result in marked redness, peeling, or discomfort.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

• Pregnancy
• Sunburn

• Skin photosensitivity

• Glaucoma
• Hypothalamic-pituitary insufficiency

There is no enhanced messaging for this drug.

More Frequent

• Severe erythema
• Severe pruritus
• Skin fissure

Less Frequent

• Folliculitis
• Purpura
• Skin and skin structure infection
• Skin atrophy

Rare or Very Rare

• Adrenocortical insufficiency
• Blistering skin
• Bullous dermatitis
• Cataracts
• Central serous chorioretinopathy
• Dyschromia
• Glaucoma
• Growth failure
• Hypothalamic-pituitary insufficiency
• Intracranial hypertension
• Ocular hypertension
• Skin hypopigmentation
• Skin photosensitivity
• Skin striae
• Skin ulcer
• Urticaria

More Frequent

• Abnormal desquamation
• Dry skin
• Erythema
• Erythema
• Localized edema
• Pruritus of skin
• Skin irritation
• Stinging of skin
• Stinging of skin

Less Frequent

• Acute pain at drug application site
• Blurred vision
• Cheilitis
• Contact dermatitis
• Headache disorder
• Paresthesia
• Pruritus of skin
• Skin rash
• Telangiectasia
• Treatment site sequelae

Rare or Very Rare

• Acneiform eruption
• Alopecia
• Blistering skin
• Contact dermatitis
• Dry skin
• Dyschromia
• Exfoliative dermatitis
• Glycosuria
• Hirsutism
• Hypercortisolism
• Hyperesthesia
• Hyperglycemia
• Miliaria
• Pain
• Perioral dermatitis
• Skin irritation
• Skin rash

No enhanced messaging available.

No enhanced messaging available.

Safe use of topical corticosteroids during pregnancy has not been established. Although there are no adequate and controlled studies to date in humans, potent corticosteroids have been shown to be teratogenic in animals following topical application. Topical corticosteroids should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. The drugs should not be used on extensive areas, in large amounts, or for prolonged periods in pregnant women.

Retinoids (e.g., isotretinoin) have been reported to cause serious fetal harm when administered orally to pregnant women. (See Cautions: Pregnancy, Fertility, and Lactation, in Isotretinoin 84:28.) Single instances of known retinoid malformations (e.g., spina bifida, hydrocephaly, heart anomalies) have been reported in some species of animals (e.g., rabbits) followingtopical administration of tazarotene during gestation. Abnormal early embryonic development (e.g., decreased litter size, decreased number of live fetuses, decreased fetal body weights) was observed in animals receiving oral tazarotene in dosages 3.4 times the systemic exposure (AUC0-24 h) in human psoriasis patients treated topically with tazarotene 0.1% cream over 35% of body surface area, 11 times the systemic exposure in human acne patients treated topically with tazarotene 0.1% cream over 15% of body surface area, or 6.7 times the systemic exposure in human photoaging patients treated topically with tazarotene 0.1% cream over 15% of body surface area. Developmental delays, teratogenic effects, and postimplantation fetal loss also have been reported in animals receiving oral tazarotene in dosages 1.1-26 or 0.7-13 times the systemic exposure in human psoriasis patients treated topically with tazarotene 0.1% cream (over 35% of body surface area) or gel (over 20% of body surface area), respectively, 3.5-85 times the systemic exposure in human acne patients treated topically with tazarotene 0.1% cream (over 15% of body surface area), or 2.1-52 times the systemic exposure in human photoaging patients treated topically with tazarotene 0.1% cream (over 15% of body surface area).

Systemic exposure to tazarotene depends on the extent of body surface area treated. In patients treated topically over sufficient body surface area (over 35 or 20% of body surface area when used as a cream or gel, respectively, in psoriasis patients), systemic exposure to tazarotene could be of the same magnitude as in these orally treated animals. Although systemic exposure anticipated in the treatment of the face alone may be less as a result of the more limited area of application of the drug, it is not known what level of exposure produces teratogenic effects in humans.

There are no adequate and controlled studies to date using tazarotene topical cream or gel in pregnant women. The manufacturer states that the 8 women in clinical trials who were inadvertently exposed to tazarotene during pregnancy subsequently delivered healthy infants. The importance of these findings is unknown because the exact timing and extent of exposure to the drug in relation to gestation are uncertain. However, tazarotene is contraindicated in women who are or may become pregnant or who intend to become pregnant during treatment. Women of childbearing potential should be warned of the potential risk and should use adequate birth-control measures during treatment with tazarotene. If the drug is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug, the drug should be discontinued and the patient informed of the potential risks to the fetus. A negative result on a reliable blood pregnancy test (i.e., having a sensitivity of at least 50 mIU/mL for human chorionic gonadotropin (hCG)) should be obtained within 2 weeks prior to beginning tazarotene therapy and therapy should begin during the next normal menstrual period.

It is not known whether topical corticosteroids are distributed into milk; however, systemic corticosteroids are distributed into milk. Topical corticosteroids should be used with caution in nursing women.

It is not known if topically applied tazarotene is distributed into human milk, but the drug appears to distribute into milk following topical application in lactating animals. The manufacturer states that caution should be exercised when tazarotene is administered to a nursing woman.

No enhanced messaging available.