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Halobetasol and Tazarotene

Medically reviewed by Drugs.com. Last updated on Aug 28, 2020.

Pronunciation

(hal oh BAY ta sol & taz AR oh teen)

Index Terms

  • Duobrii
  • Halobetasol Propionate and Tazarotene
  • Tazarotene and Halobetasol

Dosage Forms

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]

Brand Names: U.S.

  • Duobrii

Pharmacologic Category

  • Corticosteroid, Topical
  • Retinoic Acid Derivative

Pharmacology

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.

Use: Labeled Indications

Plaque psoriasis: Treatment of plaque psoriasis in adults.

Contraindications

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.

Dosing: Adult

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.

Dosing: Geriatric

Refer to adult dosing.

Administration

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).

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from freezing.

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Adverse Reactions

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

Warnings/Precautions

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.

Monitoring Parameters

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.

Reproductive Considerations

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.

Pregnancy Considerations

Based on the tazarotene component, use in pregnancy is contraindicated.

Refer to individual monographs for additional information.

Patient Education

What is this drug used for?

• It is used to treat plaque psoriasis.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stinging

• Dry skin

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit

• Cushings disease like weight gain in upper back or abdomen; moon face; severe headache; or slow healing

• Adrenal gland problems like severe upset stomach, throwing up, severe dizziness, passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss

• Skin changes like pimples, stretch marks, slow healing, or hair growth

• Application site irritation

• Thinning of the skin

• Redness

• Peeling

• Sunburn

• Vision changes

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.