Halobetasol Tazarotene

Halobetasol Topical-Tazarotene lotion is a combination medication used for topical treatment of plaque psoriasis in adults.

• Halobetasol Topical-Tazarotene is available under the following different brand names: Duobrii

Common side effects of Halobetasol Topical-Tazarotene include:

• contact dermatitis
• application site pain
• infected hair follicles
• thinning skin
• skin abrasions
• rash
• stretch marks
• skin peeling

Serious side effects of Halobetasol Topical-Tazarotene include:

• redness, swelling, or other signs of skin infection in the place where halobetasol was applied
• severe skin rash
• skin sores
• sudden weight gain
• unusual tiredness
• muscle weakness
• depression and irritability
• blurred vision or other vision changes

Rare side effects of Halobetasol Topical-Tazarotene include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Topical lotion

• 0.01%/0.045%

Plaque psoriasis

Adult dosage

• Apply a thin layer of lotion to affected areas once a day
• Not to exceed approximately 50 gram/week owing to the potential for suppressing the hypothalamic-pituitary-adrenal (HPA) axis
• Discontinue when control is achieved

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Halobetasol Topical-Tazarotene has no noted severe interactions with any other drugs
• Halobetasol Topical-Tazarotene has no noted serious interactions with any other drugs
• Halobetasol Topical-Tazarotene has no noted moderate interactions with any other drugs
• Halobetasol Topical-Tazarotene has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Pregnancy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Halobetasol Topical-Tazarotene?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Halobetasol Topical-Tazarotene?”

Cautions

• Based on animal reproduction studies, retinoid pharmacology, and potential for systemic absorption, may cause fetal harm when administered to women of reproductive potential and is contraindicated during pregnancy
• Local adverse reactions may include atrophy, striae, telangiectasias, folliculitis, and contact dermatitis; if these adverse reactions occur, discontinue treatment at least until the integrity of the 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 an appropriate antimicrobial agent if a skin infection is present or develops; if the favorable response does not occur promptly, discontinue until the infection is 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, and 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 the hypothalamic-pituitary-adrenal (HPA) axis
• Because of the potential for systemic absorption, the 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 the drug, or reduce the frequency of application
• Systemic effects of topical corticosteroids may also include Cushing syndrome, hyperglycemia, and glucosuria

Pregnancy and Lactation

• 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 pregnant women
• Safety in pregnant women has not been established
• Considering potential risks to the fetus outweigh 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 birth weight in infants with the maternal use of potent or very potent topical corticosteroids
• Pregnancy testing
• Obtain a negative result for pregnancy within 2 weeks before therapy, which should begin during menstruation
• Contraception
  • Advise women 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 is available on the presence of tazarotene, halobetasol propionate, or its metabolites in human milk, its effects on the breastfed infant, or its 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 the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breast-fed infant from the drug or the underlying maternal condition