Halobetasol Topical

Halobetasol topical is a prescription medication used for the relief of inflammation and itching associated with dermatitis, eczema, allergies, and rash. It is also used for the topical treatment of plaque psoriasis in patients aged 12 years and above.

• Halobetasol topical is available under the following different brand names: Ultravate, Bryhali, Lexette

Common side effects of Halobetasol topical include:

• application site skin reactions (stinging, burning, itching, dryness, or redness)
• skin rash
• thinning or softening of the skin
• skin rash or irritation around the mouth
• swollen hair follicles
• spider veins
• numbness or tingling
• changes in the color of treated skin
• blisters
• pimples
• crusting of treated skin
• stretch marks

Serious side effects of Halobetasol topical include:

• passes through the skin
• Cushing’s syndrome
• high blood sugar
• vision problems
• skin reactions at the treated skin site

Rare side effects of Halobetasol topical 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 and pediatric dosage

Topical cream or ointment

• 0.05% (generic)

Topical ointment

• 0.05% (0.5mg/g) (Ultravate, generic)

Topical lotion

• 0.01% (0.1mg/g) (Bryhali)
• 0.05% (0.5mg/g) (Ultravate)

Topical foam

• 0.05% (Lexette)

Inflammatory, pruritic, and steroid-responsive dermatoses

Adult dosage

• Apply cream or ointment topically to the affected area(s) two times a day
• Not to exceed 50 g/week; do not use longer than 2 consecutive weeks

Pediatric dosage

• Children aged younger than 12 years: Safety and efficacy not established
• Children aged 12 years and older: Apply cream or ointment topically to the affected area(s) two times a day
• Not to exceed 50 g/week; do not use longer than 2 weeks
• Lotion and foam are not approved for this indication in children aged younger than 18 years

Plaque psoriasis

Adult dosage

• 0.05% lotion or foam: Apply a thin layer of lotion to affected skin two times a day for up to 2 weeks
• 0.01% lotion: Apply a thin layer to affected areas once a day for up to 8 weeks
• Not to exceed a total dose of 50 g/week

Pediatric dosage

• Children aged younger than 12 years: Safety and efficacy not established
• Children aged 12 years and older (0.05% lotion or 0.05% foam): Apply a thin layer of lotion to affected skin two times a day for up to 2 weeks
• Not to exceed a total dose of 50 g/week

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 has no noted severe interactions with any other drugs
• Halobetasol topical has no noted serious interactions with any other drugs
• Halobetasol topical has no noted moderate interactions with any other drugs
• Halobetasol topical 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

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Halobetasol topical?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Halobetasol topical?”

Cautions

• Chronic topical corticosteroid therapy may interfere with growth and development in children
• Use medium to very high potency topical corticosteroids for below 2 weeks to reduce local and systemic side effects
• Use low-potency topical corticosteroids for chronic therapy
• Avoid medium to very high potency on the face, folds, and groin because can increase steroid absorption
• Kaposi sarcoma reported with prolonged corticosteroid therapy
• Local effects may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria; these effects more likely with prolonged use, occlusive dressings, or higher potency corticosteroids (eg, halobetasol); some local adverse reactions may be irreversible
• May increase the risk of posterior subcapsular cataracts and glaucoma (reported in postmarketing experience with topical corticosteroids); advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation
• Use an appropriate antimicrobial agent if a skin infection is present or develops; if a favorable response does not occur promptly, discontinue use until the infection has been adequately treated; if the infection continues, discontinue halobetasol
• Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation; consider confirming allergic contact dermatitis with a patch test; discontinue therapy if allergic contact dermatitis is established
• Effects on the endocrine system
  • Therapy has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis; systemic effects of topical corticosteroids may include reversible HPA axis suppression, with potential for glucocorticosteroid insufficiency; this may occur during treatment or upon withdrawal of treatment of the topical corticosteroid
  • Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria; use of more than one corticosteroid-containing product at the same time may increase total systemic exposure to topical corticosteroids
  • Pediatric patients may be more susceptible than adults to systemic toxicity from the use of topical corticosteroids due to their larger surface-to-body mass ratios
  • Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent corticosteroids, use over large surface areas, prolonged use, occlusive use, use on an altered skin barrier, concomitant use of multiple corticosteroid-containing products, liver failure, and young age; an ACTH stimulation test may help evaluate patients for HPA axis suppression
  • If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid; manifestations of adrenal insufficiency may require supplemental systemic corticosteroids; recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids

Pregnancy and Lactation

• Data are unavailable for use in pregnant women to inform any drug-associated risks for birth defects or miscarriage; published data report an increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy
• Lactation
  • Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects in the infant
  • Unknown whether topical corticosteroids result in sufficient systemic absorption to produce detectable quantities in human milk
  • Advise breastfeeding women not to apply halobetasol directly to the nipple and areola to avoid direct infant exposure