Dosing & Uses
Dosage Forms & Strengths
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
Apply cream or ointment topically to affected area(s) BID
Not to exceed 50 g/week; do not use longer than 2 consecutive weeks
Plaque Psoriasis
Lotion and foam indicated for topical treatment of plaque psoriasis in patients aged ≥12 years
0.05% lotion or foam: Apply thin layer of lotion to affected skin BID for up to 2 weeks
0.01% lotion: Apply thin layer to affected areas qDay for up to 8 weeks
Not to exceed total dose of 50 g/week
Dosage Forms & Strengths
topical cream
- 0.05% (0.5mg/g) (generic)
topical ointment
- 0.05% (0.5mg/g) (Ultravate, generic)
topical lotion
- 0.05% (0.5mg/g) (Ultravate)
topical foam
- 0.05% (Lexette)
Inflammatory, Pruritic, and Steroid-responsive Dermatoses
<12 years: Safety and efficacy not established
≥12 years: Apply cream or ointment topically to affected area(s) BID
Not to exceed 50 g/wk; do not use longer than 2 wk
Lotion and foam not approved for this indication in children aged ≤18 yr
Plaque Psoriasis
Indicated for topical treatment of plaque psoriasis in patients aged ≥12 years
<12 years: Safety and efficacy not established
≥12 years (0.05% lotion or 0.05% foam): Apply thin layer of lotion to affected skin BID for up to 2 weeks
Not to exceed total dose of 50 g/week
Adverse Effects
1-10%
Telangiectasia (1%)
Application site atrophy (1%)
Headache (1%)
Frequency Not Defined
Skin atrophy
Striae
Acneform lesions
Intracranial hypertension
Allergic contact dermatitis
Pruritus
Pustulation
Perioral dermatitis
Urticaria
Hypertrichosis
Leukoderma
Pigmentation changes
HPA suppression (with higher potency used >2 wk)
Postmarketing Reports
Folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria
Warnings
Contraindications
None
Cautions
Chronic topical corticosteroid therapy may interfere with growth and development in children
Use medium to very high potency topical corticosteroids for <2 wk to reduce local and systemic side effects
Use low-potency topical corticosteroids for chronic therapy
Avoid medium to very high potency on face, folds, 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 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 infection has been adequately treated; if 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 patch test; discontinue therapy if allergic contact dermatitis is established
Effects on endocrine system
- Therapy has been shown to suppress 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 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 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 be helpful in evaluating patients for HPA axis suppression
- If HPA axis suppression is documented, attempt to gradually withdraw drug, reduce 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 & Lactation
Pregnancy
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
Animal studies
- Systemic administration during organogenesis to pregnant rats at 13-33 times the human topical dose and to pregnant rabbits at 3 times the human topical dose resulted in teratogenic and embryotoxic effects
Lactation
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects in 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
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.Pharmacology
Mechanism of Action
High potency corticosteroid that elicits anti-inflammatory, antipruritic and vasoconstrictive actions
Mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear; however, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins; these proteins may control biosynthesis of potent mediators of inflammation (eg, prostaglandins, leukotrienes) by inhibiting the release of their common precursor arachidonic acid; arachidonic acid is released from membrane phospholipids by phospholipase A2
Pharmacokinetics
Metabolism: Liver
Excretion: Urine
Absorption: Dependent on nature of skin at application; occlusion and inflammation may increase absorption
Administration
Topical Administration
For dermatological use only; not for ophthalmic, oral, or intravaginal use
Apply thin layer to affected skin and rub in gently
Discontinue when control achieved; if no improvement within 2 weeks, reassess diagnosis
Prolonged treatment is not recommended and total dosage should not exceed 50 g/week owning to potential for HPA suppression
Do not use with occlusive dressing unless directed by physician
Avoid use on face, scalp, groin, or axillae
Storage
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Lexette topical - | 0.05 % foam |  | |
| Lexette topical - | 0.05 % foam |  | |
| Bryhali topical - | 0.01 % lotion |  | |
| Bryhali topical - | 0.01 % lotion |  | |
| halobetasol propionate topical - | 0.05 % ointment |  | |
| halobetasol propionate topical - | 0.05 % cream |  | |
| halobetasol propionate topical - | 0.05 % cream |  | |
| halobetasol propionate topical - | 0.05 % ointment |  | |
| halobetasol propionate topical - | 0.05 % ointment |  | |
| halobetasol propionate topical - | 0.05 % cream |  | |
| halobetasol propionate topical - | 0.05 % ointment |  | |
| halobetasol propionate topical - | 0.05 % ointment |  | |
| halobetasol propionate topical - | 0.05 % cream |  | |
| halobetasol propionate topical - | 0.05 % cream |  | |
| halobetasol propionate topical - | 0.05 % cream |  | |
| halobetasol propionate topical - | 0.05 % ointment |  | |
| Ultravate topical - | 0.05 % lotion |  | |
| Ultravate topical - | 0.05 % lotion |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
halobetasol propionate topical
HALOBETASOL FOAM - TOPICAL
(HAL-oh-BAY-ta-sol)
COMMON BRAND NAME(S): Lexette
USES: This medication is used to treat certain skin conditions (such as psoriasis). Halobetasol helps reduce the itching, redness, scaling, and swelling that can occur with these conditions. This medication is a very strong (super-high potency) corticosteroid.
HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using halobetasol foam and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Use this medication only on the skin. However, do not use it on the face, groin, or underarms unless directed to do so by your doctor.Shake the can well before using. Wash and dry your hands before applying the medication. Hold the can upside down to spray a small amount into the palm of your hand. Apply a thin layer onto the affected area(s) as directed by your doctor, usually 2 times daily. After applying the foam, gently rub in until the medication disappears. Do not cover, bandage, or wrap the area unless directed to do so by your doctor.After applying the medication, wash your hands, unless you are using this medication to treat the hands. Avoid getting this medication in the eyes, nose, or mouth. If you get the medication in these areas, rinse with plenty of water.Use this medication only for the condition it was prescribed for. Do not apply more than directed, or use it more often or for longer than prescribed by your doctor.Tell your doctor if your condition does not get better or if it gets worse after 2 weeks.
SIDE EFFECTS: Burning, stinging, irritation, dryness, or redness at the application site may occur. Acne, new/unwanted hair growth, small red bumps on the skin (folliculitis), skin thinning/discoloration, or stretch marks may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Skin infections can become worse when using this medication. Tell your doctor promptly if redness, swelling, or irritation does not improve.Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using halobetasol, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.Do not use if there is an infection or sore in the area to be treated.Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: This medication may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless your doctor tells you to. A different medication may be necessary in those cases.Lab and/or medical tests (such as adrenal gland function) may be done while you are using this medication, especially if you use this drug for a long time or apply it over large areas of the body. Keep all medical and lab appointments.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature. Do not freeze. Do not puncture the can or expose to high heat or open flame. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised April 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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