halobetasol topical (Rx)

Brand and Other Names:Ultravate, Bryhali, more...Lexette
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Dosing & Uses

AdultPediatric

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

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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

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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

May suppress hypothalamic-pituitary adrenal (HPA) axis; children may exhibit greater susceptibility to HPA axis suppression and Cushing syndrome owing to larger skin surface area to body weight ratio

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)

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 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

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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.

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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

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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)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Ultravate topical
-
0.05 % cream
Ultravate topical
-
0.05 % lotion
Ultravate topical
-
0.05 % lotion
Ultravate topical
-
0.05 % ointment
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 % cream
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 % ointment
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

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
halobetasol propionate topical

HALOBETASOL - TOPICAL

(HAL-oh-BAY-ta-sol)

COMMON BRAND NAME(S): Ultravate

USES: This medication is used to treat a variety of skin conditions (such as eczema, dermatitis, psoriasis, rash). Halobetasol reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a very strong (super-high potency) corticosteroid.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using halobetasol 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.Apply a thin film of the medication to the affected area and gently rub in as directed by your doctor, usually one to two times a day. 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. If applying this medication near the eyes, avoid getting it in the eyes as this may worsen or cause glaucoma. Also avoid getting this medication in the nose or mouth.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.

SIDE EFFECTS: Burning, stinging, itching, dryness or redness may occur when first applied to the skin. This should disappear in a few days as your body adjusts to the medication. If any of these effects persist or worsen, notify 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.Tell your doctor right away if you have any serious side effects, including: stretch marks, skin thinning/discoloration, acne, excessive hair growth, "hair bumps" (folliculitis).Skin infections can become worse when using this medication. Notify 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 (e.g., 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, especially of: poor blood circulation, immune system problems, certain skin conditions (rosacea, perioral dermatitis).Do not use if there is an infection or sore present 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 not known whether this drug, when applied to the skin, passes into breast milk. Other medications in this class, when taken by mouth, pass into breast milk. 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: 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. This medication may be harmful if swallowed.

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.Tell all your doctors you use or have used this medication.

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 away from light and moisture. Do not store in the bathroom. 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 September 2021. Copyright(c) 2021 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.

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Formulary

FormularyPatient Discounts

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Adding plans allows you to:

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.