halobetasol (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% (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 are indicated for topical treatment of plaque psoriasis in patients aged ≥18 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

Total dose should not exceed 50 g/week

Dosage Forms & Strengths

topical cream or ointment

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

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 use in children aged ≤18 yr

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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)

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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

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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Formulary

FormularyPatient Discounts

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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.