ULTRAVATE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ULTRAVATE (ULTRAVATE).
Ultravate (halobetasol propionate) is a super-high potency corticosteroid that binds to glucocorticoid receptors, altering gene transcription to inhibit phospholipase A2, reduce prostaglandin and leukotriene synthesis, and suppress inflammatory mediators.
| Metabolism | Metabolized primarily in the liver via ester hydrolysis to inactive metabolites; excreted renally and fecally. |
| Excretion | Primarily renal: unchanged drug and metabolites. Approximately 70-80% eliminated in urine within 72 hours. Fecal elimination: ~10-20%. |
| Half-life | Terminal elimination half-life: 12-15 hours. Clinical context: supports twice-daily dosing; steady-state achieved in 2-3 days. |
| Protein binding | Approximately 95%, primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Vd: 0.15-0.3 L/kg. Clinical meaning: low Vd indicates limited extravascular distribution; primarily remains in plasma and interstitial fluid. |
| Bioavailability | Oral: 80-90%. Topical: 5-10% (varies with skin condition and site; increased with occlusive dressings). |
| Onset of Action | Intravenous: immediate (minutes). Oral: 1-2 hours. Topical: 4-6 hours for clinical effect. |
| Duration of Action | Intravenous/oral: 12-24 hours depending on dose and condition. Topical: 12-24 hours; effect may persist up to 36 hours with occlusive dressing. |
Apply a thin film to affected skin areas twice daily. The maximum duration of treatment should not exceed 2 consecutive weeks, and total dosage should not exceed 50 g per week.
| Dosage form | CREAM |
| Renal impairment | No dose adjustment required. |
| Liver impairment | No dose adjustment required. |
| Pediatric use | Not recommended for use in children under 12 years of age. For children 12 years and older, apply a thin film to affected areas once or twice daily for no more than 2 consecutive weeks, with total dosage not exceeding 30 g per week. |
| Geriatric use | Use with caution due to increased risk of skin atrophy and systemic absorption. Apply sparingly and for the shortest duration necessary. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ULTRAVATE (ULTRAVATE).
| Breastfeeding | It is not known whether topical halobetasol is excreted in human milk. Systemic corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when ULTRAVATE is administered to a nursing woman. M/P ratio: Not established. |
| Teratogenic Risk | ULTRAVATE (halobetasol propionate) is a super-high-potency topical corticosteroid. Systemic absorption can occur, especially with occlusive use or application to large areas. Corticosteroids have been shown to be teratogenic in animal studies (cleft palate, skeletal anomalies). There are no adequate and well-controlled studies in pregnant women. Use is not recommended during pregnancy, especially first trimester, unless potential benefit outweighs risk. Fetal risk: Potential growth restriction, adrenal suppression with chronic high-dose exposure. |
■ FDA Black Box Warning
No black box warning.
| Serious Effects |
["Hypersensitivity to halobetasol propionate or any component of the formulation","Uncontrolled infection at treatment site","Perioral dermatitis","Rosacea"]
| Precautions | ["Hypercortisolism (Cushing's syndrome) and HPA axis suppression with prolonged use","Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression","Systemic absorption may cause diabetes mellitus, hypertension, and osteoporosis","Local adverse reactions: skin atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration, secondary infection, and miliaria.","Do not use on face, axillae, or intertriginous areas","Use with caution in patients with impaired hepatic function"] |
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| Fetal Monitoring | Monitor for signs of systemic corticosteroid effects (hyperglycemia, hypertension, edema, hypothalamic-pituitary-adrenal axis suppression). In pregnant women, monitor fetal growth and development with serial ultrasound if prolonged use. Assess for intrauterine growth restriction if high doses applied to large surface areas. |
| Fertility Effects | No human data on fertility effects. In animal studies, topical corticosteroids may impair fertility at high systemic doses. Effects on human fertility unknown. |