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. |
| Molecular Weight | 470 |
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 | Avoid use. Topical corticosteroids are associated with low birth weight and oral clefts in some studies. Risk outweighs benefit. |
| 2nd trimester | Use only if potential benefit justifies risk. Limited data suggest possible fetal growth restriction with prolonged use. |
| 3rd trimester | Use with caution; may cause fetal adrenal suppression or low birth weight if used extensively. |
Clinical note
Comprehensive clinical and safety monograph for ULTRAVATE (ULTRAVATE).
| Placental transfer | Minimal placental transfer after topical administration due to high protein binding and rapid metabolism. Systemic absorption is low, but extensive or occlusive use may increase transfer. |
| Breastfeeding | Excretion into breast milk negligible after topical use; avoid application to breast area to prevent infant ingestion. Use with caution if applying to large areas or under occlusion. |
■ FDA Black Box Warning
No black box warning.
| Serious Effects |
Hypersensitivity to any componentUntreated bacterial, viral, or fungal infectionsRosaceaPerioral dermatitis
| 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 |
| Food/Dietary | No clinically significant food interactions. |
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| Lactation Rating | L2 (Safer) |
| 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. |
| 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. |
| Clinical Pearls | ULTRAVATE (halobetasol propionate) is a super-high-potency topical corticosteroid. Limit use to 2 consecutive weeks and maximum 50 g/week due to risk of HPA axis suppression. Avoid application on face, groin, axillae, or intertriginous areas. Use only for plaque psoriasis unresponsive to lower-potency steroids. |
| Patient Advice | Apply a thin layer to affected skin only, usually once or twice daily. · Do not use on face, armpits, or groin unless directed. · Do not cover treated area with bandages or wraps unless instructed. · Do not use for longer than 2 weeks. · Wash hands after application unless treating hands. · Avoid contact with eyes or mouth. · Report signs of skin infection or worsening condition. |