Dosing and uses of Ultravate (halobetasol)
Adult dosage forms and strengths
cream/ointment/lotion
- 0.05%
Inflammatory, Pruritic & Steroid-Responsive Dermatoses
Apply topically to affected area(s) BId
Not to exceed 50 g/week; do not use longer than 2 consecutive weeks
Pediatric dosage forms and strengths
cream/ointment/lotion
- 0.05%
Inflammatory, Pruritic & Steroid-Responsive Dermatoses
<12 years: Safety and efficacy not established
>12 years: Apply topically to affected area(s) BId
Not to exceed 50 g/wk; do not use longer than 2 wk
Ultravate (halobetasol) adverse (side) effects
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)
Warnings
Contraindications
Underlying infection
Hypersensitivity
Ophthalmic use
Cautions
Chronic topical corticosteroid therapy may interfere with growth and development in children
Use med to very high potency for <2 wk to reduce local and systemic side effects
Use low potency for chronic therapy
Avoid medium to very high potency on face, folds, groin because can increase steroid absorption
Children may exhibit greater susceptibility to corticosteroid-induced HPA axis suppression and Cushing's syndrome due to larger skin surface area to body weight ratio
Kaposi's sarcoma reported with prolonged corticosteroid therapy
Use lower potency for children (ie, increase BSA/kg, therefore increase systemic absorption)
Pregnancy and lactation
Pregnancy category: C
Lactation: excretion of topical corticosteroids in breast milk is unknown; use with caution
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 of Ultravate (halobetasol)
Mechanism of action
Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation
Pharmacokinetics
Metabolism: Liver
Excretion: Urine
Absorption: Dependent on nature of skin at application; occlusion and inflammation may increase absorption
