(hal oh BAY ta sol)
Dermatoses (cream and ointment): Relief of inflammatory and pruritic manifestations of corticosteroid-response dermatoses [super high potency topical corticosteroid]
Plaque psoriasis (lotion): Treatment of plaque psoriasis in patients ≥18 years of age
Hypersensitivity to halobetasol or any component of the formulation
Lotion: There are no contraindications listed in the manufacturers labeling.
Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Plaque psoriasis: Lotion: Topical: Apply a thin layer to affected skin twice daily for up to 2 weeks; total dosage should not exceed 50 g/week. Discontinue therapy when control is achieved; if no improvement is seen in 2 weeks, reassessment of diagnosis may be necessary.
Steroid-responsive dermatoses: Cream and Ointment: Topical: Apply sparingly to skin once or twice daily; treatment should not exceed 2 consecutive weeks and total dosage should not exceed 50 g/week. Discontinue therapy when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.
Refer to adult dosing.
Children ≥12 years and Adolescents: Cream and Ointment: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturers labeling.
There are no dosage adjustments provided in the manufacturers labeling.
Topical: For external use only; not for ophthalmic, oral, or intravaginal use; do not apply to the face, scalp, groin, or axillae. Use of occlusive dressings is not recommended unless directed by a health care provider. Apply thin film to affected area and rub in gently and completely.
Store at 25 ‚ °C (77 ‚ °F); excursions permitted to 15 ‚ °C and 30 ‚ °C (59 ‚ °F to 86 ‚ °F). Do not freeze.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External, as propionate:
Ultravate: 0.05% (50 g) [contains cetyl alcohol]
Generic: 0.05% (15 g, 50 g)
Kit, External, as propionate:
Halonate: 0.05 & 12 % (Foam) [contains cetyl alcohol, propylene glycol, trolamine (triethanolamine)]
Ultravate PAC: 0.05 & 12 % (Cream) [DSC] [contains cetyl alcohol, methylparaben, propylene glycol, propylparaben]
Lotion, External, as propionate:
Ultravate: 0.05% (60 mL) [contains butylparaben, cetyl alcohol, propylene glycol, propylparaben]
Ointment, External, as propionate:
Ultravate: 0.05% (50 g) [contains propylene glycol]
Generic: 0.05% (15 g, 50 g)
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
Growth in pediatric patients; signs/symptoms of HPA axis suppression/adrenal insufficiency; bacterial or fungal skin infection
1% to 10%:
Central nervous system: Localized burning (2% to 4%)
Dermatologic: Pruritus (4%), stinging of the skin (2% to 4%)
Frequency not defined:
Central nervous system: Intracranial hypertension (systemic effect reported in children treated with topical corticosteroids), paresthesia
Dermatologic: Acneiform eruption, allergic contact dermatitis, atrophic striae, erythema, folliculitis, hypertrichosis, hypopigmentation, leukoderma, miliaria, perioral dermatitis, pustules, secondary skin infection, skin atrophy, skin rash, telangiectasia, urticaria, vesicular eruption, xeroderma
Endocrine & metabolic: Glycosuria, HPA-axis suppression, hyperglycemia, hypokalemia
Concerns related to adverse effects:
- Adrenal suppression: May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
- Contact dermatitis: Allergic contact dermatitis can occur, it is usually diagnosed by failure to heal rather than clinical exacerbation. Discontinue therapy if irritation develops.
- Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).
- Local effects: Local adverse reactions may occur (eg, skin atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection miliaria); may be irreversible. Local adverse reactions are more likely to occur with occlusive dressings and/or prolonged use. If irritation develops, discontinued use and institute appropriate therapy.
- Skin infections: Use appropriate antibacterial or antifungal agents to treat concomitant skin infections; discontinue treatment if infection does not resolve promptly.
- Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushings syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Special populations:
- Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
Other warnings/precautions:
- Appropriate use: If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Do not use the cream or ointment for the treatment of perioral dermatitis or rosacea.
C
Teratogenic effects have been observed in animal reproduction studies. Topical products are not recommended for extensive use, in large quantities, or for long periods of time in pregnant women (Reed, 1997).
Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Halobetasol has high range potency.
Percutaneous absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, and the use of occlusive dressings; <6% of a topically applied dose enters circulation within 96 hours
Primarily hepatic
Urine
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience dry skin, burning, itching, or stinging. Have patient report immediately to prescriber signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of skin changes (pimples, stretch marks, slow healing, or hair growth), or severe skin irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.