Halobetasol propionate
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
4 CONTRAINDICATIONS None. None 5 WARNINGS AND PRECAUTIONS - Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. Systemic absorption may require evaluation for HPA axis suppression. Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria.
Adverse reactions may be more likely to occur with occlusive use or more potent corticosteroids. ( 5.2 , 5.5 ) Topical corticosteroids may increase the risk of cataract and glaucoma formation. If visual symptoms occur, consider referral to an ophthalmologist tor evaluation. Initiate appropriate therapy if concomitant skin infections develop. 5.1 Effects on Endocrine System Halobetasol Propionate Lotion 0.05% has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency.
This may occur during treatment or upon withdrawal of treatment of the topical corticosteroid.The potential for hypothalamic-pituitary adrenal (HPA) suppression with Halobetasol Propionate Lotion 0.05% was evaluated in the following studies: In a study of 20 adult subjects with moderate to severe plaque psoriasis involving 20% of their body surtace area.Halobetasol Propionate Lotion 0.05% produced HPA axis suppression when used twice daily for two weeks in 5 out of 20 (25%) adult subjects with plaque psoriasis.
Of the 14 subjects evaluated for HPA axis suppression, adrenal suppression occurred in 1 subject (7%) which recovered upon retest [see Clinical Pharmacology] . Because of the potential for systemic absorption, use of topical corticosteroids, including Halobetasol Propionate Lotion 0.05%, may require that patients be evaluated periodically for evidence of HPA axis suppression.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.
Contraindications
None. None (4)
Pregnancy and lactation
Pregnancy
8.1 Pregnancy There are no available data on Halobetasol Propionate Lotion 0.05% use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published data report an increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. In animal reproduction studies, halobetasol propionate administered systemically during organogenesis to pregnant rats at 13 and 33 times the human topical dose and to pregnant rabbits at 3 times the human topical dose resulted in teratogenic and embryotoxic effects [see Data].
The clinical relevance of the animal findings is not clear. The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality.
However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants. Animal Data Halobetasol propionate has been shown to be teratogenic in rats and rabbits when given systemically during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits. These doses are approximately 13, 33, and 3 times, respectively, the human topical dose of halobetasol propionate, 0.05%. Halobetasol propionate was embryotoxic in rabbits but not in rats.Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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