HALOBETASOL PROPIONATE- halobetasol propionate ointment
Taro Pharmaceuticals U.S.A., Inc.
For Dermatological Use Only
Not for Ophthalmic Use.
Halobetasol Propionate Ointment, 0.05% contains halobetasol propionate, a synthetic corticosteroid for
topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used
topically as an antiinflammatory and antipruritic agent.
Chemically halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β -methylpregna-
1, 4-diene-3-20-dione, 17-propionate, C
H ClF O . It has the following structural formula:
Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in
Each gram of Halobetasol Propionate Ointment contains 0.5 mg/g of halobetasol propionate in a base of
aluminium stearate, pentaerythritol cocoate, propylene glycol, sorbitan sesquioleate, stearyl citrate,
white petrolatum and white wax.
Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and
vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids,
in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase
A inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the
biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting
the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane
phospholipids by phospholipase A .
The extent of percutaneous absorption of topical corticosteroids is determined by many factors
including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with
hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however,
occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can
be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may
increase percutaneous absorption.
Human and animal studies indicate that less than 6% of the applied dose of halobetasol propionate enters
the circulation within 96 hours following topical administration of the ointment.
Studies performed with Halobetasol Propionate Ointment indicate that it is in the super-high range of
potency as compared with other topical corticosteroids.
INDICATIONS AND USAGE
Halobetasol Propionate Ointment, 0.05% is a super-high potency corticosteroid indicated for the relief
of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment
beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week
because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in
children under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been
achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Halobetasol Propionate Ointment is contraindicated in those patients with a history of hypersensitivity to
any of the components of the preparation.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal
(HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of
treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced
in some patients by systemic absorption of topical corticosteroids while on treatment.
Patients applying a topical steroid to a large surface area or to areas under occlusion should be
evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH
stimulation, A.M. plasma cortisol, and urinary free-cortisol tests. Patients receiving super potent
corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be
treated at any one time due to the increased risk of HPA suppression.
Halobetasol Propionate Ointment produced HPA axis suppression when used in divided doses at 7
grams per day for one week in patients with psoriasis. These effects were reversible upon
discontinuation of treatment.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the
frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is
generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of
glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For
information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their
larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use).
If irritation develops, Halobetasol Propionate Ointment should be discontinued and appropriate therapy
instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to
heal rather than noting a clinical exacerbation as with most topical products not containing
corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent
should be used. If a favorable response does not occur promptly, use of Halobetasol Propionate
Ointment should be discontinued until the infection has been adequately controlled.
Halobetasol Propionate Ointment should not be used in the treatment of rosacea or perioral dermatitis,
and it should not be used on the face, groin, or in the axillae.
Information for Patients
Patients using topical corticosteroids should receive the following information and instructions:
The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH-stimulation
test; A.M. plasma cortisol test; Urinary free-cortisol test.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol
Positive mutagenicity effects were observed in two genotoxicity assays. Halobetasol propionate was
positive in a Chinese hamster micronucleus test, and in a mouse lymphoma gene mutation assay in vitro.
Studies in the rat following oral administration at dose levels up to 50 µg/kg/day indicated no
impairment of fertility or general reproductive performance.
In other genotoxicity testing, halobetasol propionate was not found to be genotoxic in the
Ames/Salmonella assay, in the sister chromatid exchange test in somatic cells of the Chinese hamster, in
chromosome aberration studies of germinal and somatic cells of rodents, and in a mammalian spot test to
determine point mutations.
Pregnancy Category C
Corticosteroids have been shown to be teratogenic in laboratory animals when administered
systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic
after dermal application in laboratory animals.
Halobetasol propionate has been shown to be teratogenic in SPF rats and chinchilla-type rabbits when
given systemically during gestation at doses of 0.04 to 0.1 mg/kg in rats and 0.01 mg/kg in rabbits.
These doses are approximately 13, 33 and 3 times, respectively, the human topical dose of Halobetasol
Propionate Ointment. 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.
There are no adequate and well-controlled studies of the teratogenic potential of halobetasol
propionate in pregnant women. Halobetasol Propionate Ointment should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus.
The medication is to be used as directed by the physician. It is for external use only. Avoid
contact with the eyes.
The medication should not be used for any disorder other than that for which it was prescribed.
The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be
occlusive unless directed by the physician.
Patients should report to their physician any signs of local adverse reactions.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere
with endogenous corticosteroid production, or cause other untoward effects. It is not known whether
topical administration of corticosteroids could result in sufficient systemic absorption to produce
detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be
exercised when Halobetasol Propionate Ointment is administered to a nursing woman.
Safety and effectiveness of Halobetasol Propionate Ointment in pediatric patients have not been
established and use in pediatric patients under 12 is not recommended. Because of a higher ratio of skin
surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression
and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at
greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including
striae have been reported with inappropriate use of topical corticosteroids in infants and children.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and
intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of
response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles,
headaches, and bilateral papilledema.
Of approximately 850 patients treated with halobetasol propionate ointment in clinical studies, 21%
were 61 years and over and 6% were 71 years and over. No overall differences in safety or
effectiveness were observed between these patients and younger patients; and other reported clinical
experience has not identified differences in responses between the elderly and younger patients, but
greater sensitivity of some older individuals cannot be ruled out.
In controlled clinical trials, the most frequent adverse events reported for Halobetasol Propionate
Ointment included stinging or burning in 1.6% of the patients. Less frequently reported adverse
reactions were pustulation, erythema, skin atrophy, leukoderma, acne, itching, secondary infection,
telangiectasia, urticaria, dry skin, miliaria, paresthesia, and rash.
The following additional local adverse reactions are reported infrequently with topical corticosteroids,
and they may occur more frequently with high potency corticosteroids, such as Halobetasol Propionate
Ointment. These reactions are listed in an approximate decreasing order of occurrence: folliculitis,
hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis,
secondary infection, striae and miliaria.
Topically applied Halobetasol Propionate Ointment can be absorbed in sufficient amounts to produce
systemic effects (see PRECAUTIONS).
DOSAGE AND ADMINISTRATION
Apply a thin layer of Halobetasol Propionate Ointment to the affected skin once or twice daily, as
directed by your physician, and rub in gently and completely.
Halobetasol Propionate Ointment is a high potency topical corticosteroid; therefore, treatment should
be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other
corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen
within 2 weeks, reassessment of diagnosis may be necessary.
Halobetasol Propionate Ointment should not be used with occlusive dressings.
Halobetasol Propionate Ointment, 0.05% is supplied in 5 g physician samples (tubes only - NDC 51672-
1322-5), 15 g (NDC 51672-1322-1) and 50 g (NDC 51672-1322-3) tubes.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or
Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532
Revised: June, 2012
PRINCIPAL DISPLAY PANEL
FOR DERMATOLOGICAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.
halobetasol propionate ointment
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
Ha lo beta so l Pro pio na te (UNII: 9 1A0 K1TY3Z) (Halo betaso l - UNII:9 P6 159 HM7T)
Halo betaso l Pro pio nate
0 .5 mg in 1 g
Stre ng th
a luminum stea ra te (UNII: U6 XF9 NP8 HM)
pro pylene g lyco l (UNII: 6 DC9 Q16 7V3)
so rbita n sesquio lea te (UNII: 0 W8 RRI5W5A)
mo no stea ryl citra te (UNII: YWW9 37R1QR)
petro la tum (UNII: 4T6 H12BN9 U)
white wa x (UNII: 7G1J5DA9 7F)
Taro Pharmaceuticals U.S.A., Inc.
Marketing Start Date
Marketing End Date
5 g in 1 TUBE
1 in 1 CARTON
15 g in 1 TUBE
1 in 1 CARTON
50 g in 1 TUBE
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
ANDA0 76 9 9 4
12/16 /20 0 4
T aro Pharmaceuticals U.S.A., Inc. (145186370)
Ad d re s s
Busine ss Ope rations
Taro Pharmaceuticals Inc.
20 6 26 329 5