HALOBETASOL PROPIONATE

Main information

  • Trade name:
  • HALOBETASOL PROPIONATE- halobetasol propionate ointment
  • Composition:
  • Halobetasol Propionate 0.5 mg in 1 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HALOBETASOL PROPIONATE- halobetasol propionate ointment
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • 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.
  • Product summary:
  • 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 www.fda.gov/medwatch.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 51672-1322-1, 51672-1322-3, 51672-1322-5
  • Last update:
  • 25-05-2019

Summary of Product characteristics: dosage, interactions, side effects

HALOBETASOL PROPIONATE- halobetasol propionate ointment

Taro Pharmaceuticals U.S.A., Inc.

----------

Halobetasol Propionate

Ointment, 0.05%

Rx only

For Dermatological Use Only

Not for Ophthalmic Use.

DESCRIPTION

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

water.

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.

CLINICAL PHARMACOLOGY

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 .

Pharmacokinetics

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.

CONTRAINDICATIONS

Halobetasol Propionate Ointment is contraindicated in those patients with a history of hypersensitivity to

any of the components of the preparation.

PRECAUTIONS

General

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:

1.

2.

3.

4.

Laboratory Tests

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

propionate.

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

Teratogenic effects

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.

Nursing Mothers

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.

Pediatric Use

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.

Geriatric Use

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.

ADVERSE REACTIONS

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.

OVERDOSAGE

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.

HOW SUPPLIED

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.

STORAGE

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

www.fda.gov/medwatch.

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Dist by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532

Revised: June, 2012

PK-4732-1

PRINCIPAL DISPLAY PANEL

NDC 51672-1322-1

15 g

Halobetasol Propionate

Ointment 0.05%

FOR DERMATOLOGICAL USE ONLY.

NOT FOR OPHTHALMIC USE.

TARO

Rx only

Keep this and all medications out of the reach of children.

HALOBETASOL PROPIONATE

halobetasol propionate ointment

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:516 72-1322

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

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

Inactive Ingredients

Ingredient Name

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.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:516 72-1322-5

5 g in 1 TUBE

2

NDC:516 72-1322-1

1 in 1 CARTON

2

15 g in 1 TUBE

3

NDC:516 72-1322-3

1 in 1 CARTON

3

50 g in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 9 9 4

12/16 /20 0 4

Labeler -

T aro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Taro Pharmaceuticals Inc.

20 6 26 329 5

MANUFACTURE(516 72-1322)

Revised: 6/2014