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Name:Halonate
Manufacturer:Jsj Pharmaceuticals
Category:Prescription Marketed Drugs


Halonate (halobetasol Propionate ointmanet 0.05%)

HALONATE  - halobetasol propionate ointment 
JSJ Pharmaceuticals

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Halonate (halobetasol Propionate ointmanet 0.05%)

Halonate 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 anti-inflammatory and anti-pruritic agent.

Chemically halobetasol propionate is 21-chloro-6α, 9-difluoro-11β,17-dihydroxy-16β-methylpregna-1,
4-diene-3-20-dione, 17-propionate, C25H31ClF2O5. It has the following structural formula:

Image of Chemical Structure


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 aluminum stearate, beeswax, pentaerythritol cocoate, petrolatum, propylene glycol, sorbitan
sesquioleate, and stearyl citrate.

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 A2 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 A2.

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.

Halobetasol Propionate Ointment 0.05% is a superhigh 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.

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 anti-bacterial
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.


Patients using topical corticosteroids should receive the following information and instructions:

1) The medication is to be used as directed by the physician. It is for external use only. Avoid contact
with the eyes.

2) The medication should not be used for any disorder other than that for which it was prescribed.

3) The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be
occlusive unless directed by the physician.

4) Patients should report to their physician any signs of local adverse reactions.


The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH-stimulation
test; A.M. plasma cortisol test; Urinary freecortisol test.

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.

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.

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).

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 super-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.

Halonate™ is supplied in the following:

(NDC 68712-034-01) one 50 g tube of halobetasol propionate ointment 0.05% packaged with one
4 oz can of ammonium lactate mousse 12%

STORAGE: Store between 15°C and 30°C (59°F and 86°F).

Manufactured by:

G and W Laboratories, Inc.
South Plainfield, NJ  07080


Manufactured for:

JSJ Pharmaceuticals
Charleston, SC  29401
1-800-499-4468
www.jsjpharm.com

Image of Carton


HALONATE 
halobetasol ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68712-034
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOBETASOL PROPIONATE (HALOBETASOL ) HALOBETASOL PROPIONATE 0.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM STEARATE  
WAX, YELLOW  
PENTAERYTHRITOL  
PETROLATUM  
PROPYLENE GLYCOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68712-034-01 50 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077721 08/01/2009

Labeler - JSJ Pharmaceuticals (615074866)
Establishment
Name Address ID/FEI Operations
G and W Labs 073149986 manufacture

Revised: 08/2009 JSJ Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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