Ultravate® (halobetasol propionate cream) Cream,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 antipruritic 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:

Halobetasol propionate has the molecular weight of 485.It is a white crystalline powder insoluble in water.

Each gram of Ultravate Cream contains 0.5 mg/g of halobetasol propionate in a cream base of cetyl alcohol,glycerin,isopropyl isostearate,isopropyl palmitate,steareth-21,diazolidinyl urea,methylchloroisothiazolinone,(and) methylisothiazolinone and water.

Last updated on RxList: 7/21/2008

Ultravate Cream 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 50g/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.

Apply a thin layer of Ultravate Cream to the affected skin once or twice daily,as directed by your physician,and rub in gently and completely.

Ultravate (halobetasol propionate cream) Cream 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.

Ultravate Cream should not be used with occlusive dressings.

Ultravate® (halobetasol propionate cream) Cream,0.05% is supplied in the following tube sizes:

15 g (NDC 0072-1400-15)
50 g (NDC 0072-1400-50)

Storage

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

Bristol-Myers Squibb Company, Princeton,NJ 08543, USA. FDA Rev date: 9/17/2004

Last updated on RxList: 7/21/2008

In controlled clinical trials,the most frequent adverse events reported for Ultravate Cream included stinging,burning or itching in 4.4% of the patients.Less frequently reported adverse reactions were dry skin,erythema,skin atrophy,leukoderma,vesicles 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 Ultravate Cream.These reactions are listed in an approximate decreasing order of occurrence:folliculitis,hypertrichosis,acneiform eruptions,hypopigmentation,perioral dermatitis,allergic contact der-matitis,secondary infection,striae and miliaria.

No information provided.

Last updated on RxList: 7/21/2008

No information provided.

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.

Ultravate Cream 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 corti-costeroids.Infrequently,signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic cor-ticosteroids.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,Ultravate Cream 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 Ultravate Cream should be discontinued until the infection has been adequately controlled.

Ultravate Cream 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.

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 Ultravate Cream.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. Ultravate Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corti-costeroid 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 Ultravate Cream is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Ultravate Cream 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 400 patients treated with Ultravate Cream in clinical studies, 25% 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.

Last updated on RxList: 7/21/2008

Topically applied Ultravate Cream can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Ultravate Cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Last updated on RxList: 7/21/2008

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.

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 cream.

Studies performed with Ultravate Cream indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

Last updated on RxList: 7/21/2008

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.

Last updated on RxList: 7/21/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

HALOBETASOL - TOPICAL

(hal-oh-BAY-tuh-sole)

COMMON BRAND NAME(S): Ultravate

USES: This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Halobetasol reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a very strong (super-high potency) corticosteroid.

HOW TO USE: Use this medication on the skin only. Do not use it on the face, groin or underarms unless directed to do so by your doctor.

Before applying the medication, clean and dry the affected area. Apply a thin film of the medication to the affected area and gently rub in, one to two times daily or as directed by your doctor. Do not wrap, cover or bandage the area unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants.

After applying the medication, wash your hands unless you are using this medication to treat the hands. If applying this medication near the eyes, avoid getting it in the eyes as this may worsen or cause glaucoma. Also avoid getting this medication in the nose or mouth.

Use this medication only for the condition prescribed. Do not use it for longer than two weeks in a row unless directed to do so by your doctor.

If your condition worsens or does not improve in 2 weeks, contact your doctor.

SIDE EFFECTS: Burning, stinging, itching, dryness or redness may occur when first applied to the skin. This should disappear in a few days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, excessive hair growth, "hair bumps" (folliculitis).

Skin infections can become worse when using this medication. Notify your doctor promptly if redness, swelling or irritation does not improve.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using halobetasol, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, immune system problems, certain skin conditions (rosacea, perioral dermatitis).

Do not use if there is an infection or sore present in the area to be treated.

Though very unlikely, it is possible this medication will be absorbed into your bloodstream. This may have undesirable consequences that may require additional corticosteroid treatment. This is especially true for children, those who have used this drug for an extended period of time, and those who have serious medical problems such as serious infections, injuries, or surgeries. This precaution applies for up to one year after you stop using this drug.

Tell your doctor immediately if any of the following side effects occur: vision problems, persistent headache, increased thirst or urination, unusual weakness or weight loss, dizziness.

Consult your doctor or pharmacist for more details and inform them that you use (or have used) this medication.

Caution is advised when using this drug in children because they may be more sensitive to the effects of steroid excess. Though it is unlikely to occur with topical corticosteroids, this medication may affect growth in infants and children if used for prolonged periods. Monitor your child's height and rate of growth periodically.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug, when applied to the skin, passes into breast milk. Other medications in this class, when taken by mouth, pass into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: oral corticosteroids (e.g., prednisone), drugs that suppress the immune system (e.g., cyclosporine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medication may be harmful if swallowed.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests (e.g., adrenal gland function tests, morning cortisol blood test) may be performed periodically to monitor your progress or check for side effects if you use this drug for two weeks or longer. Consult your doctor for more details.

Inform all your doctors you use (or have used) this medication.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.