Lac-Hydrin Ten 10 % Topical Cream
Generic Name: HALOBETASOL PROPIONATE
Brand Name: Ultravate X
OVERDOSAGE
Topically applied Ultravate Ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
DESCRIPTION
Ultravate® (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 antipruritic agent.
Chemically halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3-20-dione, 17-propionate, C25H3 1ClF2O5.
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 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.
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HOW SUPPLIED
Ultravate® (halobetasol propionate) Ointment, 0.05% is supplied in the following tube size: 50 g (NDC 10631-102-50) STORAGE Store between 15°C and 30°C (59°F and 86°F).
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5090133 (Flat), 5090134 (Folded) Revised November 2011
GERIATRIC USE
Geriatric Use Of approximately 400 patients treated with Ultravate® Ointment 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.
INDICATIONS AND USAGE
Ultravate 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.
PEDIATRIC USE
Pediatric Use Safety and effectiveness of Ultravate 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.
PREGNANCY
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 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.
Ultravate Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
NUSRING MOTHERS
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 Ultravate Ointment is administered to a nursing woman.
INFORMATION FOR PATIENTS
Information for Patients Patients using Ultravate® Ointment should receive the following information and instructions: 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.
DOSAGE AND ADMINISTRATION
Apply a thin layer of Ultravate Ointment to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.
Ultravate (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.
Ultravate Ointment should not be used with occlusive dressings.