|Halobetasol Halobetasol Cream
|Drugs search, click the first letter of a drug name:
| A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 9 Home
Generic Name: Halobetasol propionate
Dosage Form: Ointment, 0.05%
FOR DERMATOLOGICAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Halobetasol propionate ointment 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, C25H31CIF2O5 . 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 aluminum stearate, beeswax, pentaerythritol cocoate, petrolatum, propylene glycol, sorbitan sesquioleate, and stearyl citrate.
Halobetasol - 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 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 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 for Halobetasol
Halobetasol propionate ointment 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 corticosteroid, 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 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:
Laboratory Tests: The following tests may be helpful in evaluating patients for HPA axis suppression:
Carcinogenesis, Mutagenesis, 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, 0.05%. 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.
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.
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, urticara, 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).
Halobetasol 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 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 two weeks, reassessment of diagnosis may be necessary.
Halobetasol propionate ointment should not be used with occlusive dressings.
How is Halobetasol Supplied
Halobetasol Propionate Ointment, 0.05% is supplied in the following tube sizes:
Store at 20°-25°C (68°-77°F), with excursions permitted between 15°-30°C (59°-86°F).
E. FOUGERA & CO.
Where can I get more information about Halobetasol Halobetasol Cream ? We recommend to use www.Drugs.com
Typical mistypes for Halobetasol Halobetasol Cream
galobetasol halobetasol cream, balobetasol halobetasol cream, nalobetasol halobetasol cream, jalobetasol halobetasol cream, ualobetasol halobetasol cream, yalobetasol halobetasol cream, hzlobetasol halobetasol cream, hslobetasol halobetasol cream, hwlobetasol halobetasol cream, hqlobetasol halobetasol cream, hakobetasol halobetasol cream, hapobetasol halobetasol cream, haoobetasol halobetasol cream, halibetasol halobetasol cream, halkbetasol halobetasol cream, hallbetasol halobetasol cream, halpbetasol halobetasol cream, hal0betasol halobetasol cream, hal9betasol halobetasol cream, halovetasol halobetasol cream, halonetasol halobetasol cream, halohetasol halobetasol cream, halogetasol halobetasol cream, halobwtasol halobetasol cream, halobstasol halobetasol cream, halobdtasol halobetasol cream, halobrtasol halobetasol cream, halob4tasol halobetasol cream, halob3tasol halobetasol cream, haloberasol halobetasol cream, halobefasol halobetasol cream, halobegasol halobetasol cream, halobeyasol halobetasol cream, halobe6asol halobetasol cream, halobe5asol halobetasol cream, halobetzsol halobetasol cream, halobetssol halobetasol cream, halobetwsol halobetasol cream, halobetqsol halobetasol cream, halobetaaol halobetasol cream, halobetazol halobetasol cream, halobetaxol halobetasol cream, halobetadol halobetasol cream, halobetaeol halobetasol cream, halobetawol halobetasol cream, halobetasil halobetasol cream, halobetaskl halobetasol cream, halobetasll halobetasol cream, halobetaspl halobetasol cream, halobetas0l halobetasol cream, halobetas9l halobetasol cream, halobetasok halobetasol cream, halobetasop halobetasol cream, halobetasoo halobetasol cream, halobetasol galobetasol cream, halobetasol balobetasol cream, halobetasol nalobetasol cream, halobetasol jalobetasol cream, halobetasol ualobetasol cream, halobetasol yalobetasol cream, halobetasol hzlobetasol cream, halobetasol hslobetasol cream, halobetasol hwlobetasol cream, halobetasol hqlobetasol cream, halobetasol hakobetasol cream, halobetasol hapobetasol cream, halobetasol haoobetasol cream, halobetasol halibetasol cream, halobetasol halkbetasol cream, halobetasol hallbetasol cream, halobetasol halpbetasol cream, halobetasol hal0betasol cream, halobetasol hal9betasol cream, halobetasol halovetasol cream, halobetasol halonetasol cream, halobetasol halohetasol cream, halobetasol halogetasol cream, halobetasol halobwtasol cream, halobetasol halobstasol cream, halobetasol halobdtasol cream, halobetasol halobrtasol cream, halobetasol halob4tasol cream, halobetasol halob3tasol cream, halobetasol haloberasol cream, halobetasol halobefasol cream, halobetasol halobegasol cream, halobetasol halobeyasol cream, halobetasol halobe6asol cream, halobetasol halobe5asol cream, halobetasol halobetzsol cream, halobetasol halobetssol cream, halobetasol halobetwsol cream, halobetasol halobetqsol cream, halobetasol halobetaaol cream, halobetasol halobetazol cream, halobetasol halobetaxol cream, halobetasol halobetadol cream, halobetasol halobetaeol cream, halobetasol halobetawol cream, halobetasol halobetasil cream, halobetasol halobetaskl cream, halobetasol halobetasll cream, halobetasol halobetaspl cream, halobetasol halobetas0l cream, halobetasol halobetas9l cream, halobetasol halobetasok cream, halobetasol halobetasop cream, halobetasol halobetasoo cream, halobetasol halobetasol xream, halobetasol halobetasol vream, halobetasol halobetasol fream, halobetasol halobetasol dream, halobetasol halobetasol ceeam, halobetasol halobetasol cdeam, halobetasol halobetasol cfeam, halobetasol halobetasol cteam, halobetasol halobetasol c5eam, halobetasol halobetasol c4eam, halobetasol halobetasol crwam, halobetasol halobetasol crsam, halobetasol halobetasol crdam, halobetasol halobetasol crram, halobetasol halobetasol cr4am, halobetasol halobetasol cr3am, halobetasol halobetasol crezm, halobetasol halobetasol cresm, halobetasol halobetasol crewm, halobetasol halobetasol creqm, halobetasol halobetasol crean, halobetasol halobetasol creak, halobetasol halobetasol creaj, alobetasol halobetasol cream, hlobetasol halobetasol cream, haobetasol halobetasol cream, halbetasol halobetasol cream, haloetasol halobetasol cream, halobtasol halobetasol cream, halobeasol halobetasol cream, halobetsol halobetasol cream, halobetaol halobetasol cream, halobetasl halobetasol cream, halobetaso halobetasol cream, halobetasol halobetasol cream, halobetasol halobetasol cream, halobetasol alobetasol cream, halobetasol hlobetasol cream, halobetasol haobetasol cream, halobetasol halbetasol cream, halobetasol haloetasol cream, halobetasol halobtasol cream, halobetasol halobeasol cream, halobetasol halobetsol cream, halobetasol halobetaol cream, halobetasol halobetasl cream, halobetasol halobetaso cream, halobetasol halobetasolcream, halobetasol halobetasol ream, halobetasol halobetasol ceam, halobetasol halobetasol cram, halobetasol halobetasol crem, halobetasol halobetasol crea, ahlobetasol halobetasol cream, hlaobetasol halobetasol cream, haolbetasol halobetasol cream, halboetasol halobetasol cream, haloebtasol halobetasol cream, halobteasol halobetasol cream, halobeatsol halobetasol cream, halobetsaol halobetasol cream, halobetaosl halobetasol cream, halobetaslo halobetasol cream, halobetaso l halobetasol cream, halobetasol halobetasol cream, halobetasol h alobetasol cream, halobetasol ahlobetasol cream, halobetasol hlaobetasol cream, halobetasol haolbetasol cream, halobetasol halboetasol cream, halobetasol haloebtasol cream, halobetasol halobteasol cream, halobetasol halobeatsol cream, halobetasol halobetsaol cream, halobetasol halobetaosl cream, halobetasol halobetaslo cream, halobetasol halobetaso lcream, halobetasol halobetasolc ream, halobetasol halobetasol rceam, halobetasol halobetasol ceram, halobetasol halobetasol craem, halobetasol halobetasol crema, hhalobetasol halobetasol cream, haalobetasol halobetasol cream, hallobetasol halobetasol cream, haloobetasol halobetasol cream, halobbetasol halobetasol cream, halobeetasol halobetasol cream, halobettasol halobetasol cream, halobetaasol halobetasol cream, halobetassol halobetasol cream, halobetasool halobetasol cream, halobetasoll halobetasol cream, halobetasol halobetasol cream, halobetasol halobetasol cream, halobetasol hhalobetasol cream, halobetasol haalobetasol cream, halobetasol hallobetasol cream, halobetasol haloobetasol cream, halobetasol halobbetasol cream, halobetasol halobeetasol cream, halobetasol halobettasol cream, halobetasol halobetaasol cream, halobetasol halobetassol cream, halobetasol halobetasool cream, halobetasol halobetasoll cream, halobetasol halobetasol cream, halobetasol halobetasol ccream, halobetasol halobetasol crream, halobetasol halobetasol creeam, halobetasol halobetasol creaam, halobetasol halobetasol creamm, etc.