Flixovate 0.05%The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content. Fluticasone propionate a propionate de fluticasone flixovate of Fluticasone is reported as an ingredient of Flixovate in the following countries:. This means it is still under development and may contain inaccuracies. It is not intended as a substitute for the expertise and judgement of your physician, pharmacist or other healthcare professional.
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The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. It has the following structural formula:. Fluticasone propionate has a molecular weight of It is a white to off-white powder and is insoluble in water. Get emergency medical help if you have any of these signs of an allergic reaction: Although the risk of serious side effects is low when fluticasone topical is applied to the skin, side effects can occur if the medication is absorbed into your bloodstream.
Stop using this medicine and call your doctor at once if you have signs of absorbing fluticasone topical through your skin, such as:. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established.
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. These adverse reactions were usually mild; self-limiting; and consisted primarily of pruritus , dryness, numbness of fingers, and burning. These events occurred in 2. The local drug-related adverse events for the patients enrolled in both studies are shown in Table 1.
In the study enrolling both adult and pediatric patients, the incidence of local adverse events in the pediatric patients ages 1 to 12 years was comparable to the patients ages 13 to 62 years. Fifty-one pediatric patients ages 3 months to 5 years, with moderate to severe eczema, were enrolled in an open-label HPA axis safety study.
Follow-up testing after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally responsive HPA axis. The following local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreas ing order of occurrence: Also, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroid products.
Formaldehyde may cause allergic sensitization or irritation upon contact with the skin. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitaryadrenal HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment.
Manifestations of Cushing syndrome , hyperglycemia , and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a potent topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
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 steroid. 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.
Fluticasone propionate cream, 0. There was some evidence of corresponding decrease in the hour urinary free cortisol levels. Fluticasone propionate cream contains the excipient imidurea which releases traces of formaldehyde as a breakdown product. 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.
ACTH stimulation test A. Two month studies were performed in mice to evaluate the carcinogenic potential of fluticasone propionate when given topically as an 0. No evidence of carcinogenicity was found in either study. Fluticasone propionate was not mutagenic in the standard Ames test , E. It was not clastogenic in mouse micronucleus or cultured human lymphocyte tests.
These doses are approximately 15 and 30 times, respectively, the human systemic exposure following use of the recommended human topical dose of fluticasone propionate cream, 0. 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. This dose is approximately 14 and 45 times, respectively, the human topical dose of fluticasone propionate cream, 0. There are no adequate and well-controlled studies in pregnant women.
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. Adverse effects including striae have been reported with use of topical corticosteroids in pediatric patients.
HPA axis suppression, Cushing syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels to an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients.
Like other topical corticosteroids, fluticasone propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear.
However, corticosteroids are thought to act by the induction of phospholipase A 2 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 2.
Fluticasone propionate is lipophilic and has a strong affinity for the glucocorticoid receptor. It has weak affinity for the progesterone receptor, and virtually no affinity for the mineralocorticoid, estrogen , or androgen receptors.
The therapeutic potency of glucocorticoids is related to the half-life of the glucocorticoid-receptor complex. The half-life of the fluticasone propionate-glucocorticoid receptor complex is approximately 10 hours. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier.
Occlusive dressing enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. In a human study of 12 healthy males receiving In another study of 6 healthy males administered 25 g of 0. In an animal study using radiolabeled 0. Absorption from the skin continued for the duration of the study 7 days , indicating a long retention time at the application site. Following intravenous administration of 1 mg fluticasone propionate in healthy volunteers, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding.
The apparent volume of distribution averaged 4. Fluticasone propionate is weakly and reversibly bound to erythrocytes. Fluticasone propionate is not significantly bound to human transcortin. No metabolites of fluticasone propionate were detected in an in vitro study of radiolabeled fluticasone propionate incubated in a human skin homogenate.
Fluticasone propionate is metabolized in the liver by cytochrome P 3A4-mediated hydrolysis of the 5- fluoromethyl carbothioate grouping. This metabolite has approximately 2, times less affinity than the parent drug for the glucocorticoid receptor of human lung cytosol in vitro and negligible pharmacological activity in animal studies.
Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man. Following intravenous dose of 1 mg in healthy volunteers, fluticasone propionate showed polyexponential kinetics and had an average terminal half-life of 7.
The investigator's global evaluation after 28 days of treatment is shown in Table 3. The mean improvements over baseline in the clinical signs at the end of treatment are shown in Table 4. The investigator's global evaluation after 28 days of treatment is shown in Table 5. The mean improvements over baseline at the end of treatment are shown in Table 6. Clinical Signs and Symptoms: Patients using topical corticosteroids should receive the following information and instructions:.
You are encouraged to report negative side effects of prescription drugs to the FDA. Last reviewed on RxList: Find Lowest Prices on. For Consumers What are the possible side effects of fluticasone topical Cutivate? Stop using this medicine and call your doctor at once if you have signs of absorbing fluticasone topical through your skin, such as: Test Your Medical IQ.
Moderate to Severe Forms of Psoriasis Slideshow. General Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitaryadrenal HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Distribution Following intravenous administration of 1 mg fluticasone propionate in healthy volunteers, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding.
Metabolism No metabolites of fluticasone propionate were detected in an in vitro study of radiolabeled fluticasone propionate incubated in a human skin homogenate. Excretion Following intravenous dose of 1 mg in healthy volunteers, fluticasone propionate showed polyexponential kinetics and had an average terminal half-life of 7.
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. This medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or 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.