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G&w fluticasone

PRESCRIBING INFORMATION
Fluticasone Propionate Cream 0.05%
For Dermatologic Use Only–Not for Ophthalmic Use.
Fluticasone
DESCRIPTION: Fluticasone Propionate Cream 0.05% contains fluticasone
Propionate Cream
propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid, S-fluoromethylester], a synthetic fluorinated cortico-steroid, for topical dermatologic use.
Patients applying a potent topical steroid to a large surface area or to areas The topical corticosteroids constitute a class of primarily synthetic steroids under occlusion should be evaluated periodically for evidence of HPA axis used as anti-inflammatory and antipruritic agents.
suppression. This may be done by using the ACTH stimulation, A.M. plasmacortisol, and urinary free cortisol tests.
Chemically, fluticasone propionate is C25H31F3O5S. It has the followingstructural formula: 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 discontinu- ation of topical corticosteroids. Infrequently, signs and symptoms of gluco- corticosteroid insufficiency may occur requiring supplemental systemic cor- ticosteroids. For information on systemic supplementation, see prescribinginformation for those products.
Fluticasone Propionate Cream, 0.05% caused depression of A.M. plasma cor- tisol levels in 1 of 6 adult patients when used daily for 7 days in patients withpsoriasis or eczema involving at least 30% of the body surface. After 2 days of treatment, this patient developed a 60% decrease from pretreatment valuesin the A.M. plasma cortisol level.
Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water.
There was some evidence of corresponding decrease in the 24-hour urinaryfree cortisol levels. The A.M. plasma cortisol level remained slightly Each gram of Fluticasone Propionate Cream contains fluticasone propionate depressed for 48 hours but recovered by day 6 of treatment.
0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water, Fluticasone Propionate Cream, 0.05%, caused HPA axis suppression in 2 of 43 pediatric patients, ages 2 and 5 years old, who were treated for 4 weekscovering at least 35% of the body surface area. Follow-up testing 12 days CLINICAL PHARMACOLOGY
after treatment discontinuation, available for 1 of the 2 subjects, demonstrated Like other topical corticosteroids, fluticasone propionate has anti-inflammatory, a normally responsive HPA axis (see PRECAUTIONS: Pediatric Use).
antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, Pediatric patients may be more susceptible to systemic toxicity from equiva- corticosteroids are thought to act by the induction of phospholipase A2 lent doses due to their larger skin surface to body mass ratios (see PRE- inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation suchas prostaglandins and leukotrienes by inhibiting the release of their common Fluticasone Propionate Cream, 0.05% may cause local cutaneous adverse precursor, arachidonic acid. Arachidonic acid is released from membrane If irritation develops, Fluticasone Propionate Cream should be discontinued Fluticasone propionate is lipophilic and has a strong affinity for the glucocor- and appropriate therapy instituted. Allergic contact dermatitis with cortico- ticoid receptor. It has weak affinity for the progesterone receptor, and virtually steroids is usually diagnosed by observing failure to heal rather than noting no affinity for the mineralocorticoid, estrogen, or androgen receptors. The a clinical exacerbation as with most topical products not containing cortico- therapeutic potency of glucocorticoids is related to the half-life of the gluco- steroids. Such an observation should be corroborated with appropriate corticoid-receptor complex. The half-life of the fluticasone propionate-gluco- corticoid receptor complex is approximately 10 hours.
If concomitant skin infections are present or develop, an appropriate antifun- Studies performed with Fluticasone Propionate Cream indicate that it is in the gal or antibacterial agent should be used. If a favorable response does not medium range of potency as compared with other topical corticosteroids.
occur promptly, use of Fluticasone Propionate Cream should be discontinueduntil the infection has been adequately controlled.
Pharmacokinetics: Absorption: The activity of Fluticasone Propionate Cream
is due to the parent drug, fluticasone propionate. The extent of percutaneous
Fluticasone Propionate Cream should not be used in the presence of preex- absorption of topical corticosteroids is determined by many factors, including isting skin atrophy and should not be used where infection is present at the the vehicle and the integrity of the epidermal barrier. Occlusive dressing treatment site. Fluticasone Propionate Cream should not be used in the treat- enhances penetration. Topical corticosteroids can be absorbed from normal ment of rosacea and perioral dermatitis.
intact skin. Inflammation and/or other disease processes in the skin increasepercutaneous absorption.
Information for Patients: Patients using topical corticosteroids should
receive the following information and instructions:
In a human study of 12 healthy males receiving 12.5 g of 0.05% fluticasonepropionate cream twice daily for 3 weeks, plasma levels were generally below 1. This medication is to be used as directed by the physician. It is for external the level of quantification (0.05 ng/mL). In another study of 6 healthy males use only. Avoid contact with the eyes.
administered 25 g of 0.05% fluticasone propionate cream under occlusion for5 days, plasma levels of fluticasone ranged from 0.07 to 0.39 ng/mL.
2. This medication should not be used for any disorder other than that for In an animal study using radiolabeled 0.05% fluticasone propionate cream and ointment preparations, rats received a topical dose of 1 g/kg for a 24- 3. The treated skin area should not be bandaged or otherwise covered or hour period. Total recovery of radioactivity was approximately 80% at the end wrapped so as to be occlusive unless directed by the physician.
of 7 days. The majority of the dose (73%) was recovered from the surface ofthe application site. Less than 1% of the dose was recovered in the skin at 4. Patients should report to their physician any signs of local adverse reac- the application site. Approximately 5% of the dose was absorbed systemi- cally through the skin. Absorption from the skin continued for the durationof the study (7 days), indicating a long retention time at the application site.
5. Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis. Fluticasone Propionate Cream should Distribution: Following intravenous administration of 1 mg fluticasone propi-
not be applied in the diaper areas as diapers or plastic pants may consti- onate in healthy volunteers, the initial disposition phase for fluticasone pro- tute occlusive dressing (see DOSAGE AND ADMINISTRATION).
pionate was rapid and consistent with its high lipid solubility and tissue bind-ing. The apparent volume of distribution averaged 4.2 L/kg (range, 2.3 to 16.7 6. This medication should not be used on the face, underarms, or groin areas L/kg). The percentage of fluticasone propionate bound to human plasma pro- teins averaged 91%. Fluticasone propionate is weakly and reversibly boundto erythrocytes. Fluticasone propionate is not significantly bound to human 7. As with other corticosteroids, therapy should be discontinued when con- trol is achieved. If no improvement is seen within 2 weeks, contact thephysician.
Metabolism: No metabolites of fluticasone propionate were detected in an in
vitro study of radiolabeled fluticasone propionate incubated in a human skin
Laboratory Tests: The following tests may be helpful in evaluating patients
homogenate. The total blood clearance of systemically absorbed fluticasone propionate averages 1,093 mL/min (range, 618 to 1,702 mL/min) after a 1-mg intravenous dose, with renal clearance accounting for less than 0.02% of the total. Fluticasone propionate is metabolized in the liver by cytochromeP450 3A4-mediated hydrolysis of the 5-fluoromethyl carbothioate grouping.
This transformation occurs in 1 metabolic step to produce the inactive 17-β-carboxylic acid metabolite, the only known metabolite detected in man. This metabolite has approximately 2,000 times less affinity than the parent drugfor the glucocorticoid receptor of human lung cytosol in vitro and negligible Carcinogenesis, Mutagenesis, and Impairment of Fertility: Two 18-month
pharmacological activity in animal studies. Other metabolites detected in vitro studies were performed in mice to evaluate the carcinogenic potential of using cultured human hepatoma cells have not been detected in man.
fluticasone propionate when given topically (as an 0.05% ointment) and orally.
No evidence of carcinogenicity was found in either study.
Excretion: Following intravenous dose of 1 mg in healthy volunteers, flutica-
sone propionate showed polyexponential kinetics and had an average terminal
Fluticasone propionate was not mutagenic in the standard Ames test, E. coli half-life of 7.2 hours (range, 3.2 to 11.2 hours).
fluctuation test, S. cerevisiae gene conversion test, or Chinese Hamster ovarian G & W Labs Fluticasone Propionate Cream Rev cell assay. It was not clastogenic in mouse micronucleus or cultured human INDICATIONS AND USAGE:
Fluticasone Propionate Cream is a medium potency corticosteroid indicated forthe relief of the inflammatory and pruritic manifestations of corticosteroid- In a fertility and general reproductive performance study in rats, fluticasone responsive dermatoses. Fluticasone Propionate Cream may be used with cau- propionate administered subcutaneously to females at up to 50 mcg/kg per tion in pediatric patients 3 months of age or older. The safety and efficacy of day and to males at up to 100 mcg/kg per day (later reduced to 50 mcg/kg drug use for longer than 4 weeks in this population have not been established. per day) had no effect upon mating performance or fertility. These doses are The safety and efficacy of Fluticasone Propionate Cream in pediatric patients approximately 15 and 30 times, respectively, the human systemic exposure below 3 months of age have not been established.
following use of the recommended human topical dose of fluticasone propi-onate cream, 0.05%, assuming human percutaneous absorption of approxi- CONTRAINDICATIONS:
mately 3% and the use in a 70-kg person of 15 g/day.
Fluticasone Propionate Cream is contraindicated in those patients with a historyof hypersensitivity to any of the components in the preparation.
Pregnancy: Teratogenic Effects: Pregnancy Category C. Corticosteroids
have been shown to be teratogenic in laboratory animals when administered
PRECAUTIONS:
systemically at relatively low dosage levels. Some corticosteroids have been General: Systemic absorption of topical corticosteroids can produce
shown to be teratogenic after dermal application in laboratory animals.
reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the Teratology studies in the mouse demonstrated fluticasone propionate to be potential for glucocorticosteroid insufficiency after withdrawal from treat- teratogenic (cleft palate) when administered subcutaneously in doses of ment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria 45 mcg/kg per day and 150 mcg/kg per day. This dose is approximately 14 can also be produced in some patients by systemic absorption of topical cor- and 45 times, respectively, the human topical dose of fluticasone propionate cream, 0.05%. There are no adequate and well-controlled studies in pregnant chronic plaque psoriasis following reduction or discontinuation of potent women. Fluticasone Propionate Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. OVERDOSAGE: Topically applied Fluticasone Propionate Cream can be absorbed
Nursing Mothers: Systemically administered corticosteroids appear in human
in sufficient amounts to produce systemic effects (see PRECAUTIONS).
milk and could suppress growth, interfere with endogenous corticosteroidproduction, or cause other untoward effects. It is not known whether topical DOSAGE AND ADMINISTRATION: Fluticasone Propionate Cream may be
administration of corticosteroids could result in sufficient systemic absorption used in adult and pediatric patients 3 months of age or older. Safety and effi- to produce detectable quantities in human milk. Because many drugs are cacy of Fluticasone Propionate Cream in pediatric patients for more than 4 excreted in human milk, caution should be exercised when Fluticasone weeks of use have not been established (see PRECAUTIONS: Pediatric Use).
Propionate Cream is administered to a nursing woman.
The safety and efficacy of Fluticasone Propionate Cream in pediatric patientsbelow 3 months of age have not been established.
Pediatric Use: Fluticasone Propionate Cream may be used with caution in
pediatric patients as young as 3 months of age. The safety and efficacy of Atopic Dermatitis: Apply a thin film of Fluticasone Propionate Cream to the
drug use for longer than 4 weeks in this population have not been estab- affected skin areas once or twice daily. Rub in gently.
lished. The safety and efficacy of Fluticasone Propionate Cream in pediatric patients below 3 months of age have not been established.
Other Corticosteroid-Responsive Dermatoses: Apply a thin film of Fluticasone
Propionate Cream to the affected skin areas twice daily. Rub in gently.
Fluticasone Propionate Cream, 0.05%, caused HPA axis suppression in 2 of43 pediatric patients, ages 2 and 5 years old, who were treated for 4 weeks As with other corticosteroids, therapy should be discontinued when control covering at least 35% of the body surface area. Follow-up testing 12 days is achieved. If no improvement is seen within 2 weeks, reassessment of diag- after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally responsive HPA axis (see ADVERSE REACTIONS). Adverse effectsincluding striae have been reported with use of topical corticosteroids in Fluticasone Propionate Cream should not be used with occlusive dressings.
Fluticasone Propionate Cream should not be applied in the diaper area, asdiapers or plastic pants may constitute occlusive dressings.
HPA axis suppression, Cushing's syndrome, linear growth retardation,delayed weight gain, and intracranial hypertension have been reported in Geriatric Use: In studies where geriatric patients (65 years of age or older,
pediatric patients receiving topical corticosteroids. Manifestations of adrenal see PRECAUTIONS) have been treated with Fluticasone Propionate Cream, suppression in pediatric patients include low plasma cortisol levels to an safety did not differ from that in younger patients; therefore, no dosage absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
CLINICAL STUDIES:
Geriatric Use: A limited number of patients above 65 years of age (n = 126)
Psoriasis Studies: In 2 vehicle-controlled studies, Fluticasone Propionate
have been treated with Fluticasone Propionate Cream in US and non-US Cream applied twice daily was significantly more effective than the vehicle in clinical trials. While the number of patients is too small to permit separate the treatment of moderate to severe psoriasis. The investigator’s global eval- analysis of efficacy and safety, the adverse reactions reported in this popu- uation after 28 days of treatment is shown in Table 3.
lation were similar to those reported by younger patients. Based on available data, no adjustment of dosage of Fluticasone Propionate in geriatric patients Table 3: Physician’s Assessment of Clinical Response
Fluticasone Propionate Cream Vehicle
ADVERSE REACTIONS:
In controlled clinical trials of twice-daily administration, the total incidence of adverse reactions associated with the use of Fluticasone Propionate Cream was approximately 4%. These adverse reactions were usually mild; self- limiting; and consisted primarily of pruritus, dryness, numbness of fingers, and burning. These events occurred in 2.9%, 1.2%, 1.0%, and 0.6% of Two clinical studies compared once- to twice-daily administration of Flutic-asone Propionate Cream for the treatment of moderate to severe eczema. Thelocal drug-related adverse events for the 491 patients enrolled in both studies The clinical signs of psoriasis were scored on a scale of 0 = absent, 1 = mild, are shown in Table 1. In the study enrolling both adult and pediatric patients, 2 = moderate, and 3 = severe. The mean improvements over baseline in the the incidence of local adverse events in the 119 pediatric patients ages 1 to clinical signs at the end of treatment are shown in Table 4.
12 years was comparable to the 140 patients ages 13 to 62 years.
Table 4: Clinical Signs: Mean Improvements Over Baseline
Fifty-one pediatric patients ages 3 months to 5 years, with moderate to severe Fluticasone Propionate Cream Vehicle
eczema, were enrolled in an open-label HPA axis safety study. FluticasonePropionate Cream was applied twice daily for 3 to 4 weeks over an arithmetic mean body surface area of 64% (range, 35% to 95%). The mean morning cortisol levels with standard deviations before treatment (prestimulation mean value = 13.76 ± 6.94 mcg/dL, poststimulation mean value = 30.53 ± 7.23 mcg/dL) and at end treatment (prestimulation mean value = 12.32 ±6.92 mcg/dL, poststimulation mean value = 28.84 ± 7.16 mcg/dL) showed Atopic Dermatitis Studies: In 2 controlled 28-day studies, Fluticasone
little change. In 2 of 43 (4.7%) patients with end-treatment results, peak Propionate Cream once daily was equivalent to Fluticasone Propionate Cream cortisol levels following cosyntropin stimulation testing were ≤ 18 µg/dL, twice daily in the treatment of moderate to severe eczema. The investigator’s indicating adrenal suppression. Follow-up testing after treatment discontinu- global evaluation after 28 days of treatment is shown in Table 5.
ation, available for 1 of the 2 subjects, demonstrated a normally responsiveHPA axis. Local drug-related adverse events were transient burning, resolving Table 5: Physician’s Assessment of Clinical Response
the same day it was reported; transient urticaria, resolving the same day itwas reported; erythematous rash; dusky erythema, resolving within 1 month Fluticasone Propionate
Fluticasone Propionate
after cessation of Fluticasone Propionate Cream; and telangiectasia, resolving Cream Once Daily
Cream Twice Daily
within 3 months after stopping Fluticasone Propionate Cream.
Table 1: Drug-Related Adverse Events — Skin
Fluticasone Fluticasone
Once Daily Twice Daily Twice Daily
Adverse Events (n = 210) (n = 203)
The clinical signs and symptoms of atopic dermatitis were scored on a scale of 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The mean improve- ments over baseline at the end of treatment are shown in Table 6.
Table 6: Clinical Signs and Symptoms: Mean Improvements Over Baseline
Fluticasone Propionate
Fluticasone Propionate
Cream Once Daily
Cream Twice Daily
Table 2: Adverse Events* From Pediatric Open-Label Trial (n = 51)
HOW SUPPLIED: Fluticasone Propionate Cream, 0.05% is supplied in:
Adverse Events
Fluticasone Twice Daily
G & W Labs Fluticasone Propionate Cream Rev Store between 2° and 30°C (36° and 86°F).
G&W Laboratories, Inc.
† n = 41The following local adverse reactions have been reported infrequently withtopical corticosteroids, and they may occur more frequently with the use ofocclusive dressings and higher potency corticosteroids. These reactions arelisted in an approximately decreasing order of occurrence: irritation, folli-culitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergiccontact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
Also, there are reports of the development of pustular psoriasis from

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