What Is Fluticasone Propionate Cream Used For

What is Cutivate and how is it used?

Cutivate is a prescription medicine used to care for the symptoms of Atopic Dermatitis and Corticosteriod-responsive Dermatoses. Cutivate may be used solitary or with other medications.

Cutivate belongs to a class of drugs chosen Corticosteroids, Topical.

It is not known if Cutivate is rubber and effective in children younger than 3 months of age.

What are the possible side effects of Cutivate?

Cutivate may cause serious side furnishings including:

hives,
difficulty breathing,
swelling of your face lips, tongue, or throat,
skin pain,
skin tenderness,
swelling,
wounds that volition not heal,
severe peel irritation subsequently using the medicine,
weight gain (particularly in your face, upper back and trunk),
thinning or discolored skin,
increased trunk pilus,
muscle weakness,
nausea,
diarrhea,
tiredness,
mood changes,
menstrual changes, and
sexual changes

Get medical help right away, if you lot have any of the symptoms listed above.

The most common side effects of Cutivate include:

skin redness,
itching,
rash,
burning or stinging of treated skin,
increased hair growth, and
lightheadedness

Tell the doctor if you take any side effect that bothers you or that does non go away. These are not all the possible side furnishings of Cutivate. For more information, ask your doctor or pharmacist. Call your doc for medical advice about side effects. Yous may study side effects to FDA at 1-800-FDA-1088.

Description

CUTIVATE® (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6α,11β,16α,17α)-6,ix,-difluoro-11-hydroxy-16-methyl-iii-oxo-17-(1-oxopropoxy)androsta-one,4-diene- 17-carbothioic acid, S-fluoromethyl ester], a constructed fluorinated corticosteroid, for topical dermatologic employ. The topical corticosteroids constitute a grade of primarily synthetic steroids used equally anti-inflammatory and antipruritic agents.

Chemically, fluticasone propionate is C₂₅H₃₁F₃O₅Due south. Information technology has the following structural formula:

CUTIVATE® (fluticasone propionate) Structural Formula Illustration

Fluticasone propionate has a molecular weight of 500.six. It is a white to off-white powder and is insoluble in water.

Each gram of CUTIVATE® Cream contains fluticasone propionate 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acrid, purified water, and imidurea equally preservative.

3 pharmacies most 11430 have coupons for Beser (Make Names:Cutivate Foam for 30GM of 0.05%)

INDICATIONS

CUTIVATE® Cream is a medium authority corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CUTIVATE® Cream may exist used with caution in pediatric patients 3 months of historic period or older. The safety and efficacy of drug utilize for longer than 4 weeks in this population accept non been established. The safety and efficacy of CUTIVATE® Cream in pediatric patients beneath 3 months of age have not been established.

DOSAGE AND Administration

CUTIVATE® Cream may be used in adult and pediatric patients 3 months of age or older. Rubber and efficacy of CUTIVATE® Cream in pediatric patients for more than iv weeks of use take not been established (see PRECAUTIONS: Pediatric Use). The safety and efficacy of CUTIVATE® Cream in pediatric patients below iii months of age take not been established.

Atopic Dermatitis

Apply a thin film of CUTIVATE® Cream to the affected skin areas once or twice daily. Rub in gently.

Other Corticosteroid-Responsive Dermatoses

Apply a thin motion picture of CUTIVATE® Cream to the affected skin areas twice daily. Rub in gently.

Equally with other corticosteroids, therapy should be discontinued when control is accomplished. If no comeback is seen within 2 weeks, reassessment of diagnosis may be necessary.

CUTIVATE® Foam should not be used with occlusive dressings. CUTIVATE® Cream should not exist practical in the diaper expanse, as diapers or plastic pants may plant occlusive dressings.

Geriatric Use

In studies where geriatric patients (65 years of age or older, meet PRECAUTIONS) have been treated with CUTIVATE® Cream, condom did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

HOW SUPPLIED

CUTIVATE® (fluticasone propionate cream) Cream 0.05% is supplied in:

30-thousand tubes (NDC 10337-332-thirty), and
60-one thousand tubes (NDC 10337-332-threescore).

Store betwixt 2° and thirty°C (36° and 86° F).

PharmaDerm®, A division of Fougera Pharmaceuticals Inc., Melville, NY 11747 United states of america. Revised: Jun 2012

QUESTION

Psoriasis causes the pinnacle layer of skin cells to go inflamed and grow too apace and fleck off. See Answer

Side Furnishings & Drug Interactions

SIDE EFFECTS

In controlled clinical trials of twice-daily administration, the full incidence of agin reactions associated with the utilise of CUTIVATE® Foam was approximately 4%. These agin reactions were usually mild; self-limiting; and consisted primarily of pruritus, dryness, numbness of fingers, and called-for. These events occurred in 2.9%, one.2%, 1.0%, and 0.6% of patients, respectively.

Two clinical studies compared once- to twice-daily administration of CUTIVATE® Foam for the handling of moderate to astringent eczema. The local drug-related adverse events for the 491 patients enrolled in both studies are shown in Tabular array one. In the study enrolling both adult and pediatric patients, the incidence of local agin events in the 119 pediatric patients ages ane to 12 years was comparable to the 140 patients ages 13 to 62 years.

Fifty-ane pediatric patients ages 3 months to 5 years, with moderate to severe eczema, were enrolled in an open-label HPA axis prophylactic written report. CUTIVATE® Cream was applied twice daily for 3 to four weeks over an arithmetic mean torso surface surface area of 64% (range, 35% to 95%). The hateful morning cortisol levels with standard deviations before treatment (prestimulation mean value = 13.76 ± 6.94 mcg/dL, poststimulation hateful value = 30.53 ± 7.23 mcg/dL) and at end treatment (prestimulation mean value = 12.32 ± vi.92 mcg/dL, poststimulation hateful value = 28.84 ± 7.16 mcg/dL) showed lilliputian change. In 2 of 43 (4.7%) patients with end-treatment results, peak cortisol levels following cosyntropin stimulation testing were ≤ 18 μg/dL, indicating adrenal suppression. Follow-up testing after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a unremarkably responsive HPA centrality. Local drug-related agin events were transient called-for, resolving the same twenty-four hours it was reported; transient urticaria, resolving the aforementioned mean solar day information technology was reported; erythematous rash; dusky erythema, resolving within 1 calendar month after cessation of CUTIVATE® Cream; and telangiectasia, resolving inside iii months after stopping CUTIVATE® Cream.

Table 1: Drug-Related Agin Events—Skin

Agin Events	Fluticasone Once Daily (n=210)	Fluticasone Twice Daily (n = 203)	Vehicle Twice Daily (due north = 78)
Skin infection	i (0.5%)	0	0
Infected eczema	1 (0.5%)	ii (i.0%)	0
Viral warts	0	ane (0.5%)	0
Herpes simplex	0	i (0.5%)	0
Impetigo	one (0.5%)	0	0
Atopic dermatitis	1 (0.5%)	0	0
Eczema	1 (0.5%)	0	0
Exacerbation of eczema	4 (i.ix%)	1 (0.5%)	1 (1.3%)
Erythema	0	two (1.0%)	0
Burning	2 (1.0%)	two (1.0%)	2 (2.vi%)
Stinging	0	ii (1.0%)	1 (one.3%)
Skin irritation	6 (2.9%)	2 (i.0%)	0
Pruritus	two (1.0%)	4 (1.nine%)	4 (five.one%)
Exacerbation of pruritus	4 (1.ix%)	i (0.5%)	one (1.three%)
Folliculitis	1 (0.5%)	1 (0.five%)	0
Blisters	0	1 (0.5%)	0
Dryness of skin	iii (one.four%)	1 (0.five%)	0

Tabular array 2: Adverse Events * From Pediatric Open up-Label Trial (due north = 51)

Agin Events	Fluticasone Twice Daily
Called-for	1 (2.0%)
Dusky erythema	1 (ii.0%)
Erythematous rash	ane (2.0%)
Facial telangiectasia†	two (4.9%)
Non-facial telangiectasia	1 (two.0%)
Urticaria	ane (two.0%)
*See text for additional item. †northward = 4 1.

The following local agin reactions accept been reported infrequently with topical corticosteroids, and they may occur more than frequently with the use of occlusive dressings and college potency corticosteroids. These reactions are listed in an approximately decreas ing order of occurrence: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, hypertrichosis and miliaria. Besides, at that place are reports of the evolution of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of strong topical corticosteroid products.

DRUG INTERACTIONS

No information provided.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

CUTIVATE® Cream contains the excipient imidurea which releases formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitization or irritation upon contact with the skin. CUTIVATE® Cream should non exist used in individuals with hypersensitivity to formaldehyde equally it may prevent healing or worsen dermatitis.

General

Systemic absorption of topical corticosteroids tin can produce reversible hypothalamic-pituitaryadrenal (HPA) centrality suppression with the potential for glucocorticosteroid insufficiency after withdrawal from handling. Manifestations of Cushing syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic assimilation of topical corticosteroids while on treatment.

Patients applying a potent topical steroid to a big surface area or to areas under occlusion should be evaluated periodically for prove of HPA centrality suppression. This may be washed by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.

If HPA centrality suppression is noted, an attempt should exist fabricated to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis role is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For data on systemic supplementation, see prescribing information for those products.

Fluticasone propionate cream, 0.05% caused depression of A.G. plasma cortisol levels in 1 of 6 adult patients when used daily for 7 days in patients with psoriasis or eczema involving at to the lowest degree 30% of the body surface. After two days of treatment, this patient developed a 60% decrease from pretreatment values in the A.M. plasma cortisol level.

There was some evidence of corresponding decrease in the 24-hour urinary gratis cortisol levels. The A.K. plasma cortisol level remained slightly depressed for 48 hours but recovered by day 6 of treatment.

Fluticasone propionate cream, 0.05%, acquired HPA axis suppression in 2 of 43 pediatric patients, ages 2 and v years old, who were treated for 4 weeks roofing at least 35% of the trunk area. Followup testing 12 days after treatment discontinuation, bachelor for 1 of the two subjects, demonstrated a commonly responsive HPA axis (see PRECAUTIONS: Pediatric Use).

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).

Fluticasone propionate cream, 0.05% may cause local cutaneous adverse reactions (run across ADVERSE REACTIONS).

Fluticasone propionate foam contains the excipient imidurea which releases traces of formaldehyde as a breakup product. Formaldehyde may crusade allergic sensitization or irritation upon contact with the pare.

If irritation develops, CUTIVATE® Foam should exist discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is unremarkably diagnosed past observing failure to heal rather than noting a clinical exacerbation as with almost topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant pare infections are present or develop, an appropriate antifungal or antibacterial agent should exist used. If a favorable response does not occur promptly, use of CUTIVATE® Foam should exist discontinued until the infection has been fairly controlled.

CUTIVATE® Foam should not be used in the presence of preexisting skin atrophy and should not be used where infection is present at the handling site. CUTIVATE® Cream should not exist used in the treatment of rosacea and perioral dermatitis.

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA centrality suppression:

ACTH stimulation examination
A.Thou. plasma cortisol test
Urinary complimentary cortisol examination

Carcinogenesis, Mutagenesis, And Impairment Of Fertility

Ii eighteen-month studies were performed in mice to evaluate the carcinogenic potential of fluticasone propionate when given topically (every bit an 0.05% ointment) and orally. No evidence of carcinogenicity was found in either report.

Fluticasone propionate was non mutagenic in the standard Ames test, E. coli fluctuation test, S. cerevisiae gene conversion exam, or Chinese Hamster ovarian cell analysis. It was not clastogenic in mouse micronucleus or cultured human lymphocyte tests.

In a fertility and general reproductive performance report in rats, fluticasone propionate administered subcutaneously to females at up to fifty mcg/kg per day and to males at upward to 100 mcg/kg per day (after reduced to 50 mcg/kg per day) had no effect upon mating performance or fertility. These doses are approximately 15 and xxx times, respectively, the human systemic exposure post-obit use of the recommended homo topical dose of fluticasone propionate cream, 0.05%, assuming human percutaneous absorption of approximately 3% and the apply in a 70-kg person of 15 thousand/twenty-four hours.

Pregnancy

Teratogenic Effects

Pregnancy Category C. Corticosteroids have been shown to exist teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to exist teratogenic after dermal application in laboratory animals. Teratology studies in the mouse demonstrated fluticasone propionate to be teratogenic (cleft palate) when administered subcutaneously in doses of 45 mcg/kg/twenty-four hours and 150 mcg/kg/day. This dose is approximately fourteen and 45 times, respectively, the human topical dose of fluticasone propionate cream, 0.05%. There are no adequate and well-controlled studies in pregnant women. CUTIVATE® Cream should exist used during pregnancy but if the potential benefit justifies the potential run a risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human being milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Information technology is not known whether topical administration of corticosteroids could upshot in sufficient systemic assimilation to produce detectable quantities in human milk. Because many drugs are excreted in human being milk, caution should be exercised when CUTIVATE® Foam is administered to a nursing woman.

Pediatric Use

CUTIVATE® Cream may be used with circumspection in pediatric patients as young equally 3 months of age. The safety and efficacy of drug use for longer than 4 weeks in this population have non been established. The prophylactic and efficacy of CUTIVATE® Foam in pediatric patients below three months of historic period have non been established.

Fluticasone propionate cream, 0.05%, caused HPA axis suppression in ii of 43 pediatric patients, ages 2 and 5 years old, who were treated for 4 weeks covering at least 35% of the body surface area. Followup testing 12 days after treatment discontinuation, available for 1 of the ii subjects, demonstrated a ordinarily responsive HPA axis (run across ADVERSE REACTIONS). Agin effects including striae have been reported with employ of topical corticosteroids in pediatric patients.

HPA axis suppression, Cushing syndrome, linear growth retardation, delayed weight proceeds, 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 absenteeism of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Employ

A limited number of patients above 65 years of age (n = 126) accept been treated with CUTIVATE® Cream in US and not-US clinical trials. While the number of patients is too small to allow separate analysis of efficacy and rubber, the adverse reactions reported in this population were similar to those reported past younger patients. Based on available data, no adjustment of dosage of CUTIVATE® in geriatric patients is warranted.

Overdosage & Contraindications

OVERDOSE

Topically practical CUTIVATE® Cream can be absorbed in sufficient amounts to produce systemic effects (run into PRECAUTIONS).

CONTRAINDICATIONS

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

CLINICAL PHARMACOLOGY

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 idea to deed past the induction of phospholipase A₂ inhibitory proteins, collectively chosen lipocortins. Information technology 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.

Fluticasone propionate is lipophilic and has a strong affinity for the glucocorticoid receptor. It has weak analogousness for the progesterone receptor, and virtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The therapeutic dominance of glucocorticoids is related to the one-half-life of the glucocorticoid-receptor circuitous. The one-half-life of the fluticasone propionate-glucocorticoid receptor circuitous is approximately 10 hours.

Studies performed with CUTIVATE® Foam indicate that information technology is in the medium range of potency as compared with other topical corticosteroids.

Pharmacokinetics

Assimilation

The activity of CUTIVATE® is due to the parent drug, fluticasone propionate. 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 exist absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increment percutaneous absorption.

In a human study of 12 good for you males receiving 12.five g of 0.05% fluticasone propionate cream twice daily for iii weeks, plasma levels were generally below the level of quantification (0.05 ng/mL). In another study of 6 good for you males administered 25 g of 0.05% fluticasone propionate cream under apoplexy for 5 days, plasma levels of fluticasone ranged from 0.07 to 0.39 ng/mL.

In an creature study using radiolabeled 0.05% fluticasone propionate cream and ointment preparations, rats received a topical dose of 1 g/kg for a 24-60 minutes period. Total recovery of radioactivity was approximately eighty% at the end of vii days. The bulk of the dose (73%) was recovered from the surface of the awarding site. Less than 1% of the dose was recovered in the skin at the application site. Approximately 5% of the dose was absorbed systemically through the skin. Absorption from the pare continued for the duration of the report (vii days), indicating a long retention time at the awarding site.

Distribution

Following intravenous administration of one 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 4.2 50/kg (range, ii.3 to xvi.7 L/kg). The percent of fluticasone propionate jump to human plasma proteins averaged 91%. Fluticasone propionate is weakly and reversibly jump to erythrocytes. Fluticasone propionate is not significantly jump to human transcortin.

Metabolism

No metabolites of fluticasone propionate were detected in an in vitro study of radiolabeled fluticasone propionate incubated in a homo pare homogenate. The total blood clearance of systemically captivated fluticasone propionate averages i,093 mL/min (range, 618 to ane,702 mL/min) later a ane-mg intravenous dose, with renal clearance accounting for less than 0.02% of the full. Fluticasone propionate is metabolized in the liver by cytochrome P450 3A4-mediated hydrolysis of the 5- fluoromethyl carbothioate group. This transformation occurs in 1 metabolic step to produce the inactive17-ÃŸ-carboxylic acid metabolite, the only known metabolite detected in man. This metabolite has approximately 2,000 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 being hepatoma cells accept not been detected in man.

Excretion

Following intravenous dose of 1 mg in good for you volunteers, fluticasone propionate showed polyexponential kinetics and had an boilerplate terminal one-half-life of 7.2 hours (range, three.2 to 11.ii hours).

Clinical Studies

Psoriasis Studies

In 2 vehicle-controlled studies, CUTIVATE® Foam applied twice daily was significantly more constructive than the vehicle in the treatment of moderate to severe psoriasis. The investigator's global evaluation after 28 days of treatment is shown in Table three.

Tabular array 3: Physician'south Assessment of Clinical Response

	CUTIVATE® Foam		Vehicle
	Written report 1 (n = 59)	Study 2 (n = 74)	Study i (n = 66)	Study 2 (northward = 75)
Cleared	8%	one%	3%	1%
Excellent	29%	28%	11%	17%
Good	27%	34%	20%	28%
Off-white	27%	15%	33%	25%
Poor	7%	22%	24%	27%
Worse	two%	0	9%	1%

The clinical signs of psoriasis were scored on a calibration of 0 = absent, i = mild, 2 = moderate, and 3 = astringent. The mean improvements over baseline in the clinical signs at the cease of treatment are shown in Table four.

Tabular array 4: Clinical Signs : Mean Improvements Over Baseline

	CUTIVATE® Foam		Vehicle
	Study ane	Written report ii	Report 1	Study two
Erythema	ane.19	1.07	0.55	0.84
Thickening	1.22	ane.17	0.81	0.97
Scaling	i.53	one.39	0.95	ane.21

Atopic Dermatitis Studies

In 2 controlled 28-mean solar day studies, CUTIVATE® Cream once daily was equivalent to CUTIVATE® Cream twice daily in the treatment of moderate to severe eczema. The investigator's global evaluation after 28 days of treatment is shown in Table five.

Table 5: Dr.'s Assessment of Clinical Response

	CUTIVATE® Cream One time Daily		CUTIVATE® Cream Twice Daily
	Study ane (northward = 64)	Report 2 (n = 106)	Written report i (n = 65)	Study 2 (northward = 100)
Cleared	30%	20%	48%	21%
Excellent	42%	32%	32%	fifty%
Proficient	17%	26%	five%	12%
Fair	3%	14%	6%	ten%
Poor	5%	three%	8%	four%
Worse	3%	6%	ii%	three%

The clinical signs and symptoms of atopic dermatitis were scored on a calibration of 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The mean improvements over baseline at the stop of handling are shown in Table 6.

Table half-dozen: Clinical Signs and Symptoms : Hateful Improvements Over Baseline

	CUTIVATE® Cream In one case Daily		CUTIVATE® Cream Twice Daily
	Study 1	Study 2	Study ane	Report ii
Erythema	ane.7	one.5	ane.eight	one.7
Pruritus	ii.1	one.vi	2.1	i.7
Thickening	i.6	1.iii	1.6	1.5
Lichenification	ane.2	1.2	1.2	1.3
Vesiculation	0.5	0.four	0.5	0.5
Crusting	0.6	0.7	0.8	0.8

PATIENT Information

Patients using topical corticosteroids should receive the following information and instructions:

This medication is to be used as directed past the md. It is for external use merely. Avoid contact with the eyes.
This medication should not be used for any disorder other than that for which it was prescribed.
The treated peel area should non be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
Patients should report to their medico whatever signs of local adverse reactions.
Parents of pediatric patients should exist advised not to use this medication in the treatment of diaper dermatitis. CUTIVATE® Cream should non be practical in the diaper areas as diapers or plastic pants may constitute occlusive dressing (see DOSAGE AND Administration).
This medication should not be used on the confront, underarms, or groin areas unless directed by a physician.
As with other corticosteroids, therapy should be discontinued when control is accomplished. If no improvement is seen within ii weeks, contact the physician.

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