Cutivate Cream (Fluticasone Propionate Cream)
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Cutivate Cream (Fluticasone Propionate Cream)

CUTIVATE®
(fluticasone propionate) Cream, 0.05%

For Dermatologic Use Only - Not for Ophthalmic Use.

DRUG DESCRIPTION

CUTIVATE® (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:

CUTIVATE® (fluticasone propionate) Structural Formula Illustration

Fluticasone propionate has a molecular weight of 500.6. 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 acid, purified water, and imidurea as preservative.

What are the possible side effects of fluticasone topical (Cutivate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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:

  • blurred vision, or seeing halos around lights;
  • headache, back ache, weakness,...

Read All Potential Side Effects and See Pictures of Cutivate Cream »

Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

CUTIVATE® (fluticasone propionate cream) Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CUTIVATE® (fluticasone propionate cream) Cream may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of CUTIVATE® (fluticasone propionate cream) Cream in pediatric patients below 3 months of age have not been established.

DOSAGE AND ADMINISTRATION

CUTIVATE® (fluticasone propionate cream) Cream may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of CUTIVATE® (fluticasone propionate cream) Cream in pediatric patients for more than 4 weeks of use have not been established (see PRECAUTIONS: Pediatric Use). The safety and efficacy of CUTIVATE® (fluticasone propionate cream) Cream in pediatric patients below 3 months of age have not been established.

Atopic Dermatitis: Apply a thin film of CUTIVATE® (fluticasone propionate cream) Cream to the affected skin areas once or twice daily. Rub in gently.

Other Corticosteroid-Responsive Dermatoses: Apply a thin film of CUTIVATE® (fluticasone propionate cream) Cream to the affected skin areas twice daily. Rub in gently.

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.

CUTIVATE® (fluticasone propionate cream) Cream should not be used with occlusive dressings. CUTIVATE® (fluticasone propionate cream) Cream should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with CUTIVATE® (fluticasone propionate cream) Cream, safety 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:

15-g tubes (NDC 0462-0332-15),
30-g tubes (NDC 0462-0332-30), and
60-g tubes (NDC 0462-0332-60).

Store between 2° and 30° C (36° and 86° F).

Revised: 09/2010. PharmaDerm®., A division of Nycomed US Inc. Melville, NY 11747 USA. www.pharmaderm.com.

Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Clinical Trial Experience

In controlled clinical trials of twice-daily administration, the total incidence of adverse reactions associated with the use of CUTIVATE® (fluticasone propionate cream) 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 patients, respectively.

Two clinical studies compared once- to twice-daily administration of CUTIVATE® (fluticasone propionate cream) Cream for the treatment of moderate to severe eczema. The local drug-related adverse events for the 491 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 119 pediatric patients ages 1 to 12 years was comparable to the 140 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. CUTIVATE® (fluticasone propionate cream) 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 little 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 normally responsive HPA axis. Local drug-related adverse events were transient burning, resolving the same day it was reported; transient urticaria, resolving the same day it was reported; erythematous rash; dusky erythema, resolving within 1 month after cessation of CUTIVATE® (fluticasone propionate cream) Cream; and telangiectasia, resolving within 3 months after stopping CUTIVATE® (fluticasone propionate cream) Cream.

Table 1: Drug-Related Adverse Events—Skin

Adverse Events Fluticasone
Once Daily
(n = 210)
Fluticasone
Twice Daily
(n = 203)
Vehicle
Twice Daily
(n = 78)
Skin infection 1 (0.5%) 0 0
Infected eczema 1 (0.5%) 2 (1.0%) 0
Viral warts 0 1 (0.5%) 0
Herpes simplex 0 1 (0.5%) 0
Impetigo 1 (0.5%) 0 0
Atopic dermatitis 1 (0.5%) 0 0
Eczema 1 (0.5%) 0 0
Exacerbation of 4 (1.9%) 1 (0.5%) 1 (1.3%)
eczema      
Erythema 0 2 (1.0%) 0
Burning 2 (1.0%) 2 (1.0%) 2 (2.6%)
Stinging 0 2 (1.0%) 1 (1.3%)
Skin irritation 6 (2.9%) 2 (1.0%) 0
Pruritus 2 (1.0%) 4 (1.9%) 4 (5.1%)
Exacerbation of      
pruritus 4 (1.9%) 1 (0.5%) 1 (1.3%)
Folliculitis 1 (0.5%) 1 (0.5%) 0
Blisters 0 1 (0.5%) 0
Dryness of skin 3 (1.4%) 1 (0.5%) 0

Table 2: Adverse Events* From Pediatric Open-Label Trial (n = 51)

Adverse Events Fluticasone Twice Daily
Burning 1 (2.0%)
Dusky erythema 1 (2.0%)
Erythematous rash 1 (2.0%)
Facial telangiectasia† 2 (4.9%)
Non-facial telangiectasia 1 (2.0%)
Urticaria 1 (2.0%)
*See text for additional detail.
† n = 41.

Post Marketing Experience

Systemic adverse events with CUTIVATE® (fluticasone propionate cream) Cream and CUTIVATE® (fluticasone propionate cream) Ointment have included: immunosuppression/Pneumocystis carinii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/ glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling).

The following localized adverse reactions have been reported during post approval use of CUTIVATE® (fluticasone propionate cream) Cream: skin discoloration, erythema, irritation, edema/swelling, atrophy, contusion, dermatitis, pain, sepsis, hemorrhage, acneiform eruptions.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the Cutivate Cream (fluticasone propionate cream) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

No information provided.

PRECAUTIONS

CUTIVATE® (fluticasone propionate cream) 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® (fluticasone propionate cream) Cream should not be used in individuals with hypersensitivity to formaldehyde as it may prevent healing or worsen dermatitis.

General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (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. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.

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.

CUTIVATE Cream (fluticasone propionate cream) , 0.05% caused depression of A.M. plasma cortisol levels in 1 of 6 adult patients when used daily for 7 days in patients with psoriasis or eczema involving at least 30% of the body surface. After 2 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 free cortisol levels. The A.M. plasma cortisol level remained slightly depressed for 48 hours but recovered by day 6 of treatment.

CUTIVATE Cream (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 weeks covering at least 35% of the body surface area. Follow-up testing 12 days after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally 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).

The following local adverse reactions have been reported 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 decreasing order of occurrence: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, hypertrichosis, and miliaria.

CUTIVATE Cream (fluticasone propionate cream) , 0.05% may cause local cutaneous adverse reactions (see ADVERSE REACTIONS).

If irritation develops, CUTIVATE® (fluticasone propionate cream) Cream 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 CUTIVATE® (fluticasone propionate cream) Cream should be discontinued until the infection has been adequately controlled.

CUTIVATE® (fluticasone propionate cream) Cream should not be used in the presence of preexisting skin atrophy and should not be used where infection is present at the treatment site. CUTIVATE® (fluticasone propionate cream) Cream should not be used in the treatment of rosacea and perioral dermatitis.

Laboratory Tests

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

ACTH stimulation test
A.M. plasma cortisol test
Urinary free cortisol test

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Two 18-month studies were performed in mice to evaluate the carcinogenic potential of fluticasone propionate when given topically (as an 0.05% ointment) and orally. No evidence of carcinogenicity was found in either study.

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

In a fertility and general reproductive performance study in rats, fluticasone propionate administered subcutaneously to females at up to 50 mcg/kg per day and to males at up to 100 mcg/kg per day (later reduced to 50 mcg/kg per day) had no effect upon mating performance or fertility. 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, 0.05%, assuming human percutaneous absorption of approximately 3% and the use in a 70-kg person of 15 g/day.

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. Teratology studies in the mouse demonstrated fluticasone propionate to be teratogenic (cleft palate) when administered subcutaneously in doses of 45 mcg/kg/day and 150 mcg/kg/day. This dose is approximately 14 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® (fluticasone propionate cream) Cream 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 CUTIVATE® (fluticasone propionate cream) Cream is administered to a nursing woman.

Pediatric Use

CUTIVATE® (fluticasone propionate cream) 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® (fluticasone propionate cream) Lotion should not be used in individuals with hypersensitivity to formaldehyde as it may prevent healing or worsen dermatitis.

CUTIVATE® (fluticasone propionate cream) Cream should be discontinued if control is achieved before 4 weeks. If no improvement is seen within 2 weeks, contact a physician. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established.

The safety and efficacy of CUTIVATE® (fluticasone propionate cream) Cream in pediatric patients below 3 months of age have not been established.

Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis unless directed by the physician. CUTIVATE® (fluticasone propionate cream) Lotion should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressing.

CUTIVATE Cream (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 weeks covering at least 35% of the body surface area. Follow-up testing 12 days after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally responsive HPA axis (see ADVERSE REACTIONS). 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. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Geriatric Use

A limited number of patients above 65 years of age (n = 126) have been treated with CUTIVATE® (fluticasone propionate cream) Cream in US and non-US clinical trials. 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. Based on available data, no adjustment of dosage of CUTIVATE® in geriatric patients is warranted.

Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Topically applied CUTIVATE® (fluticasone propionate cream) Cream can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

CONTRAINDICATIONS

CUTIVATE® (fluticasone propionate cream) Cream is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation (see PRECAUTIONS).

Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.

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 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.

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.

Studies performed with CUTIVATE® (fluticasone propionate cream) Cream indicate that it is in the medium range of potency as compared with other topical corticosteroids.

Pharmacokinetics

Absorption

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 be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

In a human study of 12 healthy males receiving 12.5 g of 0.05% fluticasone propionate cream twice daily for 3 weeks, plasma levels were generally below the level of quantification (0.05 ng/mL). In another study of 6 healthy males administered 25 g of 0.05% fluticasone propionate cream under occlusion for 5 days, plasma levels of fluticasone ranged from 0.07 to 0.39 ng/mL.

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-hour period. Total recovery of radioactivity was approximately 80% at the end of 7 days. The majority of the dose (73%) was recovered from the surface of the application 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 skin continued for the duration of the study (7 days), indicating a long retention time at the application site.

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. The apparent volume of distribution averaged 4.2 L/kg (range, 2.3 to 16.7 L/kg). The percentage of fluticasone propionate bound to human plasma proteins averaged 91%. Fluticasone propionate is weakly and reversibly bound to erythrocytes. Fluticasone propionate is not significantly bound to human transcortin.

Metabolism

No metabolites of fluticasone propionate were detected in an in vitro study of radiolabeled fluticasone propionate incubated in a human skin 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 cytochrome P450 3A4mediated hydrolysis of the 5-fluoromethyl carbothioate grouping. This transformation occurs in 1 metabolic step to produce the inactive17-B-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 hepatoma cells have not been detected in man.

Excretion

Following intravenous dose of 1 mg in healthy volunteers, fluticasone propionate showed polyexponential kinetics and had an average terminal half-life of 7.2 hours (range, 3.2 to 11.2 hours).

Clinical Studies

Psoriasis Studies: In 2 vehicle-controlled studies, CUTIVATE® (fluticasone propionate cream) Cream applied twice daily was significantly more effective 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 3.

Table 3: Physician's Assessment of Clinical Response

  CUTIVATE® Cream Vehicle
Study 1
(n = 59)
Study 2
(n = 74)
Study 1
(n = 66)
Study 2
(n = 75)
Cleared 8% 1% 3% 1%
Excellent 29% 28% 11% 17%
Good 27% 34% 20% 28%
Fair 27% 15% 33% 25%
Poor 7% 22% 24% 27%
Worse 2% 0 9% 1%

The clinical signs of psoriasis were scored on a scale of 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The mean improvements over baseline in the clinical signs at the end of treatment are shown in Table 4.

Table 4: Clinical Signs: Mean Improvements Over Baseline

  CUTIVATE®Cream Vehicle
Study 1 Study 2 Study 1 Study 2
Erythema 1.19 1.07 0.55 0.84
Thickening 1.22 1.17 0.81 0.97
Scaling 1.53 1.39 0.95 1.21

Atopic Dermatitis Studies: In 2 controlled 28-day studies, CUTIVATE® (fluticasone propionate cream) Cream once daily was equivalent to CUTIVATE Cream (fluticasone propionate 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 5.

Table 5: Physician's Assessment of Clinical Response

  CUTIVATECream
Once Daily
CUTIVATE®Cream
Twice Daily
Study 1
(n = 64)
Study 2
(n = 106)
Study 1
(n = 65)
Study 2
(n = 100)
Cleared 30% 20% 48% 21%
Excellent 42% 32% 32% 50%
Good 17% 26% 5% 12%
Fair 3% 14% 6% 10%
Poor 5% 3% 8% 4%
Worse 3% 6% 2% 3%

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 improvements over baseline at the end of treatment are shown in Table 6.

Table 6: Clinical Signs and Symptoms: Mean Improvements Over Baseline

  CUTIVATE®Cream
Once Daily
CUTIVATE® Cream
Twice Daily
Study 1 Study 2 Study 1 Study 2
Erythema 1.7 1.5 1.8 1.7
Pruritus 2.1 1.6 2.1 1.7
Thickening 1.6 1.3 1.6 1.5
Lichenification 1.2 1.2 1.2 1.3
Vesiculation 0.5 0.4 0.5 0.5
Crusting 0.6 0.7 0.8 0.8

Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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

  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2. This medication should not be used for any disorder other than that for which it was prescribed.
  3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
  4. Patients should report to their physician any signs of local adverse reactions as well as non-healing or worsening of skin condition.
  5. Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis. CUTIVATE® (fluticasone propionate cream) Cream should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressing (see DOSAGE AND ADMINISTRATION).
  6. This medication should not be used on the face, underarms, or groin areas unless directed by a physician.
  7. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
  8. Patients should report to their physician if they are allergic to formaldehyde.

Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

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

  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2. This medication should not be used for any disorder other than that for which it was prescribed.
  3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
  4. Patients should report to their physician any signs of local adverse reactions as well as non-healing or worsening of skin condition.
  5. Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis. CUTIVATE® (fluticasone propionate cream) Cream should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressing (see DOSAGE AND ADMINISTRATION).
  6. This medication should not be used on the face, underarms, or groin areas unless directed by a physician.
  7. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
  8. Patients should report to their physician if they are allergic to formaldehyde.

Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.

CUTIVATE®
(fluticasone propionate) Cream, 0.05%

For Dermatologic Use Only - Not for Ophthalmic Use.

DRUG DESCRIPTION

CUTIVATE® (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:

CUTIVATE® (fluticasone propionate) Structural Formula Illustration

Fluticasone propionate has a molecular weight of 500.6. 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 acid, purified water, and imidurea as preservative.

Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.

CUTIVATE®
(fluticasone propionate) Cream, 0.05%

For Dermatologic Use Only - Not for Ophthalmic Use.

DRUG DESCRIPTION

CUTIVATE® (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:

CUTIVATE® (fluticasone propionate) Structural Formula Illustration

Fluticasone propionate has a molecular weight of 500.6. 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 acid, purified water, and imidurea as preservative.

Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.

CUTIVATE®
(fluticasone propionate) Cream, 0.05%

For Dermatologic Use Only - Not for Ophthalmic Use.

DRUG DESCRIPTION

CUTIVATE® (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:

CUTIVATE® (fluticasone propionate) Structural Formula Illustration

Fluticasone propionate has a molecular weight of 500.6. 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 acid, purified water, and imidurea as preservative.

Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.

Cutivate Cream Patient Information Including Side Effects

Brand Names: Cutivate

Generic Name: fluticasone topical (Pronunciation: floo TIK a sone TOP i kal)

What is fluticasone topical (Cutivate Cream)?

Fluticasone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Fluticasone topical (for the skin) is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Fluticasone topical should not be used to treat rosacea, severe acne, or viral skin infections such as chickenpox or herpes.

Fluticasone topical may also be used for purposes not listed in this medication guide.

What are the possible side effects of fluticasone topical (Cutivate Cream)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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:

  • blurred vision, or seeing halos around lights;
  • headache, back ache, weakness, confusion, mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face;
  • muscle weakness, feeling tired; or
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Less serious side effects may include:

  • mild skin itching, burning, peeling, or dryness;
  • changes in color of treated skin;
  • thinning or softening of your skin;
  • skin rash or irritation around your mouth;
  • redness or crusting around your hair follicles;
  • blisters, pimples, or crusting of treated skin; or
  • stretch marks.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Cutivate Cream (fluticasone propionate cream) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about fluticasone topical (Cutivate Cream)?

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body. Do not use fluticasone topical in larger amounts, or for longer than recommended by your doctor. Do not apply to your face, underarms, or groin area unless your doctor tells you to.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with fluticasone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

Do not use this medication on a child without medical advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use.

Do not use fluticasone topical for longer than 2 weeks. Talk with your doctor if your symptoms do not improve, or if you develop signs of a bacterial, fungal, or viral skin infection.

Cutivate Cream Patient Information including How Should I Take

What should I discuss with my healthcare provider before using fluticasone topical (Cutivate Cream)?

You should not use this medication if you are allergic to fluticasone or formaldehyde.

To make sure you can safely use fluticasone topical, tell your doctor if you have any type of skin infection.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

FDA pregnancy category C. It is not known whether fluticasone topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether fluticasone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on a child without medical advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I use fluticasone topical (Cutivate Cream)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Wash your hands before and after using fluticasone topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount to the affected area and rub it gently into the skin. Do not apply the medication over a large area of skin, or use it long-term on the face. Do not use fluticasone topical on broken or infected skin. Also avoid using this medication in open wounds.

If you are treating your scalp, part the hair and apply the medicine directly to the scalp, rubbing in gently. Avoid washing or rubbing the treated scalp area right away. Wait until the medicine has dried thoroughly.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with fluticasone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

Do not use fluticasone topical for longer than 2 weeks without your doctor's advice. Talk with your doctor if your symptoms do not improve, or if you develop signs of a bacterial, fungal, or viral skin infection.

If you use this medication long-term, your blood may need to be tested. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using fluticasone topical.

Store at room temperature away from moisture, heat, and light. Do not freeze. Keep the tube or bottle tightly closed when not in use.

Cutivate Cream Patient Information including If I Miss a Dose

What happens if I miss a dose (Cutivate Cream)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Cutivate Cream)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of fluticasone topical is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using fluticasone topical (Cutivate Cream)?

Do not use fluticasone topical to treat any skin condition that has not been checked by your doctor.

Do not use this medication to treat skin conditions around your mouth, rectum, or genital areas. Do not apply to your face, underarms, or groin area unless your doctor tells you to.

Avoid getting this medication in your eyes. If this does happen, rinse with water.

Avoid using other steroid medications on the areas you treat with fluticasone topical unless you doctor tells you to.

What other drugs will affect fluticasone topical (Cutivate Cream)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluticasone topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about fluticasone topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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