Cutivate Lotion (Fluticasone Propionate Lotion)
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Cutivate Lotion (Fluticasone Propionate Lotion)

CUTIVATE
(fluticasone propionate) Lotion

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.

DRUG DESCRIPTION

CUTIVATE® (fluticasone propionate) Lotion, 0.05% contains fluticasone propionate [S(fluoromethyl)6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17βcarbothioate, 17-propionate], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as antiinflammatory and antipruritic agents.

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

CUTIVATE (fluticasone propionate) Structural Formula Illustration

Fluticasone propionate is a white to off-white powder with a molecular weight of 500.6. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.

Each gram of CUTIVATE® Lotion contains 0.5mg fluticasone propionate in a base of cetostearyl alcohol, isopropyl myristate, propylene glycol, cetomacrogol 1000, dimethicone 360, citric acid, sodium citrate, and purified water, with imidurea, methylparaben, and propylparaben as preservatives.

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 Lotion »

Last reviewed on RxList: 6/16/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

CUTIVATE® (fluticasone propionate) Lotion is indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 1 year 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® Lotion in pediatric patients below 1 year of age have not been established.

DOSAGE AND ADMINISTRATION

CUTIVATE® Lotion may be used in adult and pediatric patients 1 year of age or older. The safety and efficacy of CUTIVATE® Lotion in pediatric patients below 1 year of age have not been established (see PRECAUTIONS: Pediatric Use).

Atopic Dermatitis

Apply a thin film of CUTIVATE® Lotion to the affected skin areas once 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. The safety and efficacy of drug use for longer than 4 weeks have not been established.

CUTIVATE® Lotion should not be used with occlusive dressings or applied in the diaper area unless directed by a physician.

HOW SUPPLIED

CUTIVATE® Lotion is supplied in

60 mL bottle NDC 0462-0434-60

Store between 15° and 30°C (59° and 86°F).

Do not refrigerate.

Keep container tightly sealed.

Revised: 05/2011. PharmaDerm®, A division of Nycomed US Inc. Melville, NY 11747 USA

Last reviewed on RxList: 6/16/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Clinical Trial Experience

In 2 multicenter vehicle-controlled clinical trials of once-daily application of CUTIVATE® Lotion by 196 adult and 242 pediatric patients, the total incidence of adverse reactions considered drug related by investigators was approximately 4%. Events were local cutaneous events, usually mild and self-limiting, and consisted primarily of burning/stinging (2%). All other drug-related events occurred with an incidence of less than 1%, and inclusively were contact dermatitis, exacerbation of atopic dermatitis, folliculitis of legs, pruritus, pustules on arm, rash, and skin infection.

The incidence of drug-related events on drug compared to vehicle (4% and 5%, respectively) was similar. The incidence of drug-related events between study populations of 242 pediatric patients (age 3 months to < 17 years) and 196 adult patients (17 years or older) (4% and 5%, respectively) was also similar.

In an open-label study of 44 pediatric patients applying CUTIVATE® Lotion to at least 35% of body surface area twice daily for 3 or 4 weeks, the overall incidence of drug-related adverse events was 14%. Events were local, cutaneous, and inclusively were dry skin (7%), stinging at application site (5%), and excoriation (2%).

Table 2: Drug Related Adverse Events from Controlled Clinical Trials (n=438)

Adverse Events CUTIVATE® Lotion
N=221
Vehicle
N=217
Burning/Stinging skin 4 (2%) 3 (1%)
Contact Dermatitis 0 1 ( < 1%)
Exacerbation of Atopic dermatitis 0 1 ( < 1%)
Folliculitis of legs 2 ( < 1%) 0
Irritant Contact Dermatitis 0 1 ( < 1%)
Pruritus 1 ( < 1%) 1 ( < 1%)
Pustules on Arms 1 ( < 1%) 0
Rash 1 ( < 1%) 2 ( < 1%)
Skin Infection 0 3 (1%)

Table 3: Drug Related Adverse Events From Pediatric Open Label Trial (n=44)

Adverse Events CUTIVATE® Lotion Twice Daily
Dry skin at multiple sites 3 (7%)
Stinging at Application Sites 2 (5%)
Excoriation 1 (2%)

The table below summarizes all adverse events by body system that occurred in at least 1% of patients in either the drug or vehicle group in controlled clinical trials.

Table 4: Adverse Events Occurring in ≥ 1% of Patients from Either Arm from Controlled Clinical Trials (n=438)

Body System CUTIVATE®Lotion
N = 221
Vehicle Lotion
N = 217
Any Adverse Event 77 (35%) 82 (38%)
Skin
  Burning and Stinging 4 (2%) 3 (1%)
  Pruritus 3 (1%) 5 (2%)
  Rash 2 (<1%) 3 (1%)
  Skin Infection 0 3 (1%)
Ear, Nose, Throat
  Common Cold 9 (4%) 5 (2%)
  Ear Infection 3 (1%) 3 (1%)
  Nasal Sinus Infection 2 (<1%) 4 (2%)
  Rhinitis 1 (<1%) 3 (1%)
  Upper Respiratory Tract Infection 6 (3%) 7 (3%)
Gastrointestinal
  Normal Tooth Eruption 2 (< 1%) 3 (1%)
  Diarrhea 3 (1%) 0
  Vomiting 3 (1%) 2 (<1%)
Lower Respiratory
  Cough 7 (3%) 6 (3%)
  Influenza 5 (2%) 0
  Wheeze 0 3 (1%)
Neurology
  Headache 4 (2%) 5 (2%)
Non-Site Specific
  Fever 8 (4%) 8 (4%)
  Seasonal Allergy 2 ( < 1%) 3 (1%)

During the clinical trials, eczema herpeticum occurred in a 33-year-old male patient treated with CUTIVATE® Lotion. Additionally, a 4-month-old patient treated with CUTIVATE® Lotion in the open-label trial had marked elevations of the hepatic enzymes AST and ALT.

Post Marketing Experience

Systemic adverse events with CUTIVATE® Cream and CUTIVATE® 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® Lotion: erythema, edema/swelling, bleeding, and a reported lack of efficacy.

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 Lotion (fluticasone propionate lotion) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 6/16/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

No information provided

PRECAUTIONS

CUTIVATE® Lotion contains the excipient imidurea which releases formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitization or irritation upon contact with the skin. CUTIVATE® Lotion 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's 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 cosyntropin (ACTH1·24) stimulation testing.

Forty-two pediatric patients (4 months to < 6 years of age) with moderate to severe atopic eczema who were treated with CUTIVATE® Lotion for at least 3-4 weeks were assessed for HPA axis suppression and 40 of these subjects applied at least 90% of applications. None of the 40 evaluable patients suppressed, where the sole criterion for HPA axis suppression is a plasma cortisol level of less than or equal to 18 micrograms per deciliter after cosyntropin stimulation. Although HPA axis suppression was observed in 0 of 40 pediatric patients (upper 95% confidence bound is 7.2%), the occurrence of HPA axis suppression in any patient and especially with longer use cannot be ruled out. In other studies with fluticasone propionate topical formulations, adrenal suppression has been observed.

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.

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 Lotion, 0.05% may cause local cutaneous adverse reactions (see ADVERSE REACTIONS).

If irritation develops, CUTIVATE® Lotion 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® Lotion should be discontinued until the infection has been adequately controlled.

CUTIVATE® Lotion 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® Lotion should not be used in the treatment of rosacea and perioral dermatitis.

Patients that apply CUTIVATE® Lotion to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).

Laboratory Tests

The cosyntropin (ACTH1·24) stimulation test may be helpful in evaluating patients for HPA axis suppression.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

In an oral (gavage) mouse carcinogenicity study, doses of 0.1, 0.3 and 1 mg/kg/day fluticasone propionate were administered to mice for 18 months. Fluticasone propionate demonstrated no tumorigenic potential at oral doses up to 1 mg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study.

In a dermal mouse carcinogenicity study, 0.05% fluticasone propionate ointment (40 μl) was topically administered for 1, 3 or 7 days/week for 80 weeks. Fluticasone propionate demonstrated no tumorigenic potential at dermal doses up to 6.7 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study.

In a 52 week dermal photo-carcinogenicity study conducted in hairless albino mice with concurrent exposure to low level ultraviolet radiation (40 weeks of treatment followed by 12 weeks of observation), topically treated lotion vehicle animals and 0.05% fluticasone propionate lotion animals demonstrated shorter time to benign skin tumor formation compared to untreated control animals. Lotion vehicle treated animals developed benign skin tumors in a shorter time than 0.05% fluticasone propionate lotion treated animals. Although applicability of results to clinical use of CUTIVATE® Lotion in humans is unknown, and enhanced tumor growth in patients treated with CUTIVATE® Lotion has not been reported, patients should exercise general precautions in minimizing UV light exposure by avoiding excessive or unnecessary exposure to either natural or artificial sunlight (including sunbathing, tanning booths, sun lamps, etc.)

Fluticasone propionate revealed no evidence of mutagenic or clastogenic potential based on the results of five in vitro genotoxicity tests (Ames assay, E. coli fluctuation test, S. cerevisiae gene conversion test, Chinese hamster ovary cell chromosome aberration assay and human lymphocyte chromosome aberration assay) and one in vivo genotoxicity test (mouse micronucleus assay).

No evidence of impairment of fertility or effect on mating performance was observed in a fertility and general reproductive performance study conducted in male and female rats at subcutaneous doses up to 50 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).

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.

Systemic embryofetal development studies were conducted in mice, rats and rabbits. Subcutaneous doses of 15, 45 and 150 μg/kg/day of fluticasone propionate were administered to pregnant female mice from gestation days 6 – 15. A teratogenic effect characteristic of corticosteroids (cleft palate) was noted after administration of 45 and 150 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 15 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).

Subcutaneous doses of 10, 30 and 100 μg/kg/day of fluticasone propionate were administered to pregnant female rats in two embryofetal development studies (one study administered fluticasone propionate from gestation days 6 – 15 and the other study from gestation days 7 – 17). In the presence of maternal toxicity, fetal effects noted at 100 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) included decreased fetal weights, omphalocele, cleft palate, and retarded skeletal ossification. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 10 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).

Subcutaneous doses of 0.08, 0.57 and 4 μg/kg/day of fluticasone propionate were administered to pregnant female rabbits from gestation days 6 – 18. Fetal effects noted at 4 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) included decreased fetal weights, cleft palate and retarded skeletal ossification. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 0.57 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).

Oral doses of 3, 30 and 300 μg/kg/day fluticasone propionate were administered to pregnant female rabbits from gestation days 8 – 20. No fetal or teratogenic effects were noted at oral doses up to 300 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study. However, no fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration (see CLINICAL PHARMACOLOGY).

Fluticasone propionate crossed the placenta following administration of a subcutaneous or an oral dose of 100 μg/kg tritiated fluticasone propionate to pregnant rats.

There are no adequate and well-controlled studies in pregnant women. During clinical trials of CUTIVATE® Lotion, women of childbearing potential were required to use contraception to avoid pregnancy. Therefore, CUTIVATE® Lotion 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® Lotion is administered to a nursing woman.

Pediatric Use

CUTIVATE® Lotion contains the excipient imidurea which releases formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitization or irritation upon contact with the skin. CUTIVATE® Lotion should not be used in individuals with hypersensitivity to formaldehyde as it may prevent healing or worsen dermatitis.

CUTIVATE® Lotion should be discontinued if control is achieved before 4 weeks. If no improvement is seen within 2 weeks, contact a physician. The safety of the use of CUTIVATE® Lotion for longer than 4 weeks has not been established.

The safety and efficacy of CUTIVATE® Lotion in pediatric patients below 1 year 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® Lotion should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressing.

Forty-two pediatric patients (4 months to < 6 years of age) with moderate to severe atopic eczema who were treated with CUTIVATE® Lotion for at least 3-4 weeks were assessed for HPA axis suppression and 40 of these subjects applied at least 90% of applications. None of the 40 evaluable patients suppressed, where the sole criterion for HPA axis suppression is a plasma cortisol level of less than or equal to 18 micrograms per deciliter after cosyntropin stimulation. Although HPA axis suppression was observed in 0 of 40 pediatric patients (upper 95% confidence bound is 7.2%), the occurrence of HPA axis suppression in any patient and especially with longer use cannot be ruled out.

In other studies with fluticasone propionate topical formulations, adrenal suppression has been observed. CUTIVATE® (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 patients, demonstrated a normally responsive HPA axis.

HPA axis suppression, Cushing's 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 corticosterois 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.

In addition, local adverse events including cutaneous atrophy, striae, telangiectasia, and pigmentation change have been reported with topical use of corticosteroids in pediatric patients.

Geriatric Use

A limited number of patients above 65 years of age have been treated with CUTIVATE® Lotion in US and non-US clinical trials. Specifically only 8 patients above 65 years of age were treated with CUTIVATE® Lotion in controlled clinical trials. The number of patients is too small to permit separate analyses of efficacy and safety.

Last reviewed on RxList: 6/16/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Topically applied CUTIVATE® Lotion can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

CONTRAINDICATIONS

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

Last reviewed on RxList: 6/16/2011
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.

Although fluticasone propionate has a weak affinity for the progesterone receptor and virtually no affinity for the mineralocorticoid, estrogen or androgen receptors, the clinical relevance as related to safety is unknown. Fluticasone propionate is lipophilic and has strong affinity for the glucocorticoid receptor. 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.

Pharmacokinetics

Absorption

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.

Distribution

Following intravenous administration of 1 mg of 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 1093 mL/min (range, 618 to 1702 mL/min) after a 1-mg intravenous dose, with renal clearance accounting for less than 0.02% of the total.

Orally absorbed fluticasone propionate has demonstrated extensive first-pass metabolism with no unchanged drug detected in the plasma up to 6 hours after dosing. Fluticasone propionate is metabolized in the liver by cytochrome P450 3A4-mediated hydrolysis of the 5-fluoromethyl carbothiolate grouping. This transformation occurs in 1 metabolic step to produce the inactive 17β-carboxylic acid metabolite, the only known metabolite detected in man. This metabolite has approximately 2000 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 an 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).

Special Population (Pediatric)

Plasma fluticasone levels were measured in patients 2 years - 6 years of age in an HPA axis suppression study. A total of 13 (62%) of 21 patients tested had measurable fluticasone at the end of 3 - 4 weeks of treatment. The mean ± SD fluticasone plasma values for patients aged under 3 years was 47.7 ± 31.7 pg/mL and 175.5 ± 243.6 pg/mL. Three patients had fluticasone levels over 300 pg/mL, with one of these having a level of 819.81 pg/mL. No data was obtained for patients < 2 years of age.

Clinical Studies

CUTIVATE® Lotion applied once daily was superior to vehicle in the treatment of atopic dermatitis in two studies. The two studies enrolled 438 patients with atopic dermatitis aged 3 months and older, of which 169 patients were selected as having clinically significant* signs of erythema, infiltration/papulation and erosion/oozing/crusting at baseline. Table 1 presents the percentage of patients who completely cleared of erythema, infiltration/papulation and erosion/oozing/crusting at Week 4 out of those patients with clinically significant baseline signs.

Table 1: Complete Clearance Rate CUTIVATE® Lotion Vehicle

  CUTIVATE® Lotion Vehicle
Study 1 9/45 (20%) 0/37 (0%)
Study 2 7/44 (16%) 1/43 (2%)
*Clinically significant was defined as having moderate or severe involvement for at least two of the three signs (erythema, infiltration/papulation, or erosion/oozing/crusting) in at least 2 body regions. Patients who had moderate to severe disease in a single body region were excluded from the analysis.

Last reviewed on RxList: 6/16/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients using CUTIVATE® Lotion should receive the following information and instructions:

  1. CUTIVATE® Lotion is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2. CUTIVATE® Lotion 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 unless directed by the physician. CUTIVATE® Lotion should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressing (see DOSAGE AND ADMINISTRATION).
  6. CUTIVATE® Lotion should not be used on the face, underarms, or groin areas unless directed by a physician.
  7. CUTIVATE® Lotion therapy should be discontinued if control is achieved before 4 weeks. If no improvement is seen within 2 weeks, contact a physician. The safety of the use of CUTIVATE® Lotion for longer than 4 weeks has not been established.
  8. Patients should report to their physician if they are allergic to formaldehyde.
  9. Patients that apply CUTIVATE® Lotion to exposed portions of the body should follow physician advice and routine precautions to avoid excessive or unnecessary exposure to either natural or artificial sunlight (such as sunbathing, tanning booths, sun lamps, etc.).

Last reviewed on RxList: 6/16/2011
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients using CUTIVATE® Lotion should receive the following information and instructions:

  1. CUTIVATE® Lotion is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2. CUTIVATE® Lotion 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 unless directed by the physician. CUTIVATE® Lotion should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressing (see DOSAGE AND ADMINISTRATION).
  6. CUTIVATE® Lotion should not be used on the face, underarms, or groin areas unless directed by a physician.
  7. CUTIVATE® Lotion therapy should be discontinued if control is achieved before 4 weeks. If no improvement is seen within 2 weeks, contact a physician. The safety of the use of CUTIVATE® Lotion for longer than 4 weeks has not been established.
  8. Patients should report to their physician if they are allergic to formaldehyde.
  9. Patients that apply CUTIVATE® Lotion to exposed portions of the body should follow physician advice and routine precautions to avoid excessive or unnecessary exposure to either natural or artificial sunlight (such as sunbathing, tanning booths, sun lamps, etc.).

Last reviewed on RxList: 6/16/2011
This monograph has been modified to include the generic and brand name in many instances.

CUTIVATE
(fluticasone propionate) Lotion

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.

DRUG DESCRIPTION

CUTIVATE® (fluticasone propionate) Lotion, 0.05% contains fluticasone propionate [S(fluoromethyl)6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17βcarbothioate, 17-propionate], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as antiinflammatory and antipruritic agents.

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

CUTIVATE (fluticasone propionate) Structural Formula Illustration

Fluticasone propionate is a white to off-white powder with a molecular weight of 500.6. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.

Each gram of CUTIVATE® Lotion contains 0.5mg fluticasone propionate in a base of cetostearyl alcohol, isopropyl myristate, propylene glycol, cetomacrogol 1000, dimethicone 360, citric acid, sodium citrate, and purified water, with imidurea, methylparaben, and propylparaben as preservatives.

Last reviewed on RxList: 6/16/2011
This monograph has been modified to include the generic and brand name in many instances.

CUTIVATE
(fluticasone propionate) Lotion

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.

DRUG DESCRIPTION

CUTIVATE® (fluticasone propionate) Lotion, 0.05% contains fluticasone propionate [S(fluoromethyl)6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17βcarbothioate, 17-propionate], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as antiinflammatory and antipruritic agents.

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

CUTIVATE (fluticasone propionate) Structural Formula Illustration

Fluticasone propionate is a white to off-white powder with a molecular weight of 500.6. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.

Each gram of CUTIVATE® Lotion contains 0.5mg fluticasone propionate in a base of cetostearyl alcohol, isopropyl myristate, propylene glycol, cetomacrogol 1000, dimethicone 360, citric acid, sodium citrate, and purified water, with imidurea, methylparaben, and propylparaben as preservatives.

Last reviewed on RxList: 6/16/2011
This monograph has been modified to include the generic and brand name in many instances.

CUTIVATE
(fluticasone propionate) Lotion

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.

DRUG DESCRIPTION

CUTIVATE® (fluticasone propionate) Lotion, 0.05% contains fluticasone propionate [S(fluoromethyl)6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17βcarbothioate, 17-propionate], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as antiinflammatory and antipruritic agents.

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

CUTIVATE (fluticasone propionate) Structural Formula Illustration

Fluticasone propionate is a white to off-white powder with a molecular weight of 500.6. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.

Each gram of CUTIVATE® Lotion contains 0.5mg fluticasone propionate in a base of cetostearyl alcohol, isopropyl myristate, propylene glycol, cetomacrogol 1000, dimethicone 360, citric acid, sodium citrate, and purified water, with imidurea, methylparaben, and propylparaben as preservatives.

Last reviewed on RxList: 6/16/2011
This monograph has been modified to include the generic and brand name in many instances.

Cutivate Lotion 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 Lotion)?

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 Lotion)?

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 Lotion (fluticasone propionate lotion) Side Effects Center for a complete guide to possible side effects »

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

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 Lotion Patient Information including How Should I Take

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

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 Lotion)?

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 Lotion Patient Information including If I Miss a Dose

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

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 Lotion)?

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 Lotion)?

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 Lotion)?

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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