Embedded Files
Pharmacologic Category
Dosing: Adult
Corticosteroid-responsive dermatoses: Topical: Cream, ointment: Apply a thin film to affected area twice daily. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Atopic dermatitis: Topical:
Cream: Apply a thin film to affected area 1 to 2 times daily. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Lotion: Apply a thin film to affected area once daily. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Pediatric
Note: If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Safety and efficacy of use >4 weeks in pediatric patients have not been established.
Atopic dermatitis: Infants ≥3 months, Children, and Adolescents: Topical:
Cream: Apply thin film to affected area once or twice daily
Lotion: Apply thin film to affected area once daily
Corticosteroid-responsive dermatoses: Infants ≥3 months, Children, and Adolescents: Topical: Cream: Apply thin film to affected area twice daily
Dosing: Renal Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling.
Use: Labeled Indications
Dermatoses:
Lotion: For the relief of the inflammatory and pruritic manifestations of atopic dermatoses in patients 3 months of age or older.
Cream and ointment: For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 3 months of age or older. Ointment is indicated for use in adults only.
Class and Related Monographs
Administration: Topical
Apply sparingly in a thin film. Rub in lightly. Avoid contact with eyes; generally not for routine use on the face, underarms, or groin area. Unless otherwise directed by healthcare professional, do not use with occlusive dressing.
Administration: Pediatric
Topical: Apply thin film to affected area, gently rub in until disappears; do not use on open skin; avoid application on face, underarms, or groin area unless directed by health care professional; avoid contact with eyes; do not occlude area unless directed; do not apply to diaper area
Storage/Stability
Cream and ointment: Store at 2°C to 30°C (36°F to 86°F).
Lotion: Store at 15°C to 30°C (59°F to 86°F); do not refrigerate; keep tightly sealed.
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used to treat skin irritation.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Burning
• Stinging
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit
• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss
• Cushing syndrome like weight gain in upper back or abdomen; moon face; severe headache; or slow healing
• Skin changes like acne, stretch marks, slow healing, or hair growth
• Skin infection
• Skin thinning
• Skin irritation
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Medication Safety Issues
Sound-alike/look-alike issues:
Pediatric patients: High-risk medication:
International issues:
Contraindications
Cream and ointment: Hypersensitivity to fluticasone or any component of the formulation.
Lotion: There are no contraindications listed in the manufacturer's labeling.
Warnings/Precautions
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
• Contact dermatitis: Allergic contact dermatitis can occur and is usually diagnosed by failure to heal rather than clinical exacerbation; discontinue fluticasone if appropriate.
• Localized reactions: May cause local reactions, including skin atrophy; risk increased with use under occlusion.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Disease-related concerns:
• Skin infections: Use appropriate antibacterial or antifungal agents to treat concomitant skin infections; discontinue treatment if infection does not resolve promptly.
Special populations:
• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients. Safety and efficacy of lotion and cream (in children) beyond 4 weeks of use have not been established.
Dosage form specific issues:
• Lotion and cream: Contain imidurea, an excipient; imidurea releases trace amounts of formaldehyde which may cause irritation or allergic sensitization upon contact with skin. Discontinue lotion if irritation occurs and institute appropriate therapy.
Other warnings/precautions:
• Appropriate use: Avoid contact with eyes; generally not for routine use on the face, underarms, or groin area (including diaper area). Avoid use with occlusive dressing unless directed by a health care provider. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Geriatric Considerations
Due to age-related changes in skin, limit use of topical corticosteroids.
Warnings: Additional Pediatric Considerations
Topical corticosteroids may be absorbed percutaneously. The extent of absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Hypothalamic-pituitary-adrenal (HPA) suppression may occur, particularly in younger children or in patients receiving high doses for prolonged periods; acute adrenal insufficiency (adrenal crisis) may occur with abrupt withdrawal after long-term therapy or with stress. Infants and small children may be more susceptible to HPA axis suppression or other systemic toxicities due to larger skin surface area to body mass ratio; use with caution in pediatric patients. HPA axis suppression occurred in two children (2 and 5 years of age) of 43 pediatric patients treated topically with fluticasone cream for 4 weeks; application covered at least 35% of body surface area. HPA axis suppression was not reported with use of fluticasone lotion for at least 3 to 4 weeks in young pediatric patients (4 months to <6 years) during clinical trials; however, it cannot be ruled out when topical fluticasone is used in any patient and especially with longer use.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events have been observed with systemic corticosteroids in some animal reproduction studies.
Systemic bioavailability of topical corticosteroids is variable (integrity of skin, use of occlusion, etc.) and may be further influenced by trimester of pregnancy (Chi 2017). In general, the use of topical corticosteroids is not associated with a significant risk of adverse pregnancy outcomes. However, there may be an increased risk of low birth weight infants following maternal use of potent or very potent topical products, especially in high doses. Use of mild to moderate potency topical corticosteroids is preferred in pregnant females and the use of large amounts or use for prolonged periods of time should be avoided (Chi 2016; Chi 2017; Murase 2014). Also avoid areas of high percutaneous absorption (Chi 2017). The risk of stretch marks may be increased with use of topical corticosteroids (Murase 2014).
Breast-Feeding Considerations
It is not known if sufficient quantities of fluticasone are absorbed following topical administration to produce detectable amounts in breast milk.
Systemic corticosteroids are present in breast milk. Although the manufacturer recommends that caution be used when administering fluticasone to breastfeeding females, topical corticosteroids are generally considered acceptable for use (Butler 2014; WHO 2002). Do not apply topical corticosteroids to breast until breastfeeding ceases (Leachman 2006); hypertension was noted in a breastfed infant when a high potency topical corticosteroid was applied to the nipple (Butler 2014; Leachman 2006).
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
1% to 10%:
Central nervous system: Numbness of fingers (1%)
Dermatologic: Telangiectasia (children: 2% to 5%), pruritus (3%), skin irritation (3%), erythematous rash (children: 2%), exacerbation of eczema (2%), infected eczema (1%), xeroderma (1%)
<1%, postmarketing, and/or case reports: Acneiform eruption, blurred vision, Cushing’s syndrome, dermatitis, edema, folliculitis, hemorrhage, hyperglycemia, immunosuppression, leukopenia, secondary infection, sepsis, skin atrophy, skin discoloration, thrombocytopenia, urticaria, warts (common)
Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Drug Interactions Open Interactions
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination
Monitoring Parameters
Growth (adolescents and children); signs/symptoms of HPA axis suppression/adrenal insufficiency; possible eosinophilic conditions (including eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]); skin infections.
Advanced Practitioners Physical Assessment/Monitoring
May take as long as 2 weeks before full benefit of medication is known. Monitor for possible eosinophilic conditions (including eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]) and signs/symptoms of HPA axis suppression/adrenal insufficiency. Assess growth in adolescents and children.
Nursing Physical Assessment/Monitoring
May take as long as 2 weeks before full benefit of medication is known. Monitor for possible eosinophilic conditions (including eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]) and signs/symptoms of HPA axis suppression/adrenal insufficiency. Assess growth in adolescents and children.
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External, as propionate:
Generic: 0.05% (15 g, 30 g, 60 g)
Lotion, External, as propionate:
Beser: 0.05% (60 mL) [contains methylparaben, propylene glycol, propylparaben]
Cutivate: 0.05% (120 mL) [contains cetostearyl alcohol, methylparaben, propylene glycol, propylparaben]
Generic: 0.05% (60 mL, 120 mL)
Ointment, External, as propionate:
Generic: 0.005% (15 g, 30 g, 60 g)
Dosage Forms: Canada
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment, External, as propionate:
Cutivate: 0.005% (15 g, 30 g, 60 g) [contains propylene glycol]
Anatomic Therapeutic Chemical (ATC) Classification
- D07AC17
Generic Available (US)
Yes
Pricing: US
Cream (Fluticasone Propionate External)
0.05% (per gram): $1.14 - $1.23
Lotion (Beser External)
0.05% (per mL): $9.09
Lotion (Cutivate External)
0.05% (per mL): $10.69
Lotion (Fluticasone Propionate External)
0.05% (per mL): $6.50
Ointment (Fluticasone Propionate External)
0.005% (per gram): $1.14 - $2.54
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Mechanism of Action
Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Fluticasone has intermediate range potency.
Pharmacodynamics/Kinetics
Absorption: Percutaneous absorption is variable and dependent upon many factors including vehicle used, integrity and thickness of epidermis, surface area of application, and use of occlusive dressings (not recommended)
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
No significant effects or complications reported
Effects on Bleeding
No information available to require special precautions
Related Information
Index Terms
Fluticasone Propionate
FDA Approval Date
December 14, 1990
References
American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278.[PubMed 9024461]
Beser (fluticasone propionate) [prescribing information]. Fairfield, NJ: Medimetriks Pharmaceuticals, Inc; October 2018.
Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014;70(3):417.[PubMed 24528912]
Chi CC, Kirtschig G, Aberer W, et al. Updated evidence-based (S2e) European Dermatology Forum guideline on topical corticosteroids in pregnancy. J Eur Acad Dermatol Venereol. 2017;31(5):761-773.[PubMed 28233354]
Chi CC, Wang SH, Kirtschig G. Safety of topical corticosteroids in pregnancy. JAMA Dermatol. 2016;152(8):934-935.[PubMed 27366995]
Cutivate Cream (fluticasone topical) [prescribing information]. Melville, NY: PharmaDerm; June 2012.
Cutivate Lotion (fluticasone topical) [prescribing information]. Melville, NY: PharmaDerm; January 2015.
Cutivate Ointment (fluticasone topical) [prescribing information]. Melville, NY: PharmaDerm; February 2015.
Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006;24(2):167-197, vi.[PubMed 16677965]
Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191.[PubMed 32265601]
Murase JE, Heller MM, Butler DC. Safety of dermatologic medications in pregnancy and lactation: Part I. Pregnancy. J Am Acad Dermatol. 2014;70(3):401.[PubMed 24528911]
Reed BR. Dermatologic drugs, pregnancy, and lactation. A conservative guide. Arch Dermatol. 1997;133(7):894-898.[PubMed 9236528]
Schaffer ET, Fitzgerald JF, Molleston JP, et al, "Comparison of Oral Prednisone and Topical Fluticasone in the Treatment of Eosinophilic Esophagitis: A Randomized Trial in Children," Clin Gastroenterol Hepatol, 2008, 6(2):165-73.[PubMed 18237866]
Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259.[PubMed 19188870]
World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. Available at http://www.who.int/maternal_child_adolescent/documents/55732/en/
Brand Names: International
Allevisone (TW); Cutisone (BD); Cutivat (DK, IS); Cutivate (AE, AR, AT, BB, BD, BE, BG, BH, BM, BS, CH, CN, CY, CZ, EC, EE, EG, ES, GB, GY, HK, ID, JM, KR, KW, LB, LK, LT, LU, LV, MT, MY, NL, PE, PH, PK, PL, PR, PT, PY, QA, RO, RU, SA, SG, SI, TR, TT, TW, UA, UY, VE, VN, ZW); Flixovate (FR); Flupion (BD); Flutivate (BR, CL, DE); Futisone (TW); Medicort (ID); Potencort (QA); Ticason (BD); Zoflut (IN)
Last Updated 9/17/20
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