Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External, as propionate:
Cutivate: 0.05% (30 g [DSC], 60 g [DSC]) [contains cetyl alcohol, propylene glycol]
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)
Pharmacology
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.
Pharmacokinetics/Pharmacodynamics
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)
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.
Contraindications
Cream and ointment: Hypersensitivity to fluticasone or any component of the formulation.
Lotion: There are no contraindications listed in the manufacturer's labeling.
Dosage and Administration
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: 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
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.
Storage
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.
Drug Interactions
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
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)
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.
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.
Pregnancy
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).
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience burning or stinging. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit), signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), signs of Cushings disease (weight gain in upper back or abdomen; moon face; severe headache; or slow healing), signs of skin changes (acne, stretch marks, slow healing, or hair growth), signs of skin infection, skin thinning, or skin irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
