Version May 2024
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.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Fluticasone (topical): Pediatric drug information")
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
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Dermatologic: Burning sensation of skin (≤2%), eczema (<1%; infected: 1%; herpeticum: <1%), erythema of skin (≤1%), erythematous rash (2%), exacerbation of eczema (2%), pruritus (≤3%; exacerbation: 2%), skin irritation (≤3%), stinging of the skin (≤2%), telangiectasia (2% to 5%), urticaria (≤2%, can be an acute reaction with pharyngeal edema), xeroderma (1%)
Endocrine & metabolic: HPA-axis suppression (≤4%)
Gastrointestinal: Diarrhea (1%), vomiting (1%)
Nervous system: Numbness of fingers (1%)
<1%:
Dermatologic: Atopic dermatitis, folliculitis, hypertrichosis, impetigo, pustules (including pustular psoriasis), skin infection, warts (viral)
Infection: Herpes simplex infection
Frequency not defined: Endocrine & metabolic: Decreased plasma cortisol
Postmarketing:
Cardiovascular: Edema
Dermatologic: Acneiform eruption, skin atrophy, skin rash
Endocrine & metabolic: Cushing’s syndrome, glycosuria, hyperglycemia
Hematologic & oncologic: Hemorrhagic eruption (application-site), leukopenia, thrombocytopenia
Immunologic: Immunosuppression
Local: Application-site edema
Nervous system: Hypoesthesia
Ophthalmic: Blurred vision
Cream and ointment: Hypersensitivity to fluticasone or any component of the formulation.
Lotion: There are no contraindications listed in the manufacturer's labeling.
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 acneiform eruptions, folliculitis, hypertrichosis, hypopigmentation, irritation, miliaria, perioral dermatitis, secondary infection, skin atrophy, and striae; risk increased with use under occlusion.
• Ocular effects: Topical corticosteroids, including fluticasone, may increase the risk of posterior subcapsular cataracts and glaucoma. Monitor for ocular symptoms. Avoid contact with eyes.
• 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: May 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.
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).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External, as propionate:
Generic: 0.05% (15 g, 30 g, 60 g)
Lotion, External, as propionate:
Beser: 0.05% (60 mL [DSC]) [contains methylparaben, propylene glycol, propylparaben]
Cutivate: 0.05% (120 mL [DSC]) [contains cetostearyl alcohol, methylparaben, propylene glycol, propylparaben]
Generic: 0.05% (60 mL, 120 mL [DSC])
Ointment, External, as propionate:
Generic: 0.005% (15 g, 30 g, 60 g)
Yes
Cream (Fluticasone Propionate External)
0.05% (per gram): $1.14 - $1.23
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.
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]
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.
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
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.
Cutivate may be confused with Ultravate
KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).
Allegro: Brand name for fluticasone [Israel], but also the brand name for frovatriptan [Germany]
Allegro [Israel] may be confused with Allegra and Allegra-D brand names for fexofenadine and fexofenadine/pseudoephedrine, respectively, [US, Canada, and multiple international markets]
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Fluticasone (Topical). Risk C: Monitor therapy
Nirmatrelvir and Ritonavir: May increase the serum concentration of Corticosteroids (Topical). Risk C: Monitor therapy
Topical corticosteroids may be used for the treatment of corticosteroid-responsive dermatosis, such as atopic dermatitis, in patients planning a pregnancy (Vestergaard 2019).
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, although this risk is likely to be low (Andersson 2021; Chi 2015; Chi 2017).
When first-line treatments, such as emollients, are insufficient, topical corticosteroids may be used for the treatment of atopic dermatitis in pregnant patients (Vestergaard 2019). Topical corticosteroids are classified by potency; the medication and formulation (eg, cream, gel, and/or salt form) contribute to the potency classification (Oakley 2021; Stacey 2021; Tadicherla 2009). In general, use of the least potent product in limited amounts is recommended during pregnancy. Mild to moderate potency corticosteroids are preferred; potent to very potent topical corticosteroids should only be used as alternative therapy in limited amounts under obstetrical care. Pregnant patients should avoid application of topical corticosteroids to areas with high percutaneous absorption (eg, armpit, skin folds, vulva) (Chi 2017), and caution should be used when applying to areas prone to striae formation (eg, abdomen, breast, thighs) (Vestergaard 2019). Fluticasone is not metabolized by the placenta similarly to other topical corticosteroids; use should be avoided during pregnancy (Vestergaard 2019).
It is not known if sufficient quantities of fluticasone are absorbed following topical administration to produce detectable amounts in breast milk; however, systemic corticosteroids are present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Topical corticosteroids are generally considered acceptable for use in patients who are breastfeeding (Butler 2014; WHO 2002).
Avoid application of topical corticosteroids to the nipple and areola area until breastfeeding ceases; hypertension was noted in a breastfed infant when a high potency topical corticosteroid was applied to the nipple (AAD-NPF [Elmets 2021]; Butler 2014; Leachman 2006). If needed, apply topical corticosteroids immediately after breastfeeding, then clean nipples prior to the next feeding (Vestergaard 2019).
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]); ocular symptoms; skin infections.
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.
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)
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
