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Fluticasone (Topical)

Medically reviewed by Drugs.com. Last updated on Sep 27, 2020.

Pronunciation

(floo TIK a sone)

Index Terms

  • Fluticasone Propionate

Dosage Forms

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)

Brand Names: U.S.

  • Beser
  • Cutivate

Pharmacologic Category

  • Corticosteroid, Topical

Pharmacology

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)

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.

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

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

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 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

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.