fluticasone topical (Rx)

Brand and Other Names:Cutivate
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

cream

  • 0.05%

ointment

  • 0.005%

lotion

  • 0.05%

Atopic Dermatitis

Cream/lotion: Apply qDay-q12hr; reassess diagnosis if no improvements within 2 weeks

Corticosteroid-responsive Dermatoses

Cream/lotion: Apply qDay or q12hr; reassess diagnosis if no improvements within 2 weeks

Dosage Forms & Strengths

cream

  • 0.05%

lotion

  • 0.05%

Atopic Dermatitis

Lotion

  • <3 months: Safety & efficacy not established
  • >3 months: As adults; apply cream/lotion sparingly qDay-q12hr

Lotion

  • <1 year: Safety & efficacy not established
  • >1 year: As adults; apply sparingly qDay

Corticosteroid-responsive Dermatoses

Cream

  • <3 months: Safety & efficacy not established
  • >3 months: Apply qDay or q12hr; reassess diagnosis if no improvements within 2 weeks
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Adverse Effects

1-10%

Pruritus (2.9%)

Dryness (1.2%)

Skin irritation: (3%)

Eczema (1%)

Telangiectasia (2-5%)

Numbness of fingers (1%)

<1%

Burning

Folliculitis

Acneiform lesions

Urticaria

Hypertrichosis

Lightheadedness

Viral

Warts

Impetigo

Skin infection

Frequency Not Defined

Striae

Pigmentation changes

HPA suppression (with higher potency used >2 wk)

Erythema

Cushing syndrome

Sepsis

Hemorrhage reported

Edema/swelling

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Warnings

Contraindications

Hypersensitivity

Underlying infection

Skin atrophy

Perioral dermatitis

Rosacea

Ophthalmic use

Cautions

Safety/efficacy in peds use longer than 4 wk not established

Ointment not indicated for atopic dermatitis

Use med to very high potency for <2 wk to reduce local and systemic side effects

Use low potency for chronic therapy

Reversible HPA axis suppression and resulting clinical glucocorticoid insufficiency can occur during or after withdrawal of treatment; risk factors include use over large surface area, prolonged use, use under occlusion, altered skin barrier, liver failure, and young age; children may exhibit greater susceptibility to corticosteroid-induced HPA axis suppression and Cushing's syndrome due to larger skin surface area to body weight ratio; modify use if HPA axis suppression is suspected;

Avoid medium to very high potency on face, folds, groin because can increase steroid absorption

Use lower potency for children (ie, increase BSA/kg, therefore increase systemic absorption)

Contains imidurea as excipient which releases formaldehyde as a breakdown product; may cause allergic sensitization or irritation upon contact

May cause irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, hypertrichosis, and miliaria; especially with high-potency or occlusive dressings

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Pregnancy & Lactation

Pregnancy

There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; observational studies suggest an increased risk of low birth weight infants with use of greater than 300 grams of potent or very potent topical corticosteroids during pregnancy; advise pregnant women that therapy may increase risk of having a low birth weight infant and to use drug on smallest area of skin and for shortest duration possible

Animal data

  • In animal reproduction studies, subcutaneous administration to pregnant mice, rats, and rabbits during organogenesis caused malformations characteristic of corticosteroids in each species; available data do not allow calculation of relevant comparisons between systemic exposure of fluticasone propionate observed in animal studies to systemic exposure that would be expected in humans after topical use

Lactation

There are no data on presence of drug in human milk, its effects on breastfed infant, or on milk production; not known whether topical administration could result in sufficient systemic absorption to produce detectable quantities in human milk

Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

To minimize potential exposure to breastfed infant via breast milk, use on smallest area of skin and for shortest duration possible while breastfeeding; advise breastfeeding women not to apply drug directly to nipple and areola prior to breastfeeding to avoid direct infant exposure

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation

Pharmacokinetics

Absorption: 6% (animal studies; 5% systemic, 1% in skin)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Cutivate topical
-
0.05 % lotion
Cutivate topical
-
0.05 % cream
Cutivate topical
-
0.05 % cream
fluticasone propionate topical
-
0.05 % lotion
fluticasone propionate topical
-
0.05 % cream
fluticasone propionate topical
-
0.05 % cream
fluticasone propionate topical
-
0.05 % cream
fluticasone propionate topical
-
0.05 % lotion
fluticasone propionate topical
-
0.05 % cream
fluticasone propionate topical
-
0.05 % cream
fluticasone propionate topical
-
0.05 % cream
fluticasone propionate topical
-
0.005 % ointment
fluticasone propionate topical
-
0.005 % ointment
fluticasone propionate topical
-
0.005 % ointment
fluticasone propionate topical
-
0.005 % ointment
fluticasone propionate topical
-
0.005 % ointment
fluticasone propionate topical
-
0.005 % ointment
fluticasone propionate topical
-
0.05 % cream
fluticasone propionate topical
-
0.05 % cream
fluticasone propionate topical
-
0.05 % cream
fluticasone propionate topical
-
0.05 % lotion
Xhance nasal
-
93 mcg/actuation aerosol
Xhance nasal
-
93 mcg/actuation aerosol
Beser topical
-
0.05 % lotion
ArmonAir Digihaler inhalation
-
113 mcg/actuation aerosol
Flonase Allergy Relief nasal
-
50 mcg/actuation suspension
Flonase Allergy Relief nasal
-
50 mcg/actuation suspension
Flovent HFA inhalation
-
220 mcg/actuation aerosol
Flovent HFA inhalation
-
110 mcg/actuation aerosol
Flovent HFA inhalation
-
44 mcg/actuation aerosol
Flovent Diskus inhalation
-
100 mcg/actuation aerosol
Flovent Diskus inhalation
-
250 mcg/actuation aerosol
Flovent Diskus inhalation
-
100 mcg/actuation aerosol
Flovent Diskus inhalation
-
250 mcg/actuation aerosol
Flovent Diskus inhalation
-
50 mcg/actuation aerosol
ClariSpray nasal
-
50 mcg/actuation suspension
Children's Flonase Allergy Relief nasal
-
50 mcg/actuation suspension
fluticasone propionate nasal
-
50 mcg/actuation suspension
fluticasone propionate nasal
-
50 mcg/actuation suspension
fluticasone propionate nasal
-
50 mcg/actuation aerosol
fluticasone propionate nasal
-
50 mcg/actuation suspension
fluticasone propionate nasal
-
50 mcg/actuation suspension
fluticasone propionate nasal
-
50 mcg/actuation suspension
fluticasone propionate nasal
-
50 mcg/actuation aerosol
fluticasone propionate nasal
-
50 mcg/actuation aerosol
fluticasone propionate nasal
-
50 mcg/actuation aerosol
fluticasone propionate nasal
-
50 mcg/actuation suspension
fluticasone propionate nasal
-
50 mcg/actuation suspension
fluticasone propionate nasal
-
50 mcg/actuation aerosol
fluticasone propionate nasal
-
50 mcg/actuation aerosol
fluticasone propionate nasal
-
50 mcg/actuation suspension

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
fluticasone propionate topical

FLUTICASONE PROPIONATE - TOPICAL

(floo-TIK-a-sone)

COMMON BRAND NAME(S): Cutivate

USES: This medication is used to treat a variety of skin conditions (such as eczema, psoriasis, rash). Fluticasone reduces swelling (inflammation), itching, and redness. This medication is a medium-strength corticosteroid. It is available in several forms, including cream, ointment, and lotion. Your doctor will choose the type of product based on your skin condition and the area of your body to be treated.Fluticasone ointment is not recommended for use by children because of the risk of serious side effects.

HOW TO USE: Use this medication on the skin only. However, do not use it on the face, groin, or underarms, or for diaper rash, unless directed to do so by your doctor.Wash and dry your hands before using. Clean and dry the affected area. Apply a thin film of medication to the affected area and gently rub in, usually once or twice daily as directed by your doctor. Do not bandage, cover, or wrap the area unless directed to do so by your doctor.Wash your hands after each use, unless you are using this medication to treat the hands. Avoid getting this medication in your eyes because it may worsen or cause glaucoma. Also avoid getting it in your nose or mouth. If medication gets in these areas, rinse with plenty of water.Use this medication only for the condition prescribed. Do not apply large amounts of this medication, use it more often, or use it for longer than prescribed. Your condition will not improve any faster, and your risk of side effects may increase.Tell your doctor if your condition does not improve in 2 weeks or if it worsens.

SIDE EFFECTS: Burning, itching, stinging, or dryness may occur when you apply this medication, but usually only lasts a short time. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: stretch marks, skin thinning/discoloration, acne, excessive hair growth, hair bumps (folliculitis).Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using fluticasone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as formaldehyde), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, immune system problems.Corticosteroids can make skin infections worse and more difficult to treat. Tell your doctor if you have a skin infection or if your condition does not improve.Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for a long time or apply it over large areas of the body. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.