Dosing & Uses
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
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
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
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.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)
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
fluticasone propionate topical - | 0.05 % cream | ![]() | |
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 - | 0.05 % 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 - | 0.005 % ointment | ![]() | |
fluticasone propionate topical - | 0.005 % ointment | ![]() | |
fluticasone propionate topical - | 0.005 % ointment | ![]() | |
fluticasone propionate topical - | 0.05 % lotion | ![]() | |
fluticasone propionate topical - | 0.05 % cream | ![]() | |
fluticasone propionate topical - | 0.05 % lotion | ![]() | |
Children's Flonase Allergy Relief nasal - | 50 mcg/actuation suspension | ![]() | |
Children's Flonase Allergy Relief nasal - | 50 mcg/actuation suspension | ![]() | |
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 | ![]() | |
Flovent HFA inhalation - | 220 mcg/actuation aerosol | ![]() | |
Flovent HFA inhalation - | 44 mcg/actuation aerosol | ![]() | |
Flovent HFA inhalation - | 110 mcg/actuation aerosol | ![]() | |
Flonase Allergy Relief nasal - | 50 mcg/actuation suspension | ![]() | |
Flonase Allergy Relief nasal - | 50 mcg/actuation suspension | ![]() | |
Flonase Allergy Relief nasal - | 50 mcg/actuation suspension | ![]() | |
Flonase Allergy Relief nasal - | 50 mcg/actuation suspension | ![]() | |
Flonase Allergy Relief nasal - | 50 mcg/actuation suspension | ![]() | |
Flonase Allergy Relief 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 | ![]() | |
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 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 aerosol | ![]() | |
fluticasone propionate nasal - | 50 mcg/actuation suspension | ![]() | |
ArmonAir Digihaler inhalation - | 113 mcg/actuation aerosol | ![]() | |
ClariSpray nasal - | 50 mcg/actuation suspension | ![]() | |
Xhance nasal - | 93 mcg/actuation aerosol | ![]() | |
Xhance nasal - | 93 mcg/actuation aerosol | ![]() | |
Beser topical - | 0.05 % lotion | ![]() |
Copyright © 2010 First DataBank, Inc.
Patient Handout
fluticasone propionate inhalation
FLUTICASONE POWDER - ORAL INHALATION
(floo-TIK-a-sone)
COMMON BRAND NAME(S): ArmonAir Digihaler, ArmonAir RespiClick
USES: Fluticasone is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you maintain your normal activities and decreases time lost from work or school. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier.This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Follow the product directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.Make sure the cap is closed before you start using your inhaler. Hold the inhaler upright and open the cap until it "clicks." Inhale this medication by mouth as directed by your doctor, usually twice daily (in the morning and evening, 12 hours apart). Inhale each dose deeply to get the drug into your lungs. You may or may not taste/feel the drug when you inhale. Either is normal. Do not breathe out into the device. Close the cap firmly after each use.Do not take the inhaler apart or wash the mouthpiece or any part of the device. Do not open the cap unless you are ready for your next dose.If you are using other inhalers at the same time, wait at least one minute between the use of each medication, and use this drug (the corticosteroid) last.To prevent dry mouth, hoarseness, and oral yeast infections from developing, gargle, rinse your mouth with water and spit out after each use. Do not swallow the rinse water.The dosage is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. This medication works best if used at evenly spaced times. To help you remember, use it at the same times each day. Do not increase your dose, use this drug more often, or stop using it without first consulting your doctor.If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. If you suddenly stop taking the drug, you may also have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may slowly lower the dose of your old medication after you begin using fluticasone. Tell your doctor or pharmacist right away if you have withdrawal. See also Precautions section.It may take 1 to 2 weeks or longer before you get the full benefit of this drug. Tell your doctor if your symptoms do not get better or if they get worse.Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.
SIDE EFFECTS: See also Precautions section.Dry/irritated throat, hoarseness, or coughing may occur as your body adjusts to the medication. If any of these effects last or get worse, 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: white patches in your mouth or on your tongue, signs of infection (such as sore throat that doesn't go away, fever, chills), mental/mood changes (such as depression, mood swings, agitation), vision problems, increased thirst/urination, easy bruising/bleeding, bone pain.Rarely, this medication may cause sudden severe wheezing/trouble breathing right after you use it. If this occurs, use your quick-relief inhaler and get medical help right away.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 milk proteins), 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: current/past infections (such as tuberculosis, herpes), bone loss (osteoporosis), eye problems (such as cataracts, glaucoma), liver disease.If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be 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 a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication may temporarily slow down a child's growth if used for a long time. However, poorly controlled asthma can also slow down growth. 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 drug 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.Other medications can affect the removal of fluticasone from your body, which may affect how fluticasone works. Examples include some azole antifungals (such as ketoconazole), HIV protease inhibitors (such as lopinavir), ritonavir, among others.
OVERDOSE: 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.Lab and/or medical tests (such as cortisol levels, lung function, eye exams, bone density tests) should be done while you are using this medication. Keep all medical and lab appointments.Avoid substances that can worsen breathing problems by causing irritation or allergic reaction, such as smoke, pollen, pet dander, dust, and mold.Learn to use a peak flow meter, use it daily, and promptly report worsening breathing problems (such as readings in the yellow/red range, increased use of quick-relief inhalers).Because the flu virus can worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year.In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your doctor about your risk, and about available treatments for osteoporosis. Lifestyle changes that help promote healthy bones include doing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements. Consult your doctor for specific advice. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium).
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: Store at room temperature away from moisture, heat, and sunlight. Do not store in the bathroom. Keep all medications away from children and pets.Do not remove the device from its original foil package until ready to use. Discard the device 30 days after you remove it from the original foil package or after all the doses have been used, whichever comes first.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.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised August 2022. Copyright(c) 2023 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.
Formulary
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