causal relationship between fluticasone propionate and these underlying conditions not established Transferring patients from systemic corticosteroid therapy Particular care needed for patients transferred from systemically active corticosteroids to ICS; deaths due to adrenal insufficiency during and after transfer from systemic corticosteroids to less systemically available ICS After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function During periods of stress or a severe asthma attack, instruct patients who have been withdrawn from systemic corticosteroids to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction; patients should carry warning card indicating possible need for supplementary systemic steroids in such emergencies Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to ICS; prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy with ICS Lung function (mean forced expiratory volume in 1 second [FEV1] or morning peak expiratory flow [AM PEF]), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids Patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension Transfer of patients from systemic corticosteroid therapy to ICS may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions) Systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to these effects; if effects occur, ICS dose should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids, and other treatments for management of asthma symptoms should be considered Pregnancy Insufficient data on use in pregnant women Animal studies No fetal structural abnormalities were observed in animal (ie, rats, rabbits) reproduction studies during organogenesis at doses 4 times (rat) and 1 times (rabbit) the maximum recommended human daily inhalation dose Clinical considerations In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control Lactation No information is available on the presence of fluticasone furoate in human milk, the effects on the breastfed child, or the effects on milk production Low concentrations of other inhaled corticosteroids have been detected in human milk The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child from fluticasone furoate or from the underlying maternal conditionPregnancy 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. Mechanism of Action Synthetic trifluorinated corticosteroid that elicits anti-inflammatory activity Exact mechanism of action is unknown, but corticosteroids have shown to exhibit anti-inflammatory effect on neutrophils, eosinophils, macrophages, mast cells, lymphocytes, and mediators (histamine, leukotrienes, cytokines, eicosanoids) Exhibits binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate Absorption Bioavailability, inhaled: 13.9% (inhaled portion of the dose delivered to the lung) Bioavailability, oral: 1.3% (low from swallowed portion due to extensive first-pass metabolism) Peak plasma time: 0.5-1 hr AUC: 26% lower in patients with asthma compared with healthy volunteers Distribution Protein bound: 99.6% Vd: 661 L Metabolism Cleared from systemic circulation principally by hepatic metabolism via CYP3A4 Metabolites have significantly reduced activity Elimination Half-life: 24 hr (with repeat dosing) Excretion: >99% feces; ~1% urine Inhaled Administration For oral inhalation only Rinse mouth with water and expectorate after each dose to prevent oral/esophageal candidiasis Storage Store at room temperature between 68-77°F (20-25°C); excursions permitted from 59-86°F (15-30°C) Store in a dry place away from direct heat or sunlight BRAND FORM. UNIT PRICE PILL IMAGE Children's Flonase Sensimist nasal- 27.5 mcg/actuation suspensionFlonase Sensimist nasal- 27.5 mcg/actuation suspensionFlonase Sensimist nasal- 27.5 mcg/actuation suspensionFlonase Sensimist nasal- 27.5 mcg/actuation suspensionFlonase Sensimist nasal- 27.5 mcg/actuation suspensionArnuity Ellipta inhalation- 50 mcg/actuation aerosolArnuity Ellipta inhalation- 200 mcg/actuation aerosolArnuity Ellipta inhalation- 200 mcg/actuation aerosolArnuity Ellipta inhalation- 100 mcg/actuation aerosolArnuity Ellipta inhalation- 100 mcg/actuation aerosolCopyright © 2010 First DataBank, Inc.Select a drug:fluticasone furoate nasalfluticasone furoate inhalationPrint Patient Educationfluticasone furoate nasal FLUTICASONE FUROATE SPRAY - NASAL (floo-TIK-a-sone FURE-oh-ate) COMMON BRAND NAME(S): Veramyst USES: Fluticasone is used to treat seasonal and year-round allergy symptoms such as stuffy/runny nose, itching, and sneezing. It may also reduce other symptoms of seasonal allergies such as red, itchy, and watery eyes. This medication belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages. HOW TO USE: If you are using the over-the-counter product to self-treat, read and follow all directions on the product package before using this medication. If your doctor has prescribed this medication, read the Patient Information Leaflet before you start using fluticasone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Use this medication in the nose as directed by your doctor or the product package, usually once a day. Do not spray in your eyes or mouth.Gently blow your nose before using this drug. Shake the container well before each use. Follow the instructions on how to properly prime the bottle if you are using it for the first time, if you have not used it for more than 30 days, or if you have left the cap off for 5 or more days.The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or use this drug more often or for longer than directed. Your condition will not improve any faster, and your risk of side effects will increase. You may be directed to start with a higher dose of this drug for the first week until you have begun to feel better, then decrease your dose. Children may need to use this drug for a shorter amount of time to lower the risk of side effects. If a child is using the over-the-counter product, read the package information to see how long he/she should use it and when you should check with the doctor.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.Clean the applicator regularly. Keep track of the number of sprays used from the container. Discard the container after you have used the number of sprays specified on the manufacturer's package.This medication does not work right away. It may take several days before you get the full benefit of this drug. If your condition does not improve after 1 week, or if it worsens, stop using this medication and consult your doctor or pharmacist. If you think you may have a serious medical problem, get medical help right away. SIDE EFFECTS: Nosebleeds or sores in the nose may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.If your doctor has directed you to use this medication, remember that 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: sore throat that doesn't go away, signs of nasal damage (such as pain, severe nosebleeds, a constant whistling sound from your nose), facial pain, eye pain, white patches in your nose/back of your throat, painful swallowing.Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. 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, 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: recent nose problems (such as injury, ulcers, surgery), infections (including tuberculosis, herpes eye infection), certain eye problems (glaucoma, cataracts), liver disease.Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Rarely, using corticosteroid medications for a long time 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 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 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.If you use this medication for a long time, lab and/or medical tests (such as nose exams, height measurement in children) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.Avoid substances (such as pollen, pet dander, dust mites, mold, and smoke) that can worsen allergy symptoms. MISSED DOSE: If you are using this product on a regular schedule and 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 upright with the cap on at room temperature. Do not refrigerate or freeze. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain