fluticasone inhaled (Rx)

Brand and Other Names:Flovent Diskus, Flovent HFA, more...ArmonAir Digihaler
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

aerosol for inhalation (Flovent HFA)

  • 44mcg/actuation
  • 110mcg/actuation
  • 220mcg/actuation

powder for inhalation (Flovent Diskus)

  • 50mcg/actuation
  • 100mcg/actuation
  • 250mcg/actuation

powder for inhalation (ArmonAir Digihaler)

  • 55mcg/actuation
  • 113mcg/actuation
  • 232mcg/actuation

Asthma

Indicated for maintenance treatmentas prophylactic therapy; not indicated for relief of acute bronchospasm

Starting dosage is based on disease severity and current asthma therapy and strength

Inhaled aerosol (Flovent HFA)

  • Initial (not on inhaled corticosteroid): 88 mcg (2 actuations of 44 mcg) inhaled PO q12hr
  • Other patients and those with inadequate response after 2 weeks: May increase dose; not to exceed 880 mcg inhaled PO q12hr

Inhaled powder (Flovent Diskus)

  • Initial (not on inhaled corticosteroid): 100 mcg inhaled PO q12hr
  • Other patients and those with inadequate response after 2 weeks: May increase dose; not to exceed 1000 mcg inhaled PO q12hr

Inhaled powder (ArmonAir Digihaler)

  • Not to exceed 232 mg inhaled PO q12hr
  • Patients with greater asthma severity, use higher dose: 113-232 mcg inhaled PO q12hr

  • Patients not taking inhaled corticosteroids, with less severe asthma: 55 mcg inhaled PO q12hr

  • Switching from another inhaled corticosteroid: 1 inhalation of low (55 mcg), medium (113 mcg), or high (232 mcg) q12hr based on strength of previous inhaled corticosteroid and disease severity

Esophagitis (Orphan)

Orphan designation for treatment of eosinophilic esophagitis

Sponsors

  • Aptalis Pharma US, Inc, 100 Somerset Corporate Blvd, Bridgewater, NJ 08807
  • Banner Life Sciences, LLC; 4125 Premier Drive; High Point, North Carolina 27265

Dosage Forms & Strengths

aerosol for inhalation (Flovent HFA)

  • 44mcg/actuation
  • 110mcg/actuation
  • 220mcg/actuation

powder for inhalation (Flovent Diskus)

  • 50mcg/actuation
  • 100mcg/actuation
  • 250mcg/actuation

powder for inhalation (ArmonAir Digihaler)

  • 30mcg/actuation
  • 55mcg/actuation
  • 113mcg/actuation
  • 232mcg/actuation

Asthma

Maintenance treatment as prophylactic therapy; not indicated for relief of acute bronchospasm

Starting dosage is based on prior asthma therapy and disease severity

Inhaled aerosol (Flovent HFA)

  • <4 years: Safety and efficacy not established
  • 4-11 years: 88 mcg (2 actuations of 44 mcg) inhaled PO q12hr
  • ≥12 years
    • Initial (not on inhaled corticosteroid): 88 mcg (2 actuations of 44 mcg) inhaled PO q12hr
    • Other patients and those with inadequate response after 2 weeks: May increase dose; not to exceed 880 mcg inhaled PO q12hr

Inhaled powder (Flovent Diskus)

  • <4 years: Safety and efficacy not established
  • 4-11 years
    • Initial (not on inhaled corticosteroid): 50 mcg inhaled PO q12hr
    • Other patients and those with inadequate response after 2 weeks: May increase to 100 mcg q12hr
  • ≥12 years
    • Initial (not on inhaled corticosteroid): 100 mcg inhaled PO q12hr
    • Other patients and those with inadequate response after 2 weeks: May increase dose; not to exceed 1000 mcg inhaled PO q12hr

Inhaled powder (ArmonAir Digihaler)

<4 years: Safety and efficacy not established

  • 4-11 years
    • Patients not taking inhaled corticosteroids, with less severe asthma: 30 mcg inhaled PO q12hr
    • Switching from another inhaled corticosteroid: 30-55 mcg inhaled PO q12hr based on strength of previous inhaled corticosteroid
    • Doses exceeding 55 mcg BID: Not studied
  • ≥12 years
    • Patients with greater asthma severity, use higher dose: 113-232 mcg inhaled PO q12hr
    • Patients not taking inhaled corticosteroids, with less severe asthma: 55 mcg inhaled PO q12hr
    • Switching from another inhaled corticosteroid: 1 inhalation of low (55 mcg), medium (113 mcg), or high (232 mcg) q12hr based on strength of previous inhaled corticosteroid and disease severity
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Interactions

Interaction Checker

and fluticasone inhaled

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            Contraindicated (0)

              Serious - Use Alternative (6)

              • abametapir

                abametapir will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

              • apalutamide

                apalutamide will decrease the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

              • chloramphenicol

                chloramphenicol will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • fexinidazole

                fexinidazole will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

              • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)

                ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC) will increase the level or effect of fluticasone inhaled by unspecified interaction mechanism. Avoid or Use Alternate Drug. Coadministration may reduce serum cortisol concentrations; alternative corticosteroids should be considered, particularly for long term use

              • primidone

                primidone will decrease the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              Monitor Closely (46)

              • atazanavir

                atazanavir will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • carbamazepine

                carbamazepine will decrease the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • cenobamate

                cenobamate will decrease the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

              • ceritinib

                ceritinib will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • clarithromycin

                clarithromycin will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • cobicistat

                cobicistat increases levels of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • conivaptan

                conivaptan will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • darunavir

                darunavir will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                elvitegravir/cobicistat/emtricitabine/tenofovir DF will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • fedratinib

                fedratinib will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

              • fosamprenavir

                fosamprenavir will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • fosphenytoin

                fosphenytoin will decrease the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • grapefruit

                grapefruit will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • idelalisib

                idelalisib will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • imatinib

                imatinib will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • indinavir

                indinavir will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • isoniazid

                isoniazid will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • istradefylline

                istradefylline will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

              • itraconazole

                itraconazole will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • ketoconazole

                ketoconazole will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • letermovir

                letermovir increases levels of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • levoketoconazole

                levoketoconazole will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • lopinavir

                lopinavir will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • mifepristone

                mifepristone will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • mitotane

                mitotane will decrease the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • nefazodone

                nefazodone will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • nelfinavir

                nelfinavir will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • nicardipine

                nicardipine will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • nirmatrelvir

                nirmatrelvir will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration may increase certain systemic corticosteroid concentrations. Increased risk for Cushing syndrome and adrenal suppression. Consider alternant corticosteroids, including beclomethasone and prednisolone).

              • nirmatrelvir/ritonavir

                nirmatrelvir/ritonavir will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration may increase certain systemic corticosteroid concentrations. Increased risk for Cushing syndrome and adrenal suppression. Consider alternant corticosteroids, including beclomethasone and prednisolone).

              • ofatumumab SC

                ofatumumab SC, fluticasone inhaled. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • phenobarbital

                phenobarbital will decrease the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • phenytoin

                phenytoin will decrease the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • posaconazole

                posaconazole will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • quinidine

                quinidine will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • ribociclib

                ribociclib will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifabutin

                rifabutin will decrease the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ritonavir

                ritonavir will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • rucaparib

                rucaparib will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

              • saquinavir

                saquinavir will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • stiripentol

                stiripentol, fluticasone inhaled. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

              • tazemetostat

                tazemetostat will decrease the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tipranavir

                tipranavir will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              • trastuzumab

                trastuzumab, fluticasone inhaled. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, fluticasone inhaled. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • voriconazole

                voriconazole will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong CYP3A4 inhibitors may increase fluticasone systemic exposure

              Minor (4)

              • acetazolamide

                acetazolamide will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • anastrozole

                anastrozole will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • cyclophosphamide

                cyclophosphamide will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • larotrectinib

                larotrectinib will increase the level or effect of fluticasone inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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              Adverse Effects

              >10%

              Oral candidiasis (<31%)

              Throat irritation (3-22%)

              Upper respiratory tract infection (16-18%)

              Fatigue or malaise (16%)

              Nasal congestion (16%)

              Rhinitis (≤13%)

              Musculoskeletal pain (2-12%)

              Headache (5-11%)

              1-10%

              Nasal congestion (8%)

              Sinusitis or sinus infection (4-7%)

              Cough (4-6%)

              Bronchitis (2-6%)

              Hoarseness or dysphonia (2-6%)

              Allergic rhinitis (5%)

              Nasal discharge (5%)

              Upper respiratory inflammation (2-5%)

              Muscle injury (≤5%)

              Gastrointestinal (GI) discomfort or pain (1-4%)

              Frequency Not Defined

              Hypersensitivity reactions (including anaphylaxis, angioedema, rash, urticaria)

              Respiratory: Rhinitis, rhinorrhea or postnasal drip, nasal sinus disorders, laryngitis

              GI: Diarrhea, loss of taste, viral infections, dyspeptic symptoms, discomfort, pain, hyposalivation

              Muscular: Musculoskeletal pain, stiffness, tightness, rigidity, injuries, soreness

              Other: Dizziness, migraine, fever, viral infection, pain, chest symptoms, viral skin infections, soft tissue injuries, urinary infections

              Postmarketing Reports

              Special senses: Aphonia, facial and oropharyngeal edema, throat soreness, irritation, cataracts

              Endocrine: Cushingoid features, growth velocity reduction in children and adolescents, hyperglycemia, osteoporosis, weight gain

              GI: Dental caries, tooth discoloration, esophageal candidiasis

              Psychiatry: Agitation, aggression, anxiety, depression, restlessness; behavioral changes, including hyperactivity and irritability (rarely and primarily in children)

              Immunologic: Immediate and delayed hypersensitivity reactions, including urticaria, anaphylaxis, rash, angioedema, bronchospasm

              Respiratory: Asthma exacerbation, chest tightness, cough, dyspnea, immediate and delayed bronchospasm, paradoxical bronchospasm, pneumonia, wheezing

              Skin: Contusions, cutaneous hypersensitivity reactions, ecchymoses, pruritus

              Rare cases of systemic eosinophilic conditions (some with features of vasculitis consistent with Churg-Strauss syndrome, which is often treated with systemic corticosteroids)

              Eye: Cataracts, blurred vision, and central serous chorioretinopathy

              Nervous system disorders: Tremor

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              Warnings

              Contraindications

              Hypersensitivity to drug, components or milk proteins, which may result in anaphylaxis, angioedema, rash, and urticaria

              Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required

              Cautions

              Respiratory tract tuberculosis, untreated fungal or bacterial infections, viral or parasitic infections, ocular herpes simplex; care must be taken to avoid exposure

              Nasal septum perforation, epistaxis, wheezing

              Glaucoma, increased intraocular pressure, and cataracts reported in patients following long-term administration of drug; monitor closely; consider referral to an ophthalmologist in patients who develop ocular symptoms or use inhaler long term

              Risk of more serious or fatal course of chickenpox or measles in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); if patient exposed to chickenpox, may administer prophylaxis with varicella-zoster immune globulin (VZIG); if a patient is exposed to measles, may administer prophylaxis with pooled intramuscular immunoglobulin (IG; See respective package inserts for complete VZIG and IG prescribing information); if chickenpox develops, treatment with antiviral agents may be considered; use with caution, if at all, in patients with active or quiescent tuberculosis infections of respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex

              Use with caution in immunocompromised patients

              Risk of infections of nose and pharynx, including Candida albicans; must rinse mouth after inhalation to reduce risk; treat with appropriate local or systemic (eg, oral) antifungal therapy while treatment continues; at times therapy may need to be interrupted

              Paradoxical bronchospasm may occur with immediate increase in wheezing after dosing; if bronchospasm occurs following dosing treat immediately with an inhaled, short-acting bronchodilator; discontinued therapy immediately; and institute alternative therapy

              Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients; monitor growth of pediatric patients receiving ICS routinely (eg. via stadiometry); to minimize systemic effects of orally inhaled corticosteroids, titrate each patient’s dosage to lowest dosage that effectively controls his/her symptoms

              Decreases in bone mineral density (BMD) reported with long-term administration of products containing ICS; clinical significance of small changes in BMD with regard to longterm consequences such as fracture is unknown; monitor and treat patients with established standards of care patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants, oral corticosteroids)

              Anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose reported; patients with severe milk protein allergy should not use product

              Therapy not to be regarded as bronchodilator and not indicated for rapid relief of bronchospasm; instruct patient to contact physicians immediately when episodes of asthma that are not responsive to bronchodilators occur during course of treatment; during such episodes, patients may require therapy with oral corticosteroids

              Eosinophilic conditions

              • In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions; some patients have clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy; these events, have been associated (not always) with reduction and/or withdrawal of oral corticosteroid therapy following introduction of fluticasone propionate
              • Cases of serious eosinophilic conditions have also been reported with other ICS in this clinical setting; physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients; a 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
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              Pregnancy & Lactation

              Pregnancy

              There are no randomized clinical studies in pregnant women; in women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes (eg, pre-eclampsia in the mother, 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

              Fluticasone propionate concentrations in plasma after inhaled therapeutic doses are low; concentrations in human breast milk are likely to be correspondingly low

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

              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

              Anti-inflammatory corticosteroid; exact mechanism of action is unknown, but agent has been shown to exhibit anti-inflammatory effect on neutrophils, eosinophils, macrophages, mast cells, lymphocytes, and mediators (histamine, leukotrienes, cytokines, eicosanoids)

              Absorption

              Bioavailability: 30%

              Onset: 24 hr (maximum, 1-2 wk)

              Distribution

              Protein bound: 99%

              Vd: 4.2 L/kg

              Metabolism

              Metabolized in liver by CYP3A4

              Metabolites: 17-Beta carboxylic acid

              Elimination

              Half-life: 11-12 hr

              Excretion: Feces (parent drug), urine (<5% metabolites)

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              Administration

              Orally Inhaled Administration

              Aerosol

              • Prime inhaler (4 actuations into air) before first use and after prolonged (>7 days) idleness
              • Shake well before each actuation
              • Valve holding chamber and face mask may be used for younger patients

              Powder

              • Does not require priming
              • Do not use with a spacer
              • Keep the inhaler in a cool dry place; never wash or put any part of the inhaler in water
              • Routine maintenance is not required; if the mouthpiece needs cleaning, gently wipe with a dry cloth or tissue as needed
              • Hold your breath for about 10 seconds after inhaling; then breathe out fully
              • After each dose, rinse your mouth with water and spit it out; do not swallow the water
              • Diskus
                • Always use in a level, flat position
                • Make sure the lever firmly clicks into place

              Storage

              Store at 68-77ºF (20-25ºC); excursions permitted to 59-86ºF (15-30ºC)

              Flovent HFA

              • Contents under pressure: Do not puncture, do not use or store near heat or open flame
              • Exposure to temperatures >120ºF may cause bursting; never throw canister into fire or incinerator
              • Store inhaler with mouthpiece down

              Flovent Diskus

              • Store in a dry place away from direct heat or sunlight
              • Discard 6 wk (50-mcg strength) or 2 months (100- and 250-mcg strengths) after opening foil pouch or when counter reads “0”, whichever comes first
              • Inhaler is not reusable; do not attempt to take inhaler apart

              ArmonAir Digihaler

              • Avoid exposure to extreme heat, cold, or humidity
              • Discard 30 days after opening foil pouch or when counter reads “0”, whichever comes first
              • Inhaler is not reusable; do not attempt to take inhaler apart
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Children's Flonase Allergy Relief nasal
              -
              50 mcg/actuation suspension
              Children's Flonase Allergy Relief nasal
              -
              50 mcg/actuation suspension
              Beser topical
              -
              0.05 % lotion
              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 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
              ClariSpray nasal
              -
              50 mcg/actuation suspension
              Xhance nasal
              -
              93 mcg/actuation aerosol
              Xhance nasal
              -
              93 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 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
              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
              ArmonAir Digihaler inhalation
              -
              113 mcg/actuation aerosol

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

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              Patient Education
              fluticasone propionate nasal

              FLUTICASONE BREATH-ACTIVATED SPRAY - NASAL

              (floo-TIK-a-sone)

              COMMON BRAND NAME(S): Xhance

              USES: Fluticasone is used to treat certain growths in the nose (nasal polyps). It belongs to a class of drugs known as corticosteroids. Fluticasone works by reducing swelling (inflammation) in the nasal passages. This can help decrease symptoms such as stuffy nose.

              HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication 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, usually twice a day. Do not spray in the eyes or mouth. Gently blow your nose before using this drug. Follow the instructions to properly prime the spray pump if you are using the spray for the first time or if you have not used it for 7 days or more. When priming the pump, make sure to spray away from your face.To use the spray, remove the protective cap and shake the container well. Tilt your head slightly forward and carefully insert the nasal applicator into a nostril. Insert the mouthpiece into your mouth. Blow hard into the mouthpiece. While blowing into the mouthpiece, press on the bottle to spray the medicine into your nostril. Do not spray directly onto the middle wall of your nose (nasal septum). Do not close your other nostril or breathe in through your nose while the medicine is being sprayed. Repeat in the other nostril.The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Do not increase your dose or use it more often than directed.Keep track of the number of sprays used from the bottle. Discard the bottle after you have used the number of sprays written on the manufacturer's package.This medication does not work right away. It may take several days for symptoms to get better and several months or longer before you get the full benefit of this drug.Tell your doctor if your condition does not get better or if it gets worse.

              SIDE EFFECTS: Nosebleeds or nose dryness/irritation may occur. 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: pain/sores in your nose, white patches in your nose/mouth, 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, wheezing/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 this medication, tell your doctor or pharmacist if you are allergic to fluticasone; 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: eye problems (such as glaucoma, cataracts), infections (including tuberculosis, herpes eye infection), recent nose problems (such as injury, ulcers, surgery), liver disease.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.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.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).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.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.

              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 light. 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 2022. Copyright(c) 2022 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

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
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              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.