Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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.
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
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
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.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)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| 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 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 % 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 |  | |
| ClariSpray 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 |  | |
| Children's Flonase Allergy Relief nasal - | 50 mcg/actuation suspension |  | |
| Children's Flonase Allergy Relief nasal - | 50 mcg/actuation suspension |  | |
| ArmonAir Digihaler inhalation - | 113 mcg/actuation aerosol |  | |
| Beser topical - | 0.05 % lotion |  | |
| Xhance nasal - | 93 mcg/actuation aerosol |  | |
| Xhance nasal - | 93 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 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.
Patient Handout
fluticasone propionate topical
FLUTICASONE PROPIONATE - TOPICAL
(floo-TIK-a-sone pro-pi-on-ate)
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 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: stretch marks, skin thinning/discoloration, acne, excessive hair growth, small red bumps on the skin (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.Lab and/or medical tests (such as adrenal gland function) may be done while you are using this medication, especially if you use this drug for a long time or apply it over large areas of the body. 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: 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 December 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
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.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
