Fluticasone Inhaled

Fluticasone Inhaled is a prescription medicine used to treat the symptoms of asthma.

• Fluticasone Inhaled is available under the following different brand names: Flovent Diskus, Flovent HFA, ArmonAir Digihaler

Adult and pediatric dosage

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

Adult dosage

Inhaled aerosol (Flovent HFA)

• Initial (not on Inhaled corticosteroid): 88 mcg (2 actuation of 44 mcg) Inhaled orally every 12 hours
• Other patients and those with an inadequate response after 2 weeks: May increase dose; not to exceed 880 mcg Inhaled orally every 12 hours

Inhaled powder (Flovent Diskus)

• Initial (not on Inhaled corticosteroid): 100 mcg Inhaled orally every 12 hours
• Other patients and those with an inadequate response after 2 weeks: May increase dose; not to exceed 1000 mcg Inhaled orally every 12 hours

Inhaled powder (ArmonAir Digihaler)

• Not to exceed 232 mg Inhaled orally every 12 hours
• Patients with greater asthma severity, use higher dose: 113-232 mcg Inhaled orally every 12 hours
• Patients not taking Inhaled corticosteroids, with less severe asthma: 55 mcg Inhaled orally every 12 hours
• Switching from another Inhaled corticosteroid: 1 inhalation of low (55 mcg), medium (113 mcg), or high (232 mcg) every 12 hours based on strength of previous Inhaled corticosteroid and disease severity

Pediatric dosage

Inhaled aerosol (Flovent HFA)

• Children below 4 years: Safety and efficacy not established
• Children between 4-11 years: 88 mcg (2 actuation of 44 mcg) Inhaled orally every 12 hours
• Children above 12 years:
  • Initial (not on Inhaled corticosteroid): 88 mcg (2 actuation of 44 mcg) Inhaled orally every 12 hours
  • Other patients and those with an inadequate response after 2 weeks: May increase dose; not to exceed 880 mcg Inhaled orally every 12 hours

Inhaled powder (Flovent Diskus)

• Children below 4 years: Safety and efficacy not established
• Children between 4-11 years:
  • Initial (not on Inhaled corticosteroid): 50 mcg Inhaled orally every 12 hours
  • Other patients and those with an inadequate response after 2 weeks: May increase to 100 mcg every 12 hours
• Children above 12 years:
  • Initial (not on Inhaled corticosteroid): 100 mcg Inhaled orally every 12 hours
  • Other patients and those with an inadequate response after 2 weeks: May increase dose; not to exceed 1000 mcg Inhaled orally every 12 hours

Inhaled powder (ArmonAir Digihaler)

• Children below 4 years: Safety and efficacy not established
• Children between 4-11 years:
  • Patients not taking Inhaled corticosteroids, with less severe asthma: 30 mcg Inhaled orally every 12 hours
  • Switching from another Inhaled corticosteroid: 30-55 mcg Inhaled orally every 12 hours based on strength of previously Inhaled corticosteroid
  • Doses exceeding 55 mcg twice a day: Not studied
• Children above 12 years:
  • Patients with greater asthma severity, use higher dose: 113-232 mcg Inhaled orally every 12 hours
  • Patients not taking Inhaled corticosteroids, with less severe asthma: 55 mcg Inhaled orally every 12 hours
  • Switching from another Inhaled corticosteroid: 1 inhalation of low (55 mcg), medium (113 mcg), or high (232 mcg) every 12 hours based on strength of previous Inhaled corticosteroid and disease severity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Fluticasone Inhaled include:

• cold symptoms such as stuffy nose, sneezing, sore throat, sinus pain,
• low fever,
• cough,
• wheezing,
• chest tightness,
• hoarseness or deepening voice,
• white patches or sores inside the mouth or on the lips,
• headache,
• nausea,
• vomiting, and
• upset stomach.

Serious side effects of Fluticasone Inhaled include:

• weakness,
• tired feeling,
• nausea,
• vomiting,
• lightheadedness,
• wheezing,
• choking,
• breathing problems after using the medicine,
• blurred vision,
• tunnel vision,
• eye pain,
• seeing halos around lights,
• worsening of asthma symptoms,
• fever,
• cough,
• stomach pain,
• weight loss,
• skin rash,
• severe tingling,
• numbness,
• chest pain,
• upper stomach pain,
• loss of appetite,
• dark urine,
• clay-colored stools, and
• yellowing of the skin or eyes.

Rare side effects of Fluticasone Inhaled include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Fluticasone Inhaled has severe interactions with no other drugs.
• Fluticasone Inhaled has serious interactions with the following drugs:
  • abametapir
  • apalutamide
  • chloramphenicol
  • fexinidazole
  • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
  • primidone
• Fluticasone Inhaled has moderate interactions with at least 45 other drugs
• Fluticasone Inhaled has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to drug, components, or milk proteins, may result in anaphylaxis, angioedema, rash, and urticaria
• Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fluticasone Inhaled?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fluticasone Inhaled?”

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 the 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 the 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 an 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 the lowest dosage that effectively controls his/her symptoms
• Decreases in bone mineral density (BMD) reported with long-term administration of products containing ICS; the clinical significance of small changes in BMD about long-term 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 a 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 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 the 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, several 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 a warning card indicating a 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 every week 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 insufficiencies, 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 the management of asthma symptoms should be considered

Pregnancy and Lactation

• There are no randomized clinical studies in pregnant women; in women with poorly or moderately controlled asthma, there is an 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 underlying maternal condition