General MedicationsRESPIRATORY (INHALATION)High Alert

FLUTICASONE PROPIONATE

Standard Dose

2 DOSAGE AND ADMINISTRATION • For oral inhalation only. ( 2.1 ) • Starting dosage is based on prior asthma therapy and disease severity. ( 2.2 ) • Adult and adolescent patients aged 12 years and older: 88 mcg twice daily up to a maximum dosage of 880 mcg twice daily. ( 2.2 ) • Pediatric patients aged 4 to 11 years: 88 mcg twice daily. ( 2.2 ) 2.1 Administration Information Fluticasone propionate inhalation aerosol should be administered by the orally inhaled route only. After inhalation, rinse mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. A valved holding chamber and mask may be used to deliver Fluticasone propionate inhalation aerosol to young patients. Priming Prime fluticasone propionate inhalation aerosol before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 spray into the air away from the face. Avoid spraying in eyes. 2.2 Recommended Dosage Adult and Adolescent Patients Aged 12 Years and Older The recommended starting dosage for patients aged 12 years and older who are not on an inhaled corticosteroid (ICS): 88 mcg (2 inhalations of 44 mcg fluticasone propionate) twice daily by oral inhalation, approximately 12 hours apart. • The maximum recommended dosage for patients aged 12 years and older is 880 mcg twice daily. Pediatric Patients Aged 4 to 11 Years The recommended dosage for patients aged 4 to 11 years: 88 mcg (2 inhalations of 44 mcg fluticasone propionate) twice daily by oral inhalation, approximately 12 hours apart. General Dosing Recommendations The starting dosage is based on previous asthma therapy and asthma severity, including consideration of patients’ current control of asthma symptoms and risk of future exacerbation. If symptoms arise between doses, an inhaled short-acting beta 2 -agonist should be used for immediate relief. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. For other patients, and for patients who do not respond adequately to the starting dosage after 2 weeks of therapy, higher dosages may provide additional asthma control. If a dosage regimen fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength with a higher strength, initiating an ICS and long-acting beta 2 -agonist (LABA) combination product, or initiating oral corticosteroids, should be considered. After asthma stability has been achieved, titrate to the lowest effective dosage to reduce the possibility of side effects.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE Fluticasone propionate inhalation aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older.

Summary

Limitations of Use Fluticasone propionate inhalation aerosol is not indicated for the relief of acute bronchospasm.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Fluticasone propionate inhalation aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of Use Fluticasone propionate inhalation aerosol is not indicated for the relief of acute bronchospasm. Fluticasone propionate inhalation aerosol is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. ( 1 ) Limitations of use: Not indicated for relief of acute bronchospasm. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION • For oral inhalation only. ( 2.1 ) • Starting dosage is based on prior asthma therapy and disease severity. ( 2.2 ) • Adult and adolescent patients aged 12 years and older: 88 mcg twice daily up to a maximum dosage of 880 mcg twice daily. ( 2.2 ) • Pediatric patients aged 4 to 11 years: 88 mcg twice daily. ( 2.2 ) 2.1 Administration Information Fluticasone propionate inhalation aerosol should be administered by the orally inhaled route only. After inhalation, rinse mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. A valved holding chamber and mask may be used to deliver Fluticasone propionate inhalation aerosol to young patients. Priming Prime fluticasone propionate inhalation aerosol before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 spray into the air away from the face. Avoid spraying in eyes. 2.2 Recommended Dosage Adult and Adolescent Patients Aged 12 Years and Older The recommended starting dosage for patients aged 12 years and older who are not on an inhaled corticosteroid (ICS): 88 mcg (2 inhalations of 44 mcg fluticasone propionate) twice daily by oral inhalation, approximately 12 hours apart. • The maximum recommended dosage for patients aged 12 years and older is 880 mcg twice daily. Pediatric Patients Aged 4 to 11 Years The recommended dosage for patients aged 4 to 11 years: 88 mcg (2 inhalations of 44 mcg fluticasone propionate) twice daily by oral inhalation, approximately 12 hours apart. General Dosing Recommendations The starting dosage is based on previous asthma therapy and asthma severity, including consideration of patients’ current control of asthma symptoms and risk of future exacerbation. If symptoms arise between doses, an inhaled short-acting beta 2 -agonist should be used for immediate relief. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. For other patients, and for patients who do not respond adequately to the starting dosage after 2 weeks of therapy, higher dosages may provide additional asthma control. If a dosage regimen fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength with a higher strength, initiating an ICS and long-acting beta 2 -agonist (LABA) combination product, or initiating oral corticosteroids, should be considered. After asthma stability has been achieved, titrate to the lowest effective dosage to reduce the possibility of side effects. Warnings and cautions 5 WARNINGS AND PRECAUTIONS • Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. ( 5.1 ) • Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. ( 5.3 ) • Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to fluticasone propionate inhalation aerosol. ( 5.4 ) • Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue fluticasone propionate inhalation aerosol slowly. ( 5.5 ) • Assess for decrease in bone mineral density initially and periodically thereafter. ( 5.7 ) • Monitor growth of pediatric patients. ( 5.8 ) • Glaucoma and cataracts may occur with long-term use of ICS. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use fluticasone propionate inhalation aerosol long term. ( 5.9 ) 5.1 Oropharyngeal Candidiasis In clinical trials, the development of localized infections of the mouth and pharynx with Candida alb

Monitoring

• 5 WARNINGS AND PRECAUTIONS • Candida albicans infection of the mouth and pharynx may occur.
• Monitor patients periodically.
• Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
• ( 5.1 ) • Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex).

Interaction Notes

• 7 DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended.
• May increase risk of systemic corticosteroid effects.
• ( 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone propionate is a substrate of CYP3A4.
• The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with fluticasone propionate inhalation aerosol is not recommended because increased systemic corticosteroid adverse effects may occur.