Fluticasone Propionate

DRUG INFORMATION

  ADULT
    - ( 2.2 ) • Treatment of asthma in patients aged 12 years and older: 100 mcg twice
      daily up to a maximum recommended dosage of 1,000 mcg twice daily.
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section 'dosage
      and administration', retrieved 2026-08-29
    - ( 2.2 ) • Treatment of asthma in patients aged 4 to 11 years: 50 mcg twice daily
      up to a maximum recommended dosage of 100 mcg twice daily.
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section 'dosage
      and administration', retrieved 2026-08-29
    - The recommended starting dosage for patients aged 12 years and older who are not
      on an inhaled corticosteroid (ICS) is 100 mcg twice daily, approximately 12 hours
      apart.
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section 'dosage
      and administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of FLOVENT DISKUS in children aged 4 years and older
      have been established [see Adverse Reactions (6.1), Clinical Pharmacology (12.3),
      Clinical Studies (14.2)] . The safety and effectiveness of FLOVENT DISKUS in
      children younger than 4 years have not been established. Effects on Growth Orally
      inhaled corticosteroids may cause a reduction in growth velocity when administered
      to pediatric patients.
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section
      'pediatric use', retrieved 2026-08-29
    - • For oral inhalation only. ( 2.1 ) • Starting dosage is based on prior asthma
      therapy and disease severity. ( 2.2 ) • Treatment of asthma in patients aged 12
      years and older: 100 mcg twice daily up to a maximum recommended dosage of 1,000
      mcg twice daily. ( 2.2 ) • Treatment of asthma in patients aged 4 to 11 years: 50
      mcg twice daily up to a maximum recommended dosage of 100 mcg twice daily.
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section 'dosage
      and administration', retrieved 2026-08-29
    - A 52-week placebo-controlled trial to assess the potential growth effects of
      fluticasone propionate inhalation powder (FLOVENT ROTADISK) at 50 and 100 mcg
      twice daily was conducted in the U.S. in 325 prepubescent children (244 males and
      81 females) aged 4 to 11 years.
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section
      'pediatric use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Therefore, patients with hepatic disease should be closely monitored. 8.7 Renal
      Impairment Formal pharmacokinetic studies using FLOVENT DISKUS have not been
      conducted in patients with renal impairment.
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section 'use in
      specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Hepatic impairment: Monitor patients for signs of increased drug exposure.
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section 'use in
      specific populations', retrieved 2026-08-29
    - No overall differences in safety or effectiveness were observed between these
      subjects and younger subjects, and other reported clinical experience has not
      identified differences in responses between the elderly and younger subjects, but
      greater sensitivity of some older individuals cannot be ruled out. 8.6 Hepatic
      Impairment Formal pharmacokinetic studies using FLOVENT DISKUS have not been
      conducted in patients with hepatic impairment.
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section 'use in
      specific populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary There are insufficient data on the use of FLOVENT DISKUS in pregnant
      women.
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section
      'pregnancy', retrieved 2026-08-29
    - There are clinical considerations with the use of FLOVENT DISKUS in pregnant
      women.
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section
      'pregnancy', retrieved 2026-08-29
    - (See Clinical Considerations.) In animals, teratogenicity characteristic of
      corticosteroids, decreased fetal body weight, and/or skeletal variations in rats,
      mice, and rabbits were observed with subcutaneously administered maternal toxic
      doses of fluticasone propionate less than the maximum recommended human daily
      inhaled dose (MRHDID) on a mcg/m 2 basis.
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - In a pre- and post-natal development study in pregnant rats dosed from late
      gestation through delivery and lactation (Gestation Day 17 to Postpartum Day 22),
      fluticasone propionate was not associated with decreases in pup body weight, and
      had no effects on developmental landmarks, learning, memory, reflexes, or
      fertility at doses up to 0.2 times the MRHDID (on a mcg/m 2 basis with maternal
      subcutaneous doses up to 50 mcg/kg/day).
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section 'use in
      specific populations', retrieved 2026-08-29
    - Other corticosteroids have been detected in human milk.
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section 'use in
      specific populations', retrieved 2026-08-29
    - However, fluticasone propionate concentrations in plasma after inhaled therapeutic
      doses are low and therefore concentrations in human breast milk are likely to be
      correspondingly low [see Clinical Pharmacology (12.3)] .
      Source: US FDA label for fluticasone propionate (FLOVENT DISKUS), section 'use in
      specific populations', retrieved 2026-08-29