FLOVENT DISKUS 50
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FLOVENT DISKUS 50 (FLOVENT DISKUS 50).
Glucocorticoid receptor agonist; anti-inflammatory transcription factor modulation; inhibits phospholipase A2, reduces arachidonic acid release, decreases prostaglandin and leukotriene synthesis; suppresses cytokine production and inflammatory cell migration.
| Metabolism | Hepatic via CYP3A4 to inactive metabolites; presystemic clearance in lung and liver. |
| Excretion | Primarily fecal (87-90%) after hepatic metabolism; renal excretion accounts for <5% as unchanged drug and metabolites. |
| Half-life | Terminal elimination half-life is approximately 14-17.5 hours; this supports once- or twice-daily dosing in asthma maintenance. |
| Protein binding | 91% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Large, approximately 4.2 L/kg; indicates extensive tissue distribution with slow equilibration. |
| Bioavailability | Absolute bioavailability by inhalation via Diskus is approximately 18-22% of the delivered dose due to extensive first-pass metabolism of swallowed fraction. |
| Onset of Action | 12-24 hours after first inhalation via Diskus device; full therapeutic benefit may take 1-2 weeks or longer. |
| Duration of Action | Approximately 12 hours; product labeling supports twice-daily dosing for continuous asthma control. |
1 inhalation (50 mcg) twice daily, administered via oral inhalation.
| Dosage form | POWDER |
| Renal impairment | No dosage adjustment required for renal impairment. |
| Liver impairment | No dosage adjustment recommended per manufacturer labeling; no specific Child-Pugh based guidelines available. |
| Pediatric use | Children 4 years and older: 1 inhalation (50 mcg) twice daily. Not indicated for children under 4 years. |
| Geriatric use | No specific dose adjustments in elderly; use with caution due to potential for decreased renal function and increased sensitivity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FLOVENT DISKUS 50 (FLOVENT DISKUS 50).
| Breastfeeding | It is unknown if fluticasone propionate is excreted in human breast milk after inhalation. However, systemic absorption is minimal at recommended doses. Short-acting beta-agonists used concurrently are preferred. Benefits of breastfeeding and maternal asthma control should be weighed. M/P ratio not available for inhaled route; systemic levels are low. |
| Teratogenic Risk | Epidemiologic data do not show an increased risk of major congenital anomalies from inhaled corticosteroids (ICS) including fluticasone propionate. However, inadequate treatment of asthma during pregnancy is associated with increased maternal and fetal risks. Fluticasone propionate is considered low risk when used at recommended doses. Animal studies showed fetal harm at high systemic exposures, but clinical data do not suggest teratogenicity. Use only if clearly needed, especially during first trimester. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Status asthmaticus or acute asthma episodes requiring intensive measures","Hypersensitivity to fluticasone or excipients","Primary treatment of acute bronchospasm"]
| Precautions | ["Not for relief of acute bronchospasm","Risk of oral candidiasis","Paradoxical bronchospasm","Adrenal insufficiency during stress or withdrawal","Decreased bone mineral density with long-term use","Growth suppression in children","Immune suppression and increased infection risk","Systemic corticosteroid effects at high doses"] |
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| Fetal Monitoring | Regular monitoring of asthma control including peak expiratory flow (PEF) and symptom assessment. Fetal growth and well-being by serial ultrasound if asthma is severe or poorly controlled. Observe for maternal oral candidiasis or hoarseness. No specific fetal monitoring required for fluticasone alone. |
| Fertility Effects | No known adverse effects on human fertility based on available data. Animal studies with systemic corticosteroids showed reduced fertility at high doses, but this is not relevant for inhaled fluticasone at clinical doses. |