FLOVENT DISKUS 250
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FLOVENT DISKUS 250 (FLOVENT DISKUS 250).
Fluticasone propionate is a corticosteroid with potent anti-inflammatory activity. It binds to the glucocorticoid receptor, leading to inhibition of pro-inflammatory cytokines, reduction of eosinophil recruitment, and suppression of airway hyperresponsiveness.
| Metabolism | Hepatic via cytochrome P450 3A4 (CYP3A4) to inactive metabolites; also undergoes ester hydrolysis. |
| Excretion | Renal (approximately 5% as unchanged drug); fecal (majority as metabolites and unabsorbed drug). |
| Half-life | Approximately 10-12 hours (terminal elimination half-life in asthmatics). |
| Protein binding | 99% (primarily to albumin). |
| Volume of Distribution | 4.2 L/kg (indicates extensive tissue distribution). |
| Bioavailability | Inhalation: approximately 13-17% (lung deposition), oral: <1% (due to extensive first-pass metabolism). |
| Onset of Action | Inhalation: 12-24 hours (bronchodilator effect), maximal effect after several days. |
| Duration of Action | Inhalation: 12-24 hours (bronchodilator effect), clinical improvement sustained with regular use. |
250 mcg inhaled orally via DISKUS twice daily (500 mcg total daily dose).
| Dosage form | POWDER |
| Renal impairment | No dose adjustment required. |
| Liver impairment | No specific dose adjustment guidelines; use with caution in severe hepatic impairment. |
| Pediatric use | For children 4-11 years: 50-100 mcg inhaled orally twice daily. For children ≥12 years: same as adult dosing. |
| Geriatric use | No specific dose adjustment; start at lower end of dosing range and monitor for adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FLOVENT DISKUS 250 (FLOVENT DISKUS 250).
| Breastfeeding | Fluticasone propionate is excreted into human breast milk following oral administration, but the extent of excretion after inhalation is unknown. The M/P ratio has not been established. Systemic absorption is low, and the amount in breast milk is likely minimal. Consider the benefits of breastfeeding and the mother's need for asthma control. Inhaled corticosteroids are generally compatible with breastfeeding. |
| Teratogenic Risk | Fluticasone propionate (FLOVENT DISKUS 250) is an inhaled corticosteroid. Animal studies have shown teratogenic effects (cleft palate, fetal death) at high systemic exposures, but human data in pregnant women are limited. Inhaled corticosteroids are generally considered low risk due to minimal systemic absorption. No increased risk of major congenital malformations has been reported in human studies. However, use during the first trimester should be cautious. Monitor for adrenal suppression in neonates if used during pregnancy. |
■ FDA Black Box Warning
None
| Serious Effects |
["Primary treatment of status asthmaticus or acute asthma exacerbations","Hypersensitivity to fluticasone propionate or any ingredient","Severe hypersensitivity to milk proteins (lactose monohydrate contains milk proteins)"]
| Precautions | ["Risk of adrenal insufficiency during and after transfer from systemic corticosteroids","Increased susceptibility to infections (e.g., chickenpox, measles)","Paradoxical bronchospasm (discontinue and alternative therapy)","Immediate hypersensitivity reactions (urticaria, angioedema, rash)","Reduced bone mineral density with long-term use","Growth suppression in pediatric patients","Oropharyngeal candidiasis and hoarseness (rinse mouth after use)","Use cautiously in patients with tuberculosis, untreated infections, or ocular herpes simplex"] |
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| Fetal Monitoring | Monitor maternal asthma control and lung function. Assess fetal growth and well-being via ultrasound and antenatal testing as appropriate. Monitor for signs of adrenal insufficiency in the mother and neonate, especially if high doses are used. Periodic assessment of growth in children exposed in utero. |
| Fertility Effects | No specific human studies on fertility. In animal studies, fluticasone propionate did not impair fertility at doses up to 150 mcg/kg/day subcutaneously. Inhaled glucocorticoids may have minimal systemic effects, but no significant impact on human fertility is anticipated. |