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. |
| Molecular Weight | 549.64 |
| Action Class | Corticosteroid (inhaled) |
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 | Insufficient human data; animal studies show no teratogenic effects; use only if potential benefit justifies risk. |
| 2nd trimester | Insufficient human data; limited studies suggest no increased risk; use if clearly needed. |
| 3rd trimester | Insufficient human data; possible risk of fetal growth restriction with chronic high doses; monitor fetal growth. |
Clinical note
Comprehensive clinical and safety monograph for FLOVENT DISKUS 250 (FLOVENT DISKUS 250).
| Placental transfer | Limited data; likely minimal transfer due to high first-pass metabolism and protein binding. |
| Breastfeeding | No human data; likely excreted into breast milk in small amounts; use caution, especially in preterm infants. |
| Lactation Rating |
■ FDA Black Box Warning
None
| Common Effects | Headache, Throat irritation, Hoarseness/dysphonia, Cough, Upper respiratory tract infection, Sinusitis, Nausea and vomiting |
| Serious Effects | Adrenal insufficiency (with prolonged use or high doses), Increased risk of pneumonia in patients with COPD, Oropharyngeal candidiasis, Paradoxical bronchospasm, Growth suppression in children, Osteoporosis with long-term use, Cataracts and glaucoma, Hypersensitivity reactions (e.g., anaphylaxis, angioedema) |
Hypersensitivity to fluticasone or any componentStatus asthmaticusPrimary treatment of acute bronchospasm
| 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 |
Loading safety data…
| L3 (Moderately Safe) |
| 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. |
| 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. |
| Food/Dietary | No clinically significant food interactions. Grapefruit juice does not affect fluticasone. No dietary restrictions. |
| Clinical Pearls | Flovent Diskus 250 contains fluticasone propionate, an inhaled corticosteroid (ICS) for maintenance therapy of asthma. It is not indicated for acute bronchospasm; a short-acting beta-agonist (SABA) should be prescribed for rescue. Rinse mouth with water after each use (no swallowing) to reduce risk of oral candidiasis and dysphonia. Titrate to lowest effective dose. Monitor for growth suppression in children, adrenal insufficiency during stress or withdrawal, and increased risk of pneumonia in patients with COPD (not approved for COPD). |
| Patient Advice | Use this medication daily as prescribed, not for acute asthma attacks; always keep your rescue inhaler with you. · Do not stop using this medicine suddenly; your doctor will gradually reduce your dose if needed. · Rinse your mouth with water after each use (do not swallow) to prevent thrush and hoarseness. · Do not expose the diskus to moisture; store at room temperature in a dry place. · Check the dose counter; replace when empty or after the labeled number of doses. |