FLOVENT HFA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FLOVENT HFA (FLOVENT HFA).
Fluticasone propionate is a synthetic corticosteroid that binds to glucocorticoid receptors, increasing the synthesis of lipocortins, which inhibit phospholipase A2, thereby reducing arachidonic acid release and decreasing prostaglandin and leukotriene production. It also suppresses inflammatory cell migration and cytokine release, leading to reduced airway inflammation and hyperreactivity.
| Metabolism | Primarily metabolized by cytochrome P450 3A4 (CYP3A4) in the liver to inactive metabolites |
| Excretion | Primarily fecal (approximately 60-80%) after biliary elimination, with renal excretion accounting for <5% as unchanged drug and metabolites. |
| Half-life | Terminal elimination half-life is approximately 7.8 hours (range 6.5-10.6 hours) after inhalation, supporting twice-daily dosing. |
| Protein binding | 91% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is approximately 3.6 L/kg (range 2.7-4.6 L/kg), indicating extensive tissue distribution. |
| Bioavailability | Inhaled bioavailability is approximately 18% (range 10-25%), with negligible oral bioavailability due to extensive first-pass metabolism. |
| Onset of Action | Onset of bronchodilation occurs within 1-2 hours after inhalation, with peak effect at 2-4 hours. |
| Duration of Action | Duration of bronchodilator effect persists for 12-24 hours, but clinical improvement may be seen with regular twice-daily dosing over several days. |
Adult: 88-880 mcg twice daily via oral inhalation; typical starting dose: 88 mcg twice daily for patients previously on bronchodilators alone, 220 mcg twice daily for patients on inhaled corticosteroids.
| Dosage form | AEROSOL, METERED |
| Renal impairment | No dose adjustment required for renal impairment based on pharmacokinetics; fluticasone propionate is primarily hepatically metabolized. |
| Liver impairment | No specific Child-Pugh based guidelines; use with caution in severe hepatic impairment due to potential increased systemic exposure; if used, monitor for adverse effects. |
| Pediatric use | Children 4-11 years: 88 mcg twice daily via oral inhalation; maximum 88 mcg twice daily. Children 12 years and older: same as adult dosing. |
| Geriatric use | No specific dose adjustment; use lowest effective dose; monitor for local and systemic corticosteroid effects due to potential increased sensitivity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FLOVENT HFA (FLOVENT HFA).
| Breastfeeding | Fluticasone propionate is excreted in human breast milk in low concentrations. The estimated infant daily dose is less than 0.01% of the maternal weight-adjusted dose. The milk-to-plasma (M/P) ratio is unknown, but systemic exposure to the infant is expected to be minimal due to low bioavailability and high protein binding. |
| Teratogenic Risk | Inhaled corticosteroids like fluticasone propionate are not associated with a major increase in risk of congenital malformations. First trimester: limited data, but no consistent evidence of teratogenicity. Second and third trimesters: may be associated with low birth weight and increased risk of preeclampsia, but benefits of asthma control likely outweigh risks. |
■ FDA Black Box Warning
None
| Serious Effects |
["Status asthmaticus or acute episodes of asthma requiring intensive measures","Hypersensitivity to fluticasone propionate or any excipient in the formulation"]
| Precautions | ["Increased risk of adrenal insufficiency when switching from systemic corticosteroids to inhaled corticosteroids","Potential for opportunistic infections (e.g., candidiasis) due to immunosuppression","May cause reduction in growth velocity in pediatric patients","Monitor for hypersensitivity reactions (e.g., angioedema, rash)","Use caution in patients with tuberculosis, untreated infections, or ocular herpes simplex"] |
| Food/Dietary | No specific food interactions. No dietary restrictions required. Grapefruit juice has no known interaction with fluticasone propionate. |
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| Fetal Monitoring | Monitor maternal asthma symptoms, peak expiratory flow (PEF), and FEV1 regularly. Assess for signs of adrenal insufficiency or uncontrolled asthma. Fetal monitoring includes serial ultrasound for growth, amniotic fluid volume, and umbilical artery Doppler if poor asthma control. Monitor for preeclampsia and gestational diabetes due to potential corticosteroid effects. |
| Fertility Effects | No specific data on fertility effects in humans. In animal studies, no significant effects on fertility were observed at inhaled doses up to 150 mcg/kg/day. However, systemic corticosteroids can impair fertility, but inhaled doses produce minimal systemic exposure. |
| Clinical Pearls | FLOVENT HFA (fluticasone propionate) is an inhaled corticosteroid (ICS) for maintenance therapy of asthma, not for acute bronchospasm. Rinse mouth with water after each use to prevent oropharyngeal candidiasis and hoarseness. Do not use as a rescue inhaler; prescribe a short-acting beta-agonist for acute symptoms. Dose depends on prior asthma therapy and severity; start low and titrate. Monitor for decreased growth velocity in children, adrenal insufficiency with prolonged high doses, and possible pneumonia risk in COPD patients (though not indicated for COPD). Shake well before use; prime with 4 test sprays when new or if not used for 7 days. |
| Patient Advice | Use exactly as prescribed; do not stop suddenly, as this may worsen asthma. · Do not use FLOVENT HFA for sudden breathing problems; always carry a rescue inhaler (e.g., albuterol). · Rinse mouth with water (do not swallow) after each use to reduce risk of mouth infections and hoarseness. · Prime the inhaler with 4 test sprays into the air when first opening or if not used for 7 days. · Shake the inhaler well before each use. · Keep track of the number of sprays; discard after 120 actuations (label on canister indicates total). · Store at room temperature (15-30°C); protect from freezing and direct sunlight. · Do not puncture or burn the canister, even when empty. · Seek medical attention if asthma symptoms worsen or if you need more rescue inhaler than usual. · Do not use if you have a dairy allergy? (FLOVENT HFA may contain lactose; check individual product). |