Dosing and uses of Flovent Diskus, Flovent HFA (fluticasone inhaled)
Adult dosage forms and strengths
aerosol for inhalation
- 44mcg/actuation
- 110mcg/actuation
- 220mcg/actuation
powder for inhalation
- 50mcg/actuation
- 100mcg/actuation
- 250mcg/actuation
Asthma
Maintenance treatment
Inhaled aerosoL
- Prior bronchodilator use: 88 mcg (2 actuations of 44 mcg) PO q12hr; not to exceed 440 mcg q12hr
- Prior inhaled corticosteroid use: 88-220 mcg PO q12hr; not to exceed 440 mcg q12hr
- Prior PO corticosteroid use: 440 mcg PO q12hr; not to exceed 880 mcg q12hr
Inhaled powder
- Prior bronchodilator use: 100 mcg PO q12hr; not to exceed 500 mcg q12hr
- Prior inhaled corticosteroid use: 100-250 mcg PO q12hr; not to exceed 500 mcg q12hr
- Prior PO corticosteroid use: 500-1000 mcg PO q12hr; not to exceed 1000 mcg q12hr
Eosinophilic Esophagitis (Orphan)
Not FDA-approved for orphan indication
Orphan sponsor
- Aptalis Pharma US, Inc, 100 Somerset Corporate Blvd, Bridgewater, NJ 08807
Dosing Considerations
Starting dosages >100 mcg q12hr may be considered in patients who have poorer asthma control or previously required higher-than-usual dosages of inhaled corticosteroids
Patients on long-term PO corticosteroid therapy: Do not reduce prednisone faster than 2.5-5 mg/day on weekly basis, beginning after >1 week of therapy with inhaled powder; monitor carefully
Prior PO corticosteroid use: Starting dose should be determined on basis of individual patient assessment
Esophagitis (Orphan)
Orphan designation for treatment of eosinophilic esophagitis
Sponsors
- Aptalis Pharma US, Inc, 100 Somerset Corporate Blvd, Bridgewater, NJ 08807
- Banner Life Sciences, LLC; 4125 Premier Drive; High Point, North Carolina 27265
Pediatric dosage forms and strengths
aerosol for inhalation
- 44mcg/actuation
- 110mcg/actuation
- 220mcg/actuation
powder for inhalation
- 50mcg/actuation
- 100mcg/actuation
- 250mcg/actuation
Asthma
Maintenance treatment
Inhaled aerosoL
- <4 years: Safety and efficacy not established
- 4-12 years: 88 mcg (2 actuations of 44 mcg) PO q12hr
- >12 years (prior inhaled corticosteroid use): 88-220 mcg PO q12hr; not to exceed 440 mcg q12hr
- >12 years (prior PO corticosteroid use): 440 mcg PO q12hr; not to exceed 880 mcg q12hr
Inhaled powder
- <4 years: Safety and efficacy not established
- 4-12 years: 50-100 mcg PO q12hr
- >12 years (prior bronchodilator use): 100 mcg PO q12hr; not to exceed 500 mcg q12hr
- >12 years (prior inhaled corticosteroid use): 100-250 mcg PO q12hr; not to exceed 500 mcg q12hr
- >12 years (prior PO corticosteroid use): 500-1000 mcg PO q12hr; not to exceed 1000 mcg q12hr
Flovent Diskus, Flovent HFA (fluticasone inhaled) adverse (side) effects
>10%
Oral candidiasis (<31%)
Throat irritation (3-22%)
Upper respiratory tract infection (16-18%)
Fatigue or malaise (16%)
Nasal congestion (16%)
Rhinitis (≤13%)
Musculoskeletal pain (2-12%)
Headache (5-11%)
1-10%
Nasal congestion (8%)
Sinusitis or sinus infection (4-7%)
Cough (4-6%)
Bronchitis (2-6%)
Hoarseness or dysphonia (2-6%)
Allergic rhinitis (5%)
Nasal discharge (5%)
Upper respiratory inflammation (2-5%)
Muscle injury (≤5%)
Gastrointestinal (GI) discomfort or pain (1-4%)
Frequency not defined
Hypersensitivity reactions (including anaphylaxis, angioedema, rash, urticaria)
Respiratory: Rhinitis, rhinorrhea or postnasal drip, nasal sinus disorders, laryngitis
GI: Diarrhea, loss of taste, viral infections, dyspeptic symptoms, discomfort, pain, hyposalivation
Muscular: Musculoskeletal pain, stiffness, tightness, rigidity, injuries, soreness
Other: Dizziness, migraine, fever, viral infection, pain, chest symptoms, viral skin infections, soft tissue injuries, urinary infections
Postmarketing Reports
Special senses: Aphonia, facial and oropharyngeal edema, throat soreness, irritation, cataracts
Endocrine: Cushingoid features, growth velocity reduction in children and adolescents, hyperglycemia, osteoporosis, weight gain
GI: Dental caries, tooth discoloration, esophageal candidiasis
Psychiatry: Agitation, aggression, anxiety, depression, restlessness; behavioral changes, including hyperactivity and irritability (rarely and primarily in children)
Immunologic: Immediate and delayed hypersensitivity reactions, including urticaria, anaphylaxis, rash, angioedema, bronchospasm
Respiratory: Asthma exacerbation, chest tightness, cough, dyspnea, immediate and delayed bronchospasm, paradoxical bronchospasm, pneumonia, wheezing
Skin: Contusions, cutaneous hypersensitivity reactions, ecchymoses, pruritus
Rare cases of systemic eosinophilic conditions (some with features of vasculitis consistent with Churg-Strauss syndrome, which is often treated with systemic corticosteroids)
Nervous system disorders: Tremor
Warnings
Contraindications
Hypersensitivity to drug, components or milk proteins, which may result in anaphylaxis, angioedema, rash, and urticaria
Primary treatment of status asthmaticus, acute bronchospasm
Cautions
Respiratory tract tuberculosis, untreated fungal or bacterial infections, viral or parasitic infections, ocular herpes simplex; care must be taken to avoid exposure
Nasal septum perforation, epistaxis, wheezing
Cataracts, glaucoma, increased intraocular pressure may occur; monitor for glaucoma and cataracts
Risk of more serious or fatal course of chickenpox or measles in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); care must be taken to avoid exposure
Hypercorticism and adrenal suppression may occur with high dosages or at regular dosage in susceptible individuals; if such changes occur, taper withdrawal gradually
May decrease growth velocity in children; monitor growth of pediatric patients
Assess for decrease in bone mineral density initially and periodically thereafter
Use with caution in immunocompromised patients
Prolonged use of corticosteroids may increase incidence of secondary infection
Risk of infections of nose and pharynx, including Candida albicans; must rinse mouth after inhalation to reduce risk
Excessive use may suppress hypothalamic-pituitary-adrenal function; monitor closely, especially postoperatively or during periods of stress
During periods of stress or severe status asthmaticus, supplementary systemic corticosteroids may be immediately required; patient should carry warning card indicating possible need for supplementary systemic steroids in such emergencies
Pregnancy and lactation
Pregnancy: There are no randomized clinical studies in pregnant women; in women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma controL
Lactation: Fluticasone propionate concentrations in plasma after inhaled therapeutic doses are low; concentrations in human breast milk are likely to be correspondingly low; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from the drug or from underlying maternal condition
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Flovent Diskus, Flovent HFA (fluticasone inhaled)
Mechanism of action
Anti-inflammatory corticosteroid; exact mechanism of action is unknown, but agent has been shown to exhibit anti-inflammatory effect on neutrophils, eosinophils, macrophages, mast cells, lymphocytes, and mediators (histamine, leukotrienes, cytokines, eicosanoids)
Absorption
Bioavailability: 30%
Onset: 24 hr (maximum, 1-2 wk)
Distribution
Protein bound: 99%
Vd: 4.2 L/kg
Metabolism
Metabolized in liver by CYP3A4
Metabolites: 17-Beta carboxylic acid
Elimination
Half-life: 11-12 hr
Excretion: Feces (parent drug), urine (<5% metabolites)
Administration
Instructions
Prime inhaler (4 actuations into air) before first use and after prolonged (>7 days) idleness
Valve holding chamber and face mask may be used for younger patients
