Dosing and uses of Aerospan HFA (flunisolide inhaled)
Adult dosage forms and strengths
aerosol inhaler
- 80mcg/actuation (flunisolide hemihydrate)
Asthma
Indicated for maintenance treatment of asthma as prophylactic therapy; also may be used to reduce or eliminate the need for oral corticosteroids
2 actuations (160 mcg) inhaled PO BID; may titrate upward, not to exceed 4 actuations (320 mcg) BId
Pediatric dosage forms and strengths
aerosol inhaler
- 80mcg/actuation (flunisolide hemihydrate)
Asthma
Indicated for maintenance treatment of asthma as prophylactic therapy; also may be used to reduce or eliminate the need for oral corticosteroids
<6 years: Safety and efficacy not established
6-11 years: 1 actuation (80 mcg) inhaled PO BID initially; may titrate upward, not to exceed 2 actuations (160 mcg) BId
≥12 years: 2 actuations (160 mcg) inhaled PO BID; may titrate upward, not to exceed 4 actuations (320 mcg) BId
Aerospan HFA (flunisolide inhaled) adverse (side) effects
>10%
Headache (8.8-13.8%)
Pharyngitis (16.6-17.5%)
Rhinitis (3.5-15.7%)
1-10%
Sinusitis (4.1-8.8%)
Increased cough (1.8-8.5%)
Fever (0.9-6.9%)
Allergic reaction (4.2-4.6%)
Vomiting (4.2-4.6%)
Pain (1.8-4.6%)
Rash (1.8-3.7%)
Infection (0.9-3.7%)
Dyspepsia (2.1-3.5%)
Urinary tract infection (0.9%-3.5%)
Epistaxis (0.9-3.2%)
Ear Pain (1-3%)
Conjunctivitis (1-3%)
Vaginitis (1-3%)
Moniliasis (1-3%)
Taste perversion (1-3%)
Frequency not defined
Vertical growth suppression
Warnings
Contraindications
Hypersensitivity
Status asthmaticus, acute bronchospasm episodes
Cautions
Not a bronchodilator; not indicated for rapid relief of bronchospasm (see Contraindications)
Tapering PO corticosteroids: Implement inhaled corticosteroids for 1 week before gradually tapering PO corticosteroid dose
May suppress hypothalamic-pituitary-adrenal axis in patients receiving high doses and children
During periods of stress or severe status asthmaticus may require immediate supplementary systemic corticosteroids
Bronchospasm may occur following inhalation (treat with fast acting bronchodilator); stop flunisolide therapy and select alternative anti-inflammatory agents (corticosteroids)
Immunocompromised patients; TB, untreated systemic fungal, bacterial, parasitic or viral infections, ocular herpes simplex
Risk of Candida albicans or Aspergillus niger infection of mouth and pharynx; clean inhaler mouthpiece and spacer
Rare instances of glaucoma, increased intraocular pressure, and cataracts reported with long-term use
Chronic corticosteroid use may decrease growth rate in children
Corticosteroids are known to cause immunosuppression resulting in increased susceptibility to infection (eg, chicken pox, measles); avoid live virus vaccines if immunosuppressed
Development of Kaposi's sarcoma associated with prolonged corticosteroid therapy (consider discontinuing therapy)
Not for use in the treatment of status asthmaticus or acute bronchospasm
May cause hyperglycemia; use caution in patients with diabetes mellitus
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether distributed in breast milk
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 Aerospan HFA (flunisolide inhaled)
Mechanism of action
Elicits potent glucocorticoid and weak mineralocorticoid effects; acts topically at site of deposition in the bronchial tree to inhibit inflammatory cells and release of inflammatory mediators
Absorption
Bioavailability: 7%
Peak Plasma Time: 5-10 min
Peak Plasma Concentration: 1.9-3.3 ng/mL
AUC: 1.2-2.5 ng.hr/mL
Distribution
Vd: 170-350 L
Metabolism
Rapidly and extensively converted to 6 beta-OH flunisolide and to water-soluble conjugates during the first pass through the liver by the cytochrome P450 enzyme system, particularly the enzyme CYP3A4
Elimination
Half-life: 1.3-1.7 hr
Excretion: Minimal in urine
