flunisolide inhaled (Discontinued)

Brand and Other Names:
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

aerosol inhaler

  • 80mcg/actuation (flunisolide hemihydrate)

Asthma

January 2018: Aerospan HFA discontinued; no generic available in U.S.

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

Dosage Forms & 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

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Adverse 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

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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

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Pregnancy & 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.

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Pharmacology

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

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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.