Pronunciation:

(floo NISS oh lide)

U.S. Brand Names:

Generic Available:

Canadian Brand Names:

Use:

Pregnancy Risk Factor:

Pregnancy Implications:

Lactation:

Contraindications:

Warnings/Precautions:

May cause suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving 20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections. Withdrawal and discontinuation of the corticosteroid should be done slowly and carefully

Controlled clinical studies have shown that orally-inhaled and intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. (In studies of orally-inhaled corticosteroids, the mean reduction in growth velocity was approximately 1 centimeter per year [range 0.3-1.8 cm per year] and appears to be related to dose and duration of exposure.) The growth of pediatric patients receiving inhaled corticosteroids, should be monitored routinely (eg, via stadiometry). To minimize the systemic effects of orally-inhaled and intranasal corticosteroids, each patient should be titrated to the lowest effective dose.

May suppress the immune system, patients may be more susceptible to infection. Use with caution in patients with systemic infections or ocular herpes simplex. Avoid exposure to chickenpox and measles.

Adverse Reactions:

>10%:

Cardiovascular: Pounding heartbeat

Central nervous system: Dizziness, headache, nervousness

Dermatologic: Itching, rash

Endocrine & metabolic: Adrenal suppression, menstrual problems

Gastrointestinal: GI irritation, anorexia, sore throat, bitter taste

Local: Nasal burning, Candida infection of the nose or pharynx, atrophic rhinitis

Respiratory: Sneezing, cough, upper respiratory tract infection, bronchitis, nasal congestion, nasal dryness

Miscellaneous: Increased susceptibility to infection

1% to 10%:

Central nervous system: Insomnia, psychic changes

Dermatologic: Acne, urticaria

Gastrointestinal: Increase in appetite, xerostomia, dry throat, loss of taste perception

Ocular: Cataracts

Respiratory: Epistaxis

Miscellaneous: Diaphoresis, loss of smell

<1%, postmarketing and/or case reports: Abdominal fullness, bronchospasm, dyspnea, growth suppression

Overdosage/Toxicology:

Drug Interactions:

Salmeterol: The addition of salmeterol has been demonstrated to improve response to inhaled corticosteroids (as compared to increasing steroid dosage).

Mechanism of Action:

Pharmacodynamics/Kinetics:

Absorption: Nasal inhalation: ~50%

Metabolism: Rapidly hepatic to active metabolites

Bioavailability: 40% to 50%

Half-life elimination: 1.8 hours

Excretion: Urine and feces (equal amounts)

Dosage:

Children >6 years:

Oral inhalation: 2 inhalations twice daily (morning and evening) up to 4 inhalations/day

Nasal: 1 spray each nostril twice daily (morning and evening), not to exceed 4 sprays/day each nostril

Adults:

Oral inhalation: 2 inhalations twice daily (morning and evening) up to 8 inhalations/day maximum

Nasal: 2 sprays each nostril twice daily (morning and evening); maximum dose: 8 sprays/day in each nostril

Administration:

Patient Education:

Inhaler: Sit when using. Take deep breaths for 3-5 minutes, and clear nasal passages before administration (use decongestant as needed). Hold breath for 5-10 seconds after use, and wait 1-3 minutes between inhalations. Follow package insert instructions for use. Do not exceed maximum dosage. If also using inhaled bronchodilator, use before flunisolide. Rinse mouth and throat after use to reduce aftertaste and prevent candidiasis.

Additional Information:

Effects of inhaled/intranasal steroids on growth have been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with orally-inhaled and intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch up" growth following discontinuation of treatment with inhaled corticosteroids has not been adequately studied.

Anesthesia and Critical Care Concerns/Other Considerations:

Dental Health: Effects on Dental Treatment:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Mental Health: Effects on Mental Status:

Mental Health: Effects on Psychiatric Treatment:

Dosage Forms:

Aerosol for oral inhalation:

AeroBid®: 250 mcg/actuation (7 g) [100 metered doses; contains CFCs]

AeroBid-M®: 250 mcg/actuation (7 g) [100 metered doses; contains CFCs; menthol flavor]

Solution, intranasal spray (Nasarel®): 25 mcg/actuation (25 mL) [200 sprays; contains benzalkonium chloride]

International Brand Names: