Product: Alvesco

Company: Sepracor

Pharmacologic class: Corticosteroid

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Active ingredient: Ciclesonide 80 µg/inhalation, 160 µg/inhalation; metered-dose inhaler.

Indication: Maintenance treatment of asthma as prophylactic therapy in patients >12 years of age.

Pharmacology: Alvesco is a metered-dose oral inhaler product with a dose counter that delivers ciclesonide,
a nonhalogenated corticosteroid, to the airways using hydrofluoroalkane-134 as a propellant. Ciclesonide is a prodrug that is hydrolized to its active metabolite, desciclesonide, which is further metabolized in the liver to other active metabolites.

The exact mechanism of action of corticosteroids in the management of asthma is unknown; however, they have been shown to have a wide range of activity against mediators of inflammation involved in the inflammatory response seen with asthma. 

Clinical trials: Six randomized, double-blind, placebo-controlled studies were conducted to evaluate the
efficacy of Alvesco in the management of mild-to-severe asthma in patients >12 years of age.
In patients previously treated with bronchodilators alone, subjects treated with Alvesco had significant improvements in the morning pre-dose forced expiratory flow rate at one second (FEV1) at Week 16. For this and other measures of asthma control and the need for rescue albuterol, the improvement was greatest in patients given 80 µg twice daily compared with those using 160 µg once daily.

In patients previously maintained on inhaled corticosteroids, the FEV1was improved, and asthma symptom scores, am peak expiratory flow, and decreased need for rescue albuterol remained stable at 12 weeks for
those receiving Alvesco vs. those given placebo.

For patients previously maintained on oral corticosteroids, patients using Alvesco 320 µg or 640 µg twice daily significantly reduced their prednisone needs by 47% and 62%, respectively, compared with those on placebo, whose prednisone needs increased by 4%. There was no significant difference seen with Alvesco 640 µg twice daily compared with 320 µg twice daily.

Adults: Previously on bronchodilators alone: initially 80 µg twice daily, maximum 160 µg twice daily. Previously on inhaled corticosteroids: initially 80 µg twice daily; maximum 320 µg twice daily. Previously on oral corticosteroids (see literature): 320 µg twice daily. Rinse mouth after use; avoid eyes. 

Children: Not recommended.

Contraindications: Not for primary treatment of acute attack.

Precautions: Infections. If exposed to chickenpox or measles, consider immuno-globulin prophylactic therapy. If adrenal insufficiency exists following systemic corticosteroid therapy, replacement with inhaled corticosteroids may exacerbate symptoms of adrenal insufficiency (e.g., lassitude). Monitor for hypercorticism and hypothalamic-pituitary-adrenal axis suppression (if occurs, reduce dose gradually). Monitor for growth suppression in children. Monitor for changes in vision, increased intraocular pressure, cataracts. Pregnancy (Cat. C). Nursing mothers.

Adverse reactions: Headache, nasopharyngitis, sinusitis, throat pain, upper respiratory infection, arthralgia, nasal congestion, back pain; rare: bronchospasm, immunosuppression, glaucoma, cataracts, oral candidiasis, decreased bone mineral density.

How supplied: Inhaler 80 µg/inhalation—6.1 g, (60 inhalations); Inhaler 160 µg/inhalation—6.1 g (60 inhalations), 9.6 g (120 inhalations)

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