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Frequently asked questions

Click on a link below to view answers to frequently asked questions regarding the following topics:

About PULMICORT RESPULES

About Pharmacy Manufacturing

About Nebulizers

Helping Patients and Caregivers with Nebulizer Use

About nebulizers

1. How do nebulizers work?

Nebulizers deliver aerosolized liquid medicine by a facemask or mouthpiece. Successful nebulizer therapy does not depend on significant patient cooperation or coordination. This may be an advantage in the treatment of pediatric asthma, and the NIH recognizes the nebulizer as an effective delivery device for young children.

Nebulizers are widely used in the U.S. to deliver non-steroidal asthma medications; PULMICORT RESPULES is the only inhaled corticosteroid approved for use in a nebulizer for pediatric patients.

2. What types of nebulizers are there?

There are two main types of nebulizers: jet and ultrasonic devices.

Jet nebulizers form droplets by using a compressor to deliver a pressurized jet stream of air down a narrow tube and through an opening. This creates a vacuum (through the Venturi effect), thus drawing liquid from a reservoir. The resultant small droplets of liquid are propelled out of the machine by the continued jet stream.

Ultrasonic nebulizers produce aerosolized droplets using high-frequency sound waves generated by a special crystal. Liquid drug is usually delivered to the crystal, where it forms a thin layer. Electricity excites the crystals, causing them to vibrate at extremely high frequency. This vibration forces the thin liquid layer through an adjacent mesh, creating a fine mist. Droplet size varies with the frequency of the sound waves created by the vibrating crystals.

3. Can PULMICORT RESPULES be used in any type of nebulizer?

No, PULMICORT RESPULES can only be used in jet nebulizers. Jet nebulizers are a commonly used device for all aerosolized medications and the only effective device for delivery of suspensions such as PULMICORT RESPULES. Because of their physical characteristics, suspended drug particles are generally poorly nebulized in ultrasonic devices.

4. Can multiple nebulized medicines be combined with PULMICORT RESPULES?

No, PULMICORT RESPULES, when mixed with other nebulized medications, has not been adequately accessed. PULMICORT RESPULES should be administered separately in the nebulizer.

Indication and Important Safety Information

PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children ages 12 months to 8 years.

PULMICORT RESPULES is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm.

Common adverse events reported in clinical trials, regardless of relationship to treatment, included respiratory infection, rhinitis, coughing, otitis media, viral infection, gastroenteritis, ear infection, oral thrush/candidiasis, and epistaxis.

Inhaled corticosteroids may cause a reduction in growth velocity. The long-term effect on final adult height is unknown.

PULMICORT RESPULES, like other inhaled corticosteroids, may impact the hypothalamic-pituitary-adrenal axis, especially in susceptible individuals, in young children, and in patients given high doses for prolonged periods.

Particular care is needed for patients who are transferred from systemically active corticosteroids to less systemically available corticosteroids, because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids (see WARNINGS in full Prescribing Information).

Patients taking immunosuppressant doses of corticosteroids should avoid exposure to infections such as chicken pox and measles.

[Please see accompanying full Prescribing Information (PDF).]

References

  1. Kofman C, Berlinski A, Zaragoza S, et al. Aerosol therapy for pediatric outpatients. RT: J Respir Care Pract. 2004;117:26-28.