Corticosteroids used for asthma

There is no evidence of safe and effective use of topical corticosteroids in pregnant mothers. Therefore, they should be used only if clearly needed. Long term use and large applications of topical corticosteroids may cause birth defects in the unborn. It is not known whether topical corticosteroids enter breast milk. Therefore, caution must be exercised before using it in nursing mothers. Topical corticosteroids should not be applied to the breasts of nursing mothers unless the mothers instructed to do so by the physician.

The NIAMS gratefully acknowledges the assistance of the following individuals in the preparation and review of previous versions of this publication: Gayle Lester, ., Joan McGowan, ., James Panagis, ., Susana Serrate-Sztein, ., and Bernadette Tyree, ., NIAMS/NIH; Kenneth D. Brandt, ., Indiana University School of Medicine, Indianapolis, IN; Victor M. Goldberg, ., University Hospitals of Cleveland, OH; Marc C. Hochberg, ., ., University of Maryland, Baltimore, MD; John Klippel, ., Arthritis Foundation, Atlanta, GA; and Roland Moskowitz, ., Case Western Reserve University, Cleveland, OH. Special thanks also go to the patients who reviewed this publication and provided valuable input.

There is little evidence as to what percentage of a topical corticosteroid dose is absorbed systemically. Studies investigating systemic effects do not measure how much of the corticosteroid is in the blood, but instead focus on measuring cortisol as a marker of hypothalamic-pituitary-adrenal (HPA) axis suppression. After a few weeks’ treatment with potent or very potent topical corticosteroids temporary HPA axis suppression does occur. However, this resolves upon cessation of the topical corticosteroid, without the need for dose tapering. 5, 19 HPA axis suppression is more marked when topical corticosteroids are applied under occlusion, . with wet wraps.

Oral inhaled corticosteroids are important in the treatment of asthma since their delivery is targeted directly to the lung, which is the site of action. Triamcinolone acetonide (TAA) is an effective and safe corticosteroid that is marketed as a metered-dose inhaler (MDI) with an integrated spacer (Azmacort) for the treatment of asthma. Due to the phasing out of chlorofluorocarbon (CFC) propellants, Azmacort has been reformulated with a non-CFC propellant. Due to the complexities of oral inhaled formulations and the topical nature of drug delivery to the lung for efficacy, the reformulation of oral inhaled MDIs requires careful consideration and support throughout their development, using a combination of in vitro and in vivo studies to ensure clinical comparability for both efficacy and safety. This paper describes a chronological series of studies designed to support the reformulation of Azmacort. These included in vitro studies to estimate respirable fraction, in vivo pulmonary deposition studies, in vivo pharmacokinetic-pharmacodynamic studies to estimate the systemic effects of each formulation, and final clinical studies in adult and pediatric patients to confirm the clinical comparability of the new formulation of Azmacort. The results of these studies, performed at various stages during the development of new formulations, were critical in guiding the reformulation efforts for Azmacort.

Corticosteroids used for asthma

corticosteroids used for asthma

Oral inhaled corticosteroids are important in the treatment of asthma since their delivery is targeted directly to the lung, which is the site of action. Triamcinolone acetonide (TAA) is an effective and safe corticosteroid that is marketed as a metered-dose inhaler (MDI) with an integrated spacer (Azmacort) for the treatment of asthma. Due to the phasing out of chlorofluorocarbon (CFC) propellants, Azmacort has been reformulated with a non-CFC propellant. Due to the complexities of oral inhaled formulations and the topical nature of drug delivery to the lung for efficacy, the reformulation of oral inhaled MDIs requires careful consideration and support throughout their development, using a combination of in vitro and in vivo studies to ensure clinical comparability for both efficacy and safety. This paper describes a chronological series of studies designed to support the reformulation of Azmacort. These included in vitro studies to estimate respirable fraction, in vivo pulmonary deposition studies, in vivo pharmacokinetic-pharmacodynamic studies to estimate the systemic effects of each formulation, and final clinical studies in adult and pediatric patients to confirm the clinical comparability of the new formulation of Azmacort. The results of these studies, performed at various stages during the development of new formulations, were critical in guiding the reformulation efforts for Azmacort.

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