led sympathomimetic drugs.
5.12 Reduction in Bone Mineral Density
Decreases in bone mineral density (BMD) have been observed with long-term administration ofproducts containing inhaled corticosteroids. The clinical significance of small changes in BMDwith regard to long-term consequences such as fracture is unknown. Patients with major riskfactors for decreased bone mineral content, such as prolonged immobilization, family history ofosteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oralcorticosteroids) should be monitored and treated with established standards of care.
5.13 Effect on Growth
Orally inhaled corticosteroids, including AirDuo Digihaler, may cause a reduction in growthvelocity when administered to pediatric patients. Monitor the growth of pediatric patientsreceiving AirDuo Digihaler routinely (e.g., via stadiometry). To minimize the systemic effects oforally inhaled corticosteroids, including AirDuo Digihaler, titrate each patient’s dosage to thelowest dosage that effectively controls his/her symptoms [see Dosage and Administration (2),Use in Specific Populations (8.4)].
5.14 Glaucoma and Cataracts
Glaucoma, increased intraocular pressure, and cataracts have been reported in patients followingthe long-term administration of inhaled corticosteroids, including fluticasone propionate, acomponent of AirDuo Digihaler. Therefore, close monitoring is warranted in patients with achange in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Effects of treatment with other Fluticasone Propionate and Salmeterol Inhalation Powder 500/50,fluticasone propionate 500 mcg, salmeterol 50 mcg, or placebo on development of cataracts orglaucoma was eva luated in a subset of 658 subjects with COPD in the 3-year survival trial.
Ophthalmic examinations were conducted at baseline and at 48, 108, and 158 weeks.Conclusions about cataracts cannot be drawn from this trial because the high incidence ocataracts at baseline (61% to 71%) resulted in an inadequate number of subjects treated withother Fluticasone Propionate and Salmeterol Inhalation Powder 500/50 who were eligible andavailable for eva luation of cataracts at the end of the trial (n = 53). The incidence of newlydiagnosed glaucoma was 2% with other Fluticasone Propionate and Salmeterol InhalationPowder 500/50, 5% with fluticasone propionate, 0% with salmeterol, and 2% with placebo.
5.15 Eosinophilic Conditions and Churg-Strauss Syndrome
In rare cases, patients on inhaled fluticasone propionate, a component of AirDuo Digihaler, maypresent with systemic eosinophilic conditions. Some of these patients have clinical features ofvasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemiccorticosteroid therapy. These events usually, but not always, have been associated with thereduction and/or withdrawal of oral corticosteroid therapy following the introduction of fluticasone propionate. Cases of serious eosinophilic conditions have also been reported withother inhaled corticosteroids in this clinical setting. Physicians should be alert to eosinophilia,vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathypresenting in their patients. A causal relationship between fluticasone propionate and theseunderlying conditions has not been established.
5.16 Coexisting Condit |
