32 mcg
(n=146)
%
fluticasone
propionate
/salmeterol
MDPI
55/14 mcg
(n=128)
%
fluticasone
propionate
/salmeterol
MDPI
113/14 mcg
(n=269)
%
fluticasone
propionate
/salmeterol
MDPI
232/14 mcg
(n=145)
%
Placebo
(n=273)
%
Nasopharyngitis 5.4 5.8 4.8 8.6 4.8 6.9 4.4
Oral candidiasis* 3.1 2.9 4.8 1.6 2.2 3.4 0.7
Headache 1.6 7.3 4.8 5.5 4.8 2.8 4.4
Cough 1.6 1.8 3.4 2.3 3.7 0.7 2.6
Back pain 0 1.5 1.4 3.1 0.7 0 1.8
*Oral candidiasis includes oropharyngeal candidiasis, oral fungal infection, and oropharyngitis fungalOther adverse reactions not previously listed (and occurring in <3% of patients and in three ormore patients on fluticasone propionate/salmeterol MDPI) that were reported more frequently bypatients with asthma treated with fluticasone propionate/salmeterol MDPI compared withpatients treated with placebo include the following:
Sinusitis, oropharyngeal pain, pharyngitis, dizziness, influenza, rhinitis allergic, respiratorytract infection, rhinitis, nasal congestion, abdominal pain upper, myalgia, pain in extremity,dyspepsia, laceration, dermatitis contact, and palpitations.Long Term Safety Study. This was a 26-week, open labeled study of 674 patientspreviouslytreated with ICS who were treated twice daily with fluticasone propionate MDPI 113 mcg or 232mcg; fluticasone propionate/salmeterol MDPI 113/14 mcg or 232/14 mcg; fluticasone propionateinhalation aerosol 110 mcg or 220 mcg; fluticasone propionate and salmeterol inhalation powder(250/50 mcg), or fluticasone propionate and salmeterol inhalation powder (500/50 mcg). Thetypes of adverse reactions were similar to those reported above in placebo-controlled studies.
6.2 Postmarketing ExperienceIn addition to adverse reactions reported from clinical trials, the following adverse reactions havebeen identified during post approval use of fluticasone propionate and/or salmeterol regardless ofindication. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness,frequency of reporting, or causal connection to fluticasone propionate and/or salmeterol or a
combination of these factors.
Cardiac Disorders: Arrhythmias (including atrial fibrillation, extrasystoles, supraventriculartachycardia), ventricular tachycardia.
Endocrine Disorders: Cushing’s syndrome, Cushingoid features, growth velocity reduction inchildren/adolescents, hypercorticism.
Eye Disorders: Glaucoma, blurred vision and central serous chorioretinopathy.
Gastrointestinal Disorders: Abdominal pain, dyspepsia, xerostomia.
Immune System Disorders: Immediate and delayed hypersensitivity reaction (including very rareanaphylactic reaction). Very rare anaphylactic reaction in patients with severe milk proteinallergy.
Infections and Infestations: Esophageal candidiasis.
Metabolic and Nutrition Disorders: Hyperglycemia, weight gain.
Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, cramps, myositis,osteoporosis.
Nervous System Disorders: Paresthesia, restlessness.
Psychiatric Disorders: Agitation, aggression, depression. Behavioral changes, includinghyperactivity and i |
