Salmeterol/fluticasone propionate
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Lareb. Inhaled and intransal fluticasone propionate and haematoma. Internet Document : [5 pages], May 2008. Available from: URL: http://www.lareb.nl 801112124 Netherlands
Salmeterol/fluticasone propionate Haematoma and purpura following inhalation and/or intranasal administration: 18 case reports Twelve patients (patients 1–12) developed haematoma during treatment with salmeterol/fluticasone propionate via inhalation, fluticasone propionate via inhalation or nose spray, or a combination of both drugs; another six patients (patients 13–18) developed purpura while receiving inhaled fluticasone propionate [see table].
Patient characteristics Patient/ agea/sex
Drugs, dosage and therapeutic indicationb
Time to onset
1/53/F
S/FP (powder; 50/250µg twice daily) FP (nose spray; 50µg twice daily) Nasal polyps FP (powder; 500µg twice daily) FP (powder and nose spray) CARA S/FP (aerosol; 50/250µg twice daily) FP (nose spray; 50µg once daily) Allergic rhinitis S/FP (aerosol; 50/250µg twice daily)
9 years
2/31/F 3/71/M 4/49/F 5/65/F 6/70/F 7/62/M 8/47/F 9/14/F
10/50/F 11/78/F 12/51/F 13/72/M 14/11/M 15/71/M 16/8/F 17/69/F 18/66/F
S/FP (powder; 50/250µg twice daily) Asthma S/FP (powder; 50/500µg twice daily) COPD S/FP (aerosol; 50/250µg twice daily) FP Asthma S/FP (powder; 50/250µg once daily) COPD S/FP (aerosol; 50/250µg twice daily) Dyspnea, COPD S/FP (powder; 50/500µg) COPD FP (powder: 400 µg/day) COPD FP (aerosol; 50µg twice daily) FP (nose spray; 2 x 50µg twice daily) FP (powder; 500µg twice daily) FP (powder; 250µg twice daily) FP (powder; 500µg twice daily) FP (nose spray; 50µg twice daily) FP (powder; 500µg twice daily)
years unknown unknown unknown soon after initiation 2 years 2 years 8 days
2 days 39 days 14 days 1 year unknown NA unknown days years
CARA: unspecific chronic respiratory disease; COPD: chronic obstructive pulmonary disease; FP: fluticasone propionate; S/FP: salbutamol/fluticasone propionate; NA: not applicable a years b [Dosage and therapeutic indication not stated for all patients]
Apart from patient 15, all patients were receiving fluticasone propionate-containing drugs at the time of haematoma or purpura development. Patient 15 developed purpura after treatment discontinuation. After symptom onset, fluticasone propionate and/or salmeterol/fluticasone propionate was withdrawn in patients 1, 8, 10 and 12, and the dosage was reduced in patients 17 and 18; it was unknown if therapy was changed in patient 5. Patient 4 had a history of prior, less extensive, haematomas while receiving beclometasone. Concomitant beclometasone was withdrawn in patient 7. Patient 11 had previously received prednisone, and patients 5, 13–15 and 17 were receiving potentially confounding concomitant medications such as prednisone or NSAIDs; in patient 14, purpura developed after montelukast initiation. Patients 9 and 13 recovered, and patients 1, 7 and 17 had partial recoveries; the outcome was not stated or unknown for patients 3, 5, 11, 12, 15 and 18. The remaining patients had not recovered at last observation
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