Another subject receiving fluticasone propionate (5%) had an abnormal response at 2 years. In an embryofetal development study with pregnant rats dosed by the inhalation route throughout the period of organogenesis, fluticasone propionate produced decreased fetal body weights and skeletal variations, in the presence of maternal toxicity, at a dose approximately 0.25 times the MRHDID (on a mcg/m2 basis with a maternal inhalation dose of 25.7 mcg/kg/day); however, there was no evidence of teratogenicity. No clastogenic activity occurred in vitro in human lymphocytes or in vivo in a rat micronucleus test. The average duration of exposure to fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg was 141.3 days compared with 131.6 days for placebo. Fluticasone propionate aqueous nasal spray (200 mcg once daily) was coadministered for 7 days with ritonavir (100 mg twice daily). The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. The mean fluticasone propionate plasma concentration was 110 pg/mL. Call your doctor for medical advice about side effects. Inform patients that fluticasone propionate and salmeterol inhalation powder is not meant to relieve acute asthma symptoms or exacerbations of COPD and extra doses should not be used for that purpose. Check with your doctor right away if you or your child are having a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine. an infection due to a parasite. Each subject who withdrew from double-blind treatment for any reason was followed for the full 3-year trial period to determine survival status. The recommended dosage for patients with COPD is 1 inhalation of fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg twice daily, approximately 12 hours apart. National funding/access decisions . The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0054-0326-56). In addition, beta‑agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. In addition, there were no clinically relevant changes noted in glucose or potassium. There were no clinically relevant changes in these trials. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. The primary safety endpoint for all 4 trials was serious asthma-related events (hospitalizations, intubations, death). In addition, pneumonia was reported in a significantly increased number of subjects treated with fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg and fluticasone propionate 500 mcg (16% and 14%, respectively) compared with subjects treated with salmeterol 50 mcg or placebo (11% and 9%, respectively). In rare cases, patients on inhaled fluticasone propionate, a component of fluticasone propionate and salmeterol inhalation powder, may present with systemic eosinophilic conditions. 4.3 Contraindications. A separate subset analysis of children who remained prepubertal during the trial revealed growth rates at 52 weeks of 6.10 cm/year in the placebo group (n = 57), 5.91 cm/year in the 50-mcg group (n = 74), and 5.67 cm/year in the 100-mcg group (n = 79). The clinical significance of small changes in BMD with regard to long-term consequences such as fracture is unknown. The subjective impact of asthma on subjects’ perception of health was evaluated through use of an instrument called the Asthma Quality of Life Questionnaire (AQLQ) (based on a 7-point scale where 1 = maximum impairment and 7 = none). How should I use fluticasone propionate and salmeterol inhalation powder? Mean peak plasma concentrations of fluticasone propionate averaged 107, 94, and 120 pg/mL, respectively, indicating no significant changes in systemic exposures of fluticasone propionate. The ECG changes and/or hypokalemia that may result from the administration of non–potassium‑ sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, such as salmeterol, a component of fluticasone propionate and salmeterol inhalation powder, especially when the recommended dose of the beta-agonist is exceeded. These included precocious eyelid openings, cleft palate, sternebral fusion, limb and paw flexures, and delayed ossification of the frontal cranial bones. Concomitant Use of Fluticasone Propionate and Salmeterol Inhalation Powder with Other Respiratory Medicines: Short-acting Beta2-agonists: In clinical trials in subjects with asthma, the mean daily need for albuterol by 166 adult and adolescent subjects aged 12 years and older using fluticasone propionate and salmeterol inhalation powder was approximately 1.3 inhalations/day and ranged from 0 to 9 inhalations/day. Patients with Hepatic and Renal Impairment: Formal pharmacokinetic studies using fluticasone propionate and salmeterol inhalation powder have not been conducted in patients with hepatic or renal impairment. Therefore, patients with hepatic disease should be closely monitored. The other active component of fluticasone propionate and salmeterol inhalation powder is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Pressurised inhalation; Inhalation powder; Pressurised inhalation All products. Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Label 8 - Warning: Do not stop taking this medicine unless your doctor tells you to stop . No increase in frequency of cardiovascular adverse events was observed among subjects who averaged 6 or more inhalations per day. Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects [see Clinical Pharmacology (12.2)]. However, in clinical trials of up to 12 weeks’ duration comparing fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg and FLOVENT DISKUS 100 mcg in adolescents and adults, no differences in systemic effects of corticosteroid treatment (e.g., HPA axis effects) were observed. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Fluticasone propionate and salmeterol inhalation powder contains both fluticasone propionate and salmeterol; therefore, the risks associated with overdosage for the individual components described below apply to fluticasone propionate and salmeterol inhalation powder. In a clinical trial in subjects with COPD, 17 subjects receiving fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg twice daily concurrently with a theophylline product had adverse event rates similar to those in 161 subjects receiving fluticasone propionate and salmeterol inhalation powder without theophylline. 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