Medically reviewed by Drugs.com. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0601-02). Following orally inhaled fluticasone propionate alone, AUC(2-last) averaged 1.559 ng•h/mL (range: 0.555 to 2.906 ng•h/mL) and AUC(2-∞) averaged 2.269 ng•h/mL (range: 0.836 to 3.707 ng•h/mL). Plasma fluticasone propionate concentrations following fluticasone propionate aqueous nasal spray alone were undetectable (<10 pg/mL) in most subjects, and when concentrations were detectable, peak levels (Cmax) averaged 11.9 pg/mL (range: 10.8 to 14.1 pg/mL) and AUC(0-τ) averaged 8.43 pg•h/mL (range: 4.2 to 18.8 pg•h/mL). Flovent HFA, Flovent Diskus. In this trial, doses of fluticasone propionate inhalation powder 50 and 100 mcg twice daily significantly improved FEV1 (15% and 18% change from baseline at Endpoint, respectively) compared with placebo (7% change). Fluticasone propionate AUC(2-last) and AUC(2-∞) increased to 2.781 ng•h/mL (range: 2.489 to 8.486 ng•h/mL) and 4.317 ng•h/mL (range: 3.256 to 9.408 ng•h/mL), respectively, after coadministration of ketoconazole with orally inhaled fluticasone propionate. The maximum recommended dosage for patients aged 12 years and older is 1,000 mcg twice daily. In an embryofetal development study in pregnant rabbits that were dosed by the subcutaneous route throughout organogenesis, fluticasone propionate produced reductions of fetal body weights, in the presence of maternal toxicity, at doses approximately 0.006 times the MRHDID and higher (on a mcg/m2 basis with a maternal subcutaneous dose of 0.57 mcg/kg/day). Omphalocele, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, at a dose approximately 0.5 times the MRHDID (on a mcg/m2 basis with a maternal subcutaneous dose of 100 mcg/kg/day). Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, and osteoporosis. There are clinical considerations with the use of Flovent Diskus in pregnant women. fungal infection in your mouth or throat (thrush). A total of 592 subjects aged 4 to 11 years were treated with Flovent Diskus (dosages of 50 or 100 mcg twice daily) or placebo; an additional 174 subjects aged 4 to 11 years received FLOVENT ROTADISK (fluticasone propionate inhalation powder) at the same doses. Flovent Diskus 100 mcg is supplied as a disposable orange plastic inhaler containing a foil blister strip with 60 blisters. What are the ingredients in Flovent Diskus? Subjects on all dosages of Flovent Diskus were also less likely to discontinue study participation due to asthma deterioration (as defined by predetermined criteria for lack of efficacy including lung function and subject-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma) compared with placebo. In children with asthma aged 4 and 8 years, mean PIF through Flovent Diskus was 70 and 104 L/min, respectively (range: 48 to 123 L/min). Patients should discontinue Flovent Diskus if such reactions occur. Figures 1 through 4 display results of pulmonary function tests (mean percent change from baseline in FEV1 prior to AM dose) for 3 recommended dosages of Flovent Diskus (100, 250, and 500 mcg twice daily) and placebo from the four 12-week trials in adolescents and adults. bone thinning or weakness (osteoporosis). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies. Flovent HFA is available in 44-microgram (mcg), 110-mcg, and 220-mcg strengths. 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). An imbalance in the proportion of children entering puberty between groups and a higher dropout rate in the placebo group due to poorly controlled asthma may be confounding factors in interpreting these data. Flovent Diskus and certain other medicines may interact with each other. This is particularly important for children as Flovent's effects on the adrenal glandmay impair their growth, though the risk is considered low because the drug is inhaled … The recommended starting dosage and the highest recommended dosage of FLOVENT HFA, based on prior asthma therapy, are listed in Table 1. The volume of distribution averaged 4.2 L/kg. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Flovent Diskus long term. Arnuity Ellipta; Flovent; Flovent Rotadisk; Canadian Brand Name. Skin: Pruritus (6% and 0%) and skin rashes (8% and 3%). Lung function (mean forced expiratory volume in 1 second [FEV1] or morning peak expiratory flow [AM PEF]), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. The incidence of abnormal tests at 500 mcg twice daily was greater than placebo. You may report side effects to FDA at 1-800-FDA-1088. Call your doctor at once if you have: weakness, tired feeling, nausea, vomiting, feeling like you might pass out; wheezing, choking, or other breathing problems after using Flovent Diskus; Flovent Diskus Prices and Coupons. Advise the patient to rinse his/her mouth with water without swallowing following inhalation to help reduce the risk of oropharyngeal candidiasis. Human Data: Following inhaled administration, fluticasone propionate was detected in the neonatal cord blood after delivery. Since fluticasone propionate is predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate in plasma. A total of 592 subjects aged 4 to 11 years were treated with FLOVENT DISKUS (dosages of 50 or 100 mcg twice daily) or placebo; an additional 174 subjects aged 4 to 11 years received … The maximum recommended dosage for patients aged 12 years and older is 1,000 mcg twice daily. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief. Store in a dry place away from direct heat or sunlight. Patients should be instructed to contact their physicians immediately when episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with Flovent Diskus. Inhalation powder: Inhaler containing a foil blister strip of powder formulation for oral inhalation. No subject on placebo had an abnormal response at 1 or 2 years. Tell your healthcare provider about all the medicines you take. Know the medicines you take. This effect was observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. Flovent Diskus should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use. Adverse events, whether or not considered drug related by the investigators, reported in more than 5 subjects in the group taking Flovent Diskus and that occurred more frequently with Flovent Diskus than with placebo are shown below (percent Flovent Diskus and percent placebo). Flovent Diskus 250 mcg is supplied as a disposable orange plastic inhaler containing a foil blister strip with 60 blisters. Flovent Diskus. Oral candidiasis (<31%) Throat irritation (3-22%) Upper respiratory tract infection (16-18%) Fatigue or malaise (16%) Nasal congestion (16%) Rhinitis (≤13%) Musculoskeletal pain (2-12%) Headache (5-11%) When you are ready to take your next scheduled dose in about 12 hours, repeat Steps 1 through 5. We comply with the HONcode standard for trustworthy health information -. Table 1. Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Lower Respiratory: Cough (9% and 3%) and viral respiratory infections (9% and 6%). Non-Site Specific: Malaise and fatigue (16% and 9%) and pain (10% and 3%). Since individual sensitivity to effects on cortisol production exists, physicians should consider this information when prescribing Flovent Diskus. Should be administered by the orally inhaled corticosteroids or Bronchodilators Alone for placebo for medical advice, diagnosis or.... 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