FLOVENT HFA has been evaluated for safety in 56 pediatric subjects who received 88 mcg twice daily for 4 weeks. The effects on growth velocity of treatment with orally inhaled corticosteroids for over 1 year, including the impact on final adult height, are unknown. 28 and FLOVENT HFA 220 mcg Inhalation Aerosol are pressurized, metered-dose aerosol units 29 intended for oral inhalation only. Prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy with FLOVENT HFA.
Fluticasone propionate is weakly and reversibly bound to erythrocytes and is not significantly bound to human transcortin.The total clearance of fluticasone propionate is high (average, 1,093 mL/min), with renal clearance accounting for <0.02% of the total. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.FLOVENT HFA is a prescription inhaled corticosteroid (ICS) medicine used for the long-term treatment of asthma in people aged 4 years and older.Know the medicines you take. The clinical significance of small changes in BMD with regard to long-term consequences such as fracture is unknown. Monitor the growth of pediatric patients receiving FLOVENT HFA routinely (e.g., via stadiometry). Types of adverse reactions in these pediatric subjects were generally similar to those observed in adults and adolescents.In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of fluticasone propionate. Cases of serious eosinophilic conditions have also been reported with other ICS in this clinical setting. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 spray into the air away from the face.The starting dosage is based on previous asthma therapy and asthma severity, including consideration of patients’ current control of asthma symptoms and risk of future exacerbation. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.Patients who have been previously maintained on 20 mg or more of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. [see Drug Interactions (7.1), Clinical Pharmacology (12.3)]Table 1. During such episodes, patients may require therapy with oral corticosteroids.Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. 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).
If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. Manufacturing Quality. Hepatic impairment: Monitor patients for signs of increased drug exposure. Trials using oral dosing of labeled and unlabeled drug have demonstrated that the oral systemic bioavailability of fluticasone propionate is negligible (<1%), primarily due to incomplete absorption and presystemic metabolism in the gut and liver. However, fluticasone propionate concentrations in plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low The safety and effectiveness of FLOVENT HFA in children aged 4 years and older have been established Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.Aphonia, facial and oropharyngeal edema, and throat soreness and irritation.Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, osteoporosis, and weight gain.Immediate and delayed hypersensitivity reactions, including urticaria, anaphylaxis, rash, and angioedema and bronchospasm, have been reported.Agitation, aggression, anxiety, depression, and restlessness. FLOVENT HFA 220 mcg is supplied in 12-g pressurized aluminum canisters containing 120 metered actuations in boxes of 1 (NDC 0173-0720-20). Patients should discontinue FLOVENT HFA if such reactions occur.Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk.Inform patients that orally inhaled corticosteroids, including FLOVENT HFA, may cause a reduction in growth velocity when administered to pediatric patients. Each inhaler is packaged with a Patient Information leaflet.
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