Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. ], Inform patients that orally inhaled corticosteroids, including fluticasone propionate, may cause a reduction in growth velocity when administered to pediatric patients. Compared with fluticasone propionate CFC inhalation aerosol, Advair HFA had less effect on 24-hour urinary cortisol excretion and less or comparable effect on 24-hour serum cortisol. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. Prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy with Advair HFA. Concomitant Use of Advair HFA with Other Respiratory Medicines. Programme structure. Peak plasma salmeterol concentrations were increased by 1.4-fold (90% CI: 1.23, 1.68). Lower respiratory tract infections, including pneumonia, have been reported in patients with chronic obstructive pulmonary disease (COPD) following the inhaled administration of corticosteroids, including fluticasone propionate and Advair DISKUS. However, these events have occurred in a few patients with less severe asthma as well. Each individual trial met its pre-specified objective and demonstrated non-inferiority of ICS/LABA to ICS alone. Before using Advair HFA, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These medications can cause further narrowing and can lead to blockage of the eye's drainage system. For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, replacing the current strength of Advair HFA with a higher strength may provide additional improvement in asthma control. "There is a . Formal pharmacokinetic studies using Advair HFA have not been conducted in patients with renal impairment. Exposure to temperatures above 120F may cause bursting. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of fluticasone propionate. ICS/LABA did not show a significantly increased risk of a serious asthma-related event compared with ICS based on the pre-specified risk margin (2.7), with an estimated hazard ratio of time to first event of 1.29 (95% CI: 0.73, 2.27). Fluticasone Propionate: Healthy Subjects: Patients with Hepatic and Renal Impairment: Inhibitors of Cytochrome P450 3A4: Ritonavir: Fluticasone Propionate: 2-agonists (Albuterol or Salmeterol) or Inhaled Corticosteroids (Trial 1), 2agonists (Albuterol or Salmeterol) or Inhaled Corticosteroids (Trial 1), Advair HFA is not used to relieve sudden breathing problems. Patients should taper slowly from systemic corticosteroids if transferring to Advair HFA. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Each actuation delivers 115 mcg of fluticasone propionate and 30.45 mcg of salmeterol xinafoate equivalent to 21 mcg of salmeterol base from the mouthpiece. A 2-year trial in 160 subjects (females aged 18 to 40 years, males 18 to 50) with asthma receiving chlorofluorocarbon (CFC)-propelled fluticasone propionate inhalation aerosol 88 or 440 mcg twice daily demonstrated no statistically significant changes in BMD at any time point (24, 52, 76, and 104 weeks of double-blind treatment) as assessed by dual-energy x-ray absorptiometry at lumbar regions L1 through L4. ADVAIR HFA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta. It works by relaxing muscles in the airways to improve breathing. 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. No significant clastogenic effect was seen in cultured human peripheral lymphocytes in vitro or in the in vivo mouse micronucleus test. In Trial 3, there were more reports of hyperglycemia among adults and adolescents receiving Advair HFA, but this was not seen in Trials 1 and 2. The clinical relevance of these findings is unknown. Monitor the growth of pediatric patients receiving Advair HFA routinely (e.g., via stadiometry). Advair Diskus: For preventing an asthma attack: Adults and children 12 years of age and older1 inhalation 2 times per day (morning and evening). The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. avoid combo: combo may incr. 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. Ketoconazole, a strong inhibitor of CYP3A4, essentially completely inhibited the formation of -hydroxysalmeterol in vitro. All metered-dose inhaler treatments were inhalation aerosols given as 2 inhalations twice daily, and other maintenance therapies were discontinued. Less than 5% of a radiolabeled oral dose was excreted in the urine as metabolites, with the remainder excreted in the feces as parent drug and metabolites. [See Warnings and Precautions (5.12). ], Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. Therefore, Advair HFA, like all products containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. 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)]. Patients using Advair HFA should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason. The contents of your Advair HFA are under pressure: Do not. This placebo-controlled, 12-week, U.S. trial compared Advair HFA 115 mcg/21 mcg with fluticasone propionate CFC inhalation aerosol 110 mcg or salmeterol CFC inhalation aerosol 21 mcg, each given as 2 inhalations twice daily, in 365 subjects using ICS (daily doses of beclomethasone dipropionate 378 to 840 mcg; budesonide 800 to 1,200 mcg; flunisolide 1,250 to 2,000 mcg; fluticasone propionate inhalation aerosol 440 to 660 mcg; fluticasone propionate inhalation powder 400 to 600 mcg; or triamcinolone acetonide 900 to 1,600 mcg). 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. Clinically significant changes in blood glucose and/or serum potassium were seen infrequently during clinical trials with Advair HFA at recommended doses. The primary efficacy endpoint was morning PEF. [See Warnings and Precautions (5.2). No formal drug interaction trials have been performed with Advair HFA. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushings syndrome and adrenal suppression. Oral administration of salmeterol to pregnant rabbits caused teratogenicity characteristic of beta-adrenoceptor stimulation at maternal doses approximately 25 times the MRHDID on an AUC basis. 3, LT-09601 Vilnius. Systemic exposure (AUC) to fluticasone propionate was similar for Advair HFA (274 pgh/mL [95% CI: 150, 502]) and Advair DISKUS (338 pgh/mL [95% CI: 197, 581]). weakened immune system and increased chance of getting infections (immunosuppression). An in vitro study using human liver microsomes showed that salmeterol is extensively metabolized to -hydroxysalmeterol (aliphatic oxidation) by CYP3A4. Inflammation is an important component in the pathogenesis of asthma. If paradoxical bronchospasm occurs following dosing with Advair HFA, it should be treated immediately with an inhaled, short-acting bronchodilator; Advair HFA should be discontinued immediately; and alternative therapy should be instituted. In a 12-week trial, the safety of Advair HFA 45 mcg/21 mcg given as 2 inhalations twice daily was compared with that of fluticasone propionate 44 mcg HFA (FLOVENT HFA) 2 inhalations twice daily in 350 subjects aged 4 to 11 years with persistent asthma currently being treated with ICS. The current match involves a Texas lawsuit . Peak plasma concentrations of fluticasone propionate (N = 20 subjects) following 8 inhalations of Advair HFA 45 mcg/21 mcg, Advair HFA 115 mcg/21 mcg, and Advair HFA 230 mcg/21 mcg averaged 41, 108, and 173 pg/mL, respectively. Advair HFA has a counter attached to the canister. The primary safety endpoint for all 4 trials was serious asthma-related events (hospitalizations, intubations, death). However, since both fluticasone propionate and salmeterol are predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate and salmeterol in plasma. Excessive beta-adrenergic stimulation has been associated with seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia [see Overdosage (10)]. Metabolism: Fluticasone Propionate: The only circulating metabolite detected in man is the 17-carboxylic acid derivative of fluticasone propionate, which is formed through the CYP3A4 pathway. Dosage forms: CAP: 10 mg; TAB: 5 mg, 10 mg; ODT: 10 mg; CHEWABLE: 5 mg, 10 mg; SOL: 1 mg per mL allergy sx [5-10 mg PO qd prn] Max: 10 mg/day; 5 mg/day in pts 65 yo and older *chronic idiopathic urticaria [5-10 mg PO qd] Info: some pts may benefit from higher doses, weigh risk/benefit renal dosing [allergy sx] CrCl <30: 5 mg qd prn Use of background ICS was not required in SMART. Salmeterol: In a placebo-controlled, crossover drug interaction trial in 20 healthy male and female subjects, coadministration of salmeterol (50 mcg twice daily) and the strong CYP3A4 inhibitor ketoconazole (400 mg once daily) for 7 days resulted in a significant increase in plasma salmeterol exposure as determined by a 16-fold increase in AUC (ratio with and without ketoconazole 15.76 [90% CI: 10.66, 23.31]) mainly due to increased bioavailability of the swallowed portion of the dose. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Cushings syndrome, Cushingoid features, growth velocity reduction in children/adolescents, hypercorticism, osteoporosis. Four (4) double-blind, parallel-group clinical trials were conducted with Advair HFA in 1,517 adult and adolescent subjects (aged 12 years and older, mean baseline FEV1 65% to 75% of predicted normal) with asthma that was not optimally controlled on their current therapy. Although the clinical significance of these effects is not known, caution is advised in the coadministration of Advair HFA with nonpotassium-sparing diuretics. Available for Android and iOS devices. ], Advise patients that Advair HFA may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. In contrast, the majority of the fluticasone propionate delivered to the lung is systemically absorbed. Fertility and reproductive performance were unaffected in male and female rats at subcutaneous doses up to 50 mcg/kg (approximately 0.5 times the MRHDID for adults on a mcg/m2 basis). In a 2-year trial carried out with the DISKHALER inhalation device in 64 subjects with mild, persistent asthma (mean FEV1 91% of predicted) randomized to fluticasone propionate 500 mcg twice daily or placebo, no subject receiving fluticasone propionate had an abnormal response to 6-hour cosyntropin infusion (peak serum cortisol <18 mcg/dL). Package insert / product label If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. The effects of rising inhaled doses of salmeterol and standard inhaled doses of albuterol were studied in volunteers and in subjects with asthma. Two percent (2%) of subjects receiving Advair HFA in these trials averaged 6 or more inhalations per day over the course of the 12-week trials. How should this medicine be used? The safety and effectiveness of Advair HFA in pediatric patients younger than 12 years have not been established. See prescribing information for dosage information. Salmeterol is in a class of medications called long-acting beta-agonists (LABAs). Twenty-one micrograms (21 mcg) of salmeterol base is equivalent to 30.45 mcg of salmeterol xinafoate. Below you'll find the dos and don'ts of using CBD along with medications. This active-controlled, 12-week, non-U.S. trial compared Advair HFA 230 mcg/21 mcg with fluticasone propionate CFC inhalation aerosol 220 mcg, each given as 2 inhalations twice daily, and with Advair DISKUS 500 mcg/50 mcg given as 1 inhalation twice daily in 509 subjects using ICS (daily doses of beclomethasone dipropionate CFC inhalation aerosol 1,500 to 2,000 mcg; budesonide 1,500 to 2,000 mcg; flunisolide 1,500 to 2,000 mcg; fluticasone propionate inhalation aerosol 660 to 880 mcg; or fluticasone propionate inhalation powder 750 to 1,000 mcg). Arrhythmias (including atrial fibrillation, extrasystoles, supraventricular tachycardia), hypertension, ventricular tachycardia. The incidence of pneumonia in the subjects treated with Advair DISKUS was higher in subjects older than 65 years (9%) compared with the incidence in subjects younger than 65 years (4%). If chickenpox develops, treatment with antiviral agents may be considered. tobramycin inhaled. The clinical significance of these findings is unknown. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. There were no obvious differences in the type or frequency of adverse events reported in this age group compared with subjects aged 18 years and older. Trial 4: Clinical Trial with Advair HFA 230 mcg/21 mcg. The effect of 21 days of treatment with Advair HFA 45 mcg/21 mcg (2 inhalations twice daily with or without a spacer) or Advair DISKUS 100 mcg/50 mcg (1 inhalation twice daily) was evaluated in a trial of 31 children aged 4 to 11 years with mild asthma. In 2 replicate 1-year trials in 1,579 subjects with COPD, there was a higher incidence of pneumonia reported in subjects receiving Advair DISKUS 250 mcg/50 mcg (7%) than in those receiving salmeterol 50 mcg (3%). Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma following the long-term administration of ICS, including fluticasone propionate, a component of Advair HFA. The actual amount of drug delivered to the lung will depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. Subjects with Asthma: Hypothalamic-Pituitary-Adrenal Axis Effects: In clinical trials with fluticasone propionate inhalation powder using dosages up to and including 250 mcg twice daily, occasional abnormal short cosyntropin tests (peak serum cortisol <18 mcg/dL assessed by radioimmunoassay) were noted both in subjects receiving fluticasone propionate and in subjects receiving placebo. Cleft palate and fetal skeletal variations were observed in mouse fetuses at a dose approximately 0.2 times the MRHDID (on a mcg/m2 basis with a maternal subcutaneous dose of 45 mcg/kg/day). It is usually taken at the same time as ritonavir (Norvir) two times a day within 2 hours after a full meal. Advair Diskus should not be used to treat acute episodes of asthma or COPD. Fertility and reproductive performance were unaffected in male and female rats at oral doses up to 2,000 mcg/kg (approximately 230 times the MRHDID for adults on a mcg/m2 basis). Salmeterol: In 3 embryofetal development studies, pregnant rabbits received oral administration of salmeterol at doses ranging from 100 to 10,000 mcg/kg/day during the period of organogenesis. Advair HFA has been studied in subjects with asthma aged 12 years and older. 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