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Photo :ArmonAir Respiclick

destructive [3%:<1%), and the minimal pharmacological activity of the only metabolite detected in man. Pharmacodynamics ArmonAir Respiclick : Hypothalamic Pituitary Adrenal Axis Effects. The potential systemic effects of ArmonAir Respiclick on the HPA axis were not fully studied, but other clinical trials evaluated the systemic effects of fluticasone propionate inhalation powder on the HPA axis in healthy subjects and in subjects with asthma. ArmonAir Respiclick : Subjects with Asthma: Adults and Adolescents: Hypothalamic Pituitary Adrenal Axis Effects. There are no data regarding serum cortisol from controlled trials using ArmonAir Respiclick in healthy subjects or subjects with asthma. Pharmacokinetics Absorption Fluticasone propionate acts locally in the lung; therefore, plasma levels do not predict therapeutic effect. Trials using oral dosing of labeled and unlabeled drug have demonstrated that the oral systemic bioavailability of fluticasone propionate was negligible (> <1%), primarily due to incomplete absorption and presystemic metabolism in the gut and liver. In contrast, the majority of the fluticasone propionate delivered to the lung was systemically absorbed. Following ArmonAir Respiclick administration, the peak plasma concentration of fluticasone propionate occurs at approximately 1 hour after inhalation. The mean peak concentration following a 232 mcg single oral inhalation of ArmonAir Respiclick to patients 12 years and older with persistent asthma was 73 pg/mL. Distribution Following intravenous administration, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding. The volume of distribution averaged 4.2 L/kg. The percentage of fluticasone propionate bound to human plasma proteins averages 99%. Fluticasone propionate is weakly and reversibly bound to erythrocytes and is not significantly bound to human transcortin. Elimination Terminal half-life estimate of fluticasone propionate following oral inhalation administration of ArmonAir Respiclick was approximately 11.2 hours. Metabolism The total clearance of fluticasone propionate is high (average, 1,093 mL/min), with renal clearance accounting for less than 0.02% of the total. The only circulating metabolite detected in man is the 17β carboxylic acid derivative of fluticasone propionate, which is formed through the CYP3A4 pathway. This metabolite has less affinity (approximately 1/2,000) than the parent drug for the glucocorticoid receptor of human lung cytosol in vitro and negligible pharmacological activity in animal studies. Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man. Excretion Less than 5% of a radiolabeled oral dose of fluticasone propionate was excreted in the urine as metabolites, with the remainder excreted in the feces as parent drug and metabolites. Special Populations Age : No pharmacokinetic studies have been performed with ArmonAir Respiclick in children or geriatric patients. A subgroup analysis was conducted to compare patients aged 12-17 (n=16) and 18 (n=23) years following administration of 232 mcg ArmonAir Respiclick. No overall differences in fluticasone propionate pharmacokinetics were observed. Sex : A subgroup analysis was conducted to compare male (n=22) and female (n=17) patients following administration of 232 mcg ArmonAir Respiclick. No overall differences in fluticasone propionate pharmacokinetics were observed. Renal Impairment : The effect of renal impairment on the pharmacokinetics of ArmonAir Respiclick has not been evaluated. Hepatic Impairment : Formal pharmacokinetic studies using ArmonAir Respiclick have not been conducted in patients with hepatic impairment. However, since fluticasone propionate is predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate in plasma. Drug Interaction Studies : In vitro and in vivo drug interaction studies have not been conducted with ArmonAir Respiclick. Known clinically significant drug interactions are outlined in Drug Interactions ( 7 ) . Inhibitors of Cytochrome P450 3A4 : Ritonavir : Fluticasone propionate is a substrate of CYP3A4. Coadministration of fluticasone propionate and the strong CYP3A4 inhibitor ritonavir is not recommended based upon a multiple-dose, crossover drug interaction trial in 18 healthy subjects. Fluticasone propionate aqueous nasal spray (200 mcg once daily) was coadministered for 7 days with ritonavir (100 mg twice daily). 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 (C max ) 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). Fluticasone propionate C max and AUC 0-τ increased to 318 pg/mL (range: 110 to 648 pg/mL) and 3,102.6 pg h/mL (range: 1,207.1 to 5,662.0 pg h/mL), respectively, after coadministration of ritonavir with fluticasone propionate aqueous nasal spray. This significant increase in plasma fluticasone propionate exposure resulted in a significant decrease (86%) in serum cortisol AUC. Ketoconazole : In a placebo-controlled crossover trial in 8 healthy adult volunteers, coadministration of a single dose of orally inhaled fluticasone propionate (1,000 mcg) with multiple doses of ketoconazole (200 mg) to steady state resulted in increased plasma fluticasone propionate exposure, a reduction in plasma cortisol AUC, and no effect on urinary excretion of cortisol. 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). 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. This increase in plasma fluticasone propionate concentration resulted in a decrease (45%) in serum cortisol AUC. Erythromycin : In a multiple-dose drug interaction trial, coadministration of orally inhaled fluticasone propionate (500 mcg twice daily) and erythromycin (333 mg 3 times daily) did not affect fluticasone propionate pharmacokinetics. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Fluticasone propionate demonstrated no tumorigenic potential in mice at oral doses up to 1,000 mcg/kg (approximately 10 times the MRHDID for adults on a mcg/m 2 basis) for 78 weeks or in rats at inhalation doses up to 57 mcg/kg (approximately equivalent to the MRHDID for adults on a mcg/m 2 basis) for 104 weeks. Fluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic cells in vitro. No significant clastogenic effect was seen in cultured human peripheral lymphocytes in vitro or in the in vivo mouse micronucleus test. Fertility and reproductive performance were unaffected in male and female rats at subcutaneous doses up to 50 mcg/kg (approximately equivalent to the MRHDID for adults on a mcg/m 2 basis). Clinical Studies The safety and efficacy of ArmonAir Respiclick were evaluated in 2130 patients with asthma. The development program included 2 confirmatory trials of 12 weeks duration, a 26 week safety trial and two dose-ranging trials of 12 weeks duration. The efficacy of ArmonAir Respiclick is based primarily on the dose-ranging trials and the confirmatory trials described below. Dose-Ranging Trials Six doses of fluticasone propionate ranging from 16 mcg to 434 mcg (expressed as metered doses) administered twice daily via a multidose dry powder inhaler were evaluated in 2 randomized, double-blind, placebo-controlled 12 week trials. Trial 201 was conducted in patients who were uncontrolled at baseline and had been treated by SABA alone or in combination with non-corticosteroid asthma medication. Low dose ICS patients may have been included after a minimum of 2 weeks washout. This trial contained an open-label active comparator fluticasone propionate inhalation powder 100 mcg administered twice daily. Trial 202 was conducted in patients who were uncontrolled at baseline and had been treated with high dose ICS with or without a LABA. This study contained an open-label active comparator fluticasone propionate inhalation powder 250 mcg twice daily. The trials were dose-ranging trials of ArmonAir Respiclick and not designed to provide comparative effectiveness data and should not be interpreted as evidence of superiority/inferiority to fluticasone propionate inhalation powder. The metered doses for fluticasone multidose dry powder inhaler (16, 28, 59, 118, 225, 434 mcg) used in Trial 201 and Trial 202 (see Figure 1) are slightly different from the metered doses for the comparator products (fluticasone inhalation powder) and the Phase 3 investigational products which are the basis of the proposed commercial labeled claim (55, 113, 232 mcg for fluticasone). The changes in doses between Phase 2 and 3 resulted from optimization of the manufacturing process. Figure 1 Baseline Adjusted Least Square Mean Change in Trough Morning FEV1 (L) over 12 weeks (FAS) a FAS = full analysis set; a Trials were not designed to provide comparative effectiveness data and should not be interpreted as superiority/inferiority to fluticasone propionate inhalation powder. Trials in the Maintenance Treatment of Asthma Adult and Adolescent Patients Aged 12 Years and Older : Two Phase 3 clinical trials were conducted comparing ArmonAir Respiclick with placebo (Trial 1 and Trial 2). Trials Comparing ArmonAir Respiclick with Placebo Two double-blind, parallel-group clinical trials, Trial 1 and Trial 2, were conducted with ArmonAir Respiclick in 1375 adult and adolescent patients (aged 12 years and older, with baseline FEV 1 40% to 85% of predicted normal) with asthma that was not optimally controlled on their current therapy. All treatments were given as 1 inhalation twice a day from the RESPICLICK inhaler, and other maintenance therapies were discontinued. Trial 1 : This randomized, double-blind, placebo-controlled, 12-week, global efficacy and safety trial compared Fluticasone Propionate Multidose Dry Powder Inhaler (ArmonAir Respiclick) 55 mcg and 113 mcg (1 inhalation twice a day), Fluticasone/Salmeterol Multidose Dry Powder Inhaler (AIRDUO RESPICLICK) 55/14 mcg and 113/14 mcg (1 inhalation twice a day), and placebo in adolescents and adult patients with persistent symptomatic asthma despite low-dose or mid-dose inhaled corticosteroid or inhaled corticosteroid/LABA therapy. Patients received single-blinded placebo MDPI and were switched from their baseline ICS therapy to QVAR 40 mcg twice daily during the run-in period. Patients who met all randomization criteria were randomly assigned to receive treatment as follows: 130 received placebo, 129 received ArmonAir Respiclick 55 mcg, 130 received ArmonAir Respiclick 113 mcg, 129 received AIRDUO RESPICLICK 55/14 mcg, and 129 received AIRDUO RESPICLICK 113/14 mcg. Baseline FEV 1 measurements were similar across treatments: ArmonAir Respiclick 55 mcg 2.134 L, ArmonAir Respiclick 113 mcg 2.166 L, and placebo 2.188 L. The primary endpoints for this trial were the change from baseline in trough FEV 1 at week 12 for all patients and standardized baseline-adjusted FEV 1 AUEC 0-12h at week 12 analyzed for a subset of 312 patients who performed postdose serial spirometry. Patients receiving ArmonAir Respiclick 55 mcg and ArmonAir Respiclick 113 mcg had significantly greater improvements in trough FEV 1 (ArmonAir Respiclick 55 mcg, LS mean change of 0.172 L at 12 weeks and ArmonAir Respiclick 113 mcg, LS mean change of 0.204 L at 12 weeks) compared with placebo (LS mean change of 0.053 L at 12 weeks). Estimated mean differences between ArmonAir Respiclick 55 mcg and ArmonAir Respiclick 113 mcg compared to placebo are 0.119 L (95% CI: 0.025, 0.212) and 0.151 L (95% CI: 0.057, 0.244), respectively. In addition, the mean FEV 1 results at each visit are displayed in Figure 2. Figure 2: Mean Change from Baseline in Trough FEV 1 at Each Visit by Treatment Group Trial 1 (FAS) FAS = full analysis set; FEV 1 = forced expiratory volume in 1 second There was supportive evidence of efficacy for ArmonAir Respiclick compared with placebo for secondary endpoints such as the weekly average of daily trough morning peak expiratory flow and the total daily use of rescue medication. The Asthma Quality of Life Questionnaire (AQLQ) for patients age 18 years or the pediatric AQLQ (PAQLQ) for patients aged 12-17 were assessed in Trial 1. The responder rate for both measures was defined as an improvement in score of 0.5 or more as threshold. In Trial 1, the responder rate for patients receiving ArmonAir Respiclick 55 mcg and ArmonAir Respiclick 113 mcg was 46% and 45%, respectively, compared to 40% for patients receiving placebo with odds ratios of 1.23 (95% CI: 0.74, 2.06) and 1.25 (95% CI: 0.75, 2.08), respectively. Improvements in FEV 1 for both ArmonAir Respiclick dose groups were sustained over the 12 hours of testing at week 12 (Figure 3). No diminution in the 12 hour bronchodilator effect was observed with ArmonAir Respiclick as assessed by FEV 1 following 12 weeks of therapy. Figure 3: Serial Spirometry: Mean Change from Baseline in FEV 1 (L) at Week 12 by Time Point and Treatment Group Trial 1 (FAS; Serial Spirometry Subset) FAS = full analysis set; FEV 1 = forced expiratory volume in 1 second Trial 2 : This randomized, double-blind, placebo-controlled, 12-week, global efficacy and safety trial compared Fluticasone Propionate Multidose Dry Powder Inhaler (ArmonAir Respiclick) 113 mcg and 232 mcg (1 inhalation twice a day), Fluticasone/Salmeterol Multidose Dry Powder Inhaler (AIRDUO RESPICLICK) 113/14 mcg and 232/14 mcg (1 inhalation twice a day), and placebo in adolescents and adult patients with persistent symptomatic asthma despite inhaled corticosteroid or inhaled corticosteroid/LABA therapy. Patients received single-blinded placebo MDPI and were switched from their baseline ICS therapy to ArmonAir Respiclick 55 mcg twice daily during the run-in period. Patients who met all randomization criteria were randomly assigned to receive treatment as follows: 145 patients received placebo, 146 patients received ArmonAir Respiclick 113 mcg, 146 patients received ArmonAir Respiclick 232 mcg, 145 patients received AIRDUO RESPICLICK 113/14 mcg, and 146 patients received AIRDUO RESPICLICK 232/14 mcg. Baseline FEV 1 measurements were similar across treatments, as follows: ArmonAir Respiclick 113 mcg 2.069 L, ArmonAir Respiclick 232 mcg 2.075 L, and placebo 2.141 L. The primary endpoints for this trial were the change from baseline in trough FEV 1 at week 12 for all patients and standardized baseline-adjusted FEV 1 AUEC 0-12h at week 12 analyzed for a subset of 312 patients who performed postdose serial spirometry. Efficacy results in this trial were similar to those observed in Trial 1. Patients receiving ArmonAir Respiclick 113 mcg and ArmonAir Respiclick 232 mcg had significantly greater improvements in trough FEV 1 (ArmonAir Respiclick 113 mcg, LS mean change of 0.119 L at 12 weeks and ArmonAir Respiclick 232 mcg, LS mean change of 0.179 L at 12 weeks) compared with placebo (LS mean change of 0.004 L at 12 weeks). Estimated mean differences between ArmonAir Respiclick 113 mcg and ArmonAir Respiclick 232 mcg compared to placebo are 0.123 L (95% CI: 0.038, 0.208) and 0.183 L (95% CI: 0.098, 0.268), respectively. In addition, the mean FEV 1 results at each visit are displayed in Figure 4. Figure 4: Mean (Change from Baseline in Trough FEV 1 at Each Visit by Treatment Group Trial 2 (FAS) FAS = full analysis set; FEV 1 = forced expiratory volume in 1 second There was supportive evidence of efficacy for ArmonAir Respiclick compared with placebo for secondary endpoints such as the weekly average of daily trough morning peak expiratory flow and total daily use of rescue medication. There were fewer withdrawals due to worsening asthma in patients treated with ArmonAir Respiclick than with placebo. The AQLQ (patients age 18 years) or the PAQLQ (patients aged 12-17) were assessed in Trial 2. The responder rate for patients receiving ArmonAir Respiclick 113 mcg and ArmonAir Respiclick 232 mcg was 38% and 44%, respectively, compared to 27% for patients receiving placebo, with an odds ratio of 1.75 (95% CI:1.05, 2.93) and 2.12 (95% CI: 1.27, 3.53), respectively. Improvements in FEV 1 for both ArmonAir Respiclick dose groups were sustained over the 12 hours of testing at week 12 (Figure 5). No diminution in the 12 hour bronchodilator effect was observed with ArmonAir Respiclick as assessed by FEV 1 following 12 weeks of therapy. Figure 5: Serial Spirometry: Mean Change from Baseline in FEV 1 (L) at Week 12 by Time Point and Treatment Group Trial 2 (FAS; Serial Spirometry Subset) FAS = full analysis set; FEV 1 = forced expiratory volume in 1 second How Supplied/Storage and Handling How Supplied ArmonAir Respiclick is supplied in the following three strengths as a white dry-powder inhaler. Each inhaler has a green cap and is packaged individually in a foil pouch in a carton. Each inhaler contains 0.9g of the formulation and provides 60 actuations: STRENGTH NDC CODE ArmonAir Respiclick 55 mcg NDC 59310-705-06 ArmonAir Respiclick 113 mcg NDC 59310-711-06 ArmonAir Respiclick 232 mcg NDC 59310-722-06 Each ArmonAir Respiclick inhaler has a dose counter attached to the actuator. Patients should never try to alter the numbers for the dose counter. Discard the inhaler when the counter displays 0, 30 days after opening the foil pouch or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the inhaler is not completely empty and will continue to operate [see Patient Counseling Information ( 17 ) ]. Storage and Handling Store at room temperature (between 15º and 25ºC; 59º and 77ºF) in a dry place; excursions permitted from 59ºF to 86ºF (15ºC to 30ºC). Avoid exposure to extreme heat, cold, or humidity. Keep out of reach of children. ArmonAir Respiclick should be stored inside the unopened moisture protective foil pouch and only removed from the pouch immediately before initial use. Discard ArmonAir Respiclick 30 days after opening the foil pouch or when the counter reads 0 , whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Patients should be given the following information: Local Effects Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with ArmonAir Respiclick, but at times therapy with ArmonAir Respiclick may need to be temporarily interrupted under close medical supervision. Rinsing the mouth with water without swallowing after inhalation is advised to help reduce the risk of thrush. Status Asthmaticus and Acute Asthma Symptoms Inform patients that ArmonAir Respiclick is not a bronchodilator and is not intended for use as rescue medicine for acute asthma exacerbations. Advise patients to treat acute asthma symptoms with an inhaled, short acting beta 2 agonist such as albuterol. Instruct the patient to contact their physicians immediately if there is deterioration of their asthma. Immunosuppression Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. Hypercorticism and Adrenal Suppression Advise patients that ArmonAir Respiclick may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, instruct patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to ArmonAir Respiclick. Immediate Hypersensitivity Reactions Advise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, and hypotension), including anaphylaxis, may occur after administration of ArmonAir Respiclick. Patients should discontinue ArmonAir Respiclick if such reactions occur and contact their healthcare provider or get emergency medical help. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not take ArmonAir Respiclick. Reduction in Bone Mineral Density Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk. Reduced Growth Velocity Inform patients that orally inhaled corticosteroids, including ArmonAir Respiclick, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of adolescents taking corticosteroids by any route. Ocular Effects Long-term use of inhaled corticosteroids may increase the risk of some eye problems (cataracts or glaucoma); consider regular eye examinations. Pregnancy Inform patients who are pregnant or nursing that they should contact their physician about the use of ArmonAir Respiclick. Use Daily for Best Effect Patients should use ArmonAir Respiclick at regular intervals as directed. The daily dosage of ArmonAir Respiclick should not exceed 1 inhalation twice a day. Advise patients, if they miss a dose, to take their next dose at the same time they normally do and to not take 2 doses at one time. Individual patients will experience a variable time to onset and degree of symptom relief and the full benefit may not be achieved until treatment has been administered for 1 to 2 weeks or longer. Patients should not increase the prescribed dosage but should contact their physicians if symptoms do not improve or if the condition worsens. Instruct patients to not stop use of ArmonAir Respiclick abruptly. Patients should contact their physicians immediately if they discontinue use of ArmonAir Respiclick. Caring for and Storing the Inhaler Instruct patients to not open their inhaler unless they are taking a dose. Repeated opening and closing the cover without taking medication will waste medication and may damage the inhaler. Advise patients to keep their inhaler dry and clean at all times. Never wash or put any part of the inhaler in water. Patient should replace inhaler if washed or placed in water. Advise patients to immediately replace inhaler if mouthpiece cover is damaged or broken. Gently wipe the mouthpiece with a dry cloth or tissue as needed. Instruct patients to store the inhaler at room temperature and to avoid exposure to extreme heat, cold, or humidity. Instruct patients to never take the inhaler apart. Inform patients that ArmonAir Respiclick has a dose counter attached to the actuator. When the patient receives the inhaler, the number 60 will be displayed. The dose counter will count down each time the mouthpiece cap is opened and closed. The dose counter window displays the number of actuations left in the inhaler in units of two (e.g., 60, 58, 56, etc.). When the counter displays 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill. When the dose counter reaches 0, the background will change to solid red. Inform patients to discard ArmonAir Respiclick when the dose counter displays 0, 30 days after opening the foil pouch or after the expiration date on the product, whichever comes first. Rx only Marketed by: Teva Respiratory, LLC Frazer, PA 19355 Manufactured by: IVAX Pharmaceuticals Ireland Waterford, Ireland Copyright 2017 Teva Respiratory, LLC All rights reserved. ARMONAIR and RESPICLICK are trademarks owned by Teva Respiratory, LLC. United States Patent Nos. 6446627, 6701917, 6718972, 6748947, 6871646, 7540282, 8006690, 8651103, 8714149, 8978966, 9216260, 9463288 ARMON-001 PATIENT INFORMATION ARMONAIR RESPICLICK (ar moe nayr res-pē-klik) ( fluticasone propionate) inhalation powder 55 mcg ArmonAir Respiclick (ar moe nayr res-pē-klik) (fluticasone propionate) inhalation powder 113 mcg ArmonAir Respiclick (ar moe nayr res-pē-klik) (fluticasone propionate) inhalation powder 232 mcg What is ArmonAir Respiclick? ArmonAir Respiclick is a prescription inhaled corticosteroid (ICS) medicine for the long-term treatment of asthma in people aged 12 years and older. ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems. ArmonAir Respiclick is not used to relieve sudden breathing problems. It is not known if ArmonAir Respiclick is safe and effective in children younger than 12 years of age. Do not use ArmonAir Respiclick: to relieve sudden breathing problems. if you have a severe allergy to milk proteins or any of the ingredients in ArmonAir Respiclick. See the end of this Patient Information leaflet for a complete list of ingredients in ArmonAir Respiclick. Before using ArmonAir Respiclick, tell your healthcare provider about all of your medical conditions, including if you: have liver problems. have weak bones (osteoporosis). have an immune system problem. have eye problems such as glaucoma or cataracts. have any type of viral, bacterial, fungal or parasitic infection. are exposed to chickenpox or measles. are pregnant or plan to become pregnant. It is not known if ArmonAir Respiclick may harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ArmonAir Respiclick passes into your breast milk and can harm your baby. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. ArmonAir Respiclick and certain other medicines may affect each other causing serious side effects. Especially tell your healthcare provider if you take antifungal or anti HIV medicines. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. How should I use ArmonAir Respiclick? Read the step-by-step instructions for using ArmonAir Respiclick at the end of this Patient Information leaflet. ArmonAir Respiclick is for oral inhalation use only . Rinse your mouth with water without swallowing after each dose of ArmonAir Respiclick. Children should use ArmonAir Respiclick with an adult s help, as instructed by the child s healthcare provider. ArmonAir Respiclick comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you. ArmonAir Respiclick does not need priming. Do not use a spacer or volume holding chamber with ArmonAir Respiclick. Do not open the cap on your ArmonAir Respiclick inhaler until you are ready for your dose because this will waste your medicine or may damage your inhaler. Use ArmonAir Respiclick exactly as your healthcare provider tells you to use it. Do not use ArmonAir Respiclick more often than prescribed. It may take 1 to 2 weeks or longer after you start ArmonAir Respiclick for your asthma symptoms to get better. You must use ArmonAir Respiclick regularly. Do not stop using ArmonAir Respiclick, even if you are feeling better, unless your healthcare provider tells you to. If you miss a dose of ArmonAir Respiclick, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time. ArmonAir Respiclick does not relieve sudden symptoms . Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you. Call your healthcare provider or get medical care right away if: o your breathing problems get worse. o you need to use your rescue inhaler more often than usual. o your rescue inhaler does not work as well to relieve your symptoms. o you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row. o you use 1 whole canister of your rescue inhaler in 8 weeks. o your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you. What are the possible side effects with ArmonAir Respiclick? ArmonAir Respiclick can cause serious side effects, including : Fungal infection in your mouth and throat (thrush) . Rinse your mouth with water without swallowing after using ArmonAir Respiclick to help reduce your chance of getting thrush. Weakened immune system and increased chance of getting infections (immunosuppression) . Reduced adrenal function (adrenal insufficiency) . Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as ArmonAir Respiclick). When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include: o feeling tired ο nausea and vomiting o lack of energy ο low blood pressure o weakness Serious allergic reactions . Call your healthcare provider or get emergency medical help if you get any of the following signs or symptoms of a serious allergic reaction: o rash ο swelling of your face, mouth, and tongue o hives ο breathing problems Bone thinning or weakness (osteoporosis). Slowed growth in children . A child s growth should be checked often. Eye problems including glaucoma and cataracts . You should have regular eye exams while using ArmonAir Respiclick. Increased wheezing (bronchospasm) . Increased wheezing can happen right away after using ArmonAir Respiclick. If this occurs, stop using ArmonAir Respiclick and call your healthcare provider. Always have a rescue inhaler with you to treat sudden wheezing. Common side effects of ArmonAir Respiclick include : infection or inflammation of nose and throat (nasopharyngitis) upper respiratory tract infection thrush in your mouth or throat headache cough These are not all the possible side effects with ArmonAir Respiclick. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store ArmonAir Respiclick? Store ArmonAir Respiclick at room temperature between 59ºF and 77ºF (15ºC and 25ºC). Avoid exposure to extreme heat, cold, or humidity. Store ArmonAir Respiclick in the unopened foil pouch until you are ready to use a dose of ArmonAir Respiclick. Do not take the ArmonAir Respiclick inhaler apart. Throw away ArmonAir Respiclick when the dose counter displays 0 , 30 days after opening the foil pouch or after the expiration date on the product, whichever comes first. Keep ArmonAir Respiclick and all medicines out of the reach of children. General information about the safe and effective use of ArmonAir Respiclick . Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ArmonAir Respiclick for a condition for which it was not prescribed. Do not give your ArmonAir Respiclick to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ArmonAir Respiclick that was written for health professionals. What are the ingredients in ArmonAir Respiclick? Active ingredient : fluticasone propionate Inactive ingredients : lactose monohydrate (contains milk proteins) Marketed by: Teva Respiratory, LLC, Frazer, PA 19355; Manufactured by: IVAX Pharmaceuticals Ireland, Waterford, Ireland; Copyright 2017, Teva Respiratory, LLC; All rights reserved; ARMONAIR TM and RESPICLICK are trademarks owned by Teva Respiratory, LLC. ARMONPIL-001 Rev. 01/2017 most magnificent


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