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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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ask for forgiveness Home Parenting Single Parents Effective Coparenting Guide Tips for Effective Coparenting Being a single parent carries with it a number of specific challenges. However, beyond the inevitable trials and tribulations that will arise from raising children, single parents have the dual responsibility of learning how to effectively coparent with their child s other parent. For some, this may come naturally, but for others it can be a huge challenge; particularly if there are difficulties with communication and/or conflicting parenting styles. That being said, learning how to successfully parent your child as a team is the best way of ensuring that he or she receives the best upbringing possible. It can also lessen any of the potential negative effects of divorce on children. Read on for effective coparenting strategies that can adapt to fit any parenting situation. DO: Set a business-like tone. Instead of thinking about your child s other parent as your ex, or any other derogatory term, think of him as your business partner. In our workplace environments we tend to work with a variety of individuals, some of whom we might never associate with outside of the office. However, we always manage to find ways of relating to one another, for the sake of our jobs, or the business more generally. Think of your child s safety and well being as your business, the success of which will depend in large part on your ability to cooperate. DON T: Talk negatively about your child s other parent This includes not allowing others to talk negatively about the other parent, their family and friends, or their home, especially in front of your child. It is also not appropriate to discuss or question your child s parent s personal life with your child. In other words, do not use the child to spy on the other parent. DO: Communicate on a weekly basis Although this may seem like an impossible request for some parents especially those who have recently experienced a divorce learning how to communicate on a regular basis is extremely important, as it demonstrates to your child that as parents, you take her care very seriously. It is also a great way of curbing any unexpected dilemmas in terms of visitation, as you can keep each other informed on any up-and-coming scholastic, medical, or extracurricular activities, as well as any other appointments involving your child. To facilitate this, it is a good idea to create a schedule that includes all the topics you wish to discuss regularly, and fill it out before each meeting. If each of you makes the effort to do this prior to each meeting, you will quickly find the meetings becoming much more productive. This will also help to steer the meetings in the right direction, and away from any negative conversation. DON T: Make decisions regarding visitation in the absence of the other parent. This means not scheduling your child for activities during the other parent s period of possession without the other parent s consent. However, it is important that both parents work together to allow the child to be involved in extracurricular activities. DO: Set similar rules. It is important to establish similar household policies when it comes to disciplinary tactics as well as routines, including bedtime and feeding. Your child should understand that their behavior will be rewarded/punished similarly no matter which parent they are with. DON T: Try to win over the child by being more lenient. This will create confusion and foster resentment in your child over time. It is very important that parents avoid any tactics they feel will create favor in the eyes of their child. This includes: not making promises to the children to try and win them over at the expense of the other parent, not forcing them to choose where they would like to spend their time, and not making them feel guilty for enjoying time spent with their other parent. Login to comment Log in or sign up Forgot Password? Username: Password: CANCEL (0 Comments) Login to add a comment Post a comment You must be logged in to comment. reliable


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benefit from Drisdol Generic Name: vitamin d and related compounds (Oral route, Parenteral route) Commonly used brand name(s) In the U.S. Calciferol Delta D3 DHT DHT Intensol Drisdol Hectorol Rayaldee Rocaltrol Vitamin D Zemplar In Canada D-Vi-Sol Radiostol Forte Available Dosage Forms: Capsule, Liquid Filled Capsule Solution Tablet Capsule, Extended Release Oil Liquid Wafer Tablet, Chewable Uses For Drisdol Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are available in the foods that you eat. Vitamin D is necessary for strong bones and teeth. Lack of vitamin D may lead to a condition called rickets, especially in children, in which bones and teeth are weak. In adults it may cause a condition called osteomalacia, in which calcium is lost from bones so that they become weak. Your doctor may treat these problems by prescribing vitamin D for you. Vitamin D is also sometimes used to treat other diseases in which calcium is not used properly by the body. Ergocalciferol is the form of vitamin D used in vitamin supplements. Some conditions may increase your need for vitamin D. These include: Alcoholism Intestine diseases Kidney disease Liver disease Overactivity of the parathyroid glands with kidney failure Pancreas disease Surgical removal of stomach In addition, individuals and breast-fed infants who lack exposure to sunlight, as well as dark-skinned individuals, may be more likely to have a vitamin D deficiency. Increased need for vitamin D should be determined by your health care professional. Alfacalcidol, calcifediol, calcitriol, and dihydrotachysterol are forms of vitamin D used to treat hypocalcemia (not enough calcium in the blood). Alfacalcidol, calcifediol, and calcitriol are also used to treat certain types of bone disease that may occur with kidney disease in patients who are undergoing kidney dialysis. Claims that vitamin D is effective for treatment of arthritis and prevention of nearsightedness or nerve problems have not been proven. Some psoriasis patients may benefit from vitamin D supplements; however, controlled studies have not been performed. Injectable vitamin D is given by or under the supervision of a health care professional. Some strengths of ergocalciferol and all strengths of alfacalcidol, calcifediol, calcitriol, and dihydrotachysterol are available only with your doctor's prescription. Other strengths of ergocalciferol are available without a prescription. However, it may be a good idea to check with your health care professional before taking vitamin D on your own. Taking large amounts over long periods may cause serious unwanted effects . Importance of Diet For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement. Vitamin D is found naturally only in fish and fish-liver oils. However, it is also found in milk (vitamin D fortified). Cooking does not affect the vitamin D in foods. Vitamin D is sometimes called the "sunshine vitamin" since it is made in your skin when you are exposed to sunlight. If you eat a balanced diet and get outside in the sunshine at least 1.5 to 2 hours a week, you should be getting all the vitamin D you need. Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, fat is needed so that vitamin D can be absorbed into the body. The daily amount of vitamin D needed is defined in several different ways. For U.S. Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease. In the past, the RDA and RNI for vitamin D have been expressed in Units (U). This term has been replaced by micrograms (mcg) of vitamin D. Normal daily recommended intakes in mcg and Units are generally defined as follows: Persons U.S. Canada mcg Units mcg Units Infants and children birth to 3 years of age 7.5-10 300-400 5 10 200 400 Children 4 to 6 years of age 10 400 5 200 Children 7 to 10 years of age 10 400 2.5 5 100 200 Adolescents and adults 5 10 200 400 2.5 5 100 200 Pregnant and breast-feeding females 10 400 5 7.5 200 300 Remember: The total amount of each vitamin that you get every day includes what you get from the foods that you eat and what you may take as a supplement. Your total amount should not be greater than the RDA or RNI, unless ordered by your doctor. Taking too much vitamin D over a period of time may cause harmful effects Before Using Drisdol If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Problems in children have not been reported with intake of normal daily recommended amounts. Some studies have shown that infants who are totally breast-fed, especially with dark-skinned mothers, and have little exposure to sunlight may be at risk of vitamin D deficiency. Your health care professional may prescribe a vitamin/mineral supplement that contains vitamin D. Some infants may be sensitive to even small amounts of alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol. Also, children may show slowed growth when receiving large doses of alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol for a long time. Studies on doxercalciferol or paricalcitol have been done only in adult patients, and there is no specific information comparing the use of doxercalciferol or paricalcitol in children with use in other age groups. Geriatric Problems in older adults have not been reported with intake of normal daily recommended amounts. Studies have shown that older adults may have lower blood levels of vitamin D than younger adults, especially those who have little exposure to sunlight. Your health care professional may recommend that you take a vitamin supplement that contains vitamin D. Pregnancy It is especially important that you are receiving enough vitamin D when you become pregnant and that you continue to receive the right amounts of vitamins throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. You may need vitamin D supplements if you are a strict vegetarian (vegan-vegetarian) and/or have little exposure to sunlight and do not drink vitamin D-fortified milk. Taking too much alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol can also be harmful to the fetus. Taking more than your health care professional has recommended can cause your baby to be more sensitive than usual to its effects, can cause problems with a gland called the parathyroid, and can cause a defect in the baby's heart. Doxercalciferol or paricalcitol have not been studied in pregnant women. However, studies in animals have shown that paricalcitol causes problems in newborns. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant. Breast Feeding It is especially important that you receive the right amounts of vitamins so that your baby will also get the vitamins needed to grow properly. Infants who are totally breast-fed and have little exposure to the sun may require vitamin D supplementation. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided. Only small amounts of alfacalcidol, calcifediol, calcitriol, or dihydrotachysterol pass into breast milk and these amounts have not been reported to cause problems in nursing babies. It is not known whether doxercalciferol or paricalcitol passes into breast milk. Be sure you have discussed the risks and benefits of the supplement with your doctor. Interactions with Medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these dietary supplements, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using dietary supplements in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Boceprevir Brivaracetam Carbamazepine Clarithromycin Clobazam Clonazepam Clorazepate Cobicistat Conivaptan Diazepam Eslicarbazepine Acetate Ethosuximide Ethotoin Ezogabine Felbamate Fosphenytoin Gabapentin Idelalisib Indinavir Itraconazole Ketoconazole Lacosamide Lamotrigine Levetiracetam Lopinavir Lorazepam Methsuximide Midazolam Nefazodone Nelfinavir Oxcarbazepine Perampanel Phenobarbital Phenytoin Posaconazole Pregabalin Primidone Ritonavir Rufinamide Saquinavir Stiripentol Telaprevir Telithromycin Tiagabine Topiramate Valproic Acid Vigabatrin Voriconazole Zonisamide Interactions with Food/Tobacco/Alcohol Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Other Medical Problems The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially: Heart or blood vessel disease Alfacalcidol, calcifediol, calcitriol, or dihydrotachysterol may cause hypercalcemia (high blood levels of calcium), which may make these conditions worse. Kidney disease High blood levels of alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol may result, which may increase the chance of side effects. Sarcoidosis May increase sensitivity to alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol and increase the chance of side effects Proper Use of vitamin d and related compounds This section provides information on the proper use of a number of products that contain vitamin d and related compounds. It may not be specific to Drisdol. Please read with care. For use as a dietary supplement : Do not take more than the recommended daily amount. Vitamin D is stored in the body, and taking too much over a period of time can cause poisoning and even death. If you have any questions about this, check with your health care professional. For individuals taking the oral liquid form of this dietary supplement: This preparation should be taken by mouth even though it comes in a dropper bottle. This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food. While you are taking alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, doxercalciferol or paricalcitol , your health care professional may want you to follow a special diet or take a calcium supplement. Be sure to follow instructions carefully. If you are already taking a calcium supplement or any medicine containing calcium, make sure your health care professional knows. Dosing The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For alfacalcidol To treat bone disease in kidney patients undergoing kidney dialysis: For oral dosage form (capsules): Adults and teenagers At first, 1 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day. For oral dosage form (drops): Adults and teenagers At first, 1 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day. For oral dosage form (solution): Adults and teenagers At first, 1 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day. For parenteral dosage form (injection): Adults and teenagers At first, 1 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 12 mcg a week. To treat diseases in which calcium is not used properly by the body: For oral dosage form (capsules): Adults and teenagers At first, 0.25 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day. For oral dosage form (drops): Adults and teenagers At first, 0.25 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day. For oral dosage form (solution): Adults and teenagers At first, 0.25 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day. For calcifediol To treat diseases in which calcium is not used properly by the body or to treat bone disease in kidney patients undergoing kidney dialysis: For oral dosage form (capsules): Adults, teenagers, and children over 10 years of age At first, 300 to 350 micrograms (mcg) a week, taken in divided doses either once a day or every other day. Your doctor may change your dose if needed. Children 2 to 10 years of age 50 mcg a day. Children up to 2 years of age 20 to 50 mcg a day. To treat diseases in which calcium is not used properly by the body or to treat bone disease in kidney patients undergoing kidney dialysis: For oral dosage forms (capsules and solution): Adults, teenagers, and children At first, 0.25 micrograms (mcg) a day. Your doctor may change your dose if needed. For parenteral dosage forms (injection): Adults and teenagers At first, 0.5 mcg injected into a vein three times a week. Your doctor may change your dose if needed. Children Use and dose must be determined by your doctor. For dihydrotachysterol To treat diseases in which calcium is not used properly by the body: For oral dosage forms (capsules, solution, or tablets): Adults and teenagers At first, 100 micrograms (mcg) to 2.5 milligrams (mg) a day. Your doctor may change your dose if needed. Children At first, 1 to 5 mg a day. Your doctor may change your dose if needed. For doxercalciferol To treat an overactive parathyroid gland in patients with kidney failure: For oral dosage form (capsules): Adults 10 micrograms (mcg) three times weekly at dialysis. The doctor may change your dose if needed. Children Use and dose must be determined by your doctor. For ergocalciferol The amount of vitamin D to meet normal daily recommended intakes will be different for different individuals. The following information includes only the average amounts of vitamin D. To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes: For oral dosage form (capsules): For the U.S. Adults and teenagers 5 to 10 micrograms (mcg) (200 to 400 Units) per day. Pregnant and breast-feeding females 10 mcg (400 Units) per day. Children 4 to 10 years of age 10 mcg (400 Units) per day. Children birth to 3 years of age 7.5 to 10 mcg (300 to 400 Units) per day. For Canada Adults and teenagers 2.5 to 5 mcg (100 to 200 Units) per day. Pregnant and breast-feeding females 5 to 7.5 mcg (200 to 300 Units) per day. Children 7 to 10 years of age 2.5 to 5 mcg (100 to 200 Units) per day. Children 4 to 6 years of age 5 mcg (200 Units) per day. Children birth to 3 years of age 5 to 10 mcg (200 to 400 Units) per day. To treat deficiency: Adults, teenagers, and children Treatment dose is determined by prescriber for each individual based on severity of deficiency. To treat diseases in which calcium and phosphate are not used properly by the body: Adults and teenagers At first, 1000 to 500,000 Units a day. The doctor may change your dose if needed. Children At first, 1000 to 200,000 Units a day. The doctor may change your dose if needed. For paricalcitol To treat an overactive parathyroid gland in patients with kidney failure: For oral dosage form (capsules): Adults 1 to 2 micrograms (mcg) one time per day or 2 to 4 mcg three times a week (not more often than every other day). The doctor may change your dose if needed. Children Use and dose must be determined by your doctor. For parenteral dosage form (injection): Adults 0.04 to 0.1 micrograms (mcg) per kg no more than every other day during dialysis. The doctor may change your dose if needed. Children Use and dose must be determined by your doctor. Missed Dose Call your doctor or pharmacist for instructions. For use as a dietary supplement : If you miss taking a dietary supplement for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins. However, if your health care professional has recommended that you take this dietary supplement, try to remember to take it as directed every day. If you are taking this medicine for a reason other than as a dietary supplement and you miss a dose and your dosing schedule is: One dose every other day Take the missed dose as soon as possible if you remember it on the day it should be taken. However, if you do not remember the missed dose until the next day, take it at that time. Then skip a day and start your dosing schedule again. Do not double doses One dose a day Take the missed dose as soon as possible. Then go back to your regular dosing schedule. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses. More than one dose a day Take the missed dose as soon as possible. Then go back to your regular dosing schedule. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. If you have any questions about this, check with your health care professional. Storage Keep out of the reach of children. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Do not keep outdated medicine or medicine no longer needed. Precautions While Using Drisdol For individuals taking vitamin D without a prescription : Vitamin D is stored in the body; therefore, when you take more than the body needs, it will build up in the body. This may lead to poisoning. Problems are more likely to occur in: Adults taking 20,000 to 80,000 Units a day and more for several weeks or months. Children taking 2,000 to 4,000 Units a day for several months. If you are taking this medicine for a reason other than as a dietary supplement, your doctor should check your progress at regular visits to make sure that it does not cause unwanted effects. Do not take any nonprescription (over-the-counter [OTC]) medicine or dietary supplement that contains calcium, phosphorus, or vitamin D while you are taking any of these dietary supplements unless you have been told to do so by your health care professional. The extra calcium, phosphorus, or vitamin D may increase the chance of side effects. Do not take antacids or other medicines containing magnesium while you are taking any of these medicines. Taking these medicines together may cause unwanted effects . Drisdol Side Effects Along with its needed effects, a dietary supplement may cause some unwanted effects. Alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, and ergocalciferol do not usually cause any side effects when taken as directed. However, taking large amounts over a period of time may cause some unwanted effects that can be serious . Check with your doctor immediately if any of the following side effects occur: Late symptoms of severe overdose High blood pressure high fever irregular heartbeat stomach pain (severe) Check with your doctor as soon as possible if any of the following side effects occur: Early symptoms of overdose Bone pain constipation (especially in children or adolescents) diarrhea drowsiness dryness of mouth headache (continuing) increased thirst increase in frequency of urination, especially at night, or in amount of urine irregular heartbeat itching skin loss of appetite metallic taste muscle pain nausea or vomiting (especially in children or adolescents) unusual tiredness or weakness Late symptoms of overdose Bone pain calcium deposits (hard lumps) in tissues outside of the bone cloudy urine drowsiness increased sensitivity of eyes to light or irritation of eyes itching of skin loss of appetite loss of sex drive mood or mental changes muscle pain nausea or vomiting protein in the urine redness or discharge of the eye, eyelid, or lining of the eyelid runny nose weight loss Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Print this page The information contained in the Truven Health Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Truven Health products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Truven Health and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, TRUVEN HEALTH MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Truven Health does not assume any responsibility or risk for your use of the Truven Health products. Copyright 2017 Truven Health Analytics, Inc. All Rights Reserved.} Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... 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your beloved you'll Drugs: tr - Tr Drugs and medications listed by brand and/or generic name starting with the letter 'T'. Popular Drugs starting with 'T' Tadalafil Tamoxifen Tamsulosin Tegretol Temazepam Terazosin Testosterone Tizanidine Topamax Toprol Toradol Tradjenta Tramadol Travatan Trazodone Triamcinolone Triamterene Tricor Trulicity Tylenol Alphabetical results: 2001 to 2100 of 2334 Filter Show all Generic names only Brand names only Professional only Consumer only triprolidine Triprolidine Triprolidine and Phenylephrine Syrup Triprolidine and Pseudoephedrine Liquid Triprolidine and Pseudoephedrine Tablets Triprolidine Drops Triprolidine Hydrochloride Triprolidine Syrup Triprolidine, Phenylephrine, and Dextromethorphan Syrup Triprolidine, Pseudoephedrine, and Codeine Triptodur Triptodur Triptodur Triptodur (Triptorelin (CPP)) Triptodur (Triptorelin) Triptone triptorelin triptorelin Intramuscular, Injection Triptorelin Triptorelin Triptorelin (CPP) Triptorelin Pamoate Trisenox Trisenox Trisenox Trisenox Trisenox TriStart DHA TriStart DHA Trisyn Trital DM Trital SR Tritane Triumeq Triumeq Triumeq Triumeq Trivaris Trivaris Intravitreal ophthalmic Triveen-PRx RNF Triveen-PRx RNF Trivora Trivora Trivora -28 tablets Trixaicin Trixaicin Topical Trixaicin HP Trizivir Trizivir Trizivir Trizivir Trobicin Trocaine Trocaine Throat Trokendi XR Trokendi XR Trokendi XR Trolamine Cream and Lotion Trolamine Spray Tromethamine Tromethamine Tromethamine Tronolane Tronolane Tronolane Anesthetic for Hemorrhoids Tropazone TrophAmine Tropicacyl Tropicacyl Tropicacyl Tropicamide tropicamide Ophthalmic Tropicamide Tropicamide tropicamide ophthalmic trospium trospium Trospium Trospium Chloride Trospium Chloride Trospium Chloride Capsules Trospium Extended-Release Capsules Trospium Tablets Trosyd Af Topical Trosyd J Topical Trovan Trovan I.V. Troxyca ER Troxyca ER Tru-micin TRUEplus oral / injection Trulance Trulance Trulance Trulance Trulance Trulicity Trulicity Trulicity Trulicity Page 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Browse all Medications A B C D E F G H I J K L M N O P Q R S T U V W X Y Z FDA Consumer Updates Depression: FDA-Approved Medications May Help Dealing with ADHD: What You Need to Know Making Decisions for Your Health: Getting the Info You Need FDA: Cutting-Edge Technology Sheds Light on Antibiotic Resistance More FDA updates tremendous


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to intensify Sochlor Generic Name: Sodium Chloride Eye Drops (Hypertonic) (SOE dee um KLOR ide) Brand Name: Altachlore, Muro 128, Sochlor Overview Side Effects Reviews Q & A Pricing More Uses of Sochlor: It is used to lower swelling. It may be given to you for other reasons. Talk with the doctor. Slideshow Type 1 Diabetes: Symptoms, Treatments, and Breakthroughs What do I need to tell my doctor BEFORE I take Sochlor? If you have an allergy to sodium chloride or any other part of Sochlor (sodium chloride eye drops (hypertonic)). If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs. This is not a list of all drugs or health problems that interact with this medicine. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Sochlor with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. What are some things I need to know or do while I take Sochlor? Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists. Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Sochlor while you are pregnant. Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby. Use care when driving or doing other tasks that call for clear eyesight. How is this medicine (Sochlor) best taken? Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely. For the eye only. Wash your hands before and after use. Take out contact lenses before using Sochlor. Lenses may be put back in 15 minutes after this medicine is given. Do not put contacts back in if your eyes are irritated or infected. Do not touch the container tip to the eye, lid, or other skin. Tilt your head back and drop drug into the eye. Gently press the skin under the lower eyelid and pull the lower eyelid away from the eye slightly until you can see a small pouch. After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye. Do not use if the solution is cloudy, leaking, or has particles. Do not use if solution changes color. Gently pull down the lower lid and squeeze in how much the doctor told you to use. Let go of the lower eyelid and keep eyes closed for 1 to 2 minutes. What do I do if I miss a dose? Take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses. What are some side effects that I need to call my doctor about right away? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Change in eyesight, eye pain, or very bad eye irritation. What are some other side effects of Sochlor? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Burning. Eye irritation. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch. Side Effects (complete list) If OVERDOSE is suspected: If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. How do I store and/or throw out Sochlor? Store at room temperature. Do not freeze. Protect from heat. Store in a dry place. Do not store in a bathroom. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Check with your pharmacist about how to throw out unused drugs. Consumer Information Use and Disclaimer If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor. Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Sochlor, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sochlor. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Sochlor. Review Date: November 1, 2017 Next Side Effects Print this page Add to My Med List More about Sochlor (sodium chloride, hypertonic ophthalmic) Side Effects Support Group Pricing & Coupons 0 Reviews Add your own review/rating Drug class: miscellaneous ophthalmic agents Drug Status OTC Availability Over the counter C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Sochlor Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Miscellaneous ophthalmic agents Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... 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keep away from Jump to: Symptoms Treatment Options Action Steps Anxiety isn t one of the five stages of grief, but many mental health professionals suggest that it should be. 1 When you suffer a loss, the effects can feel paralyzing. Grieving people often feel that they have lost their sense of safety and control in life, and they find themselves panicking or worrying excessively about what or whom else they could lose in the future. They also may have trouble sleeping or taking care of themselves, which can put them at higher risk for anxiety. There are many different kinds of grief in addition to losing a loved one that can trigger anxiety. Losing a job, moving, or ending a marriage can lead to excessive worry. Poor physical health or facing your own mortality can also be challenging losses that elicit symptoms of anxiety. In addition to death, the secondary losses, such as losing financial or emotional support, can also affect mental health. Anxiety is a common and even expected part of the grieving process, but people with a syndrome known as complicated grief are at higher risk for developing an anxiety disorder. People who experience intense grief symptoms that interfere with daily life and occur more than 6 months after a loss may have complicated grief, which is frequently associated with an anxiety disorder. This relationship is bidirectional, as people with a pre-existing anxiety disorder may be at higher risk for complicated grief when they lose a loved one. 2 Article continues below Concerned you may be suffering from Anxiety or Complicated Grief? Take one of our 2-minute mental health quizzes to see if you or a loved one could benefit from further diagnosis and treatment. Take Anxiety Quiz Take Complicated Grief Quiz View all Mental Health Quizzes Symptoms If symptoms of initial anxiety after a loss do not dissipate, you may be experiencing an anxiety disorder . Symptoms of an anxiety disorder include: 3 excessive worry restlessness being easily fatigued trouble concentrating irritability sleep disturbance muscle tension specific phobias social anxiety People experiencing anxiety after a loss are also may also have panic attacks . Let your doctor know if you experience shortness of breath, chest pain, a sensation of choking, nausea, dizziness, chill or heat sensations, and fear of dying. Treatment Options While it s important not to put a timetable on the grieving process, there is help and support available to help you gain back your sense of control, manage symptoms, and calm anxious thinking. Medication, counseling, or a combination of the two can help treat anxiety. Counseling can introduce coping skills for anxiety symptoms and teach you to reframe negative thoughts and interrupt harmful behaviors. Counselors can also provide grief support by allowing a person to discuss the loss in a safe and non-judging environment. Action Steps Go back to basics Grief and anxiety can make it difficult to take care of your daily needs. So if you re not sure where to start in managing anxiety after a loss, go back the basics. Take steps to improve sleep, eat healthy, and exercise your body. Spend time with family and friends who give you energy and support. Engage in your favorite activities and put things on the calendar you know you ll enjoy. When daily tasks begin to feel more manageable, your anxiety has a greater chance of receding. Find a support community No one should ever feel alone in the grieving process. Grief support groups at your local community center, school, hospital, or place of worship are wonderful communities to help you share your thoughts and surround yourself with others who can relate and provide insight. Your employer also may provide employee assistance services that can help connect you to local grief support groups or to counseling. If you cannot find anything in your own community, consider how online groups can connect you to people experiencing similar losses. Ask for help Working through grief and anxiety should never have to be a solo endeavor. If you have financial tasks or other life tasks that need to be addressed after a loss, don t hesitate to ask family and friends to step in and lend aid. Talking with a counselor about the loss and gaining tools to manage symptoms can also help prevent complicated grief or the development of an anxiety disorder. Also, make sure that you check in with your doctor to make sure that physical health issues aren t also contributing to your level of anxiety. With the right self-care and support, you can gain back your sense of control after a loss. Life may not feel manageable now, but with time and the right tools, you can begin to sculpt the life you want for yourself and care for your mind and body. What steps can you take today to help manage your anxiety and navigate grief? If you think you or someone you care about may be suffering from Anixety, Grief, or any mental health condition, PsyCom.net strongly recommends that you seek help from a mental health professional in order to receive a proper diagnosis and support. For those in crisis, we have compiled a list of resources (some even offer free or low-cost support) where you may be able to find additional help at: https://www.psycom.net/get-help-mental-health. If you think you or someone you care about may be suffering from complicated grief or any other mental health condition, PsyCom strongly recommends that you seek help from a mental health professional in order to receive a proper diagnosis and support. We have compiled a list of resources (some even offer free or low-cost support) where you may be able to find additional help at https://www.psycom.net/get-help-mental-health . Article Sources http://www.slate.com/articles/health_and_science/medical_examiner/2013/02/five_stages_of_grief_revision_anxiety_should_replace_bargaining.html https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3994979/ http://dsm.psychiatryonline.org/doi/book/10.1176/appi.books.9780890425596 Last Updated: Dec 4, 2017 minimize


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may be [1%):65 years) as compared to young adults. Although the C max is increased 16-40%, the increase in mean AUC is approximately 30%, and can be at least partially attributed to decreased renal clearance in the elderly. Elimination half-life is only slightly (~20%) prolonged in the elderly. These differences are not considered clinically significant. (See PRECAUTIONS : Geriatric Use .) In patients with reduced renal function, the half-life of ciprofloxacin is slightly prolonged and dosage adjustments may be required. (See DOSAGE AND ADMINISTRATION .) In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. However, the kinetics of ciprofloxacin in patients with acute hepatic insufficiency have not been fully elucidated. Following a single oral dose of 10 mg/kg ciprofloxacin suspension to 16 children ranging in age from 4 months to 7 years, the mean C max was 2.4 µg/mL (range: 1.5 - 3.4 µg/mL) and the mean AUC was 9.2 µg*h/mL (range: 5.8 - 14.9 µg*h/mL). There was no apparent age-dependence, and no notable increase in C max or AUC upon multiple dosing (10 mg/kg TID). In children with severe sepsis who were given intravenous ciprofloxacin (10 mg/kg as a 1-hour infusion), the mean C max was 6.1 µg/mL (range: 4.6 - 8.3 µg/mL) in 10 children less than 1 year of age; and 7.2 µg/mL (range: 4.7 - 11.8 µg/mL) in 10 children between 1 and 5 years of age. The AUC values were 17.4 µg*h/mL (range: 11.8 - 32.0 µg*h/mL) and 16.5 µg*h/mL (range: 11.0 - 23.8 µg*h/mL) in the respective age groups. These values are within the range reported for adults at therapeutic doses. Based on population pharmacokinetic analysis of pediatric patients with various infections, the predicted mean half-life in children is approximately 4-5 hours, and the bioavailability of the oral suspension is approximately 60%. Drug-drug Interactions: The potential for pharmacokinetic drug interactions between ciprofloxacin and theophylline, caffeine, cyclosporins, phenytoin, sulfonylurea glyburide, metronidazole, warfarin, probenecid, and piperacillin sodium has been evaluated. (See PRECAUTIONS : Drug Interactions .) MICROBIOLOGY Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination. The mechanism of action of fluoroquinolones, including ciprofloxacin, is different from that of penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines; therefore, microorganisms resistant to these classes of drugs may be susceptible to ciprofloxacin and other quinolones. There is no known cross-resistance between ciprofloxacin and other classes of antimicrobials. In vitro resistance to ciprofloxacin develops slowly by multiple step mutations. Ciprofloxacin is slightly less active when tested at acidic pH. The inoculum size has little effect when tested in vitro . The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2. Ciprofloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section of the package insert for CIPRO I.V. (ciprofloxacin for intravenous infusion). Aerobic gram-positive microorganisms Enterococcus faecalis (Many strains are only moderately susceptible.) Staphylococcus aureus (methicillin-susceptible strains only) Staphylococcus epidermidis (methicillin-susceptible strains only) Staphylococcus saprophyticus Streptococcus pneumoniae (penicillin-susceptible strains) Streptococcus pyogenes Aerobic gram-negative microorganisms Citrobacter diversus Citrobacter freundii Enterobacter cloacae Escherichia coli Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae Moraxella catarrhalis Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Serratia marcescens Ciprofloxacin has been shown to be active against Bacillus anthracis both in vitro and by use of serum levels as a surrogate marker (see INDICATIONS AND USAGE and INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION ). The following in vitro data are available, but their clinical significance is unknown . Ciprofloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of 1 µg/mL or less against most (>/= 90%) strains of the following microorganisms; however, the safety and effectiveness of ciprofloxacin intravenous formulations in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials. Aerobic gram-positive microorganisms Staphylococcus haemolyticus Staphylococcus hominis Streptococcus pneumoniae (penicillin-resistant strains) Aerobic gram-negative microorganisms Acinetobacter lwoffi Aeromonas hydrophila Campylobacter jejuni Edwardsiella tarda Enterobacter aerogenes Klebsiella oxytoca Legionella pneumophila Neisseria gonorrhoeae Pasteurella multocida Salmonella enteritidis Salmonella typhi Shigella boydii Shigella dysenteriae Shigella flexneri Shigella sonnei Vibrio cholerae Vibrio parahaemolyticus Vibrio vulnificus Yersinia enterocolitica Most strains of Burkholderia cepacia and some strains of Stenotrophomonas maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile . Susceptibility Tests Dilution Techniques: Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method 1 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of ciprofloxacin powder. The MIC values should be interpreted according to the following criteria: For testing aerobic microorganisms other than Haemophilus influenzae, and Haemophilus parainfluenzae a : MIC (µg/mL) Interpretation] Antibiotics 101 Everything you need to know about antibiotics: List of Common Antibiotics & Types Antibiotics & Drinking Alcohol - Is it Safe? Antibiotics For UTI - What Are My Options? FDA Consumer Updates Depression: FDA-Approved Medications May Help Dealing with ADHD: What You Need to Know Making Decisions for Your Health: Getting the Info You Need FDA: Cutting-Edge Technology Sheds Light on Antibiotic Resistance More FDA updates turbines


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wade through Cipro HC Otic Generic Name: ciprofloxacin hydrochloride and hydrocortisone Dosage Form: otic suspension Overview Side Effects Dosage Professional Pregnancy More User Reviews Support Group Q & A Compare Alternatives Pricing & Coupons DESCRIPTION CIPRO HC OTIC (ciprofloxacin hydrochloride and hydrocortisone otic suspension) contains the synthetic broad spectrum antibacterial agent, ciprofloxacin hydrochloride, combined with the anti-inflammatory corticosteroid, hydrocortisone, in a preserved, nonsterile suspension for otic use. Each mL of CIPRO HC OTIC contains ciprofloxacin hydrochloride (equivalent to 2 mg ciprofloxacin), 10 mg hydrocortisone, and 9 mg benzyl alcohol as a preservative. The inactive ingredients are polyvinyl alcohol, sodium chloride, sodium acetate, glacial acetic acid, phospholipon 90H (modified lecithin), polysorbate, and purified water. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH. Ciprofloxacin, a fluoroquinolone, is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17 H 18 FN 3 O 3 HCI H 2 O and its chemical structure is as follows: Hydrocortisone, pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-(11(β)-, is an anti-inflammatory corticosteroid. Its empirical formula is C 21 H 30 O 5 and its chemical structure is: Slideshow Sexual Health Q+A: Your Questions Answered CLINICAL PHARMACOLOGY The plasma concentrations of ciprofloxacin were not measured following three drops of otic suspension administration because the systemic exposure to ciprofloxacin is expected to be below the limit of quantitation of the assay (0.05 μg/mL). Similarly, the predicted C max of hydrocortisone is within the range of endogenous hydrocortisone concentration (0-150 ng/mL), and therefore cannot be differentiated from the endogenous cortisol. Preclinical studies have shown that CIPRO HC OTIC was not toxic to the guinea pig cochlea when administered intratympanically twice daily for 30 days and was only weakly irritating to rabbit skin upon repeated exposure. Hydrocortisone has been added to aid in the resolution of the inflammatory response accompanying bacterial infection. Microbiology Ciprofloxacin has in vitro activity against a wide range of gram-positive and gram-negative microorganisms. The bactericidal action of ciprofloxacin results from interference with the enzyme, DNA gyrase, which is needed for the synthesis of bacterial DNA. Cross-resistance has been observed between ciprofloxacin and other fluoroquinolones. There is generally no cross-resistance between ciprofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides. Ciprofloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections of acute otitis externa as described in the INDICATIONS AND USAGE section: Aerobic gram-positive microorganism Staphylococcus aureus Aerobic gram-negative microorganisms Proteus mirabilis Pseudomonas aeruginosa INDICATIONS AND USAGE CIPRO HC OTIC is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa , Staphylococcus aureus , and Proteus mirabilis . CONTRAINDICATIONS CIPRO HC OTIC is contraindicated in persons with a history of hypersensitivity to hydrocortisone, ciprofloxacin or any member of the quinolone class of antimicrobial agents. This nonsterile product should not be used if the tympanic membrane is known or suspected to be perforated. Use of this product is contraindicated in viral infections of the external canal including varicella and herpes simplex infections. WARNINGS NOT FOR OPHTHALMIC USE. NOT FOR INJECTION. CIPRO HC OTIC should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Serious acute hypersensitivity reactions may require immediate emergency treatment. The dropper cap contains natural rubber (latex) which may cause severe allergic reactions. PRECAUTIONS GENERAL: As with other antibiotic preparations, use of this product may result in overgrowth of nonsusceptible organisms, including fungi. If the infection is not improved after one week of therapy, cultures should be obtained to guide further treatment. Information for Patients: If rash or allergic reaction occurs, discontinue use immediately and contact your physician. Do not use in the eyes. Avoid contaminating the dropper with material from the ear, fingers, or other sources. Protect from light. Shake well immediately before using. Discard unused portion after therapy is completed. Carcinogenesis, Mutagenesis, Impairment of Fertility: Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below: Salmonella/Microsome Test (Negative) E. coli DNA Repair Assay (Negative) Mouse Lymphoma Cell Forward Mutation Assay (Positive) Chinese Hamster V79 Cell HGPRT Test (Negative) Syrian Hamster Embryo Cell Transformation Assay (Negative) Saccharomyces cerevisiae Point Mutation Assay (Negative) Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative) Rat Hepatocyte DNA Repair Assay (Positive) Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results: Rat Hepatocyte DNA Repair Assay Micronucleus Test (Mice) Dominant Lethal Test (Mice) Long-term carcinogenicity studies in mice and rats have been completed for ciprofloxacin. After daily oral doses of 750 mg/kg (mice) and 250 mg/kg (rats) were administered for up to 2 years, there was no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species. No long term studies of CIPRO HC OTIC suspension have been performed to evaluate carcinogenic potential. Fertility studies performed in rats at oral doses of ciprofloxacin up to 100 mg/kg/day revealed no evidence of impairment. This would be over 1000 times the maximum recommended clinical dose of ototopical ciprofloxacin based upon body surface area, assuming total absorption of ciprofloxacin from the ear of a patient treated with CIPRO HC OTIC twice per day. Long term studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical hydrocortisone. Mutagenicity studies with hydrocortisone were negative. Pregnancy: Teratogenic Effects: Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and IV doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Animal reproduction studies have not been conducted with CIPRO HC OTIC. No adequate and well controlled studies have been performed in pregnant women. Caution should be exercised when CIPRO HC OTIC is used by a pregnant woman. Nursing Mothers: Ciprofloxacin is excreted in human milk with systemic use. It is not known whether ciprofloxacin is excreted in human milk following topical otic administration. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: The safety and efficacy of CIPRO HC OTIC have been established in pediatric patients 2 years and older (131 patients) in adequate and well-controlled clinical trials. Efficacy has been extrapolated for patients, age 1 year and above based on studies in adults and older pediatric patients. ADVERSE REACTIONS In Phase 3 clinical trials, a total of 564 patients were treated with CIPRO HC OTIC. Adverse events with at least remote relationship to treatment included headache (1.2%) and pruritus (0.4%). The following treatment-related adverse events were each reported in a single patient: migraine, hypesthesia, paresthesia, fungal dermatitis, cough, rash, urticaria, and alopecia. The following reactions have been identified during post-approval use of CIPRO HC OTIC in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to CIPRO HC OTIC, or a combination of these factors, include: dizziness, ear canal erythema, ear congestion, hypoacusis and medication residue. DOSAGE AND ADMINISTRATION SHAKE WELL IMMEDIATELY BEFORE USING. For children (age 1 year and older) and adults, 3 drops of the suspension should be instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for 1-2 minutes to avoid the dizziness which may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 30-60 seconds to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed. HOW SUPPLIED CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser. NDC 0065-8531-10 Store below 77 F (25 C). Avoid freezing. Protect from light. U.S. Pat.: www.alconpatents.com CIPRO is a registered trademark of Bayer Intellectual Property GmbH, licensed to Alcon by Bayer Intellectual Property AG. Distributed by: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 2006, 2009, 2016 Novartis T2017-38 March 2017 PRINCIPAL DISPLAY PANEL NDC 0065-8531-10 CIPRO HC OTIC (ciprofloxacin 0.2% HCl and hydrocortisone 1% otic suspension) NOT FOR OPHTHALMIC OR ORAL USE 10 mL Rx Only Alcon CIPRO HC ciprofloxacin hydrochloride and hydrocortisone suspension Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0065-8531 Route of Administration AURICULAR (OTIC) DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN) CIPROFLOXACIN 2 mg in 1 mL HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYVINYL ALCOHOL SODIUM CHLORIDE SODIUM ACETATE ACETIC ACID LECITHIN, SOYBEAN POLYSORBATE 20 WATER SODIUM HYDROXIDE HYDROCHLORIC ACID BENZYL ALCOHOL Packaging # Item Code Package Description 1 NDC:0065-8531-10 10 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020805 03/15/1999 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Operations Alcon Cusi, S.A. 462029349 MANUFACTURE(0065-8531) Revised: 03/2017 Alcon Laboratories, Inc. Next Pregnancy Warnings Print this page Add to My Med List More about Cipro HC (ciprofloxacin / hydrocortisone otic) Side Effects During Pregnancy Dosage Information Compare Alternatives Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: otic steroids with anti-infectives Consumer resources Cipro HC otic Cipro HC Cipro HC (Advanced Reading) Other Formulations Cipro Cipro I.V. injection Cipro XR Related treatment guides Acute Otitis Externa} Antibiotics 101 Everything you need to know about antibiotics: List of Common Antibiotics & Types Antibiotics & Drinking Alcohol - Is it Safe? Antibiotics For UTI - What Are My Options? FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Novartis Pharmaceuticals Corporation Drug Class Otic steroids with anti-infectives Related Drugs otic steroids with anti-infectives Ciprodex , Cortisporin Otic , Cortisporin-TC , Coly-Mycin S , Acetasol HC , Vosol HC Acute Otitis Externa ciprofloxacin otic , dexamethasone ophthalmic , Cortisporin-TC , Maxidex , benzocaine otic , Coly-Mycin S , Cetraxal , Floxin Otic , Otocain , finafloxacin otic , Americaine Otic , Benzotic , Xtoro , Cyotic , Cortic-ND , Pramox-HC , Oticin HC , AK-Dex , Cortane-B , More... Cipro HC Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } track


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