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The LCQ is also suitable for capturing longitudinal developments in cough and cough-related well-being and can be useful in clinical trials assessing new medications for cough [ 20 ]. Appointments for the next phone calls will be set during the previous phone call and will assess:.
Changes in glucose levels for patients with pre-study controlled diabetes that are deemed by GP to exceed the hypothesized benefit on cough. Continuous outcomes will be assessed by comparing mean values. Medians will be considered in addition if we identify severe departures from normal distribution. Eligible patients who consent to the study will be randomly assigned by their GP to the active treatment or the control group.
If performed, the GP will also record diagnostic test results. Participants will be asked to complete the standardized LCQ questionnaire and hand it to the GP on day 0. Participants will also be informed about the follow-up calls and that the next telephone appointment will be at day 7 of the trial. After inclusion in the study, it is at the discretion of the treating GP to re-assess each participant at the general practice, when and as often as clinically needed.
Physical examinations, lab testing, performing X-rays e. In case participants are not reached at the first call, follow-up phone calls will be performed several times and participants will be sent reminders by email.
Study schedule. To be able to detect an MCID of 1. Due to the fact that the number of recruited patients per GP is limited to 10, ICC might remain small. Sample size estimation was based on the assumption that individual LCQ scores are normally distributed. Raj et al. A recent trial with a design and study population similar to ours reported a SD of 2.
We decided to use the more conservative assumption of 3. A less conservative choice of an SD of 2. To compute the t test, the current version of the R language and environment R Foundation, www. In case of recruitment difficulties due to scheduled numbers of participants not being reached at predefined milestones, the limit of maximum of 10 randomized patients per GP can be increased.
To include participants, the recruitment period will cover two winter seasons when the incidence of upper respiratory tract infection is very high and post-infectious cough is very common.
Even though coughing is prevalent throughout the year and patients can be affected in summer as well, we expect that most participants will be enrolled during the cold months. If the enrolment goals are not met, the study will be submitted to other regional ethics committees in order to geographically expand the recruitment area.
The randomization procedure will be implemented by the Clinical Trial Unit of the University Hospital Basel, which will generate a randomization list with a treatment allocation. This list will be the basis for the University Hospital Basel Pharmacy to perform block randomization per practice, to label and to pack the study medication in glass jars. All GP practices will receive pre-randomized identically looking medication packages which will be handed to participants in the order of reception.
Following this procedure, participants will therefore be randomly allocated to either prednisone or placebo. With the randomization list being prepared by the CTU Basel and only accessible to the University Hospital Basel Pharmacy for preparing the sequentially numbered medication packages, the treatment allocation is concealed from patients, physicians, outcome assessors and other involved personal.
Participants will be enrolled by the GPs and will be assigned to the intervention randomly. GPs will distribute the randomized medication in the pre-established order set by the University Pharmacy Basel. Participants are required to return unused investigational treatments to their GPs.
All GPs, clinical investigators, outcome assessors and research staff involved in the study, as well as all patients, will remain blinded with respect to the randomization throughout the trial. In case participants require hospitalizations or they consult a different doctor not their GP , they are encouraged to take the medication guide with them.
GPs will not have access to the randomization list and in case of urgency, they have to make an unblinding request with the OSPIC study team. The GP will record individual socio-demographic characteristics and medical history, including age, sex, smoking behaviour, information on household smoking, symptoms, current treatment and doctor consultations. If performed, the GP will also record diagnostic test results such as CRP test, white blood cell count, body temperature, blood pressure, pulse, oxygen saturation, previous or present X-Ray, previous or present lung function assessments.
It has a total score addition of domain scores that ranges from 3 to 21 points, with a higher score corresponding to better health status [ 19 , 20 , 21 ]. The LCQ has already been used in a similar randomized-controlled trial assessing the effectiveness of montelukast in the treatment of post-infectious cough [ 24 ]. It is short, easy to administer and assesses the impact of cough on various aspects of life, including emotions, sleeping behaviour, work and relationships.
The LCQ contains 19 items divided over 3 domains: physical 8 items , psychological 7 items and social 4 items ; with a 7-point Likert scale [ 19 , 20 ]. Participants will complete the LCQ on paper at baseline and over the telephone at follow-up. We will use the validated German version of the original LCQ [ 18 ]. If patients prematurely stop the study or do not answer the follow-up call, the study team can contact the GP to ask about possible GP visits, AE or SAE or hospitalizations i.
Data will be collected until the time of withdrawal and will be analysed in the intention to treat analysis. Direct access to source documents will be permitted for purposes of monitoring, audits and inspections.
Study data entered in the eCRF are only accessible to authorized persons and an integrated audit trail will maintain a record of initial entries and any changes made, time and date of entry and user name of the person authorizing the entry or change. All study data will be coded by the GP, stored and analysed in a coded manner.
Password protection and user right management is used for the eCRF and ensures that only authorized study personal, data managers and local authorities, when permissible by law and necessary, will have access to the data during and after the study. Participant contact information will be collected for carrying follow-up calls and will be filled in the paper CRF form by the GP.
Participant lists will be kept at the GP practices for the entire duration of the study. All involved parties must keep the participant data strictly confidential. Detailed description of analyses will be defined in a statistical analysis plan SAP before unblinding the trial.
Analysis of the primary objective will follow the intention-to-treat ITT principle. It will be based on the full analysis set FAS which will include all patients who were randomized and gave informed consent. Patient data will be analysed according to their treatment allocation. A treatment effect of 1. Baseline characteristics of patients in the FAS will be presented stratified by group and summarized in a table.
To assess the robustness of our primary analysis, an analysis of the primary outcome without imputing data complete case analysis will be performed. In order to estimate the effect of fully adhering to the study protocol, an analysis of the primary outcome using the per-protocol data set PPS, including all patients with full i adherence to the allocated 5-day treatments took all doses as defined in the study protocol and ii complete primary outcome and LCQ [ 18 , 20 ] score at baseline will be conducted.
We will also explore interactions between covariates of the ANCOVA model of the primary analysis and how the effect of the intervention varies among GP practices. For this, a linear mixed-model with treatment group as a fixed-effect and GP practices as a random effect will be fit.
We will conduct one subgroup analysis, comparing effects on the primary outcome in current smokers vs. Subgroup effects will be analysed by interaction tests and interpreted fully exploratory. We expect that effects are more pronounced in non-smokers according to reports by Ponsioen et al.
Protocol non-adherence and impact of missing data will be assessed using a dataset that includes all patients with full i adherence to the allocated 5-day treatments took all doses as defined by the study protocol and ii complete primary outcome and LCQ [ 18 , 20 ] score at baseline.
We will consider adjustments for time-varying post-randomization confounding [ 34 ] which will be predefined in the statistical analysis plan. The reason for missing data and whether it might be at-random or not will be examined according to the European Medicines Agency EMA guidelines [ 35 ]. Missing data of all variables that are used in the statistical model to test the hypothesis will be imputed.
Data of all available variables will be used for imputation. The imputation procedure will be further defined in the SAP. The full study protocol which was approved by the Ethics Committee for North-western and Central Switzerland is available in the Supplementary material. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and eCRF in a public repository dataverse.
Independent and external researchers from the study team can seek to access the data for reuse in other projects by submitting a study synopsis to the DFK curator at dkf.
It is the responsibility of those researchers to seek a new approval for future studies from the ethics committee. Andreas Zeller. This is an investigator-driven study conducted under the supervision of Prof. Andreas Zeller, Prof. Stefan Essig. Andreas Zeller is the Principal Investigator for the study and the main responsible for the entire project.
Leuppi and Dr. Essig are also responsible with overseeing the conduct of the study. The CTU at the University Hospital Basel is tasked with handling the data management system and performing monitoring activities.
Andreas Zeller will be involved in every step connected to this study including being responsible for project development and implementation, obtaining the collaboration of general practices for recruitment and enrolment of participants, interpretation of data, writing of scientific papers and study reports, etc.
Potential side effects and complications from corticosteroid will be systematically recorded during the trial. A recently published retrospective cohort study showed that even a short time use of corticosteroids increases the incidence of severe adverse events such as sepsis or venous thromboembolism [ 25 ]. Participants will be informed and asked to immediately contact the GP or the study team in the event of any possible side-effects.
In case the GPs cannot be reached, participants should visit the nearest hospital. For safety reasons, the study team will inform the corresponding GP about every reported event to ensure patient follow-up is arranged as soon as possible. GPs and research staff will be instructed to document time of onset, duration, resolution and actions to be taken, as well as an assessment of intensity and relationship of event with study treatment. The course and outcome of the pregnancy should be followed up carefully with the GP, and any abnormal outcome regarding the mother or the child should be documented and reported.
All participating Investigators must also be informed by the Sponsor about all safety signals, including the occurrence of suspected unexpected serious adverse reactions. SAE assessments will be carried according to the severity grading scale used for adverse events occurring during trials: grade 1—mild, grade 2—moderate, grade 3—severe, grade 4—life-threatening, grade 5—death [ 37 ].
An annual safety report based on information from all participating GP practices will be prepared by the Sponsor-Investigator and submitted every year for the duration of the study to the EKNZ and to Swissmedic. Access to study documentation and data is allowed for the purposes of audit by regulatory authorities, which is independent from the investigators and Sponsor.
Data and sites monitoring will be carried by the CTU of the University Hospital Basel according to the study monitoring plan. Mandatory reporting to the EKNZ and the regulatory authority Swissmedic will be carried, and we will seek approval prior to implementing any changes to the research protocol or to research activities.
We will report changes to eligibility criteria, outcomes and unanticipated problems involving risks to participants, including the planned or premature study end. All changes will have to be first approved by the Sponsor and then reported. Necessary changes made to the protocol that are meant to eliminate apparent immediate risks to participants will be reported as soon as possible after they occur.
After ethics review and prior to implementation, investigators will be informed in writing about any changes to protocol. Information in the trial registry entries will be kept up-to-date and completed with study results after the completion of the trial.
Study results will be published in a peer-reviewed medical journal, independent of the outcomes and conclusions. All results from this study will be published in aggregated and anonymized way.
Manuscripts submitted for peer-review and presentations of any results will adhere to relevant reporting guidelines for publication as put forth by the EQUATOR-network [ 15 , 31 , 38 , 39 , 40 ]. Additionally, at the end of the study, the research team will also update the systematic review on treatments for subacute cough [ 7 ] to include the data from the OSPIC trial.
Cough is often a nonspecific symptom of respiratory disease requiring complex differential diagnosis strategies, which raise challenges for both physicians and patients [ 42 ]. A recent RCT reported the effectiveness of a chronic cough management algorithm in paediatric community care and its usefulness in easily identifying causes of chronic cough by using this tool.
Seeking medical advice for cough is the most common reason for presentation to primary care practices worldwide [ 1 ], and in the USA alone between and , there were around , general practitioner or outpatient setting visits made due to cough associated with a previous respiratory infection [ 44 ].
Post-infectious cough has a broad impact on personal health and well-being [ 2 ] and bears relevant socioeconomic costs. Physicians may experience pressure to prescribe antibiotics, despite no supporting recommendations for this course of treatment [ 4 ]. Inhaled corticosteroids and orally administered montelukast are available treatment options for post-infectious cough. In a study in general practice, no benefit from montelukast therapy was found in patients with post-infectious cough [ 24 ].
As of April , the Food and Drug Administration issued a fifth and its highest warning boxed warning for risk of neuropsychiatric events associated with montelukast [ 48 ]. As there is no established evidence-based treatment option for this very frequent condition in primary care, only a well-conducted randomized placebo-controlled trial can determine a safe and efficient therapy. Our study aims to fill this gap by determining the benefits and harms of oral corticosteroids in the treatment of patients with post-infectious cough enrolled in an RCT carried in a primary care setting.
We selected prednisone for this trial because it is a well-established oral treatment for asthma, different allergic and other respiratory conditions [ 49 ]. Additionally, it is a low-cost therapy and proving its effectiveness and safety has significant cost reduction implications for treating cough. The first reported case in Switzerland was at the end of February and was followed by extreme public health measures to stop the spread.
At the same time, research activities, administrative services and management for clinical studies are severely impacted by this public health emergency. New clinical studies were suspended, running trials were halted and research reviews prioritized protocol submissions on SARS-CoV-2 [ 50 ].
Assessing the pandemic situation over the summer and early autumn, we decided to open the GP practices recruitment by end of September Provided that researchers strictly adhere to hygiene measures, the University of Basel encouraged the research teams to resume study activities in July We did not change the schedule of the follow-up visits.
There are limitations to this trial. We use a self-reporting tool the LCQ to measure cough-related quality of life and cough resolution, which is a subjective measurement.
Other tools, such as frequency monitors, can improve cough measurement objectivity, but have significant limitations. Cough monitors are unreliable in distinguishing cough sounds from speech and other noises and require manual assessments that are impractical in the context of a trial in a primary care setting [ 51 ]. The LCQ is one of the most widely used health status questionnaires for adults suffering from cough [ 51 ] and is appraised by users as highly relevant, scoring above other similar and commonly used cough measures [ 20 ].
It is a patient-derived, valid, reliable and useful questionnaire for outcome measurement in clinical care and research activity [ 20 ]. This makes results from this study comparable with those from other studies and mitigates the substantial limitation that would result from an artificial research environment involving cough monitors. Overall, short-term use of oral corticosteroids for post-infectious cough was not previously assessed in an RCT [ 7 ]. This trial will determine the clinical effectiveness of oral corticosteroids for the treatment of post-infectious cough and may establish the first treatment option with clear patient-relevant benefits and at low-costs for this common condition.
The Protocol version approved by the responsible ethics committee at the time of submission is 2. Symptoms as the main problem in primary care: a cross-sectional study of frequency and characteristics. Scand J Prim Health Care. Article Google Scholar. A comparison of gender differences in health-related quality of life in acute and chronic coughers. Guidelines of the German Respiratory Society for diagnosis and treatment of adults suffering from acute or chronic cough. Braman SS. Postinfectious cough: ACCP evidence-based clinical practice guidelines.
Lower airways inflammatory response during rhinovirus colds. Int Arch Allergy Immunol. Bronchial inflammation and the common cold: a comparison of atopic and non-atopic individuals. Clin Exp Allergy. Treatments for subacute cough in primary care: systematic review and meta-analyses of randomized clinical trials. Br J Gen Pract. Efficacy of fluticasone on cough: a randomised controlled trial. Eur Respir J. Inhaled corticosteroid for persistent cough following upper respiratory tract infection.
Corticosteroids for acute and subacute cough following respiratory tract infection: a systematic review. Fam Pract. Inhaled corticosteroids for subacute and chronic cough in adults. Cochrane Database Syst Rev. Effect of oral prednisolone on symptom duration and severity in nonasthmatic adults with acute lower respiratory tract infection: a randomized clinical trial.
Effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throat in adults: a randomized clinical trial. Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial.
Pharmacokinetics of prednisone in normal and asthmatic subjects in relation to dose. Eur J Clin Pharmacol.
Recommendations for the management of cough in adults. Psychometric properties of the German version of the Leicester Cough Questionnaire in sarcoidosis.
PLoS One. Ward N. The Leicester Cough Questionnaire. J Physiother. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire LCQ. Health Qual Life Outcomes. Accessed 19 Oct What is the minimal important difference for the Leicester Cough Questionnaire? Pharmacology and therapeutics of cough. Berlin: Springer; Chapter Google Scholar. Montelukast for postinfectious cough in adults: a double-blind randomized placebo-controlled trial.
Lancet Respir Med. Short term use of oral corticosteroids and related harms among adults in the United States: population based cohort study. Statement on the second meeting of the International Health Regulations emergency committee regarding the outbreak of novel coronavirus nCoV.
Geneva: WHO; Accessed 17 Jun Google Scholar. Clinical features of patients infected with novel coronavirus in Wuhan, China. International council for harmonisation of technical requirements for pharmaceuticals for human use ICH. Accessed 28 May International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use.
Statistical principles for clinical trials, E9, Step 4. ICH harmonized tripartite guideline. Adult current smoking: differences in definitions and prevalence estimates. J Environ Public Health. Per-protocol analyses of pragmatic trials.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:. Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects. Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup.
The average household teaspoon may not hold the right amount of liquid. Measure the concentrated liquid with the special oral dropper that comes with the package.
If you use this medicine for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely. The dose of this medicine 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 this medicine. 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. If you miss a dose of this medicine, take it as soon as possible.
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. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be caused by this medicine.
Blood or urine tests may be needed to check for unwanted effects. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of this medicine might need to be changed for a short time while you have extra stress.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.
This medicine may cause you to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away.
If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away. Check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment.
Your doctor may want you to have your eyes checked by an ophthalmologist eye doctor. While you are being treated with prednisone, do not have any immunizations vaccines without your doctor's approval.
Prednisone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you.
Some examples of live vaccines include measles, mumps, influenza nasal flu vaccine , poliovirus oral form , rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor. This medicine may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression, mood swings, a false or unusual sense of well-being, trouble with sleeping, or personality changes while taking this medicine.
This medicine might cause thinning of the bones osteoporosis or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly. Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain skin tests.
Do not take other medicines unless they have been discussed with your doctor.
❿Prednisone dosage for uri.
Trials volume 21 , Article number: Cite this article. Metrics details. Cough is a common reason for patients to visit general practices. It can be disabling in daily activities, with substantial impact on physical and psychosocial health, leading to impaired quality of life and increased health care costs. Recommendations for the management of post-infectious cough in primary care are scarce and incoherent. A systematic review and meta-analysis of randomized clinical trials RCT assessing patient-relevant benefits and potential harms of available treatments identified six eligible RCTs assessing different treatment regimens i.
No RCT found clear patient-relevant benefits and most had an unclear or high risk of bias. Post-infectious cough is thought to be mediated by inflammatory processes that are also present in exacerbations of asthma or chronic obstructive pulmonary diseases for which there is strong evidence that oral corticosteroids provide patient-relevant benefit without relevant harm.
We therefore plan to conduct the first RCT evaluating the effectiveness of oral corticosteroids for post-infectious cough. We are conducting a triple-blinded randomized-controlled and multicentred superiority trial in primary health care practices in Switzerland. Participants will be randomly allocated to either the 5-day treatment with oral corticosteroids or placebo.
Secondary outcomes include cough-related quality of life at several time points, overall cessation of cough and adverse events. This RCT will provide evidence on whether oral corticosteroids are beneficial and safe in patients with post-infectious cough. Results can have a substantial impact on the well-being and management of these patients in Switzerland and beyond. An evidence-based treatment for this condition may reduce re-consultations with GPs and spending for antitussive drugs, thus possibly having an impact on health care spending.
Prospectively registered on 18 January Peer Review reports. Cough as a symptom of respiratory infections is frequent in primary care and is one of the most common causes to seek medical advice in general practices GP [ 1 ]. Cough after an upper respiratory tract infection can be very bothersome and disabling in daily activities and has a significant impact on physical and psycho-social health, leading to impairment in quality of life QoL [ 2 ].
Recommendations for the management of post-infectious cough in general practice are scarce and inconsistent [ 3 , 4 ]. A previous systematic review and meta-analysis of randomized controlled trials RCT carried by our group provided a wide overview of treatment options for primary care patients with post-infectious cough and examined the patient-relevant benefits and potential harms of available therapies [ 7 ].
The review found only six RCTs assessing diverse treatment regimens, such as inhaled fluticasone propionate, inhaled budesonide, salbutamol plus ipratropium-bromide, montelukast, nociception-opioidreceptor agonist, codeine and gelatine.
Most of the studies included in the review had an unclear or high risk of bias [ 7 ]. Two RCTs assessed inhaled corticosteroids for post-infectious cough [ 8 , 9 ]. Pornsuriyasak et al. The trial by Ponsioen et al. Clinical guidelines and recommendations on the use of inhaled corticosteroids are unclear [ 3 , 4 , 10 ]. A Cochrane review published in evaluated studies in which inhaled corticosteroids were tested in individuals with post-infectious or chronic cough [ 11 ].
A majority of the studies focused on patients with chronic cough and only two examined the benefits for post-infectious cough [ 11 ].
The authors concluded that no recommendation can be proposed due to the high heterogeneity and inconsistency of the studies and their results [ 11 ]. Additionally, an RCT in family practices in England found no benefit in terms of duration or severity of cough after a 5-day treatment with oral corticosteroids compared to placebo for adult patients with acute lower respiratory tract infection and without asthma [ 12 ].
Another RCT assessed the effectiveness of oral corticosteroids for patients with acute sore throat, Many of the symptoms in post-infectious cough are thought to be mediated by inflammatory processes that are also present in exacerbations of asthma or COPD [ 5 , 6 ].
However, at present, there is no established evidence-based treatment option for post-infectious cough, despite it being a very frequent condition. There is also considerable uncertainty regarding patient benefits from using inhaled or oral corticosteroids. The systematic search of our group did not identify any published RCT that assessed short-term use of oral corticosteroids for post-infectious cough [ 7 ] we updated our search in October and still found no pertinent trial.
We screened multiple study registries using the International Clinical Trials Registry Platform from the World Health Organization last search June and again found no trial investigating the use of oral corticosteroids for post-infectious cough.
A well-conducted randomized placebo-controlled trial is needed to determine the benefits and harms of using oral corticosteroids to treat post-infectious cough in patients in primary care. This randomized placebo-controlled trial aims to assess whether the benefits and harms of a 5-day prednisone treatment differ from those of a 5-day course of placebo.
We designed a protocol for a randomized, parallel-group, placebo-controlled, triple-blinded, multicentred superiority trial in a primary health care setting, with blinded patients, physicians and outcome assessors. Patients with post-infectious cough will be recruited by participating doctors in primary practices from cantons in the German-speaking part of Switzerland.
Patient recruitment will continue until the sample size is reached. A list of the general practices currently taking part in the study can be obtained from the Sponsor-Investigator.
Known or suspected diagnoses associated with cough, such as pneumonia, allergic rhinitis, sinusitis, bronchial asthma, COPD, gastroesophageal reflux disease. Other chronic diseases such as bronchiectasis, cystic fibrosis, cancer, tuberculosis, heart failure. Regular treatment known to be associated with cough e. Uncontrolled diabetes mellitus as deemed by GPs who appraise whether the potential side effects of short-time corticosteroids on glucose levels exceed the hypothesized benefit on cough.
Patients with post-infectious cough presenting to their GP will be told about the OSPIC trial and provided with a study leaflet, participant information sheet and a consent form by their GP. They will be invited by the GP to take part after being given full written and verbal explanations of the trial purpose, potential benefits and risks and the procedures involved. Those who agree to join the study will be asked to provide written consent and will be screened against the full eligibility criteria described above.
Participants will have sufficient time to ask questions and GPs will make sure to underscore that participation is voluntary and that declining to join the study does not influence in any way the standard of care provided to patients. During the informed consent process with the GP, participants will be asked to give written permission for the storage and future use of the data resulted from the study.
Placebo pills are described in detail in the next section. Placebo will be used as a comparator in this study to prevent various biases in particular as the primary endpoint is patient-reported. Potential implications on a limited applicability of the results are acknowledged and will be discussed in the study results publication.
From an ethical point of view, an inactive control placebo seems justified since there is no established therapy for post-infectious cough and because the symptoms resolve over time due to the natural course of the disease [ 7 , 12 ]. The placebo tablets match in appearance, diameter and height the intervention medication. Verbal and written instructions on how the drugs should be taken will be provided to the study participants. Even though the likelihood is very low, adverse events AE , such as allergic reactions to the study drug, psychotic or pre-psychotic episode, or serious adverse events SAE , sepsis, venous thromboembolism, fracture, can occur [ 17 ].
In any of these cases, the treatment will be stopped immediately. Medication will also be discontinued for other urgent reasons, such as pregnancy, a cancer diagnosis or an infection other than an upper respiratory tract infection. In order to facilitate adherence to the study intake schedule, participants are given a written medication guide. GPs will inform patients in depth on the importance to adhere to the 5-day medication for ensuring the effectiveness of treatment.
Furthermore, the dosing schedule is very convenient as the drugs need to be taken only once a day during breakfast and for a clearly defined and limited timeframe. In the event of a missed dose, patients are instructed to continue to take the medication the next day. Adherence to the study procedures will be checked at the follow-up phone call on day 7 from randomization when research staff will ask participants about their medication intake.
In case the study medication is prematurely stopped or discontinued patients are asked to return the empty drug glass jars to their GP. Apart from the use of corticosteroids, any co-treatment or co-medication i. Any other medical intervention used by study participants will be recorded in the electronic Case Report Forms eCRF to analyse the potential influence on outcomes. Treating doctors can independently decide to change to open-label treatment, adjust medication if they deem it necessary and for the benefit of their patients or choose additional therapeutic options.
All participants will be asked at follow-up about concurrent medication, including if they started a treatment with antibiotics. GPs and research staff are instructed to document time of onset, duration, resolution, actions to be taken, assessment of intensity and relationship with study treatment. Participants will be advised that they need to use contraceptives for the duration of the treatment and that they should inform the GP or the study team in case they suspect they have become pregnant.
Women with anamnestic risk of a pregnancy unprotected sexual intercourse in the last 2 weeks shall be excluded from this study. If a participant will become pregnant during follow-up, the participant will visit her gynaecologist. The GP will document the course and the outcome of the pregnancy. Total and individual LCQ domain scores will be calculated. The LCQ is also suitable for capturing longitudinal developments in cough and cough-related well-being and can be useful in clinical trials assessing new medications for cough [ 20 ].
Appointments for the next phone calls will be set during the previous phone call and will assess:. Changes in glucose levels for patients with pre-study controlled diabetes that are deemed by GP to exceed the hypothesized benefit on cough. Continuous outcomes will be assessed by comparing mean values. Medians will be considered in addition if we identify severe departures from normal distribution.
Eligible patients who consent to the study will be randomly assigned by their GP to the active treatment or the control group. If performed, the GP will also record diagnostic test results. Participants will be asked to complete the standardized LCQ questionnaire and hand it to the GP on day 0. Participants will also be informed about the follow-up calls and that the next telephone appointment will be at day 7 of the trial.
After inclusion in the study, it is at the discretion of the treating GP to re-assess each participant at the general practice, when and as often as clinically needed. Physical examinations, lab testing, performing X-rays e. In case participants are not reached at the first call, follow-up phone calls will be performed several times and participants will be sent reminders by email. Study schedule. To be able to detect an MCID of 1. Due to the fact that the number of recruited patients per GP is limited to 10, ICC might remain small.
Sample size estimation was based on the assumption that individual LCQ scores are normally distributed. Raj et al. A recent trial with a design and study population similar to ours reported a SD of 2. We decided to use the more conservative assumption of 3. A less conservative choice of an SD of 2. To compute the t test, the current version of the R language and environment R Foundation, www. In case of recruitment difficulties due to scheduled numbers of participants not being reached at predefined milestones, the limit of maximum of 10 randomized patients per GP can be increased.
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The absolute increases were 0. Because the greatest risk occurs in the first month after the corticosteroid is prescribed, this corresponds to roughly one additional serious complication per 1, short courses of a corticosteroid. A short course of oral corticosteroids is appropriate for many patients with acute exacerbation of asthma or chronic obstructive pulmonary disease, and for selected patients with peritonsillar abscess, 8 severe pharyngitis characterized by pain with swallowing and moderate to severe pharyngeal erythema , 9 and community-acquired pneumonia requiring hospitalization.
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Editor's Note: Dr. Address correspondence to Mark H. Reprints are not available from the author. Data will be collected until the time of withdrawal and will be analysed in the intention to treat analysis. Direct access to source documents will be permitted for purposes of monitoring, audits and inspections.
Study data entered in the eCRF are only accessible to authorized persons and an integrated audit trail will maintain a record of initial entries and any changes made, time and date of entry and user name of the person authorizing the entry or change. All study data will be coded by the GP, stored and analysed in a coded manner. Password protection and user right management is used for the eCRF and ensures that only authorized study personal, data managers and local authorities, when permissible by law and necessary, will have access to the data during and after the study.
Participant contact information will be collected for carrying follow-up calls and will be filled in the paper CRF form by the GP. Participant lists will be kept at the GP practices for the entire duration of the study.
All involved parties must keep the participant data strictly confidential. Detailed description of analyses will be defined in a statistical analysis plan SAP before unblinding the trial. Analysis of the primary objective will follow the intention-to-treat ITT principle. It will be based on the full analysis set FAS which will include all patients who were randomized and gave informed consent.
Patient data will be analysed according to their treatment allocation. A treatment effect of 1. Baseline characteristics of patients in the FAS will be presented stratified by group and summarized in a table. To assess the robustness of our primary analysis, an analysis of the primary outcome without imputing data complete case analysis will be performed. In order to estimate the effect of fully adhering to the study protocol, an analysis of the primary outcome using the per-protocol data set PPS, including all patients with full i adherence to the allocated 5-day treatments took all doses as defined in the study protocol and ii complete primary outcome and LCQ [ 18 , 20 ] score at baseline will be conducted.
We will also explore interactions between covariates of the ANCOVA model of the primary analysis and how the effect of the intervention varies among GP practices. For this, a linear mixed-model with treatment group as a fixed-effect and GP practices as a random effect will be fit. We will conduct one subgroup analysis, comparing effects on the primary outcome in current smokers vs.
Subgroup effects will be analysed by interaction tests and interpreted fully exploratory. We expect that effects are more pronounced in non-smokers according to reports by Ponsioen et al. Protocol non-adherence and impact of missing data will be assessed using a dataset that includes all patients with full i adherence to the allocated 5-day treatments took all doses as defined by the study protocol and ii complete primary outcome and LCQ [ 18 , 20 ] score at baseline.
We will consider adjustments for time-varying post-randomization confounding [ 34 ] which will be predefined in the statistical analysis plan. The reason for missing data and whether it might be at-random or not will be examined according to the European Medicines Agency EMA guidelines [ 35 ].
Missing data of all variables that are used in the statistical model to test the hypothesis will be imputed. Data of all available variables will be used for imputation. The imputation procedure will be further defined in the SAP. The full study protocol which was approved by the Ethics Committee for North-western and Central Switzerland is available in the Supplementary material. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and eCRF in a public repository dataverse.
Independent and external researchers from the study team can seek to access the data for reuse in other projects by submitting a study synopsis to the DFK curator at dkf. It is the responsibility of those researchers to seek a new approval for future studies from the ethics committee. Andreas Zeller. This is an investigator-driven study conducted under the supervision of Prof. Andreas Zeller, Prof. Stefan Essig.
Andreas Zeller is the Principal Investigator for the study and the main responsible for the entire project. Leuppi and Dr. Essig are also responsible with overseeing the conduct of the study.
The CTU at the University Hospital Basel is tasked with handling the data management system and performing monitoring activities. Andreas Zeller will be involved in every step connected to this study including being responsible for project development and implementation, obtaining the collaboration of general practices for recruitment and enrolment of participants, interpretation of data, writing of scientific papers and study reports, etc. Potential side effects and complications from corticosteroid will be systematically recorded during the trial.
A recently published retrospective cohort study showed that even a short time use of corticosteroids increases the incidence of severe adverse events such as sepsis or venous thromboembolism [ 25 ]. Participants will be informed and asked to immediately contact the GP or the study team in the event of any possible side-effects. In case the GPs cannot be reached, participants should visit the nearest hospital.
For safety reasons, the study team will inform the corresponding GP about every reported event to ensure patient follow-up is arranged as soon as possible. GPs and research staff will be instructed to document time of onset, duration, resolution and actions to be taken, as well as an assessment of intensity and relationship of event with study treatment. The course and outcome of the pregnancy should be followed up carefully with the GP, and any abnormal outcome regarding the mother or the child should be documented and reported.
All participating Investigators must also be informed by the Sponsor about all safety signals, including the occurrence of suspected unexpected serious adverse reactions.
SAE assessments will be carried according to the severity grading scale used for adverse events occurring during trials: grade 1—mild, grade 2—moderate, grade 3—severe, grade 4—life-threatening, grade 5—death [ 37 ].
An annual safety report based on information from all participating GP practices will be prepared by the Sponsor-Investigator and submitted every year for the duration of the study to the EKNZ and to Swissmedic. Access to study documentation and data is allowed for the purposes of audit by regulatory authorities, which is independent from the investigators and Sponsor. Data and sites monitoring will be carried by the CTU of the University Hospital Basel according to the study monitoring plan.
Mandatory reporting to the EKNZ and the regulatory authority Swissmedic will be carried, and we will seek approval prior to implementing any changes to the research protocol or to research activities.
We will report changes to eligibility criteria, outcomes and unanticipated problems involving risks to participants, including the planned or premature study end. All changes will have to be first approved by the Sponsor and then reported.
Necessary changes made to the protocol that are meant to eliminate apparent immediate risks to participants will be reported as soon as possible after they occur. After ethics review and prior to implementation, investigators will be informed in writing about any changes to protocol. Information in the trial registry entries will be kept up-to-date and completed with study results after the completion of the trial.
Study results will be published in a peer-reviewed medical journal, independent of the outcomes and conclusions. All results from this study will be published in aggregated and anonymized way. Manuscripts submitted for peer-review and presentations of any results will adhere to relevant reporting guidelines for publication as put forth by the EQUATOR-network [ 15 , 31 , 38 , 39 , 40 ].
Additionally, at the end of the study, the research team will also update the systematic review on treatments for subacute cough [ 7 ] to include the data from the OSPIC trial. Cough is often a nonspecific symptom of respiratory disease requiring complex differential diagnosis strategies, which raise challenges for both physicians and patients [ 42 ].
A recent RCT reported the effectiveness of a chronic cough management algorithm in paediatric community care and its usefulness in easily identifying causes of chronic cough by using this tool. Seeking medical advice for cough is the most common reason for presentation to primary care practices worldwide [ 1 ], and in the USA alone between and , there were around , general practitioner or outpatient setting visits made due to cough associated with a previous respiratory infection [ 44 ].
Post-infectious cough has a broad impact on personal health and well-being [ 2 ] and bears relevant socioeconomic costs. Physicians may experience pressure to prescribe antibiotics, despite no supporting recommendations for this course of treatment [ 4 ].
Inhaled corticosteroids and orally administered montelukast are available treatment options for post-infectious cough. In a study in general practice, no benefit from montelukast therapy was found in patients with post-infectious cough [ 24 ]. As of April , the Food and Drug Administration issued a fifth and its highest warning boxed warning for risk of neuropsychiatric events associated with montelukast [ 48 ]. As there is no established evidence-based treatment option for this very frequent condition in primary care, only a well-conducted randomized placebo-controlled trial can determine a safe and efficient therapy.
Our study aims to fill this gap by determining the benefits and harms of oral corticosteroids in the treatment of patients with post-infectious cough enrolled in an RCT carried in a primary care setting. We selected prednisone for this trial because it is a well-established oral treatment for asthma, different allergic and other respiratory conditions [ 49 ]. Additionally, it is a low-cost therapy and proving its effectiveness and safety has significant cost reduction implications for treating cough.
The first reported case in Switzerland was at the end of February and was followed by extreme public health measures to stop the spread. At the same time, research activities, administrative services and management for clinical studies are severely impacted by this public health emergency.
New clinical studies were suspended, running trials were halted and research reviews prioritized protocol submissions on SARS-CoV-2 [ 50 ]. Assessing the pandemic situation over the summer and early autumn, we decided to open the GP practices recruitment by end of September Provided that researchers strictly adhere to hygiene measures, the University of Basel encouraged the research teams to resume study activities in July We did not change the schedule of the follow-up visits.
There are limitations to this trial. We use a self-reporting tool the LCQ to measure cough-related quality of life and cough resolution, which is a subjective measurement. Other tools, such as frequency monitors, can improve cough measurement objectivity, but have significant limitations. Cough monitors are unreliable in distinguishing cough sounds from speech and other noises and require manual assessments that are impractical in the context of a trial in a primary care setting [ 51 ].
The LCQ is one of the most widely used health status questionnaires for adults suffering from cough [ 51 ] and is appraised by users as highly relevant, scoring above other similar and commonly used cough measures [ 20 ]. It is a patient-derived, valid, reliable and useful questionnaire for outcome measurement in clinical care and research activity [ 20 ].
This makes results from this study comparable with those from other studies and mitigates the substantial limitation that would result from an artificial research environment involving cough monitors. Overall, short-term use of oral corticosteroids for post-infectious cough was not previously assessed in an RCT [ 7 ]. This trial will determine the clinical effectiveness of oral corticosteroids for the treatment of post-infectious cough and may establish the first treatment option with clear patient-relevant benefits and at low-costs for this common condition.
The Protocol version approved by the responsible ethics committee at the time of submission is 2. Symptoms as the main problem in primary care: a cross-sectional study of frequency and characteristics.
Scand J Prim Health Care. Article Google Scholar. A comparison of gender differences in health-related quality of life in acute and chronic coughers. Guidelines of the German Respiratory Society for diagnosis and treatment of adults suffering from acute or chronic cough. Braman SS. Postinfectious cough: ACCP evidence-based clinical practice guidelines. Lower airways inflammatory response during rhinovirus colds. Int Arch Allergy Immunol.
Bronchial inflammation and the common cold: a comparison of atopic and non-atopic individuals. Clin Exp Allergy. Treatments for subacute cough in primary care: systematic review and meta-analyses of randomized clinical trials. Br J Gen Pract. Efficacy of fluticasone on cough: a randomised controlled trial.
Eur Respir J. Inhaled corticosteroid for persistent cough following upper respiratory tract infection. Corticosteroids for acute and subacute cough following respiratory tract infection: a systematic review. Fam Pract.
Inhaled corticosteroids for subacute and chronic cough in adults. Cochrane Database Syst Rev. Effect of oral prednisolone on symptom duration and severity in nonasthmatic adults with acute lower respiratory tract infection: a randomized clinical trial. Effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throat in adults: a randomized clinical trial.
Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial. Pharmacokinetics of prednisone in normal and asthmatic subjects in relation to dose.
Eur J Clin Pharmacol. Recommendations for the management of cough in adults. Psychometric properties of the German version of the Leicester Cough Questionnaire in sarcoidosis. PLoS One. Ward N. The Leicester Cough Questionnaire. J Physiother. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire LCQ. Health Qual Life Outcomes. Accessed 19 Oct What is the minimal important difference for the Leicester Cough Questionnaire?
Pharmacology and therapeutics of cough. 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. The presence of other medical problems may affect the use of this medicine.
Make sure you tell your doctor if you have any other medical problems, especially:. Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects. Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Measure the concentrated liquid with the special oral dropper that comes with the package.
If you use this medicine for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely. The dose of this medicine 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 this medicine. 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.
If you miss a dose of this medicine, take it as soon as possible. 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. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be caused by this medicine.
Blood or urine tests may be needed to check for unwanted effects. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away. If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress.
Your dose of this medicine might need to be changed for a short time while you have extra stress. Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems.
Talk to your doctor right away if you have more than one of these symptoms while you are using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.
Primary care physicians generally agree that we should be more thoughtful and selective about the use of antibiotics in patients with upper and lower respiratory tract infections, and about the use of opioids for conditions such as back pain. However, prescriptions for antibiotics remain common in patients with acute respiratory infections. Meta-analyses have suggested that corticosteroids may have a small benefit for acute cough and sore throat, but they included studies that were small or had a high risk of bias.
In the first, children in the United Kingdom with mild to moderate sore throat were randomized to oral dexamethasone, 10 mg, or placebo. The authors' overall assessment was that this small benefit was not worth the potential harm. Regarding cough, a recent trial identified adults with acute cough but no history of asthma, and randomized them to prednisolone, 40 mg once daily, or placebo.
This was true even for patients with wheezing on initial presentation. Regarding back pain, a study randomized adults with sciatica to a day course of prednisone, 60 mg once daily tapering to 20 mg once daily, or placebo, and found no reduction in pain, function, or other outcomes. Thus, the best evidence to date does not support a significant benefit for corticosteroids in patients with cough, sore throat, or back pain. However, there may be harms. A recent study identified 1. The median dose was 20 mg of prednisone, and the most common indications were respiratory infection, back or neck pain, and allergies.
Patients receiving an oral corticosteroid in the previous year and those receiving an inhaled or intranasal corticosteroid were excluded, as were organ transplant recipients and patients with malignancies. The researchers found a clinically and statistically significant increase in the risk of serious complications during the five to 30 days after the corticosteroid was prescribed; this risk declined over the subsequent two months.
The relative risks over that initial month were 5. The absolute increases were 0. Because the greatest risk occurs in the first month after the corticosteroid is prescribed, this corresponds to roughly one additional serious complication per 1, short courses of a corticosteroid. A short course of oral corticosteroids is appropriate for many patients with acute exacerbation of asthma or chronic obstructive pulmonary disease, and for selected patients with peritonsillar abscess, 8 severe pharyngitis characterized by pain with swallowing and moderate to severe pharyngeal erythema9 and community-acquired pneumonia requiring hospitalization.
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Adults—At first, 5 to 60 milligrams (mg) per day. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your. The standard prednisone dosage for adults is mg per day. Use our prednisone dosage chart to find the recommended and maximum dosage of prednisone. Those randomised to the active treatment arm will receive prednisolone 15 mg/m2 daily (maximum dose 40 mg) for a total of 6 days. The dose will. Usual Adult Dose for Allergic Reaction. Dosing should be individualized based on disease and patient response: Initial dose: 5 to 60 mg. Glucocorticoid-Responsive Conditions. mg/day PO in single daily dose or divided qhr. Dosing considerations. When converting from immediate-release. In a study in general practice, no benefit from montelukast therapy was found in patients with post-infectious cough [ 24 ]. Accepted : 28 October Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup.Drug information provided by: IBM Micromedex. Prednisone provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation swelling , severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, endocrine problems, eye or vision problems, stomach or bowel problems, lupus, skin conditions, kidney problems, ulcerative colitis, and flare-ups of multiple sclerosis.
Prednisone is a corticosteroid cortisone-like medicine or steroid. It works on the immune system to help relieve swelling, redness, itching, and allergic reactions. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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. Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of prednisone in children. However, pediatric patients are more likely to have slower growth and bone problems if prednisone is used for a long time.
Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prednisone in the elderly.
However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for elderly patients receiving prednisone. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding.
Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. 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 this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Using this medicine 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. Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. 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. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:. Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects. Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup.
The average household teaspoon may not hold the right amount of liquid. Measure the concentrated liquid with the special oral dropper that comes with the package.
If you use this medicine for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely. The dose of this medicine 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 this medicine. 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. If you miss a dose of this medicine, take it as soon as possible.
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. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be caused by this medicine.
Blood or urine tests may be needed to check for unwanted effects. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away. If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress.
Your dose of this medicine might need to be changed for a short time while you have extra stress. Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.
This medicine may cause you to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away.
If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away. Check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist eye doctor.
While you are being treated with prednisone, do not have any immunizations vaccines without your doctor's approval. Prednisone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent.
In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you.
Some examples of live vaccines include measles, mumps, influenza nasal flu vaccine , poliovirus oral form , rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor. This medicine may cause changes in mood or behavior for some patients.
Tell your doctor right away if you have depression, mood swings, a false or unusual sense of well-being, trouble with sleeping, or personality changes while taking this medicine. This medicine might cause thinning of the bones osteoporosis or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis.
If your child is using this medicine, tell the doctor if you think your child is not growing properly. Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain skin tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription over-the-counter [OTC] medicines and herbal or vitamin supplements. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.
Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:. 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. All rights reserved. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below.
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