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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 swellingsevere 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 vaccinepoliovirus oral formrotavirus, 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.
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No interactions were found between Delsym 12 Hour Cough Relief and prednisone. However, this does not necessarily mean no interactions exist. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an. Prednisolone tablets and liquid. Brand names: Deltacortril, Deltastab, Dilacort, Pevanti. Find out how prednisolone treats health problems and how to take. Generally, the risk of side effects is low if you take prednisolone for a short questions to ask your pharmacist or doctor before taking a medicine. You. However, this does not necessarily mean no interactions exist. Always consult your healthcare provider. To do so may increase the chance for unwanted effects. Statistical principles for clinical trials, E9, Step 4. Check if you can take prednisolone Prednisolone can be taken by adults and children. Your patient information leaflet PIL is the leaflet that comes in the package of your medicine. Read advice on diet, exercise and healthy living Taking prednisolone with other medicines Many medicines interfere with prednisolone or increase the risk of side effects. B2B Publishing. 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.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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