Moxilin capsules

Nursing can counsel on administration, verify compliance, reinforce along with the pharmacist to take the entire course, and not stop when they start to feel better. Any issues the nurse or pharmacist encounters need to go to the prescriber immediately.

These examples of interprofessional team stewardship will improve the likelihood of positive patient outcomes.

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Common harms from amoxicillin: a systematic review and meta-analysis of randomized placebo-controlled trials for any indication. Background: When prescribing antibiotics for common indications, clinicians need information about both harms and benefits, information that is currently available only from observational studies. We quantified the common harms of the most frequently prescribed antibiotic, amoxicillin, from randomized placebo-controlled trials.

Methods: For this systematic review, we searched MEDLINE, Embase and the Cochrane Central Register of Controlled Trials, without language restriction, for any randomized, participant-blinded, placebo-controlled trials of amoxicillin or amoxicillin–clavulanic acid for any indication, in any setting.

Results: Of 730 studies identified, we included 45 trials: 27 involving amoxicillin, 17 involving amoxicillin–clavulanic acid and 1 involving both.

The indications for antibiotic therapy were variable.

The risk of bias was low, although only 25 trials provided data suitable for assessment of harms, which suggested under-reporting. Diarrhea was attributed to amoxicillin only in the form of amoxicillin–clavulanic acid (Peto odds ratio [OR] 3.30, 95% confidence interval [CI] 2.23–4.87).

The OR for candidiasis (3 trials) was significantly higher (OR 7.77, 95% CI 2.23–27.11). Rashes, nausea, itching, vomiting and abnormal results on liver function tests were not significantly increased.

The results were not altered by sensitivity analyses, nor did funnel plots suggest publication bias. The number of courses of antibiotics needed to harm was 10 (95% CI 6–17) for diarrhea with amoxicillin–clavulanic acid and 27 (95% CI 24–42) for candidiasis with amoxicillin (with or without clavulanic acid). Interpretation: Diarrhea was caused by use of amoxicillin–clavulanic acid, and candidiasis was caused by both amoxicillin and amoxicillin–clavulanic acid.

Harms were poorly reported in most trials, and their true incidence may have been higher than reported. Nevertheless, these rates of common harms associated with amoxicillin therapy may inform decisions by helping clinicians to balance harms against benefits. Most antibiotics are prescribed by primary care clinicians for common infections, particularly acute respiratory infections.

1 However, for most acute respiratory infections, antibiotics provide only marginal benefits, and an inevitable consequence of this injudicious use is the prospect of antibiotic resistance. One way to reduce antibiotic prescribing in primary care is to explain to patients how little these drugs help for many common infections and to apply a process of shared decision-making during the consultation. The practice of shared decision-making requires not just an explanation of the paucity of benefits of antibiotics in most primary care situations, but also an explanation of the potential harms. Serious harms are probably sufficiently rare to be discounted by most clinicians and their patients. 3 Yet when the decision to use or not use antibiotics relates to a self-remitting illness, for which the benefits are likely to be modest at best, the more common, mild harms of antibiotics become important.

Unfortunately, common harms from antibiotics are poorly quantified, and clinicians cannot talk to patients with confidence about their likelihood.

Current understanding of the common harms of antibiotics is derived largely from observational studies. However, estimates of common harms from such studies may be biased, principally because it is difficult to distinguish adverse drug reactions from disease-related symptoms. One approach to addressing this problem is to investigate common harms encountered in randomized controlled trials of antibiotic against placebo.

This study design controls for disease-related symptoms, allowing for better quantification of antibiotic-related adverse effects.

The most common antibiotic used in primary care is amoxicillin, either alone or in combination with clavulanic acid.

“Common harms” can be defined as those frequent enough to be observable in the patient samples of most randomized trials and occurring during the recording of primary outcomes in such studies (with recognition that some of the adverse effects will occur later). Accordingly, we systematically reviewed all published placebo-controlled randomized trials of amoxicillin or amoxicillin–clavulanic acid for any indication, with the rationale that the risks of drug-induced harms are independent of the condition being treated.

This systematic review with meta-analysis was registered with Prospero on May 11, 2012 (protocol available at www.crd.york.ac.uk/prospero/, registration number CRD42012002281). We searched MEDLINE (1946 to June week 4, 2013), Embase (2010 to July 2013) and the Cochrane Central Register of Controlled Trials (to 2013, issue 7) using the Cochrane highly sensitive search strategy for randomized trials (for the full search strategy, see Appendix 1, available at www.cmaj.ca/lookup/suppl/doi:10.1503/cmaj.140848/-/DC1). We considered all randomized, participant-blinded, placebo-controlled trials, in any language, with any population, in which amoxicillin or amoxicillin–clavulanic acid was used to treat any condition.

We excluded studies that involved coadministration of any drug other than acetaminophen (paracetamol).

Outcomes of interest were any reported adverse event, including nausea, vomiting, diarrhea, rash, candidiasis, itch and abnormal results on liver function tests. and A.R.) independently screened the titles and abstracts of retrieved studies to identify those that appeared to meet the inclusion criteria.

The full texts of these articles were similarly independently assessed for eligibility. Any disagreements were resolved by discussion, and a third author (C.D.M.) arbitrated if necessary.

The two reviewers used a standardized form to independently extract data from eligible studies, including event rates (with the intention-to-treat population as the denominator) and estimates of bias.

Discrepancies were resolved by discussion, and the same third author arbitrated if necessary.

We examined the texts of included trials for reported adverse events and checked registration information at trial registers for all included trials. The two reviewers independently undertook risk-of-bias assessment

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5 Disagreements were resolved by discussion, and the same third author arbitrated if necessary. We undertook sensitivity analyses based on patient age (adult or child), drug doses and durations of therapy, and we analyzed funnel plots to determine potential publication bias. We used Peto odds ratios (ORs) to analyze the data (because of their paucity 5 ) and calculated 95% confidence intervals (CIs). We planned several subgroup analyses (see protocol at www.crd.york.ac.uk/prospero/). The numbers needed to harm (NNH) were estimated as follows: the OR for each harm was multiplied by the risk of harm with placebo (after converting this value to its odds) to derive the odds of harm in the antibiotic group; these odds were converted back to risks, and the absolute risk difference was then calculated. We identified 730 studies (after removal of duplicates), of which 573 were classified as ineligible on the basis of their titles or abstracts.