Side Effects of miconazole buccal: A Synthesis of Findings from 4 Studies

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Original Abstract of the Article

Main Research Findings

Miconazole buccal tablets are an effective treatment for oral infections like candidiasis. 4 Studies have shown that they are non-inferior to itraconazole capsules in treating oropharyngeal candidiasis. 4 However, there is a potential risk of bleeding associated with miconazole buccal tablets, particularly in individuals taking oral anticoagulants. 3 This risk is due to miconazole's ability to inhibit certain liver enzymes that metabolize anticoagulants, leading to higher blood levels of these medications. 3

Reasons for Side Effects

The primary reason for the potential for increased bleeding with miconazole buccal tablets lies in its interaction with certain liver enzymes, primarily CYP3A4. 3 CYP3A4 plays a crucial role in metabolizing anticoagulants such as warfarin. 3 When miconazole inhibits CYP3A4, it slows down the breakdown of anticoagulants, leading to higher blood levels and an increased risk of bleeding. 3

Common Side Effects

Increased Bleeding Risk

Miconazole buccal tablets, especially when used in conjunction with oral anticoagulants, can increase the risk of bleeding. 3 This is a serious concern that requires careful monitoring and consideration. 3

Countermeasures for Side Effects

Increased Bleeding Risk

If you are taking oral anticoagulants, it is crucial to consult your doctor before using miconazole buccal tablets. 3 They may recommend alternative treatment options or monitor your blood clotting levels closely to adjust your anticoagulant dosage if necessary. 3

Comparison between Studies

Common Points of Studies

The studies focused on evaluating the efficacy and safety of specific medications for treating oral infections or cardiac arrhythmias. 3 , 2 , 1 , 4 They all employed double-blind randomized controlled trial designs, considered a robust methodology for comparing treatment interventions. 1 , 4

Differences in Studies

The studies varied in the specific medication being investigated (miconazole vs. mexiletine), the targeted condition (oral infection vs. cardiac arrhythmias), and the way the drugs were administered. 3 , 2 , 1 , 4 For example, the study on miconazole focused on oral candidiasis, while the mexiletine studies dealt with ventricular ectopia or arrhythmias. 3 , 2 , 1 , 4

Precautions for Application to Real Life

When using miconazole buccal tablets, especially if you are on anticoagulant medications, it is essential to be aware of the increased risk of bleeding. 3 Consulting your doctor before using miconazole buccal tablets is crucial to ensure your safety and determine the best course of action. 3

Limitations of Current Research

Further research is needed to better understand the complex relationship between miconazole buccal tablets and the risk of bleeding, particularly in individuals taking anticoagulants. 3

Future Research Directions

Future research should focus on conducting larger clinical trials to investigate the interaction between miconazole buccal tablets and anticoagulants. 3 This research should aim to identify factors that influence the risk of bleeding, such as individual variations in drug metabolism and other medications being taken. 3

Conclusion

Miconazole buccal tablets are an effective treatment for oral candidiasis. 4 However, it is essential to be aware of the potential for increased bleeding, especially if you are taking oral anticoagulants. 3 Always consult your doctor before using miconazole buccal tablets to ensure your safety and discuss the best treatment options for your specific situation. 3

Literature analysis of 4 papers
Positive Content
3
Neutral Content
0
Negative Content
1
Article Type
3
0
0
0
4
1.

Comparative study of mexiletine and quinidine in the treatment of ventricular ectopia.

Author: AsseyM E, HudsonW M, HangerK H, MillerS C

Effective antiarrhythmic
Side effects

Mexiletine is an effective oral antiarrhythmic agent with side effects that are distinct from those of quinidine.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Relationship between plasma mexiletine levels at steady-state. Presence of ventricular arrhythmias and side effects.

Author: PeyrieuxJ C, BoisselJ P, LeizoroviczA

Suppresses arrhythmias
Constipation
Sexual problems
Tremor

Higher plasma levels of mexiletine were associated with a lower rate of ventricular arrhythmias, but also with a higher rate of side effects. The therapeutic range of mexiletine is narrow, suggesting the need for individual dose adjustments.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Miconazole buccal gel and risk for systemic bleeding: how certain topical formula can interfere with anticoagulants.

Author: De PauwA, De BackerT

Increased INR
Miconazole interaction

This report highlights four cases of patients who experienced increased international normalized ratio (INR) after using a topical oral miconazole preparation. This emphasizes the potential risk of interactions between miconazole and oral anticoagulants, even with topical administration.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

Efficacy and safety of miconazole muco-adhesive tablet versus itraconazole in oropharyngeal candidiasis: A randomized, multi-centered, double-blind, phase 3 trial.

Author: WangYufeng, ZhouHaiwen, WangWenmei, DuanNing, LuoZhixiao, ChaiHongbo, JiangLu, ChenQianming, LiuJinli, HuaHong, YanZhimin, FanYuan, XuJuanyong, GuanXiaobing, WangHongjian, LuHongzhou, LunWenhui, FeiWei, ZhangTong, ZhaoJizhi, JiaChunling, KongHui, ShenXuemin, LiuQing, WangWeizhi, TangGuoyao

Clinical cure
Mycological cure

This multi-centered, double-blinded, phase III trial found that once-daily treatment with miconazole buccal tablets was non-inferior to itraconazole with higher mycological cure rates and was tolerable with mild adverse events in patients with oropharyngeal candidiasis.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

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