Pharmacokinetic Interactions Between Eperisone Hydrochloride and Aceclofenac: A Randomized, Open-Label, Crossover Study of Healthy Korean Men

Kim, Mi Jo; Lim, Hyeong‐Seok; Noh, Yook-Hwan; Kim, Yo Han; Choi, Hee Youn; Park, Kyung-Mi; Kim, Sei-Eun; Bae, Kyun‐Seop

doi:10.1016/j.clinthera.2013.08.012

Cited by 12 publications

(11 citation statements)

References 16 publications

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“…The study reported the values of C max , T max and AUC 0-∞ as 1.25 ± 0.59 ng/ml, 1.28 ± 0.64 h and 4.21 ± 0.41 ng/ml × h, respectively 16 . Kim et al reported that the C max , T max , AUC 0-∞ , V z /F and Cl/F of Eperisone were found to be 11.8 (0.8-44.8) ng/ml, 1.0 (0.5-2.0) h and 31.3 (2.5-76.1) ng/ml × h, 115,152 www.nature.com/scientificreports www.nature.com/scientificreports/ (23,744-281,751) L and 11,477 (1,855-56,785) L/h, respectively after administration of 150 mg Eperisone as a single dose 19 . A study conducted by Tanaka reported the C max , T max and AUC 0-∞ as 7.5-7.9 ng/ml, 1.6-1.9 h, 19.7-21.1 ng/ml × h, respectively after administration of 150 mg Eperisone as a single dose in fasted state 21 .…”

Section: Discussionmentioning

confidence: 99%

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Comparative pharmacokinetics of osmotic-controlled and immediate-release Eperisone tablet formulation in healthy human subjects using a sensitive plasma LC-ESI-MS/MS method

Ahmed

Shoaib

Yousuf

et al. 2020

Sci Rep

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to evaluate and compare the pharmacokinetic (pK) characteristics of a newly developed oral osmotically controlled drug delivery system of Eperisone 150 mg tablets with Eperisone immediate release (iR) marketed tablet brand as a reference formulation. it was a single dose, two treatment, two sequence, randomized, crossover study, involving 12 healthy human subjects. A modified, sensitive Lc-eSi-MS/MS method was developed and validated as per fDA guidelines for estimation of eperisone in plasma using a simple extraction and quick protein precipitation method. non-compartmental pharmacokinetic model was used for pK analysis. Results were statistically compared using logarithmically transformed data, where p > 0.05 was considered as non-significant with 90% CI limit of 0.8-1.25. The bio-analytical method used for estimating drug plasma concentration was found to be simple, selective, linear, accurate and precise with 0.01 ng/ml as limit of detection. The comparative PK analysis revealed an insignificant difference in AUC 0-∞, AUC 0-t, V z /f, cl/f and t 1/2λz , whereas a significant difference in C max , t max and Mtts were found. the relative bioavailability of eperisone osmotic tablet was 109.7%. The osmotic controlled release drug formulation was found to release Eperisone for an extended period with less inter individual fluctuation in pharmacokinetic variables.

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Section: Discussionmentioning

confidence: 99%

“…But the peak plasma concentration and area under the plasma concentration curve reported by different workers were found to vary (C max = 0.80-44.8 ng/ml, AUC 0-∞ = 1.16-76.1 ng/ml × h) widely. Interpersonal PK variation was also noticed within a study, specifically in case of C max 16,[18][19][20][21][22][23] .…”

mentioning

confidence: 97%

Comparative pharmacokinetics of osmotic-controlled and immediate-release Eperisone tablet formulation in healthy human subjects using a sensitive plasma LC-ESI-MS/MS method

Ahmed

Shoaib

Yousuf

et al. 2020

Sci Rep

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“…Eperisone is considered to cause ADRs independent of any other co-administered drugs. In drug interaction studies, there was no known pharmacokinetic interaction between eperisone and aceclofenac13 and pelubiprofen 14…”

Section: Discussionmentioning

confidence: 99%

Eperisone-Induced Anaphylaxis: Pharmacovigilance Data and Results of Allergy Testing

Park

Lee

Yuk

et al. 2019

Allergy Asthma Immunol Res

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Purpose Eperisone is an oral muscle relaxant used in musculoskeletal disorders causing muscle spasm and pain. For more effective pain control, eperisone is usually prescribed together with nonsteroidal anti-inflammatory drugs (NSAIDs). As such, eperisone may have been overlooked as the cause of anaphylaxis compared with NSAIDs. This study aimed to analyze the adverse drug reaction (ADR) reported in Korea and suggest an appropriate diagnostic approach for eperisone-induced anaphylaxis. Methods We reviewed eperisone-related pharmacovigilance data (Korea Institute of Drug Safety-Korea Adverse Event Reporting System [KIDS-KAERS]) reported in Korea from 2010 to 2015. ADRs with causal relationship were selected. Clinical manifestations, severity, outcomes, and re-exposure information were analyzed. For further investigation, 7-year ADR data reported in a single center were also reviewed. Oral provocation test (OPT), skin prick test (SPT) and basophil activation test (BAT) were performed in this center. Results During the study period, 207 patients had adverse reactions to eperisone. The most common ADRs were cutaneous hypersensitive reactions (30.4%) such as urticaria, itchiness or angioedema. Fifth common reported ADR was anaphylaxis. There were 35 patients with anaphylaxis, comprising 16.9% of the eperisone-related ADRs. In the single center study, there were 11 patients with eperisone-induced anaphylaxis. All the patients underwent OPT and all the provoked patients showed a positive reaction. Four of the 11 patients with anaphylaxis also underwent SPT and BAT, which were all negative. Conclusions Incidence of eperisone-induced anaphylaxis calculated from the KIDS-KAERS database was 0.001%. Eperisone can cause hypersensitive reactions, including anaphylaxis, possibly by inducing non-immunoglobulin E-mediated immediate hypersensitivity.

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“…Rizaldy Taslim Pinzon , Rosa De Lima Renita Sanyasi paracetamol and aceclofenac for the treatment of musculoskeletal pain (Kim et al, 2013;Locatelli et al, 2015). Eperisone has a short muscle relaxant activity on account of its extensive first-pass metabolism after oral administration.…”

Section: Systematic Review Of Eperison For Low Back Pain Ementioning

confidence: 99%

Systematic Review of Eperisone for Low Back Pain

Pinzon¹,

Sanyasi²

2018

Asian J Pharm Pharmacol

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Background: Low back pain (LBP) is the main cause of disability. Eperisone is a centrally acting muscle relaxants. It is often used to alleviate musculoskeletal pain including LBP. This systematic review aimed to identify the Objective: effectiveness of eperisone in LBP. Systematic research was conducted by using PubMed and Cochrane with Methods: following terms to search: "eperisone", "low back pain and eperisone", "low back pain and muscle relaxant', "low back pain and antispasmodic", "randomized controlled trial eperisone", and "randomized controlled trial muscle relaxant". The quality of randomized controlled trial (RCT) study is assessed by using the Jadad score by and he selected studies t were reviewed by using PRISMA checklist as the guidance. There were 1389 citations from PubMed and Results: Cohcrane. After screening for title and abstract, irrelevant topic, availability of full text, duplication, the final result was 6 RCT. All studies have a great quality. Subjects in all study were patients with LBP. Eperisone in these study compared to eperisone with different dosage, tizanidine, thiocolchicoside, diazepam, or placebo. Thiacolchicoside was the most common comparison. Visual Analogue Scale (VAS) and Finger to Floor Distance (FFD) were the most common outcome measurement. Eperisone represents a good efficacy to treat LBP and has a better tolerability. Conclusion:

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Pharmacokinetic Interactions Between Eperisone Hydrochloride and Aceclofenac: A Randomized, Open-Label, Crossover Study of Healthy Korean Men

Cited by 12 publications

References 16 publications

Comparative pharmacokinetics of osmotic-controlled and immediate-release Eperisone tablet formulation in healthy human subjects using a sensitive plasma LC-ESI-MS/MS method

Comparative pharmacokinetics of osmotic-controlled and immediate-release Eperisone tablet formulation in healthy human subjects using a sensitive plasma LC-ESI-MS/MS method

Eperisone-Induced Anaphylaxis: Pharmacovigilance Data and Results of Allergy Testing

Systematic Review of Eperisone for Low Back Pain

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