One Case of Phenytoin Intoxication Caused by Compound Phenytoin Sodium Ephedrine Hydrochloride and Theophylline Tablets

doi:10.19803/j.1672-8629.20240626

Abstract

Abstract: Objective To provide a reference for pharmacovigilance by analyzing the clinical characteristics and mechanisms of phenytoin sodium poisoning induced by compound phenytoin sodium, ephedrine hydrochloride and theophylline tablets (CPEHTTs) in an asthmatic patient. Methods One case of dizziness and ataxia induced by CPEHTTs in a patient with asthma was analyzed. Case reports of phenytoin sodium poisoning caused by CPEHTTs were retrieved from PubMed, Web of Science, Ovid and CNKI Full-text databases. The mechanism of adverse drug reactions (ADR) was explored. Results According to the correlation evaluation of ADR, the score of the Naranjo's scale and the Results of therapeutic drug monitoring, CPEHTTs were considered to have caused phenytoin sodium poisoning. After discontinuation of the drug and initiation of symptomatic treatment, the patient’s symptoms gradually subsided and recovered. Conclusion CPEHTT may carry the risk of phenytoin sodium poisoning, so they should be used with caution.

Key words: Compound Phenytoin Sodium Ephedrine Hydrochloride and Theophylline Tablets, Phenytoin Sodium, Drug Poisoning, Adverse Drug Reactions, Pharmacovigilance

CLC Number:

R974

LEI Jianlin, WANG Na, WANG Wenzheng, WANG Yan. One Case of Phenytoin Intoxication Caused by Compound Phenytoin Sodium Ephedrine Hydrochloride and Theophylline Tablets[J]. Chinese Journal of Pharmacovigilance, 2025, 22(7): 819-822.

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https://zgywjj.magtechjournal.com/EN/Y2025/V22/I7/819

References

[1] YU LD, LI HJ, AN YJ.Analysis of Severe Mental and Behavioural Disorder Due to Long-Term Oral Administration of Phenytoin Sodium[J]. Clinical Misdiagnosis & Mistherapy(临床误诊误治), 2018, 31(3): 89-91.
[2] ZHANG LX,LI ZF,MA GY,et al.A Systematic Review of Phenytoin Intoxication Induced by Compound Phenytoin Sodium, Ephedrine Hydrochloride and Theophylline Tablets in China[J]. Medicine, 2018, 97(51): e13689.
[3] PANG DQ, LIU F, SUN Y.Clinical Features of Toxicity of Phenytoin Induced by Compound Phenytoin Ephedrine Theophylline Tablets (Report of 3 Cases)[J]. Journal of Clinical Neurology(临床神经病学杂志), 2018, 31(4): 297-300.
[4] FAN LM, RUAN SS.Ataxia and Mental Disorders Induced by Compound Phenytoin Sodium, Ephedrine Hydrochloride and Theophylline Tablets[J]. Adverse Drug Reactions Journal(药物不良反应杂志), 2018, 20(5): 386-387.
[5] LIU Y, WU SW.Ataxia Due to Compound Phenytoin Sodium, Ephedrine Hydrochloride and Theophylline Tablets: 2 Cases[J]. Medical Journal of the Chinese People Armed Police Forces(武警医学), 2018, 29(12): 1167-1168, 1172.
[6] YIN JT, WANG W, WU LJ, et al.Five Cases of Compound Phenytoin Ephedrine Theophylline Poisoning[J]. Journal of Brain and Nervous Diseases(脑与神经疾病杂志), 2021, 29(5): 292-297.
[7] WANG F, LI Y, ZHAO J, et al.Drug Treatment Management for an Elderly Patient with Polypharmacy Due to Co-Existing Chronic Diseases[J]. Chinese Journal of Clinical Rational Drug Use(临床合理用药杂志), 2021, 14(31): 152-154.
[8] WANG Z, WEI N, WANG XM.Paroxysmal Ataxia Induced by Compound Phenytoin Sodium, Ephedrine Hydrochloride and Theophylline Tablets: a Case and Literature Review[J]. Journal of Apoplexy and Nervous Diseases(中风与神经疾病杂志), 2021, 38(9): 791-793.
[9] LU FL, WANG HJ, SI HY, et al.One Case of Epissodic Extrapy-ramidal Disease Induced by Compound Phenytoin Sodium, Ephedrine Hydrochloride and Theophylline Tablets[J]. Journal of Clinical Neurology(临床神经病学杂志), 2022, 35(6): 456-457.
[10] LIU CY, ZHANG JB, WANG JJ.Misdiagnosis Analysis of Ataxia Caused by Compound Phenytoin Sodium, Ephedrine Hydrochloride and Theophylline Tablets: 1 Case[J]. Journal of Changzhi Medical College(长治医学院学报), 2024, 38(3): 236-238.
[11] FELBER R, PRAGER VR, WERDE D, et al.A Rare Case of Hemodialysis as an Extracorporeal Treatment for Severe Phenytoin Overdose[J]. Cureus, 2024, 16(9): e70338.
[12] PRASERTSUP W, CHOMCHAI S, MEKAVUTHIKUL P, et al.Phenytoin Intoxication in a Patient Receiving a Therapeutic Dose for Postoperative Seizure Prophylaxis: a Case Study[J]. Ther Drug Monit, 2023, 45(5): 573-575.
[13] IORGA A, HOROWITZ BZ. Phenytoin Toxicity[EB/OL]. (2023-08-08)[2024-08-08]. https://www.ncbi.nlm.nih.gov/books/NBK482444/.
[14] AWASTHI A, AGRAWAL N, CHAKRABORTY PP, et al. Phenytoin Toxicity[J/OL]. BMJ Case Reports, (2022-11-30)[2024-08-08]. https://doi.org/10.1136/bcr-2022-253250.
[15] MANSON LEN, NIJENHUIS M, SOREE B, et al.Dutch Pharm-acogenetics Working Group Guideline for the Gene-Drug Interaction of CYP2C9, HLA-A and HLA-B with Anti-Epileptic Drugs[J]. European Journal of Human Genetics, 2024, 32(8): 903-911.
[16] JOURNEY JD, BENTLEY TP.Theophylline Toxicity[EB/OL].[2024-08-08].https://ginasthma.org/2024-report/.
[17] ZHANG WJ, GUO GM, FAN Z, et al.Overview of Safety Studies on the Application of Herba Ephedra and Its Extracts in Recent Decades[J]. Global Traditional Chinese Medicine(环球中医药), 2021, 14(1): 173-178.
[18] ANSEEUW K, MOWRY JB, BURDMANN EA, et al.Extracorporeal Treatment in Phenytoin Poisoning: Systematic Review and Recommendations from the EXTRIP(Extracorporeal Treatments in Poisoning) Workgroup[J]. American Journal of Kidney Diseases, 2016, 67(2): 187-197.
[19] Global Initiative for Asthma.2024 GINA Main Report.Global Strategy for Asthma Management and Prevention[EB/OL]. [2024-08-08]. https://ginasthma.org/2024-report/.
[20] NMPA. Announcement of the National Medical Products Administration on Amending the Instructions for Compound Phenytoin, Ephedrine and Theophylline Tablets[EB/OL]. (2024-03-14)[2024-08-08]. https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypshmshxdgg/20240322153828122.html.