Effect of repeated Shengmai-San administration on nifedipine pharmacokinetics and the risk/benefit under co-treatment

Wang, Hong-Jaan; Tan, Elise Chia-Hui; Chiang, Tzu-Yi; Chen, Wei-Ching; Shen, Chien‐Chang; Ueng, Yune-Fang

doi:10.38212/2224-6614.3401

Cited by 5 publications

(4 citation statements)

References 53 publications

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“…Eventually, 70%–80% of nifedipine is eliminated in the urine as metabolites, with the remaining metabolites being eliminated in the feces 16,17 . Several drug‐drug interaction studies have been reported, ketoconazole, ginkgo biloba leaf extract, and Shengmai‐San increased the maximum plasma concentration (C max ) and area under the plasma concentration–time curve (AUC) of nifedipine due to their inhibitory effect on CYP 18–20 . In contrast, St. John's wort as a CYP3A4 inducer prolonged the time to maximum concentration (t max ) and increased the clearance of nifedipine 21 …”

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confidence: 99%

Pharmacokinetics and Bioequivalence of 2 Nifedipine Controlled‐Release Tablets: A Randomized, Single‐Dose, 2‐Period Crossover Study in Healthy Chinese Volunteers Under Fasting and Fed Conditions

Xin

Chen²,

Chen³

et al. 2023

Clinical Pharm in Drug Dev

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The aim of this study was to evaluate the bioequivalence of generic nifedipine controlled‐release tablet compared to branded product under fasting and fed conditions. A randomized, single‐dose, 2‐period, crossover study with a 7‐day washout period was performed in 84 healthy Chinese volunteers (fasting cohort, n = 42; fed cohort, n = 42). In each study period, volunteers were assigned to receive a single oral dose of the generic or reference product (30 mg). Blood samples were collected before dosing and up to 72 hours after administration. The plasma concentration of nifedipine was determined by a validated liquid chromatography–tandem mass spectrometry method. Pharmacokinetic parameters were obtained using a noncompartmental model and log‐transformed pharmacokinetic parameters (maximum plasma concentration, area under the plasma concentration–time curve (AUC) from time 0 to the last measurable concentration, AUC from time 0 to infinity) were used to evaluate bioequivalence. The results showed that the 90% confidence interval for the geometric mean ratio of pharmacokinetic parameters of the test and reference products ranged from 80.0% to 125.0% in both the fasting and fed cohorts, meeting the criteria for bioequivalence. No serious adverse events were reported throughout the study and no adverse events led to withdrawal from the study. Food effects were found in both the test and reference products, with mean maximum plasma concentration, AUC from time 0 to the last measurable concentration, and AUC from time 0 to infinity increased by 23.7%, 20.7%, and 20.5%, respectively, for the test product and 35.2%, 13.4%, and 14.7% for the reference product after a high‐fat and high‐calorie breakfast.

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mentioning

confidence: 99%

Pharmacokinetics and Bioequivalence of 2 Nifedipine Controlled‐Release Tablets: A Randomized, Single‐Dose, 2‐Period Crossover Study in Healthy Chinese Volunteers Under Fasting and Fed Conditions

Xin

Chen²,

Chen³

et al. 2023

Clinical Pharm in Drug Dev

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“…The bioavailability of pharmaceuticals and their associated health ailments are tabulated in Table 2. [56][57][58][59][60][61][62][63][64][65][66][67] The toxic effects on aquatic organisms exposed to pharmaceutical contaminants alter their lifetime. Analgesic exposure in the environment causes kidney diseases and morphological abnormalities in the gills.…”

Section: Health Effectsmentioning

confidence: 99%

Promising approaches and kinetic prospects of the microbial degradation of pharmaceutical contaminants

Karishma,

Yaashikaa,

Kumar

et al. 2023

Environ. Sci.: Adv.

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“…Accordingly, nifedipine clearance decreased and AUC t increased. In patients taking nifedipine/felodipine, additional SMS treatment increased the incidence of headaches but decreased all-cause mortality [ 135 ].…”

Section: Potential Hdis Between Tcm Formulas and Prescribed Cvd Drugsmentioning

confidence: 99%

“…These reports suggest a potential dose-dependent mixed type of CYP3A modulation by Schisandra ingredients. Thus, in addition to the impaired intestinal CYP3A function by Ophiopogonis Radix and its ingredients, the potent inhibition of nifedipine oxidation by schisandrin B/schisantherin A should be considered during repeated SMS treatments [ 134 , 135 ].…”

Section: Potential Hdis Between Tcm Formulas and Prescribed Cvd Drugsmentioning

confidence: 99%

Metabolism-involved drug interactions with traditional Chinese medicines in cardiovascular diseases

Liang¹,

Hsu²,

Chang³

et al. 2022

Journal of Food and Drug Analysis

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Herbal medicines have been widely used for the past millennia. Traditional Chinese medicine (TCM) is a major modality in Chinese medical care and has garnered global attention owing to its pharmacological effects and multi-targeted actions. The increased incidence of sequential or concurrent use of herbs and drugs in patients forces us to consider herb–drug interactions (HDIs) in this modern era. One of the main causes of HDIs is modulation of drug metabolism, in which cytochrome P450 (CYP), UDP-glucuronosyltransferase (UGT), and transporters play primary roles. In this review, we focus on in vivo studies of HDIs, particularly in the treatment of cardiovascular disease (CVD), which is currently the leading cause of disease-related mortality worldwide. A total of 55 HDIs are summarized, and their potential underlying mechanisms are examined. The pharmacokinetic (PK) and pharmacodynamic (PD) effects of three single herbs (Danshen, Ginseng, and Ginkgo) and four compound prescriptions (Shenmai injection, Shengmai-San, Shu-Jing-Hwo-Shiee-Tang, and Wu-Chu-Yu-Tang) are discussed. Due to the complex compositions and PK/PD profiles of TCMs, the determinants of significant HDIs have been listed to further define the pros and cons of HDIs in medical care.

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Effect of repeated Shengmai-San administration on nifedipine pharmacokinetics and the risk/benefit under co-treatment

Cited by 5 publications

References 53 publications

Pharmacokinetics and Bioequivalence of 2 Nifedipine Controlled‐Release Tablets: A Randomized, Single‐Dose, 2‐Period Crossover Study in Healthy Chinese Volunteers Under Fasting and Fed Conditions

Pharmacokinetics and Bioequivalence of 2 Nifedipine Controlled‐Release Tablets: A Randomized, Single‐Dose, 2‐Period Crossover Study in Healthy Chinese Volunteers Under Fasting and Fed Conditions

Promising approaches and kinetic prospects of the microbial degradation of pharmaceutical contaminants

Metabolism-involved drug interactions with traditional Chinese medicines in cardiovascular diseases

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