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Impact of serum acetaminophen concentration on changes in serum potassium, creatinine and urea concentrations among patients with acetaminophen overdose

Zyoud SH, Awang R, Sulaiman SA, Al-Jabi SW

Pharmacoepidemiol Drug Saf, 2011 Feb;20(2):203-8.
PMID: 21254292 DOI: 10.1002/pds.2060

Acetaminophen overdose may be accompanied by electrolyte disturbances. The basis for electrolyte change appears to be due to increased fractional urinary electrolyte excretion.

Matched MeSH terms: Acetaminophen/blood
Fulltext Relationship between serum acetaminophen concentration and N-acetylcysteine-induced adverse drug reactions

Zyoud SH, Awang R, Sulaiman SA, Khan HR, Sawalha AF, Sweileh WM, et al.

Basic Clin Pharmacol Toxicol, 2010 Sep;107(3):718-23.
PMID: 20374238 DOI: 10.1111/j.1742-7843.2010.00567.x

Intravenous N-acetylcysteine is usually regarded as a safe antidote. However, during the infusion of the loading dose, different types of adverse drug reactions (ADR) may occur. The objective of this study was to investigate the relation between the incidence of different types of ADR and serum acetaminophen concentration in patients presenting to the hospital with acetaminophen overdose. This is a retrospective study of patients admitted to the hospital for acute acetaminophen overdose over a period of 5 years (1 January 2004 to 31 December 2008). Parametric and non-parametric tests were used to test differences between groups depending on the normality of the data. SPSS 15 was used for data analysis. Of 305 patients with acetaminophen overdose, 146 (47.9%) were treated with intravenous N-acetylcysteine and 139 (45.6%) were included in this study. Different types of ADR were observed in 94 (67.6%) patients. Low serum acetaminophen concentrations were significantly associated with cutaneous anaphylactoid reactions but not other types of ADR. Low serum acetaminophen concentration was significantly associated with flushing (p < 0.001), rash (p < 0.001) and pruritus (p < 0.001). However, there were no significant differences in serum acetaminophen concentrations between patients with and without the following ADR: gastrointestinal reactions (p = 0.77), respiratory reactions (p = 0.96), central nervous reactions (p = 0.82) and cardiovascular reactions (p = 0.37). In conclusion, low serum acetaminophen concentrations were associated with higher cutaneous anaphylactoid reactions. Such high serum acetaminophen concentrations may be protective against N-acetylcysteine-induced cutaneous ADR.

Matched MeSH terms: Acetaminophen/blood*
Significance of lipid matrix aging on in vitro release and in vivo bioavailability

Choy YW, Khan N, Yuen KH

Int J Pharm, 2005 Aug 11;299(1-2):55-64.
PMID: 15955645

A polyglycolised glyceride carrier, Gelucire 50/13, was incorporated with paracetamol as a model drug, filled into hard gelatin capsules and stored at three different temperatures for various lengths of time. The resultant solidified matrix within the capsule was subjected to thermal analysis using differential scanning calorimetry (DSC) to ascertain its supramolecular structure. Polymorphic transformations towards more stable gelucire forms were observed upon aging the matrices, with samples stored at a temperature near the melting range of the lower temperature gelucire melting fraction showing the most profound changes. The increase in the rate of drug release from aged samples could be correlated to the alterations to the supramolecular structure of the gelucire. Accelerated drug release from aged samples could also be seen from in vivo studies using healthy human volunteers, although the extent of absorption was not affected. Therefore, even though the sustainability of release may be compromised by aging the gelucire matrices, the bioavailability of the incorporated drug is unlikely to be affected.

Matched MeSH terms: Acetaminophen/blood
Fulltext A randomized single-dose, two-period crossover bioequivalence study of two fixed-dose Paracetamol/Orphenadrine combination preparations in healthy volunteers under fasted condition

Cheah KY, Mah KY, Pang LH, Ng SM, Wong JW, Tan SS, et al.

BMC Pharmacol Toxicol, 2020 06 23;21(1):45.
PMID: 32576287 DOI: 10.1186/s40360-020-00416-3

BACKGROUND: Paracetamol/Orphenadrine is a fixed dose combination containing 35 mg orphenadrine and 450 mg paracetamol. It has analgesic and muscle relaxant properties and is widely available as generics. This study is conducted to investigate the relative bioavailability and bioequivalence between one fixed dose paracetamol/orphenadrine combination test preparation and one fixed dose paracetamol/orphenadrine combination reference preparation in healthy volunteers under fasted condition for marketing authorization in Malaysia.
METHOD: This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2-period crossover study with a washout period of 7 days. Paracetamol/Orphenadrine tablets were administered after a 10-h fast. Blood samples for pharmacokinetic analysis were collected at scheduled time intervals prior to and up to 72 h after dosing. Blood samples were centrifuged, and separated plasma were kept frozen (- 15 °C to - 25 °C) until analysis. Plasma concentrations of orphenadrine and paracetamol were quantified using liquid-chromatography-tandem mass spectrometer using diphenhydramine as internal standard. The pharmacokinetic parameters AUC0-∞, AUC0-t and Cmax were determined using plasma concentration time profile for both preparations. Bioequivalence was assessed according to the ASEAN guideline acceptance criteria for bioequivalence which is the 90% confidence intervals of AUC0-∞, AUC0-t and Cmax ratio must be within the range of 80.00-125.00%.
RESULTS: There were 28 healthy subjects enrolled, and 27 subjects completed this trial. There were no significant differences observed between the AUC0-∞, AUC0-t and Cmax of both test and reference preparations in fasted condition. The 90% confidence intervals for the ratio of AUC0-t (100.92-111.27%), AUC0-∞ (96.94-108.08%) and Cmax (100.11-112.50%) for orphenadrine (n = 25); and AUC0-t (94.29-101.83%), AUC0-∞ (94.77-101.68%) and Cmax (87.12-101.20%) for paracetamol (n = 27) for test preparation over reference preparation were all within acceptable bioequivalence range of 80.00-125.00%.
CONCLUSION: The test preparation is bioequivalent to the reference preparation and can be used interchangeably.
TRIAL REGISTRATION: NMRR- 17-1266-36,001; registered and approved on 12 September 2017.

Matched MeSH terms: Acetaminophen/blood
Fulltext Assessing the impact of vomiting episodes on outcome after acetaminophen poisoning

Zyoud SH, Awang R, Sulaiman SA, Al-Jabi SW

Basic Clin Pharmacol Toxicol, 2010 Nov;107(5):887-92.
PMID: 20456332 DOI: 10.1111/j.1742-7843.2010.00594.x

Identifying indices of poor prognosis at first presentation after acetaminophen poisoning is the key to both improving clinical care and determining targets for intervention. This study intended to document the prevalence, clinical characteristics and predictors of vomiting and to investigate the relationship between episodes of vomiting at first hospital presentation and outcome in acetaminophen poisoning. This retrospective cohort study included patients who attended the emergency department and were admitted within 24 hr of acetaminophen ingestion. The study was conducted over a period of 5 years from 1 January 2004 to 31 December 2008. Parametric and non-parametric tests were used to test differences between groups depending on the normality of the data. SPSS 15 was used for data analysis. Data from 291 patients were included. Vomiting was present in 65.3% of patients with acetaminophen poisoning at the time of first presentation. Multiple logistic regression showed that significant risk factors for vomiting were present among patients who reported an ingested dose of acetaminophen ≥10 g (p < 0.001) and a latency time of more than 8 hr (p = 0.030). Overall, an increasing trend in prothrombin time (p = 0.03), serum bilirubin (p < 0.001), serum creatinine (p = 0.005), serum potassium (p < 0.001), length of hospital stay (p < 0.001) and the prevalence of patients who had a serum acetaminophen level above a 'possible toxicity' treatment line (p = 0.001) were associated with an increased number of episodes of vomiting. In conclusion, vomiting was common among patients with acetaminophen poisoning. This study suggests that an increase in episodes of vomiting at first presentation appears to be an important risk marker of subsequent nephrotoxicity and hepatotoxicity.

Matched MeSH terms: Acetaminophen/blood
Enhanced amperometric detection of paracetamol by immobilized cobalt ion on functionalized MWCNTs - Chitosan thin film

Akhter S, Basirun WJ, Alias Y, Johan MR, Bagheri S, Shalauddin M, et al.

Anal Biochem, 2018 06 15;551:29-36.
PMID: 29753720 DOI: 10.1016/j.ab.2018.05.004

In the present study, a nanocomposite of f-MWCNTs-chitosan-Co was prepared by the immobilization of Co(II) on f-MWCNTs-chitosan by a self-assembly method and used for the quantitative determination of paracetamol (PR). The composite was characterized by field emission scanning electron microscopy (FESEM) and energy dispersive x-ray analysis (EDX). The electroactivity of cobalt immobilized on f-MWCNTs-chitosan was assessed during the electro-oxidation of paracetamol. The prepared GCE modified f-MWCNTs/CTS-Co showed strong electrocatalytic activity towards the oxidation of PR. The electrochemical performances were investigated by cyclic voltammetry (CV), electrochemical impedance spectroscopy (EIS) and differential pulse voltammetry (DPV). Under favorable experimental conditions, differential pulse voltammetry showed a linear dynamic range between 0.1 and 400 μmol L-1 with a detection limit of 0.01 μmol L-1 for the PR solution. The fabricated sensor exhibited significant selectivity towards PR detection. The fabricated sensor was successfully applied for the determination of PR in commercial tablets and human serum sample.

Matched MeSH terms: Acetaminophen/blood