Influence of Menstrual Cycle on the Pharmacokinetics of Paracetamol Through Salivary Compartment in Healthy Subjects

Gugilla, Sandhya R; Boinpally, Ramesh; Bolla, Samba M; Devaraj, Rambhau

doi:10.1097/00007691-200208000-00006

Cited by 6 publications

(4 citation statements)

References 33 publications

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“…Conversely, the pharmacokinetics of carbamazepine [49], nitrazepam [8] and phenobarbital [49] do not seem to be influenced by the stage of the menstrual cycle. Paracetamol had also been reported to be free of menstrual cycle influence [50] but a more recent study investigating salivary output concluded that certain pharmacokinetic parameters (C max , AUC) were significantly lower around ovulation when compared with the follicular and luteal phases [51]. Potential effects of the differing stages of the menstrual cycle on actual drug metabolism, the chemical alteration of the parent molecule, are much harder to ascertain.…”

Section: Pharmacokinetic Perturbationsmentioning

confidence: 99%

The Menstrual Cycle and Drug Metabolism

Mitchell¹,

Smith²,

Waring³

2009

CDM

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Within the field of drug metabolism, when addressing quantitative aspects, an average value is traditionally quoted, commonly the arithmetic mean with perhaps an indication of spread. Better still a range of values may be given, thereby acknowledging that various factors may precipitate differences between individuals. A single subject, however, usually only merits a single value. Nevertheless, events such as an acute illness or concurrent drug therapy serve to alert that this value may change substantially over a relatively short time-period, although any potential effects of naturally occurring phenomena, such as the female menstrual cycle, are often overlooked or disregarded. Are the biochemical and physiological changes that occur during the menstrual cycle able to influence xenobiotic metabolism? Is the idea of a stable and unwavering baseline within a single healthy individual flawed? Is it time to reassess our thinking with regards to such aspects? This brief review explores these issues and examines information available within the literature for evidence of potential influences of menstrual cycle events upon drug metabolism, defined as the actual chemical alteration of the parent molecule into another chemical species.

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Section: Pharmacokinetic Perturbationsmentioning

confidence: 99%

The Menstrual Cycle and Drug Metabolism

Mitchell¹,

Smith²,

Waring³

2009

CDM

View full text Add to dashboard Cite

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“…Among neonates, the status of prenatal drug exposure, the occurrence of perinatal events ( e.g ., asphyxia at birth), and the presence of pathophysiologic conditions ( e.g ., patent ductus arteriosus, chronic lung disease) influence the status of organ function 10 . Among adolescent girls, circulating hormone profiles can even be seen to influence drug disposition in the same child 11 . Failure to appreciate the degree of intersubject variability that is expected when study inclusion criteria stratify pediatric populations solely based on age may result in sample sizes that lack the statistical power to assess developmental dependence on drug disposition.…”

Section: Selecting the Populationmentioning

confidence: 99%

“…10 Among adolescent girls, circulating hormone profiles can even be seen to influence drug disposition in the same child. 11 Failure to appreciate the degree of intersubject variability that is expected when study inclusion criteria stratify pediatric populations solely based on age may result in sample sizes that lack the statistical power to assess developmental dependence on drug disposition.…”

Section: Selecting the Populationmentioning

confidence: 99%

Considerations in the Rational Design and Conduct of Phase I/II Pediatric Clinical Trials: Avoiding the Problems and Pitfalls

Abdel‐Rahman

Reed

Wells

et al. 2007

Clin Pharmacol Ther

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Over the past decade, there has been a heightened awareness of the need to include children in the drug development process. With this awareness has come an expansion of the infrastructure for conducting studies in children and an increase in the sponsorship of pediatric clinical trials. However, the growth in pediatric research has, in many cases, not been accompanied by an increase in the involvement of trained pediatric investigators when it comes to trial design and/or interpretation. Pediatric phase I/II protocols continue to span a spectrum from those that are carefully constructed to those that are poorly designed. This paper highlights the basic elements of phase I/II protocols that merit unique consideration when the clinical trial involves children. Illustrations are provided from our experience, which highlight problems that may arise when trials are not designed with the pediatric patient in mind.

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“…10 Nevertheless, changes in enzyme metabolism could explain documented medication fluctuations in women (eg, acetaminophen). 13 In the realm of psychopharmacological medication, few studies investigating sex-specific differences have been conducted. One study on lithium reported a potential decrease in serum concentration during the premenstrual phase.…”

Section: Introductionmentioning

confidence: 99%

Changes in Psychotropic Drug Concentrations Across the Menstrual Cycle: A Pilot Study

Spadi,

Scherf-Clavel,

Leutritz

et al. 2024

Therapeutic Drug Monitoring

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Background: The escalating prescription of psychopharmacological medications to women of reproductive age underscores the growing significance of sex-specific variations in pharmacotherapy. Despite this, clinical trials have largely overlooked these differences. Preliminary data indicate sex-specific variations in the neurobiology of affective disorders and in the metabolism, pharmacodynamics, and kinetics of therapeutic drugs. This underscores the imperative for a more nuanced exploration of menstrual cycle–dependent fluctuations in psychotropic drugs. This pilot study aimed to investigate drug and hormone fluctuations in female patients with affective disorders, aiming to enhance comprehension of the interplay between cycle-related hormone fluctuations and pharmacokinetics. The ultimate goal is to facilitate more effective and safer pharmacological therapy in the future. Methods: Blood samples were collected from 27 patients and 27 age-matched control participants at 3 distinct time points (early follicular phase, ovulation, and late luteal phase) during each menstrual cycle. Depressive and manic symptoms were assessed, and hormone concentrations were measured in the entire sample, while drug concentrations were assessed solely in the affective disorder sample using mass spectrometry. Results: Significant variations in drug concentration were observed throughout the menstrual cycle for bupropion, with a trend toward altered concentration for venlafaxine. Moreover, notable differences in hormone concentrations were identified between patients and controls, even after accounting for the impact of contraceptive use, diagnoses, and medication. Conclusions: This pilot study reinforces previously reported data, underscoring the significance of sex-specific pharmacological therapy approaches. It provides further evidence supporting the interaction among sex hormones, drugs, and symptoms of affective disorders.

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Influence of Menstrual Cycle on the Pharmacokinetics of Paracetamol Through Salivary Compartment in Healthy Subjects

Cited by 6 publications

References 33 publications

The Menstrual Cycle and Drug Metabolism

The Menstrual Cycle and Drug Metabolism

Considerations in the Rational Design and Conduct of Phase I/II Pediatric Clinical Trials: Avoiding the Problems and Pitfalls

Changes in Psychotropic Drug Concentrations Across the Menstrual Cycle: A Pilot Study

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