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pseudoephedrine

✓ Approved

Johnson & Johnson Services, Inc. · Small Molecule · Small Molecule

What is pseudoephedrine?

pseudoephedrine is a small molecule developed by Johnson & Johnson Services, Inc.. It is approved for therapeutic indications.

Drug Profile

CompanyJohnson & Johnson Services, Inc.
Drug ClassSmall Molecule
StatusApproved

Therapeutic Indications

pseudoephedrine is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Immune system disordersHypersensitivity✓ Approved

Related Research Articles

PubMedNaunyn-Schmiedeberg's archives of pharmacology2026-09-28

Pseudoephedrine intoxication: sex-specific differences in clinical symptoms.

Gezgin Funda F, Seifert Roland R

Pseudoephedrine (PSE) is an indirectly acting sympathomimetic agent used worldwide to treat cold and flu symptoms, as well as allergic rhinitis. In Germany, PSE is available exclusively as a combination product with other active ingredients such as acetylsalicylic acid, paracetamol, ibuprofen, and first- and second-generation H1 receptor antagonists. Despite the widespread availability and frequent use of PSE, the active ingredient has repeatedly been linked to serious adverse drug reactions (ADRs). Most recently, in 2024, a red-hand letter was circulated after a link was established between PSE use and the occurrence of cerebral hypoperfusion. Furthermore, the drug is not always used in accordance with guidelines for treating specific symptoms but is also misused due to its indirect sympathomimetic effect. This study includes an analysis of published PSE intoxication cases from the literature. To this end, a systematic literature search was conducted in PubMed, from which 118 patient cases were extracted from a total of 81 case reports. The individual cases were then analyzed with regard to various aspects. The United States was the leading country in terms of case reports, followed by the United Kingdom. The analyzed patient cases show differences in terms sex and symptoms. Cardiovascular events occurred predominantly in men, while gastroenterological and dermatological symptoms occurred predominantly in women. To reduce the risk of PSE poisoning, increased educational efforts by physicians and pharmacists are necessary. Furthermore, checking for contraindications could reduce the risk. Education about PSE could also be provided through reputable online platforms. This study highlights the clinical relevance of PSE poisoning and the wide range of symptoms.

PubMedJournal of pharmaceutical and biomedical analysis2026-09-27

A CotB1p-mediated one-step immobilization strategy for constructing GPCR affinity chromatography to screen multi-target natural product ligands.

Zhu Huiting H, Zhang Zilong Z, Ou Yuanyuan Y, Weng Shiyao S et al.

G protein-coupled receptors (GPCRs) are critical targets for drug discovery, yet the screening of GPCR-binding ligands from complex natural products remains challenging due to the lack of mild and universal immobilization strategies for these fragile membrane proteins. Here, we reported CotB1p-mediated one-step immobilization strategy for the construction of GPCR affinity chromatography columns to screen natural product ligands. Three asthma-related GPCRs β2-adrenergic receptor (β2AR), muscarinic M3 receptor (M3R), and cysteinyl leukotriene receptor 1 (CysLT1R) were genetically fused with the silica-binding peptide CotB1p. These fusion proteins were then directly immobilized onto macroporous silica via simple affinity adsorption, a process that avoids harsh chemical crosslinking and preserves receptor binding activity. The prepared affinity columns showed good specificity, stability, and repeatability, with retention time RSDs of 1.56%, 0.98%, and 1.68% for the β2AR, M3R, and CysLT1R columns, respectively. The three affinity columns were applied to screen ligands from a representative natural product prescription, followed by LC-MS/MS identification. Amygdalin, ephedrine/pseudoephedrine, scopolamine, atropine, forsythoside A, and phillyrin were identified as receptor-binding constituents selectively retained by different GPCR columns. Nonlinear chromatography enabled the evaluation of ligand-receptor interactions, with association constants ranging from 4.33 × 104-5.08 × 105 M⁻¹ .Molecular docking and molecular dynamics simulations further supported the possible binding modes and relative conformational stability of the ligand-receptor complexes. In addition, cellular assays in human airway smooth muscle cells indicated that the screened compounds could reduce TNF-α-induced inflammatory cytokine production. Overall, this CotB1p-mediated one-step immobilization strategy provides a mild and efficient approach for preparing functional GPCR affinity stationary phases, offering a useful analytical platform for target-resolved screening of natural product ligands against multiple GPCRs.

PubMedJournal of clinical neurology (Seoul, Korea)2026-09-02

Pseudoephedrine for Central Sympathetic Insufficiency.

Wcislo Jessica J, Posen Andrew A, Davis Jared J

PubMedFrontiers in pharmacology2026-08-26

The impact of patient age on the pharmacist's recommendation of OTC anti-common cold products before and during the COVID-19 pandemic.

Kopa-Stojak Paulina Natalia PN, Pietrusiewicz Malgorzata M, Pawliczak Rafal R

A pharmacist is the first point of contact when a patient seeks the most effective over-the-counter treatment, usually for a self-diagnosed disease, especially in the case of difficult or limited access to medical practitioners. The aim of this study is to determine the impact of the patient's age on the pharmacist's recommendation of over-the-counter anti-common cold treatment before and during the COVID-19 pandemic. This study is based on a self-developed questionnaire about pharmacists' recommendations for patients with cold symptoms collected in four large network community pharmacies in Lodz, Poland, before and during the COVID-19 pandemic. Pearson's chi-square test and odds ratios with 95% confidence intervals were used to determine the relationship between the patient's age and frequency of medication recommendations. The Mann-Whitney U test was used to determine differences in recommendations between the analyzed periods. We report higher odds of pharmacists' recommendations (odds ratio > 1; p < 0.01667) for ibuprofen with pseudoephedrine for patients aged 18-40 years, paracetamol with ascorbic acid, and phenylephrine HCl, acetylcysteine, other soluble products, and other tablets/capsules for patients aged 61-90 years before the COVID-19 pandemic. Moreover, there were higher odds of recommendations for paracetamol with ascorbic acid and phenylephrine HCl, inosines, and other soluble products for the 41-60 age cohort, and for homeopathic and herbal products for the 61-90 age cohort during the pandemic. Patients, especially older people who take several medications, require special attention when being advised about over-the-counter (OTC) medications. Our findings clearly demonstrated the constant need for improving pharmacists' counseling regarding OTC medicines (i.e., age-, comorbidities-, and drug-drug-interaction-adapting recommendations) by training and increasing professional skills.

PubMedForensic science international2026-08-24

LC-MS/MS-based impurity profiling of high-purity methamphetamine for precursor identification and regional comparison.

Kim Se-Eun SE, Bae Hyunah H, Kim Heeseung H

Methamphetamine (MA) is a widely abused illicit drug synthesized primarily using either ephedrine/pseudoephedrine or 1-phenyl-2-propanone (P2P) as precursors. These processes generate precursor-derived impurities that can provide valuable forensic intelligence. However, recent advances in purification techniques have resulted in refined MA samples containing impurities at ultra-trace levels, thereby posing analytical challenges for conventional gas chromatography-based methods. In this study, a highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed for the targeted detection of MA precursor-associated impurities at ultra-trace levels. A total of 19 impurities, including markers associated with the P2P and ephedrine/pseudoephedrine precursor classes, were analyzed using multiple reaction monitoring (MRM) mode. Chromatographic and mass spectrometric conditions were optimized to achieve high sensitivity and selectivity. The developed method demonstrated limits of detection ranging from 0.008 to 2.500 ng/mg and showed satisfactory selectivity and repeatability for qualitative identification. The method was applied to 33 high-purity seized MA samples to evaluate precursor-associated impurity profiles and regional differences based on documented geographical origins. Differences in impurity patterns were observed between samples from North America and Southeast Asia, reflecting regional variation in these profiles. P2P-related impurities were detected in North American samples, whereas Southeast Asian samples exhibited more variable profiles, including both P2P- and ephedrine/pseudoephedrine-related markers. These results demonstrate that the proposed LC-MS/MS method enables reliable detection of ultra-trace level impurities and provides a valuable analytical tool for impurity profiling and forensic intelligence applications, particularly for highly purified MA samples.

PubMedSubstance use & misuse2026-08-17

Underrecognized Substance Exposure in Pediatric Emergency Departments: Insights from Universal LC-MS/MS Confirmation.

Kardaş Zehra Z, Kondolot Meda M, Karakükçü Çiğdem Ç, Koçer Derya D et al.

Substance exposure among pediatric emergency department (ED) patients may be underrecognized because routine urine immunoassays have limited analytical sensitivity, and objective confirmatory toxicological data in pediatric ED populations remain limited. This dual-phase observational study included patients aged 6-18 years who underwent toxicological assessment in two tertiary pediatric EDs in Central Anatolia, Türkiye. The retrospective phase (2018-2021) tested each sample by either immunoassay or LC-MS/MS, depending on time of collection, but not both. The prospective phase (January 2022-2023) enrolled clinically suspected cases, all tested by both methods regardless of screening result. Logistic regression evaluated factors associated with liquid chromatography-tandem mass spectrometry (LC-MS/MS)-confirmed positivity in the prospective cohort. Results: A total of 1039 patients were included (852 retrospective; 187 prospective). In the retrospective cohort, immunoassay screening (n = 570) identified positivity in 19.8% (113/570), while LC-MS/MS on a separate subset (n = 282) identified 32.6% (92/282); these derive from non-overlapping subsets, not paired testing. In the prospective cohort, LC-MS/MS positivity was 11.2% (21/187) by standard cutoff and 18.8% (35/187) with an exploratory limit of quantitation (LOQ)-supported benzodiazepine interpretation (after excluding 18 pseudoephedrine/ephedrine-only patients). Benzodiazepines and amphetamine-type stimulants were most frequently detected. Younger age, psychiatric illness, and daily screen exposure >3 h were independently associated with positivity. Immunoassay screening showed high specificity but limited sensitivity against LC-MS/MS. Conclusions: Routine immunoassay screening may substantially underestimate pediatric substance exposure in ED settings. LC-MS/MS provides broader and more sensitive toxicological detection, though differences also partly reflect broader analyte coverage rather than sensitivity alone.

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