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pseudoephedrine (Efidac/24 / Sudafed 24)

✓ Approved

Johnson & Johnson Services, Inc. · 小分子 · 小分子

什么是 pseudoephedrine？

pseudoephedrine 是一种小分子，由Johnson & Johnson Services, Inc.研发。该药已获批，用于治疗相关适应症，给药途径：Oral (PO)。

药物档案

商品名Efidac/24, Sudafed 24
公司Johnson & Johnson Services, Inc.
药物类别小分子
给药途径Oral (PO)
状态Approved
来源： ClinicalTrials.gov, Johnson & Johnson Services, Inc.

治疗适应症

pseudoephedrine 针对 2 个适应症，涉及 2 个治疗领域。

治疗领域疾病/病症分期
Immune system disordersHypersensitivity✓ Approved
Infections and infestationsRespiratory tract infection✓ Approved

相关研究文献

PubMedCureus2026-08-02

Mycoplasma pneumoniae-Associated Reactive Infectious Mucocutaneous Eruption Mimicking Atypical Stevens-Johnson Syndrome: A Case Report.

Burbea Alexandru C AC, Verlekar Pankaj P

Reactive infectious mucocutaneous eruption (RIME) is an infection-associated mucositis syndrome previously described under terms including incomplete Stevens-Johnson syndrome (SJS), Fuchs syndrome, and Mycoplasma pneumoniae-induced rash and mucositis (MIRM). It is characterised by an infectious prodrome, prominent mucosal involvement, and sparse or absent cutaneous disease. Severe ocular involvement may clinically mimic atypical Stevens-Johnson syndrome. We report the case of a previously healthy woman in her 20s who developed coryzal symptoms and self-treated with ibuprofen, paracetamol, and pseudoephedrine before presenting with worsening cough, pyrexia, odynophagia, and bilateral conjunctival discharge. She received doxycycline and topical chloramphenicol but re-presented overnight with rapidly progressive lip swelling, dysphagia, oral mucosal ulceration, and severe bilateral ocular inflammation without cutaneous lesions. Recent exposure to non-steroidal anti-inflammatory medication and doxycycline created initial diagnostic uncertainty, while the preceding respiratory prodrome and skin-sparing mucositis supported infection-associated RIME. Ophthalmological assessment demonstrated severe ocular surface inflammation with pseudomembrane formation, early symblepharon, and progressive corneal involvement, requiring tertiary transfer and amniotic membrane grafting. Initial chest radiography and respiratory multiplex polymerase chain reaction (PCR) testing were negative, including for Mycoplasma pneumoniae; however, subsequent serology returned positive for Mycoplasma pneumoniae IgM. Later drug challenge testing demonstrated tolerance to suspected medications, supporting an infection-associated rather than drug-induced aetiology. This case highlights that Mycoplasma pneumoniae-associated RIME may mimic atypical Stevens-Johnson syndrome, particularly when severe ocular and oral mucositis occurs after recent medication exposure. Early dermatology and ophthalmology involvement, combined molecular and serological testing, and prompt ocular treatment are essential to reduce long-term ocular morbidity.

PMID 42540076
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PubMedBirth defects research2026-07-30

Intentional Dexketoprofen Overdose During Pregnancy: Maternal and Fetal Outcomes in Three Cases.

Uysal Nusret N, Gungor Mesut M, Karadas Baris B, Yilmaz Ismail I et al.

Dexketoprofen trometamol is a widely used short-acting nonsteroidal anti-inflammatory drug. Despite its widespread clinical use, pregnancy-specific safety data for dexketoprofen as an individual agent are lacking, and no previous report has described maternal or fetal outcomes following overdose in pregnant women. We present three cases of intentional dexketoprofen overdose during pregnancy. Case 1 involved a 33-year-old woman at 8 weeks of gestation who ingested dexketoprofen with ibuprofen, pseudoephedrine, and cefuroxime; she delivered a healthy male infant at 37 weeks with no congenital anomalies on follow-up. Case 2 involved a 36-year-old woman at 17 weeks who ingested dexketoprofen with ergotamine tartrate, mecloxamine, caffeine, and paracetamol; she experienced a spontaneous abortion at 20 weeks, complicated by cyst rupture requiring hysterectomy. Case 3 involved a 29-year-old woman at 6 weeks who ingested dexketoprofen, paracetamol, and chlorpheniramine, and underwent elective termination at 10 weeks. The three cases demonstrated heterogeneous pregnancy outcomes. No congenital anomalies were identified in the single evaluable live-born infant. Multiple co-ingested agents substantially complicate causal attribution, most notably ergotamine tartrate in Case 2. The limited case number and outcome heterogeneity preclude identification of a consistent pattern of fetal adverse effects or definitive conclusions regarding fetal risk. All overdoses were intentional, underscoring the importance of integrating psychiatric assessment into toxicological management during pregnancy. These cases represent the first available observational data on maternal and fetal outcomes following intentional dexketoprofen overdose in pregnancy, highlighting the need for a multidisciplinary approach in this clinical setting.

PMID 42527370
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PubMedPharmacological reports : PR2026-07-11

The onset of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with the use of decongestant agents: a European pharmacovigilance analysis.

Anatriello Antonietta A, Cantone Andrea A, Pentella Ciro C, Vastarella Maria Giovanna MG et al.

On December 1st, 2023, the Pharmacovigilance Risk Assessment Committee (PRAC) published a safety warning against using pseudoephedrine in patients with severe or uncontrolled hypertension and severe acute or chronic kidney disease for the risk of developing posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS). Based on this consideration and the availability of other decongestants with the same mechanism of action as pseudoephedrine in the European market, we decided to conduct a safety study to evaluate cases of RCVS or PRES reported with other decongestants. A European, retrospective, post-marketing surveillance study was conducted to describe individual case safety reports (ICSRs) of RCVS and PRES reported with decongestants and to compare the likelihood of reporting these events among decongestants. Data were retrieved from the EudraVigilance database from January 1st, 2001, to December 31st, 2025. A total of 65 ICSRs reported PRES or RCVS with decongestants, most of which referred to female patients aged 18-64 years. A disproportionate reporting of RCVS was found for xylometazoline (reporting odds ratio, ROR: 3.39; 95% confidence interval, CI: 1.94-5.93) and phenylephrine (ROR: 2.00; 95% CI: 1.11-3.61), and a disproportionate reporting of PRES for ephedrine (ROR: 6.44; 95% CI: 1.80-23.10) and phenylephrine (ROR: 3.47; 95% CI: 1.22-9.88) compared to all other decongestants. Our results suggest that all decongestants should be used with caution, and attention should be paid to signs and symptoms of PRES and RCVS when taking these medicines.

PMID 42432411
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PubMedScientific reports2026-07-07

AI-assisted versus manual sustainability assessment of a high-throughput LC-MS/MS method for psychotropic and OTC drugs of abuse in human plasma.

Yamani Hend Z HZ, Hesham Khaled K, Tawakkol Shereen M SM, Hussein Lobna A LA et al.

A rapid, sensitive, and selective LC-MSMS method was developed and validated for the quantification of dextromethorphan (DXM), pseudoephedrine (PSE), olanzapine (OLA), and fluoxetine (FLU) in human plasma. Mixture 1 (DXM/PSE) and mixture 2 (OLA/FLU) are fixed-dose combinations commonly misused at high doses for their euphoric effects. The proposed method employed a simple protein precipitation technique for sample preparation, using a cost-effective cross-over internal standard strategy; OLA for mixture 1 and DXM for mixture 2. Chromatographic separation was achieved on a Hypersil GOLD column (100 × 3 mm, 1.9 µm) using an isocratic mobile phase consisting of acetonitrile and 0.1% formic acid (70:30, v/v) at a flow rate of 0.3 mL/min. The short runtime of 2.5 min enables high-throughput analysis. Detection was performed in positive ionization mode using multiple reaction monitoring (MRM). The method exhibited linearity over concentration ranges of 0.05-25.0 ng/mL for DXM, 2.0-1000.0 ng/mL for PSE, 0.2-20.0 ng/mL for OLA, and 0.5-50.0 ng/mL for FLU with lower limits of quantification (LLOQs) of 0.05, 2.0, 0.2, and 0.5 ng/mL, respectively. The method was successfully validated in accordance with FDA and ICH bioanalytical method validation guidelines, demonstrating satisfactory selectivity, accuracy, and precision. The validated method demonstrated high extraction recovery (> 90%), limited, reproducible matrix effects (IS-normalized matrix factor CV ≤ 15%). This study represents a novel application of artificial intelligence (AI)-assisted evaluation, utilizing a universally accessible model to assess the greenness and whiteness of the proposed LC-MS/MS method through the Auto-AGREE and Auto-RGB 12 frameworks. The AI-generated assessments demonstrated high agreement with traditional metrics, highlighting the potential of AI tools to provide rapid and objective holistic sustainability evaluations for the global analytical community.

PMID 42409859
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PubMedCommunications chemistry2026-07-02

Exploring the photodynamical landscape of biomimetic lumichrome-ephedrine-class amine complexes across femtosecond to millisecond regimes.

Jena Subhrakant S, de la Hoz Tomás Mario M, Organero Juan Ángel JÁ, Moreno Ferrer Miquel M et al.

Flavin-amine interactions are central to neurotransmitter metabolism, yet how H-bonding and amine structure govern excited-state pathways remains unclear. Using lumichrome (LC) as a biomimetic model, we examine interactions and photobehaviour with sympathomimetic amines, norephedrine (Neph), ephedrine (Eph), and pseudoephedrine (Peph). In water, LC with amines readily forms anions. In dichloromethane, H-bonding drives ultrafast single-proton transfer (SPT) in the LC-Neph complex (~800 fs), followed by population redistribution (~14 ps) and a long-lived anion (τ ~5.4 ns), while LC-Eph and LC-Peph complexes show shorter lifetimes (~4.3-4.8 ns). Control experiments with phenethylamine confirm that the amine group drives SPT-mediated anion formation. Computational calculations support excitation-induced charge redistribution and SPT-mediated zwitterionic stabilisation. Nanosecond-millisecond transient absorption shows minor triplet quenching by Neph (τ ~0.74 → 0.66 μs), but Eph and Peph enhance quenching (τ ~0.45-0.55 μs) and photoproduct formation. This study unravels LC-sympathomimetic amine interactions, offering an avenue to interrogate excited-state pathways in flavin photochemistry.

PMID 42386889
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PubMedScientific reports2026-06-17

A novel eco-friendly HPTLC approach for the simultaneous determination of erdosteine, ibuprofen and pseudoephedrine pharmaceutical combination.

Elgammal Feda A H FAH, Hafez Maram G MG, Khalil Hadeel A HA, Gawad Dina A DA et al.

This paper introduces the first validated and ecofriendly high-performance thin-layer chromatographic (HPTLC) method for the simultaneous determination of erdosteine (ERD), ibuprofen (IBU), and pseudoephedrine (PSE) pharmaceutical combination. This drug combination aids in treating symptoms associated with upper respiratory tract infections (URTIs) by providing mucolytic, analgesic, anti-inflammatory, and decongestant effects within a single therapeutic regimen. The chromatographic separation was effectively achieved on a silica gel 60F254 plate using a mobile phase composed of ethyl acetate: methanol: ammonia (7:1.4:0.5, v/v), and UV detection at 210 nm. The analytes were well resolved with retardation factors (Rf) of 0.06, 0.23, and 0.35 for ERD, IBU, and PSE, respectively. The method demonstrated high accuracy, with recoveries ranging from 98.4% to 101.2% and excellent precision, as indicated by % RSD values below 2%. It also showed high sensitivity, with detection limits of 0.014 µg/spot, 0.002 µg/spot and 0.150 µg/spot for ERD, IBU, and PSE, respectively. The method's environmental sustainability was confirmed using the Analytical EcoScale, Analytical GREEnness (AGREE) calculator and Green Analytical Procedure Index (GAPI). Additionally, its overall whiteness profile was assessed using the Red-Green-Blue (RGB12) model approach, highlighting its analytical efficiency and eco-friendly design.

PMID 42303778
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