Last update 30 Jun 2024

Pseudoephedrine Hydrochloride

Last update 30 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryPseudoephedrine Hydrochloride, a small molecule drug, acts as an α-adrenergic receptor agonist, exerting its effects through the stimulation of α-adrenergic receptors. The drug, first approved in August 1975, is primarily utilized as a decongestant to alleviate nasal congestion caused by a variety of factors, such as the common cold, allergies, or sinusitis. Pseudoephedrine Hydrochloride operates by eliciting a response from the α-adrenergic receptors present in the smooth muscle of the blood vessels located in the nasal passages, inducing constriction and mitigating the swelling of the nasal mucosa. This process culminates in an augmented airflow through the nasal passages, relieving congestion. However, owing to its potential for abuse and the production of illegal drugs, pseudoephedrine-containing medications are currently subject to strict regulation and require a prescription in numerous countries to prevent their misuse.

Drug Type

Small molecule drug

Synonyms

Pseudoephedrine hydrochloride (USP), Nexafed, Novafed

+ [2]

Target

α-adrenergic receptor

Mechanism

α-adrenergic receptor agonists(Alpha adrenergic receptor agonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [1]

Active Indication

Rhinitis, AllergicNasal Obstruction

Inactive Indication

Common Cold

Originator Organization-

Active Organization

McNeil Products Ltd.

Johnson & Johnson Holdco (NA), Inc.

Inactive Organization

Perrigo Co. Plc

Drug Highest PhaseApproved

First Approval Date

CA (01 Jan 1992)

Regulation-

Structure

Molecular FormulaC10H16ClNO

InChIKeyBALXUFOVQVENIU-KXNXZCPBSA-N

CAS Registry345-78-8

Clinical Trials associated with Pseudoephedrine Hydrochloride

NCT05720455 / Not yet recruitingPhase 4

A Phase IV, Open Label, Clinical Trial to Assess Safety and Efficacy of Fexofenadine HCL + Pseudoephedrine HCL Fixed Dose Combination in Indian Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above (FAST Trial)

This is a single group, Phase IV clinical trial to assess the safety and effectiveness of Allegra® D. This study will be conducted in participants with allergic rhinitis who are 12 years of age and above. The individual study duration for each participant would be approximately 16 days (maximum of 13 days intervention + a 3-day post intervention observation). There would be 4 study visits in which the last visit can be done either telephonically or on site. Safety events would be captured for the entire study duration. In addition, the effectiveness of the study drug would be assessed using Nasal symptom score (NSS) and Total symptom score (TSS).

Start Date21 Jul 2024

Sponsor / Collaborator

Sanofi

NCT02175485 / CompletedPhase 4

Evaluation of Efficacy of Dellegra® Combination Tablet (Fexofenadine Hydrochloride 30mg /Pseudoephedrine Hydrochloride 60mg) in Allergic Rhinitis After Japanese Cedar Antigen Exposure in Japanese Population. Open Label Study

Primary Objective:
To collect and analyze clinical data of Allergic Rhinitis patients' Total Nasal Symptom Score (TNSS) change after Dellegra internal use under high density pure Japanese cedar pollen exposure.
Secondary Objective:
To collect and analyze clinical data of Allergic Rhinitis patients' change in Total Symptom Score (TSS) and amount of nasal discharge, safety, and overall patients' impression about efficacy of Dellegra after Dellegra internal use under high density pure Japanese cedar pollen exposure.

Start Date01 Jun 2014

Sponsor / Collaborator

Sanofi

NCT02082054 / Unknown statusPhase 2

A Phase 2, Double-Blind, Parallel-Group, Dose-Ranging Study Evaluating Safety/ Efficacy Atropine Doses With Pseudoephedrine and Chlorpheniramine in SAR Patients 12 Years of Age and Older

This active vs active comparative trial will evaluate the safety and efficacy of incremental doses of atropine in combination with pseudoephedrine 120 mg/chlorpheniramine 8 mg in adult patients with a history of seasonal allergic rhinitis. Hypotheses are defined by total nasal symptom scores (TNSS) recorded by subjects in diaries where efficacy will be established by statistical significance where p < 0.05.

Start Date01 Mar 2014

Sponsor / Collaborator

Magna Pharmaceuticals, Inc.

100 Clinical Results associated with Pseudoephedrine Hydrochloride

100 Translational Medicine associated with Pseudoephedrine Hydrochloride

100 Patents (Medical) associated with Pseudoephedrine Hydrochloride

177

Literatures (Medical) associated with Pseudoephedrine Hydrochloride

15 Sep 2023·Rapid communications in mass spectrometry : RCM

Determination of rosmarinic acid and its N-substituted analog A1 in rat plasma using high-performance liquid chromatography-tandem mass spectrometry and its application in pharmacokinetics.

Article

Author: Zhang, Shiyu ; Jiang, Minjie ; Jiang, Weizhe ; Zhang, Qinglang ; Fu, Shujie

BACKGROUND:

The aim of this study was to determine the concentration of rosmarinic acid (RA) and its analog (E)-3-(3,4-dihydroxyphenyl)-2-(3-(3,4-dihydroxyphenyl)acrylamido)propanoic acid (A1) in rat plasma following oral administration. The significance of this study lies in the development of a rapid, sensitive, and alternative method using liquid chromatography-tandem mass spectrometry for the accurate quantification and identification of RA and A1 in vivo.

METHODS:

Liquid chromatography-tandem mass spectrometry was employed to analyze RA and A1 in rat plasma. A C18 column (1.9 µm, 2.1 × 100 mm) with a C18 guard column (5 µm, 2.1 × 10 mm) and a triple-quadrupole mass spectrometer combined with an electrospray ionization source were utilized. Sample pretreatment involved a one-step protein precipitation using isopropanol:ethyl acetate (20:80, v/v) as the solvent. Pseudoephedrine hydrochloride served as a standard.

RESULTS:

The developed method exhibited a linear relationship within the concentration ranges of 5-750 ng/ml for both RA and A1. Relative standard deviations in daily courses were less than 15%, and the relative errors recorded were within 15%. This is the first study to concentrate on determining A1 and RA in rat plasma through oral administration.

CONCLUSIONS:

The liquid chromatography-tandem mass spectrometry method developed in this study offers a rapid, sensitive, and alternative approach for the accurate quantification and identification of RA and A1 in vivo. The findings serve as a significant foundation for evaluating the clinical applications of the medicine.

01 May 2023·Journal of ethnopharmacology

Ephedrae herba: A comprehensive review of its traditional uses, phytochemistry, pharmacology, and toxicology

Review

Author: Luan, Ruqiao ; Mu, Xiangyu ; Zheng, Qingge ; Zhao, Pan ; Pan, Shaobin

ETHNOPHARMACOLOGICAL RELEVANCE:

Ephedrae herba (called Mahuang in China) is the dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C. A. Mey., and Ephedra equisetina Bge. Ephedrae herba has a long history of use as an herb, and it was originally recorded in Sheng Nong's herbal classic. Ephedrae herba has also been widely used as both medicine and food. In the clinic, Ephedrae herba is commonly used for treating colds, bronchial asthma, nasal congestion, and other diseases.

AIM OF REVIEW:

This review aims to provide a systematic summary on the traditional use, chemical constituents, pharmacological effects, clinical applications, quality control, toxicology, and pharmacokinetics of Ephedrae herba to provide a theoretical basis for further reasonable development of Ephedrae herba in clinical practice and creation of new drugs.

MATERIALS AND METHODS:

Information on Ephedrae herba was gathered from various sources, including the scientific databases including CNKI, PubMed, SciFinder and ScienceDirect, classical books on traditional Chinese herbal medicine, Ph.D. and M.Sc. dissertations; Baidu Scholar; and from different professional websites.

RESULTS:

Ephedrae herba is distributed in regions of China and other areas. Ephedra and its compound preparations can be used for colds, bronchial asthma, nasal congestion and other diseases. Approximately 281 chemical constituents have been isolated from Ephedrae herba, including alkaloids, flavonoids, tannins, polysaccharides, volatile oils, organic acids, and other compounds. Among these constituents, alkaloids and volatile oils are the most abundant and represent the major bioactive constituents. Ephedrae herba possesses multiple pharmacological activities, including diuretic effect, anti-allergic effect, blood pressure regulatory, anti-inflammatory effect, anti-oxidation effect and anti-viral effects. Ephedrine hydrochloride and pseudoephedrine hydrochloride are generally selected as indicators for the quantitative determination of Ephedrae herba. The maximum dosage of Ephedrae herba should not exceed 10 g. If overused, adverse reactions such as palpitations, sweating, irritability and insomnia will occur.

CONCLUSIONS:

Ephedrae herba is an ancient herbal medicine with a broad spectrum of pharmacological activities that has been used for thousands of years in China. It is one of the most commonly used herbal components of the TCM formulas. Hydrochloride and pseudoephedrine are the major bioactive constituents. However, there is a need to further understand the mechanisms of active components of Ephedrae herba. Future studies should perform an in-depth analyses of the pharmacokinetics and mechanisms of toxicity of Ephedrae herba. Quality standards should be developed to correspond to the various application methods to ensure the efficacy of drugs in actual treatment.

13 Dec 2022·Journal of Chromatographic ScienceQ4 · CHEMISTRY

A Chemometric Strategy in the Development of a RP-UPLC Method for the Quantitative Resolution of a Two-Component Syrup Formulation

Q4 · CHEMISTRY

Article

Author: Dinç, Erdal ; Ertekin, Zehra Ceren ; Rouhani, Ghazal

Abstract:

A novel chemometric strategy was implemented in the development of a new ultraperformance liquid chromatography method for the quantitative estimation of guaifenesin and pseudoephedrine hydrochloride in a two-component syrup formulation with minimal experimental effort, time and reagent. A full factorial design with three factors was investigated to find optimal working conditions of chromatographic factors (column temperature, flow rate, and 0.1 M H3PO4% in mobile phase) that affect the chromatographic separation. Then, optimum experimental conditions providing adequate separation of the analyzed drug substances within the short runtime were determined. Under optimal experimental conditions, the retention times for guaifenesin and pseudoephedrine hydrochloride were obtained as 0.817 and 1.430 min, respectively. In the optimized RP-UPLC method, chromatographic response was reported as a linear function of concentration between 5.0 and 80.0 μg/mL for guaifenesin and 10.0–90.0 μg/mL for pseudoephedrine hydrochloride. The proposed method was carefully validated and successfully applied to quality control and analysis of a cough syrup preparation containing guaifenesin and pseudoephedrine hydrochloride. Consequently, the proposed reversed-phase ultraperformance liquid chromatography method provided an opportunity to quantify relevant drugs with small amount of reagents and short runtime.

News (Medical) associated with Pseudoephedrine Hydrochloride

28 Mar 2024

·www.prnewswire.com

U.S. News Reveals the 2024 Best OTC Medicine & Health Products

2024 edition includes 30+ new product categories evaluated, new dermatologist expert panel reviewers. WASHINGTON, March 28, 2024 /PRNewswire/ -- U.S. News & World Report, the global authority in health care rankings and consumer advice, today published the second annual Best OTC Medicine & Health Products. The latest edition of the rankings features 132 categories, with 33 brand new over-the-counter product categories included this year. The brands with the most No. 1 products among the 2024 rankings are Nature Made, followed by CeraVe and Neutrogena; the companies with the most No. 1 products are Kenvue Inc., followed by Haleon plc and Pharmavite LLC. "With hundreds of thousands of over-the-counter health products on the market in the U.S., the U.S. News annual Best OTC Medicine & Health Products rankings help consumers choose the best OTC products for themselves and their families," said Sumita Singh, general manager of Health at U.S. News. "Continuing our commitment to offer consumers trusted, data-backed ratings and rankings to help with their health care decisions, the 2024 evaluation features statistically 'best' brands evaluated by hundreds of pharmacists and dermatologists." In partnership with global market research firm The Harris Poll, U.S. News surveyed 354 pharmacists and 122 dermatologists practicing in the United States regarding 132 product categories such as adult and children's cough suppressants, men's and women's multivitamins, fish oil/omega-3 supplements, baby formula, face washes and cleansers, and retinol creams and serums. This was the first year that dermatologists were included in the survey, which was administered online in February 2024. To determine the rankings, panelists selected their top three recommended brands within each product category assigned to them. The brands that were highly ranked most often were ranked No. 1 for the corresponding product categories. U.S. News awarded the designations of Best OTC Medicine & Health Products only to those brands that satisfy U.S. News' statistical assessment of performance on the survey. Based on U.S. News' analysis, some product categories were awarded more than one winner. Some popular 2024 product category winners, ranked No. 1, evaluated by pharmacists include: Children's Cough Medicines: Children's Delsym Cough Drops: Halls Cough Suppressants: Delsym Decongestants, Oral: Sudafed (Pseudoephedrine) Diarrhea Medicines and Treatments: Imodium Eye Vitamins: Bausch + Lomb Ocuvite Fish Oil/Omega-3 Supplements: Nature Made Laxatives: MiraLAX Multivitamins for Men: Centrum Multivitamins for Women: One A Day Nausea Remedies: Dramamine Nausea Saline Nasal Sprays: Ayr Sore Throat Sprays: Chloraseptic Some popular 2024 product category winners, ranked No. 1, evaluated by dermatologists include: Eye Cream for Wrinkles: La Roche-Posay Face Moisturizers: CeraVe Face Washes and Cleansers: CeraVe Hand Creams: Neutrogena Moisturizers With SPF: CeraVe Night Creams: CeraVe Retinol Creams and Serums: Neutrogena Sunscreen for Face: EltaMD Vitamin C Serum: La Roche-Posay Vitamins for Hair Growth: Nutrafol Wrinkle Creams: Neutrogena Those looking to choose a health product that's right for them or their child should consult a medical professional as part of their decision-making process. For the full rankings, visit U.S. News' 2024 Best OTC Medicine & Health Products. Explore more of the 2024 product rankings using #BestOTCProducts on Facebook, Instagram, TikTok and X (formerly Twitter). About U.S. News & World Report U.S. News & World Report is the global leader in quality rankings that empower consumers, business leaders and policy officials to make better, more informed decisions about important issues affecting their lives and communities. A multifaceted digital media company with Education, Health, Money, Travel, Cars, News, Real Estate, Careers and 360 Reviews platforms, U.S. News provides rankings, independent reporting, data journalism, consumer advice and U.S. News Live events. More than 40 million people visit USNews.com each month for research and guidance. Founded in 1933, U.S. News is headquartered in Washington, D.C. About The Harris Poll The Harris Poll is a global consulting and market research firm that delivers proven intelligence for transformational times. Responsible for one of the longest-running surveys in the United States, Harris Poll provides unique context and social insights based on having analyzed public opinion, motivations, and social sentiment since 1963. It works with clients in three primary areas: building modern corporate reputation, crafting brand strategy and performance tracking, and data-driven thought leadership. It also delivers industry-leading healthcare insights expertise, specializing in research with patients, caregivers, nurses, physicians, specialists (across over 50 therapeutic areas) payers, hospital decision makers, policy makers, and pharmacists. Its mission is to provide insights and guidance to help leaders make the best decisions possible. To learn more, please visit . SOURCE U.S. News & World Report, L.P.

04 Dec 2023

·www.fiercepharma.com

Lawmakers want to know why it took the FDA so long to rule on decongestant phenylephrine

After decades of scientific evidence of the ineffectiveness of decongestant phenylephrine, an FDA advisory committee recently concluded the OTC drugs don't work. House Republicans want to know why it took so long. Last year, roughly 250 products that contain the decongestant phenylephrine—including popular brands such as Sudafed, NyQuil, Benadryl and Tylenol—rang up sales of nearly $1.8 billion. Just one problem: Oral phenylephrine doesn’t work. That was the unanimous conclusion of an FDA advisory committee three months ago, based on decades of mounting evidence. Now, House Republicans want to know why it took the regulator so long to figure it out. Rep. Lisa McClain (Mich.), who chairs the House oversight subcommittee on health care and financial services, has sent (PDF) a letter to FDA commissioner Robert Califf, requesting a briefing on the effectiveness of the over-the-counter (OTC) drugs by Dec. 11. “We are concerned that phenylephrine has remained approved by the FDA as an OTC drug ‘generally recognized as safe and effective’ (GRASE) for nearly fifty years despite strong scientific evidence supporting the contrary,” McClain wrote. In response to a request for comment, the FDA said in an email that it "will review the letter and will respond directly to the Senators/Congressman/Congresswoman." In September, 16 panelists on the Nonprescription Drugs Advisory Committee (NDAC) agreed to the ineffectiveness of phenylephrine after reviewing data that showed it performed no better—even at high doses—than placebo in relieving congestion. In 2007, the NDAC came to a similar conclusion on the ineffectiveness of phenylephrine, which first hit the market in 1938. While four subsequent studies showed the ineffectiveness of phenylephrine when taken as a pill, there was enough variability in the results to raise questions about how the studies were conducted. Phenylephrine is designed to reduce the swelling of blood vessels but the committee recently concluded that when it is taken orally, not enough of the drug reaches the nasal passages. The drug still is effective when delivered by way of a nasal spray or for dilating eyes for use during surgery, the FDA concluded. The regulator has yet to decide whether to ban the products. In October, CVS Health voluntarily pulled treatments from shelves that contain phenylephrine as their lone active ingredient.

04 Dec 2023

·endpts.com

House committee investigates FDA’s handling of common nasal decongestant as efficacy questions loom

A House panel is probing the FDA over how it has allowed a common ingredient in over-the-counter cold medications to stay on the market for decades after new data suggested that it doesn’t work to treat nasal congestion. In a letter sent to FDA Commissioner Rob Califf dated Sunday, Rep. Lisa McClain (R-MI), who chairs the House Oversight subcommittee on healthcare, asks the FDA to schedule a briefing with committee staff to glean more information on the agency’s handling of oral phenylephrine, the active ingredient in several cold medicines like Sudafed and Theraflu. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

100 Deals associated with Pseudoephedrine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00485	Pseudoephedrine Hydrochloride	R01BA02	DB00852

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Rhinitis, Allergic	GB	McNeil Products Ltd.	12 Feb 1997
Nasal Obstruction	US	Johnson & Johnson Holdco (NA), Inc.	15 Dec 1992

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Common Cold	Phase 3	US	Perrigo Co. Plc	01 Nov 2012

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