The purpose of this study is to investigate whether norepinephrine(N), phenylephrine(P) or ephedrine(E) have different effect on cerebral oxygenation in abdominal surgery with propofol or sevoflurane.

Start Date05 Mar 2024

Sponsor / Collaborator

Dalian Municipal Central Hospital

NCT05414877 / Not yet recruitingNot ApplicableIIT

Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy Under General Anesthesia(MRI Part): a Randomized Controlled Study

This study was a single-center, exploratory, randomized controlled trial. First, the effects of ephedrine, phenylephrine, or norepinephrine on cerebral blood flow hemodynamics in CEA patients were evaluated using DSC-MRI to investigate the specific mechanisms of the three vasopressors on cerebral blood flow and oxygen metabolism in brain tissues.

Start Date30 Sep 2023

Sponsor / Collaborator

Beijing Tiantan Hospital

NCT05993182 / CompletedPhase 4IIT

Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block - Time to Event Analysis.

compare the time of second hypotension after administration of three different doses of ephedrine 5,10,15 mg

Start Date20 Aug 2023

Sponsor / Collaborator

Aswan University

100 Clinical Results associated with Ephedrine Sulfate

100 Translational Medicine associated with Ephedrine Sulfate

100 Patents (Medical) associated with Ephedrine Sulfate

4,715

Literatures (Medical) associated with Ephedrine Sulfate

01 Dec 2024·FOOD CHEMISTRY

Validation of analytical methods for newly regulated veterinary drug residues in livestock and fishery products with maximum residue limits in Republic of Korea

Article

Author: Choi, Yong Seok ; Jang, Gui-Hyun ; Park, Dahae ; Kim, Yu Ra ; Han, Sang Beom ; Kim, Ji Young ; Shin, Ho-Chul ; Eom, Miok

Veterinary drugs play a crucial role in the treatment of various animal diseases. However, their residues, stemming from issues, such as withdrawal period lapses, overuse, or abuse, can jeopardize food safety and human health. This study addresses recent regulations in Korea concerning specific veterinary drugs (anacolin, ephedrine, menichlopholan, piperonyl butoxide, and etisazole HCl) and their ongoing discussions. This study aimed to validate two pre-developed methods for quantifying residues in livestock and fishery products using QuEChERS and liquid chromatography-tandem mass spectrometry. Both methods exhibited excellent linearity, recoveries (70.3-119%), and coefficient of variations (1.3-28%), along with low limits of detection and quantification (0.3-4 ng/g and 1-12 ng/g). This study is significant for its contribution to the detection of veterinary drugs in livestock and fishery products, given the limited research available on the methods for analyzing these substances.

01 Nov 2024·Heliyon

Enhancing drug-target interaction predictions in context of neurodegenerative diseases using bidirectional long short-term memory in male Swiss albino mice pharmaco-EEG analysis

Article

Author: Iqbal, Syed Muhammad Zeeshan ; Ghadi, Yazeed Yasin ; Shah, Syed Aziz ; Qureshi, Shahnawaz ; Ameer, Asif ; Karrila, Seppo

Background and Objective:

Emerging diseases like Parkinson or Alzheimer's, which are not curable, endanger human mental health and are challenging to research. Drug target interactions (DTI) are pivotal in the screening of candidate drugs and focus on a small pool of drug targets. Electroencephalogram shows the responses to psychotropic medicines in the brain bioelectric activity. Synaptic activity can be analyzed by using Local Field Potential recordings obtained from micro-electrodes implanted in the brain. The aim is to evaluate the effects of drug on brain bioelectric activity and increase the drug classification accuracy. The ultimate goal is to advance our understanding of how drugs affect synaptic activity and open the door to more focused treatment for neurodegenerative diseases.

Methods:

In this study, Pharmaco-EEG recordings are processed using Advanced neural network models, particularly Convolutional Neural Networks, to assess the effects of medications. The five different medicines used in this study are Ephedrine, Fluoxetine, Kratom, Morphine, and Saline. The signals observed are local field potential signals. To overcome some limits of DTI prediction, we propose Bidirectional Long Short-Term Memory (LSTM) for the categorization of intracranial EEG (i-EEG) data, departing from standard approaches. Similar EEG patterns are presumably caused by drugs that work by homologous pharmacological pathways, producing similar psychotropic effects. To improve accuracy and reduce training loss, our study introduces a bidirectional LSTM model for classification along with Bayesian optimization.

Results:

High recall, precision, and F1-Scores, particularly a 95% F1-Score for morphine, ephedrine, fluoxetine, and saline, suggest good performance in predicting these drug classes. Kratom produces a somewhat lower recall of 94%, but a high F1-Score of 97% and perfect precision of 1.00. The weighted average F1-Score, macro average, and overall accuracy are all consistently high (around 97%), indicating that the model works well throughout the spectrum of drugs.

Conclusions:

Improved model performance was demonstrated by using a diversified dataset with five drug categories and bidirectional LSTM boosted with Bayesian optimization for hyperparameter tuning. From earlier limited-category models, it represents a substantial advancement.

01 Nov 2024·European journal of hospital pharmacy : science and practice

Creating an evidence-based economic model for prefilled parenteral medication delivery in the hospital setting

Article

Author: Girgis, Haymen ; Taneja, Ashley ; Postma, Maarten ; Cribbs, Kristen A ; Weiss, Mia ; Eijsink, Job F H ; Lahue, Betsy J ; Edwards, Tyler

OBJECTIVES:

Prefilled syringes (PFS) may offer clinical and economic advantages over conventional parenteral medication delivery methods (vials and ampoules). The benefits of converting from vials and ampoules to PFS have been explained in previous drug-specific economic models; however, these models have limited generalisability to different drugs, healthcare settings and other countries. Our study aims to (1) present a comprehensive economic model to assess the impact of switching from vials to PFS delivery; and (2) illustrate through two case studies the model's utility by highlighting important features of shifting from vials to PFS.

METHODS:

The economic model estimates the potential benefit of switching to PFS associated with four key outcomes: preventable adverse drug events (pADE), preparation time, unused drugs, and cost of supplies. Model reference values were derived from existing peer-reviewed literature sources. The user inputs specific information related to the department, drug, and dose of interest and can change reference values. Two hypothetical case studies are presented to showcase model utility. The first concerns a cardiac intensive care unit in the United Kingdom administering 30 doses of 1 mg/10 mL atropine/day. The second concerns a coronavirus (COVID-19) intensive care unit in France that administers 30 doses of 10 mg/25 mL ephedrine/day.

RESULTS:

Total cost savings per hospital per year, associated with reductions in pADEs, unused drugs, drug cost and cost of supplies were £34 829 for the atropine example and €104 570 for the ephedrine example. Annual preparation time decreased by 371 and 234 hours in the atropine and ephedrine examples, respectively.

CONCLUSIONS:

The model provides a generalisable framework with customisable inputs, giving hospitals a comprehensive view of the clinical and economic value of adopting PFS. Despite increased costs per dose with PFS, the hypothetical case studies showed notable reductions in medication preparation time and a net budget savings owing to fewer pADEs and reduced drug wastage.

News (Medical) associated with Ephedrine Sulfate

28 Aug 2023

·www.biospace.com

FDA Rejects Bulk Compounding For Ephedrine Sulfate

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)-- Nexus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) issued a notice in the Federal Register that ephedrine sulfate should not be bulked by compounding facilities. Bulking is the practice of an outsourcing facility to “compound a drug using a bulk drug substance.”1 The FDA explained that bulk compounding is allowed only where there is a drug shortage or “the bulk drug substance appears on a list” set by the FDA called “the 503B Bulks List.”2 Section 503B refers to the portion of the Drug Quality and Security Act setting forth requirements when certain compounded products may be allowed. On August 21, 2023, the FDA published its conclusion as to ephedrine sulfate that the FDA “now decided not to place [it] on the 503B Bulks List.”3 The FDA confirmed that companies including Nexus with its EMERPHED® product already have FDA-approved products available for both the vial and syringe presentations of ephedrine sulfate, including “as a 5 mL single dose, prefilled syringe that contains 25 mg/5 mL (5 mg/mL) ephedrine sulfate, preservative-free, for intravenous administration, and as a 10 mL single dose, prefilled syringe that contains 50 mg/10 mL (5 mg/mL) ephedrine sulfate, preservative-free, for intravenous administration.”4 In its notice this week, the FDA also confirmed that “the products available as prefilled syringes are premixed formulations and do not require dilution prior to administration for their labeled indications.”5 The FDA concluded that “there is no clinical need for outsourcing facilities to compound using the bulk substance[] ephedrine sulfate” and “therefore we are not including these bulk drug substances on the 503B Bulks List.”6 “We are pleased that the FDA properly decided bulk compounding for ephedrine sulfate is not authorized,” said Chief Executive Officer and President, Usman Ahmed. “The FDA needs to continue to step up as a champion for compliance with the substantial restrictions Congress set forth for when compounded products may be tolerated.” Nexus’ EMERPHED® product is and remains available as an FDA-approved ephedrine sulfate product in both vial and syringe presentations. EMERPHED® was the first 10 mL ephedrine sulfate prefilled syringe approved by the FDA. About EMERPHED® (ephedrine sulfate injection) INDICATIONS AND USAGE EMERPHED® (ephedrine sulfate injection) is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. WARNINGS AND PRECAUTIONS EMERPHED® (ephedrine sulfate injection) can cause pressor effects with concomitant use with oxytocic drugs. It can also cause tachyphylaxis with repeated administration of ephedrine. CONTRAINDICATIONS None. OVERDOSAGE Overdose of EMERPHED® (ephedrine sulfate injection) can cause a rapid rise in blood pressure. In the case of an overdose, careful monitoring of blood pressure is recommended. If blood pressure continues to rise to an unacceptable level, parenteral antihypertensive agents can be administered at the discretion of the clinician. ADVERSE REACTIONS Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. To report SUSPECTED ADVERSE REACTIONS, contact Nexus Pharmaceuticals at (855) 642-2594 or FDA at 1-800-FDA-1088 or . About Nexus Pharmaceuticals LLC Nexus Pharmaceuticals LLC, a US-based healthcare company and certified diverse supplier, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor-intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most. For more information about Nexus Pharmaceuticals and its state-of-the-art manufacturing facility in Wisconsin, visit . ________________________________ 1 FDA Register, Vol. 88, No. 160, at 56838 (available at ). 2 Id. at 56839. 3 Id. 4 Id. at 56840. 5 Id. 6 Id. at 56t843.

18 Apr 2023

·www.prnewswire.com

Syringes Industry Soars with Prefilled Acting as Growth Enabler - Grand View Research, Inc.

SAN FRANCISCO, April 18, 2023 /PRNewswire/ -- The global syringes industry size was pegged at USD 43.98 billion in 2022 and will depict a CAGR of 9.02% from 2023 to 2030, according to the "Syringes Industry Data Book, 2023 – 2030," published by Grand View Research. The bullish outlook is partly attributed to the advent of 5G, demand for early diagnosis, reduced waste of product and increased patient safety. Pervasive chronic diseases have furthered the demand for state-of-the-art syringes. The American Cancer Society projected a 1.9 million cancer cases diagnosis and 609,360 cancer deaths in 2022. Myriad of syringes, such as dental syringes, prefilled syringes and disposable syringes, have received an uptick, a trend likely to continue in the ensuing period. Notably, ready-to-fill prefillable syringes garnered traction, particularly during COVID-19. A spike in demand for vaccines and injectable drugs prompted industry leaders to inject funds into the landscape. Technological advancements in the medical landscape have seen prefilled syringes grow in stature as a sought-after drug delivery solution. Healthcare workers envisage the product as a safer, easier and quicker option to administer drugs. The prefilled syringes market size stood at USD 20.61 billion in 2022 and will exhibit an impressive CAGR of 11.94% between 2023 and 2030. The growth outlook is mainly due to the demand for self-care injection devices. Predominantly, these products have amassed popularity to minimize waste, reduce chances of contamination and increase safety and accessibility. Order your copy of the Free Sample of Syringes Industry Data Book - Prefilled Syringes, Disposable Syringes, Dental and Micro Syringes Market Size, Share, Trends Analysis, And Segment Forecasts, 2023 - 2030" Data Book, published by Grand View Research Disposable syringes have witnessed surging demand on the back of an increased need to minimize disease transmissions. Bullish demand for sterilization and safety will expedite growth across emerging and advanced economies. The disposable syringes market size was pegged at USD 14.19 billion in 2022 and could observe a 6.21% CAGR over the assessment period. Syringe makers have exhibited a profound inclination for safety syringes to administer medication, prevent the risk of patient-to-patient transmission and expand penetration in curative healthcare drug discovery. Although COVID vaccination rates have seemingly dipped, the syringes industry could witness notable growth. Trends and opportunities that are slated to encourage stakeholders to bolster untapped markets are highlighted below: Heightened demand for reusable syringes to deliver anesthesia and the prevalence of dental disorders have revved up the footfall of dental syringes. Micro syringes will likely impel the market growth on the heels of the surge in clinical trials and drug discoveries. Bullish R&D activities will encourage syringe manufacturers to ramp up their production. The Europe market could witness investment galore in the wake of the infusion of funds into the healthcare sector across the U.K., France, Germany and Spain. For instance, in March 2022, the U.K. government announced pouring £200 million (approximately USD 248 million) to augment health research to underpin diagnostic and treatment. Syringe makers envisage North America as a happy hunting ground, mainly due to the rising footprint of advanced syringes for efficiency, safety and reliability. Predominantly, prefilled syringes are poised to witness compelling demand, prompting industry leaders to expand their penetration. To illustrate, in April 2022, Nevakar Injectables received U.S. FDA approval for its ready-to-use Ephedrine Sulfate Injection in a prefilled syringe. The company asserts that the green signal will help healthcare professionals to treat patients in the surgical setting. Moreover, the burgeoning geriatric population, coupled with the prevalence of infectious diseases, has spurred the regional outlook. The U.S. Census Bureau infers that nearly one in four Americans will be 65 years and older by 2060. The soaring number of adults alludes to buoyant demand for in-home caregiving and a robust healthcare system. Go through the table of content of Syringes Industry Data Book to get a better understanding of the Coverage & Scope of the study The competitive nature of the industry indicates that forward-looking companies would infuse funds into organic and inorganic strategies, including technological advancements, innovations, R&D activities and mergers & acquisitions. Additionally, geographical expansion and product launches would be pronounced through 2030. For instance, in September 2022, BD announced the rollout of a next-generation prefillable vaccine syringe for efficiency and reliability. The medical technology company states the product has strict specifications for cosmetics, contamination, processability and integrity. Check out more Industry Data Books, published by Grand View Research About Grand View Research Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research Helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead. Contact: Sherry James Corporate Sales Specialist, USA Grand View Research, Inc. Phone: 1-415-349-0058 Toll Free: 1-888-202-9519 Email: [email protected] Web: Follow Us: LinkedIn | Twitter Logo: SOURCE Grand View Research, Inc.

Vaccine

01 Mar 2023

·www.biospace.com

Nexus Pharmaceuticals, Inc. Receives FDA Approval for EMERPHED® (ephedrine sulfate injection) Pre-Filled Syringe

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)-- Nexus Pharmaceuticals, Inc. announced that it has received US Food and Drug Administration (FDA) approval for EMERPHED® (ephedrine sulfate injection) in 25mg/5mL and 50mg/10mL single-dose pre-filled syringes. The 10mL presentation is the first and only FDA-approved ready-to-administer 10mL pre-filled syringe available. This press release features multimedia. View the full release here: EMERPHED® (ephedrine sulfate injection) is available in 25mg/5mL and 50mg/10mL single-dose pre-filled syringes. (Photo: Business Wire) “We are pleased to announce the addition of our latest EMERPHED® product to our suite of existing FDA-approved, ready-to-use ephedrine sulfate products,” said Chief Executive Officer and President, Usman Ahmed. “These patented products showcase Nexus’ ability to provide innovative therapies that address clinicians’ concerns about delivering efficient and safe medications. With EMERPHED®, we look forward to transforming how patients are treated, while continuing to offer the quality they’ve come to expect.” Nexus received FDA approval for EMERPHED® (ephedrine sulfate) Injection in a ready-to-use vial in April 2020. A patent covering certain applications of EMERPHED® Ready-to-Use Ephedrine Sulfate Injection was issued by the United States Patent and Trademark Office (USPTO) in August 2021. Nexus has since earned several additional patents on its EMERPHED® line of vials and syringes and continues to pursue further parent protection related to EMERPHED®. In February 2021, the Medical College of Wisconsin published a clinical study showing the reduction of potential risk for error and ease of use of EMERPHED® (ephedrine sulfate) Injection in a ready-to-use vial as compared to commercially used concentrated ephedrine. MCW published a press release with their findings in February 2021, and the clinical study was published in the Journal of Pharmaceutical Science and Technology in June 2021. “In 2020, we were the first manufacturer to launch an FDA-approved ephedrine sulfate injection in a ready-to-use vial. Since that time, the market has changed and refined itself, so we are incredibly excited to introduce the next generation of ready-to-administer ephedrine sulfate products once again,” said Omair Ahmed, Chief Operating Officer. Nexus Pharmaceuticals’ EMERPHED® (ephedrine sulfate injection) pre-filled syringe is available immediately in cartons of ten single-dose syringes. About EMERPHED® (ephedrine sulfate injection) EMERPHED® (ephedrine sulfate injection) is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. For full prescribing information, please see the following link. To report SUSPECTED ADVERSE REACTIONS, contact Nexus Pharmaceuticals at (855) 642-2594 or FDA at 1-800-FDA-1088 or . About Nexus Pharmaceuticals, Inc. Nexus Pharmaceuticals Inc., a US-based healthcare company and certified diverse supplier, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor-intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and deliver dependable life-saving treatment options when and where they’re needed most. For more information about Nexus Pharmaceuticals and its state-of-the-art manufacturing facility in Wisconsin, visit .

Drug Approval

100 Deals associated with Ephedrine Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
D04018	Ephedrine Sulfate	R01AA03 C01CA26 S01FB02	DB01364

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypotension	US	Exela Pharma Sciences LLC	29 Apr 2016

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02025426 (CTgov)	Phase 4	Pre-Eclampsia	13	Phenylephrine (Phenylephrine)	rrdjxxebcr(qyhkglaurd) = cmfgccpgyz hehunitqvl (hbsqdvqruq, eaekvvcmut - miuixqirwp) View more	-	14 Oct 2020
				Ephedrine (Ephedrine)	rrdjxxebcr(qyhkglaurd) = kqbkopscki hehunitqvl (hbsqdvqruq, mqvramcocp - hzgufcmqlz) View more
NCT02726620 (CTgov)	Not Applicable	Hypotension	22,435	Central neuraxial anesthesia+Glycopyrrolate+dopamine+Hydroxyethyl starch solutions+Epinephrine+desflurane+bupivacaine+Sodium Chloride 0.9%+propofol+atropine+Ephedrine+Isoflurane+Dobutamine+Vasopressin+Isoproterenol+norepinephrine+Prilocaine+Benzocaine+Procaine+Terlipressin+Tetracaine+ropivacaine+Articaine+levobupivacaine+Milrinone+phenylephrine+Sevoflurane+Mepivacaine+lidocaine+Chloroprocaine (Usual Care Group)	fwrfevxwdh(knexluhwvi) = vuxjiuizxz uojotrbdxg (gldwfhitqc, qidjnyemub - gygrrtxwaq) View more	-	16 May 2019
				Central neuraxial anesthesia+Glycopyrrolate+dopamine+Hydroxyethyl starch solutions+Epinephrine+desflurane+bupivacaine+Sodium Chloride 0.9%+propofol+atropine+Ephedrine+Isoflurane+Dobutamine+Vasopressin+Isoproterenol+norepinephrine+Prilocaine+Benzocaine+Procaine+Terlipressin+Tetracaine+ropivacaine+Articaine+levobupivacaine+Milrinone+phenylephrine+Sevoflurane+Mepivacaine+lidocaine+Chloroprocaine (Hypotension Decision Support)	fwrfevxwdh(knexluhwvi) = srkkzxxxuw uojotrbdxg (gldwfhitqc, okfpqntaiy - vvjqkrpvan) View more

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