Last update 24 Dec 2024

Indomethacin

Last update 24 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryIndomethacin, a diminutive molecule that belongs to the illustrious class of nonsteroidal anti-inflammatory drugs (NSAIDs), works by inhibiting the COX enzyme, thereby impeding inflammation and pain. This drug, can be used for a vast spectrum of maladies including ductus arteriosus, periarthritis, tennis elbow, acute brachial neuritis, gouty arthritis, ankylosing spondylitis, bursitis, tendinopathy, osteoarthritis, rheumatoid arthritis, tumescence, pain, elbow tendinopathy, inflammation, and musculoskeletal pain, is celebrated for its versatility. The roots of this pioneering drug, originally cultivated by the esteemed iROKO Partners Ltd., can be traced back to June 1965, when it first received its approval. With its COX inhibiting properties, indomethacin engenders a plethora of benefits by effectively mitigating inflammation and providing pain relief in a wide range of conditions.

Drug Type

Small molecule drug

Synonyms

IM-P, Indaflex, Indometacin

+ [31]

Target

COX

Mechanism

COX inhibitors(Cyclooxygenases inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesNervous System Diseases+ [5]

Active Indication

Ductus Arteriosus, PatentInflammationMyalgia+ [12]

Inactive Indication

Acute PainArthritis, GoutyLow Back Pain+ [4]

Originator Organization

IROKO Ltd.

Active Organization

Chengdu First Pharmaceutical Co. Ltd.

Hisamitsu Pharmaceutical Co., Inc.

Kowa Co., Ltd.

+ [7]

Inactive Organization

Rising Pharmaceuticals, Inc.StartupBeijing Century Liwei Pharmaceutical Technology Development Co., Ltd.

Iroko Pharmaceuticals LLC

+ [3]

Drug Highest PhaseApproved

First Approval Date

US (10 Jun 1965),

Ankylosing SpondylitisBursitisOsteoarthritis+ [4]

Regulation-

Structure

Molecular FormulaC19H16ClNO4

InChIKeyCGIGDMFJXJATDK-UHFFFAOYSA-N

CAS Registry53-86-1

188

Clinical Trials associated with Indomethacin

NCT06572917 / Not yet recruitingPhase 3IIT

Single-dose Prophylactic INdomethacin in Extremely Preterm Infants - A Multicenter Randomized Blinded Placebo-Controlled Trial (the SPIN RCT)

In Canada, about 900 babies each year are born very early (<26 weeks of gestation) and have a high chance of dying or having a serious bleed in the brain. Families of these extremely preterm babies consider preventing severe brain bleeding as critical to their child's health and well-being. A medicine called indomethacin, when given intravenously in 3-doses, is known to reduce severe brain bleeding. But use of this drug is variable among clinicians working in the neonatal intensive care unit (NICU) due to (a) its side effects on the gut; (b) possible harm when used with other medications; (c) a notion that despite reducing brain bleeds, the child's long-term brain development is not improved. Emerging evidence suggests that a single low-dose indomethacin regimen may be equally effective in reducing severe brain bleeding as compared to a traditional 3-dose regimen.
The investigators propose a blinded randomized controlled trial, a study design where babies born <26 weeks will be randomly assigned within 12 hours of birth to either a single dose of intravenous indomethacin or similar looking placebo in the form a saline solution. The study will test if a single dose indomethacin regimen is effective in improving survival of these babies without the devastating complication of severe brain bleeding. In this study the care providers and researchers will be unaware as to which baby receives indomethacin and which baby receives placebo to ensure no one's expectations or biases can influence the results.
The investigators will conduct the study in multiple NICUs across Canada, the United States and Australia and will enroll 500 babies born <26 weeks or <750 g birth weight over a period of 3 years. This study will help the investigators determine in the most unbiased way whether a single dose of indomethacin given immediately after birth in the smallest babies born <26 weeks of gestation can safely and effectively reduce severe brain bleeding.

Start Date01 Jun 2025

Sponsor / Collaborator

University of British Columbia

CTRI/2024/05/067494 / Not yet recruitingPhase 3IIT

Comparison of rectal Indomethacin with placebo in reducing the clinical progression of mild and moderate acute pancreatitis to severe acute pancreatitis- a double blinded randomized controlled trial - NOT APPLICABLE- NO TRIAL ACRONYM

Start Date28 May 2024

Sponsor / Collaborator-

NCT06433453 / RecruitingPhase 4

Three Dimensional Ultrasonographic Detection of Human Ovulation and Anovulation

The research aims to compare diagnosis of ovulation and anovulation in 2D and 3D ultrasonography.

Start Date22 Apr 2024

Sponsor / Collaborator

University of Saskatchewan

100 Clinical Results associated with Indomethacin

100 Translational Medicine associated with Indomethacin

100 Patents (Medical) associated with Indomethacin

36,542

Literatures (Medical) associated with Indomethacin

01 Apr 2025·PHYTOCHEMISTRY

Sesquiterpene enantiomers from Alismatis Rhizoma

Article

Author: Liu, Shan-Shan ; Wang, Wei ; An, Yun-He ; Wang, Zhi-Min ; Zhu, Jing-Jing ; Li, Yun ; Yan, Li-Hua ; Zhang, Mei

A pair of dinor-sesquiterpene enantiomers (1a/1b), eight pairs of guaiane-type sesquiterpenes enantiomers (2a/2b, 3a/3b, 4a/4b, 5a/5b, 6a/6b, 7a/7b, 8a/8b, 9a/9b) and two guaiane-type sesquiterpenes (10, 11), including eleven undescribed ones (1a, 1b, 2a, 2b, 3a, 3b, 4a, 5b, 6a, 10, and 11), were isolated from the aqueous extract of Alismatis Rhizoma. The structures were elucidated by combining 1D and 2D NMR and HRESIMS spectroscopic data. The absolute configurations were determined by experimental and calculated ECD spectra, [Mo₂(OAc)₄]-induced ECD spectral analysis, and comparison of the experimental ECD spectra with those of similar analogs. Compound 5b (NO inhibition rate, 52.63%) and 8b (36.49%) showed comparable activity to indomethacin (46.36%) against LPS-induced NO production in RAW 264.7 murine macrophages at 100 μM with obvious stereoselectivity, whereas compounds 1-10 exerted no or extremely low cytotoxicities against MCF-7 and MDA-MB-231 cells (IC₅₀ ＞ 100 μM).

01 Feb 2025·JOURNAL OF PEDIATRIC SURGERY

Prediction of Intestinal Perforation by Daily Radiographic Findings in Very Low Birth Weight Infants With Meconium Ileus

Article

Author: Mise, Naoko ; Komatsu, Shugo ; Hishiki, Tomoro ; Nishimura, Katsuhiro ; Yoshida, Kazushi ; Endo, Mamiko ; Matsuura, Gen ; Takenouchi, Ayako ; Osone, Yoshiteru ; Katsumata, Yoshio ; Terui, Keita ; Kawaguchi, Yunosuke ; Sonoda, Yuko

BACKGROUND:

This study aimed to develop a prediction model for intestinal perforation from meconium ileus (MI) based on findings from plain X-ray images.

METHODS:

Very low birth weight (VLBW) infants with MI hospitalized in two tertiary centers between 2011 and 2022 were included in this study. We retrospectively reviewed clinical parameters and assessed plain X-ray images from 0 to 5 days of age. The standardized transverse diameter of intestinal gas (STDI) was calculated by dividing the largest diameter of the intestinal gas by the distance from the upper edge of L1 to the lower edge of L4. We then compared the STDI of patients with and without intestinal perforation.

RESULTS:

Among 81 VLBW infants with MI, intestinal perforation occurred in 6 (7 %). Among known risk factors, significant differences were observed between the two groups regarding pregnancy-induced hypertension (p = 0.03), weeks of gestation (p < 0.01), birthweight (p = 0.02), and indomethacin administration (p < 0.01). The mortality rate was higher in the perforation group (33 %) than in the non-perforation group (3 %) (p = 0.021). There were significant differences between the perforated and non-perforated groups regarding STDI except at 0 days of age. The positive and negative predictive cut-off values of STDI were respectively 0.08 and 0.93 on day 0, 0.30 and 1.00 on day 1, 0.33 and 0.97 on day 2, 0.33 and 1.00 on day 3, 0.29 and 1.00 on day 4, and 0.33 and 0.98 on day 5, respectively.

CONCLUSIONS:

Our novel prediction model, using STDI, predicted intestinal perforation in VLBW infants with MI.

LEVELS OF EVIDENCE:

Level Ⅲ.

01 Feb 2025·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Small-scale aqueous suspension preparation using dual centrifugation: the effect of process parameters on the sizes of drug particles

Article

Author: Holm, René ; Lund, Nanna Einshøj ; Zulbeari, Nadina

The dual centrifugation approach has in the recent years emerged as a powerful milling tool to prepare pharmaceutical suspensions in submicron range with a fast-milling capacity by milling 40 samples simultaneously in 2 mL vials. While there is some standardized milling conditions described in the literature when preparing aqueous suspensions with dual centrifugation, a more systematic and experimental understanding of the milling process to evaluate the impact of different process variables in the dual centrifuge on the final sizes of the suspended drug particles independent of the drug compound used was desired. Overall, the present study demonstrated the applicability of the dual centrifuge for small-scale screening purposes and showed the impact of process parameters on the physical attributes of prepared suspensions. In the present work, the rate of size reduction on three different model compounds, i.e., cinnarizine, haloperidol, and indomethacin, was found to be mostly influenced by the milling speed, size of milling beads, and the bead loading during milling, whereas the rotor temperature did not affect the particle size profiles when stabilized with polysorbate 20 during milling with dual centrifugation. Smaller particle sizes were in general obtained at the highest milling intensity, i.e., 1500 rpm, smallest bead size, i.e., 0.2 mm, and higher bead loadings (42 %, 56 %, and 83 %). The grinding limit of approximately 0.50 µm, 0.70 µm, and 0.35 µm for cinnarizine, haloperidol, and indomethacin, respectively, was achieved relatively fast, i.e., 30 min of milling at the specified conditions, compared to when suspensions were milled with larger bead sizes (i.e., 1.0 mm), lower milling intensities (e.g., 1000 rpm), and lower bead loadings (e.g., 14 or 28 %). The study further confirmed that a higher milling intensity was necessary during milling of haloperidol suspensions probably due to the compounds predominantly plastic properties. Sizes of indomethacin particles increased with longer milling runs up to 240 min and also higher bead loadings of 56 % and 83 %. These observations were further supported by the color conversion from white to yellow of indomethacin suspensions which indicated generation of small quantities of amorphic material after milling with a high milling intensity. Upscale investigations showed comparable particle size profiles for all three model compounds while milling at 1500 rpm for five minutes.

News (Medical) associated with Indomethacin

27 Jun 2024

·www.sciencedaily.com

Scientists use computational modeling to guide a difficult chemical synthesis

Researchers have discovered a new way to drive chemical reactions that could generate a wide variety of azetidines -- four-membered nitrogen heterocycles that have desirable pharmaceutical properties. Researchers from MIT and the University of Michigan have discovered a new way to drive chemical reactions that could generate a wide variety of compounds with desirable pharmaceutical properties. These compounds, known as azetidines, are characterized by four-membered rings that include nitrogen. Azetidines have traditionally been much more difficult to synthesize than five-membered nitrogen-containing rings, which are found in many FDA-approved drugs. The reaction that the researchers used to create azetidines is driven by a photocatalyst that excites the molecules from their ground energy state. Using computational models that they developed, the researchers were able to predict compounds that can react with each other to form azetidines using this kind of catalysis. "Going forward, rather than using a trial-and-error process, people can prescreen compounds and know beforehand which substrates will work and which ones won't," says Heather Kulik, an associate professor of chemistry and chemical engineering at MIT. Kulik and Corinna Schindler, a professor of chemistry at the University of Michigan, are the senior authors of the study, which appears today in Science. Emily Wearing, recently a graduate student at the University of Michigan, is the lead author of the paper. Other authors include University of Michigan postdoc Yu-Cheng Yeh, MIT graduate student Gianmarco Terrones, University of Michigan graduate student Seren Parikh, and MIT postdoc Ilia Kevlishvili. Light-driven synthesis Many naturally occurring molecules, including vitamins, nucleic acids, enzymes and hormones, contain five-membered nitrogen-containing rings, also known as nitrogen heterocycles. These rings are also found in more than half of all FDA-approved small-molecule drugs, including many antibiotics and cancer drugs. Four-membered nitrogen heterocycles, which are rarely found in nature, also hold potential as drug compounds. However, only a handful of existing drugs, including penicillin, contain four-membered heterocycles, in part because these four-membered rings are much more difficult to synthesize than five-membered heterocycles. In recent years, Schindler's lab has been working on synthesizing azetidines using light to drive a reaction that combines two precursors, an alkene and an oxime. These reactions require a photocatalyst, which absorbs light and passes the energy to the reactants, making it possible for them to react with each other. "The catalyst can transfer that energy to another molecule, which moves the molecules into excited states and makes them more reactive. This is a tool that people are starting to use to make it possible to make certain reactions occur that wouldn't normally occur," Kulik says. Schindler's lab found that while this reaction sometimes worked well, other times it did not, depending on which reactants were used. They enlisted Kulik, an expert in developing computational approaches to modeling chemical reactions, to help them figure out how to predict when these reactions will occur. The two labs hypothesized that whether a particular alkene and oxime will react together in a photocatalyzed reaction depends on a property known as the frontier orbital energy match. Electrons that surround the nucleus of an atom exist in orbitals, and quantum mechanics can be used to predict the shape and energies of these orbitals. For chemical reactions, the most important electrons are those in the outermost, highest energy ("frontier") orbitals, which are available to react with other molecules. Kulik and her students used density functional theory, which uses the Schrödinger equation to predict where electrons could be and how much energy they have, to calculate the orbital energy of these outermost electrons. These energy levels are also affected by other groups of atoms attached to the molecule, which can change the properties of the electrons in the outermost orbitals. Once those energy levels are calculated, the researchers can identify reactants that have similar energy levels when the photocatalyst boosts them into an excited state. When the excited states of an alkene and an oxime are closely matched, less energy is required to boost the reaction to its transition state -- the point at which the reaction has enough energy to go forward to form products. Accurate predictions After calculating the frontier orbital energies for 16 different alkenes and nine oximes, the researchers used their computational model to predict whether 18 different alkene-oxime pairs would react together to form an azetidine. With the calculations in hand, these predictions can be made in a matter of seconds. The researchers also modeled a factor that influences the overall yield of the reaction: a measure of how available the carbon atoms in the oxime are to participate in chemical reactions. The model's predictions suggested that some of these 18 reactions won't occur or won't give a high enough yield. However, the study also showed that a significant number of reactions are correctly predicted to work. "Based on our model, there's a much wider range of substrates for this azetidine synthesis than people thought before. People didn't really think that all of this was accessible," Kulik says. Of the 27 combinations that they studied computationally, the researchers tested 18 reactions experimentally, and they found that most of their predictions were accurate. Among the compounds they synthesized were derivatives of two drug compounds that are currently FDA-approved: amoxapine, an antidepressant, and indomethacin, a pain reliever used to treat arthritis. This computational approach could help pharmaceutical companies predict molecules that will react together to form potentially useful compounds, before spending a lot of money to develop a synthesis that might not work, Kulik says. She and Schindler are continuing to work together on other kinds of novel syntheses, including the formation of compounds with three-membered rings. "Using photocatalysts to excite substrates is a very active and hot area of development, because people have exhausted what you can do on the ground state or with radical chemistry," Kulik says. "I think this approach is going to have a lot more applications to make molecules that are normally thought of as really challenging to make."

11 Apr 2024

·www.biospace.com

Baxter Expands Pharmaceuticals Portfolio with New Injectable Products in the U.S.

Five new launches reinforce Baxter’s focus on differentiated products and enhance the company’s Pharmaceuticals portfolio in critical therapeutic areas Products feature ready-to-use formulations to help support patient safety and offer added convenience for healthcare professionals DEERFIELD, Ill.--(BUSINESS WIRE)-- Baxter International Inc. (NYSE:BAX), a global leader in injectables, anesthesia and drug compounding, announced the continued expansion of its Pharmaceuticals portfolio with five injectable product launches in the U.S. “These launches demonstrate Baxter’s focus on differentiated products that address unmet patient needs in key therapeutic areas, including anti-infective and anti-hypotensive medications,” said Alok Sonig, executive vice president and group president, Pharmaceuticals, at Baxter. “We are proud to offer important new options for our customers and look forward to continuing to bring new innovations to the market.” Product launches within Baxter’s Pharmaceuticals portfolio in the U.S. include the following. For all products, please see full Indications, Important Risk Information and links to full Prescribing Information below. Norepinephrine Bitartrate in 5% Dextrose Injection in a new 16 mg/250 mL strength, which is indicated to raise blood pressure in adult patients with severe, acute hypotension. Baxter offers the first and only FDA-approved ready-to-use Norepinephrine in Dextrose, and now provides Norepinephrine in 4 mg/250 mL, 8 mg/250 mL and 16 mg/250 mL strengths. Vasopressin in 0.9% Sodium Chloride Injection, the first and only FDA-approved ready-to-use Vasopressin in a flexible container. Vasopressin uses Baxter’s proprietary sterile, closed system container, which is collapsible and does not require a vented intravenous set.1 Manufactured closed drug-delivery systems decrease the need for manual admixture and reduce the possibility of contamination.2 Vasopressin is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Baxter offers Vasopressin in 20 units/100 mL and 40 units/100 mL strengths. Vancomycin Injection, USP in 5% Dextrose in new 1.25 g/250 mL and 1.5 g/300 mL strengths. These launches are Baxter’s first frozen ready-to-use offerings in 250 mL and 300 mL volumes. Vancomycin is indicated for serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. Baxter now offers Vancomycin in 500 mg/100 mL, 750 mg/150 mL, 1 g/200 mL, 1.25 g/250 mL and 1.5 g/300 mL strengths. Ropivacaine Hydrochloride Injection, USP in a ready-to-use, single-dose infusion bag. Ropivacaine is indicated in adults to produce local or regional anesthesia for surgery and for acute pain management. Baxter offers Ropivacaine in 200 mg/100 mL and 400 mg/200 mL strengths. Regadenoson Injection pre-filled syringe, a coronary vasodilator that is commonly used in pharmacologic stress testing. Baxter offers Regadenoson in a 0.4 mg/5 mL strength. Ready-to-use formats of standard concentrations of commonly prescribed drugs may offer operational efficiencies for healthcare providers. Compounding a drug for patient use is a multi-step, manual process that requires oversight by pharmacy staff. A ready-to-use product can simplify the preparation process and support patient safety by reducing the chance of contamination2 and avoiding potential errors that may occur when medications are compounded.3 These newly launched products are now available for use in the U.S. About Baxter Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit and follow us on X/Twitter, LinkedIn and Facebook. Norepinephrine Bitartrate in 5% Dextrose Injection Indications Norepinephrine Bitartrate in Dextrose Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Important Risk Information Contraindications: None. Tissue Ischemia: Administration of Norepinephrine Bitartrate in Dextrose Injection to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and reduced urine output, tissue hypoxia, lactic acidosis, and reduced systemic blood flow despite “normal” blood pressure. Address hypovolemia prior to initiating Norepinephrine Bitartrate in Dextrose Injection. Avoid use in patients with mesenteric or peripheral vascular thrombosis, as this may increase ischemia and extend the area of infarction. Gangrene of the extremities has occurred in patients with occlusive or thrombotic vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients. Extravasation of Norepinephrine Bitartrate in Dextrose Injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein, check the infusion site frequently for free flow, and monitor for signs of extravasation. Avoid administration into the veins in the leg in elderly patients. Emergency Treatment of Extravasation: Infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with 5 to 10 mg of phentolamine mesylate in 10 to 15 mL of 0.9% Sodium Chloride Injection in adults. Hypotension after Abrupt Discontinuation: Sudden cessation of the infusion rate may result in marked hypotension. When discontinuing the infusion, gradually reduce the infusion rate while expanding blood volume with intravenous fluids. Cardiac Arrhythmias: Norepinephrine Bitartrate in Dextrose Injection elevates intracellular calcium concentrations and may cause arrhythmias, particularly in the setting of hypoxia or hypercarbia. Perform continuous cardiac monitoring of patients with arrhythmias. Elderly Patients: May be at a greater risk of developing adverse reactions. Adverse Reactions: Most common adverse reactions are hypertension and bradycardia. Drug Interactions: Co-administration of Norepinephrine Bitartrate in Dextrose Injection with monoamine oxidase (MAO) inhibitors or other drugs with MAO-inhibiting properties (e.g., linezolid) or with tricyclic antidepressants can cause severe, prolonged hypertension. Anti-diabetics: Norepinephrine Bitartrate in Dextrose Injection can decrease insulin sensitivity and raise blood glucose. Concomitant use of Norepinephrine Bitartrate in Dextrose Injection with halogenated anesthetics may lead to ventricular tachycardia or ventricular fibrillation. Monitor cardiac rhythm in patients receiving concomitant halogenated anesthetics. Please see accompanying full Prescribing Information for Norepinephrine Bitartrate in 5% Dextrose Injection. Vasopressin in 0.9% Sodium Chloride Injection Indications Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Important Risk Information Contraindications: Vasopressin in Sodium Chloride Injection is contraindicated in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin. Worsening Cardiac Function: A decrease in cardiac index may be observed with the use of vasopressin. Reversible Diabetes Insipidus: Patients may experience reversible diabetes insipidus, manifested by the development of polyuria, a dilute urine, and hypernatremia, after cessation of treatment with vasopressin. Monitor serum electrolytes, fluid status and urine output after vasopressin discontinuation. Some patients may require readministration of vasopressin or administration of desmopressin to correct fluid and electrolyte shifts. Adverse Reactions: The most common adverse reactions include decreased cardiac output, bradycardia, tachyarrhythmias, hyponatremia and ischemia (coronary, mesenteric, skin, digital). Drug Interactions: Pressor effects of catecholamines and Vasopressin in Sodium Chloride Injection are expected to be additive. Indomethacin may prolong effects of Vasopressin in Sodium Chloride Injection. Co-administration of ganglionic blockers or drugs causing SIADH (syndrome of inappropriate antidiuretic hormone secretion) may increase the pressor response. Co-administration of drugs causing diabetes insipidus may decrease the pressor response. Pregnancy: May induce tonic uterine contractions that could threaten the continuation of pregnancy. Please see accompanying full Prescribing Information for Vasopressin in 0.9% Sodium Chloride Injection. Vancomycin Injection, USP in 5% Dextrose Indications Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is effective in the treatment of: Infective Endocarditis (staphylococcal endocarditis; endocarditis caused by Streptococcus viridans or S. bovis, alone or in combination with an aminoglycoside; endocarditis caused by enterococci (e.g., E. faecalis), only in combination with an aminoglycoside; diphtheroid endocarditis; early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids in combination with either rifampin, an aminoglycoside, or both) Septicemia Skin and Skin Structure Infections Bone Infections Lower Respiratory Tract Infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Important Risk Information Contraindications: Vancomycin is contraindicated in patients with known hypersensitivity to this antibiotic. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products. Infusion Reactions: Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock, and, rarely, cardiac arrest. During or soon after rapid infusion of vancomycin, patients may develop anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, or pruritus. Rapid infusion may also cause flushing of the upper body (“vancomycin infusion reaction”) or pain and muscle spasm of the chest and back. Vancomycin should be administered over a period of not less than 60 minutes. Stopping the infusion usually results in prompt cessation of these reactions. Nephrotoxicity: Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase. Monitor renal function in all patients; especially with underlying renal impairment, with co-morbidities, and receiving concomitant therapy with a known nephrotoxic drug. Ototoxicity: It may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Vancomycin should be used with caution in patients with renal insufficiency. Severe Dermatologic Reactions: Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) have been reported. Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters. Discontinue vancomycin Injection at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD. Dosage of vancomycin must be adjusted for patients with renal dysfunction. Clostridioides difficile associated diarrhea (CDAD): May range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. Hemorrhagic Occlusive Retinal Vasculitis: Including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established. Adverse Reactions: Not already mentioned above, patients have been reported to have neutropenia, phlebitis, drug fever, nausea, chills, and vasculitis in association with administration of vancomycin. Drug Interactions: Anesthetic Agents: Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing and anaphylactoid reactions. Monitor renal function in patients receiving vancomycin and concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, or cisplatin. Please see accompanying full Prescribing Information for Vancomycin Injection, USP. Ropivacaine Hydrochloride Injection, USP Indications Ropivacaine Hydrochloride Injection is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration. Important Risk Information Contraindications: Ropivacaine Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. General Warning: Delay in proper management of dose-related toxicity, underventilation, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions, and readiness for emergencies. It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. Unintended Intravenous Injection: In performing Ropivacaine Hydrochloride Injection blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. Ropivacaine hydrochloride injection should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary. Intra-Articular Infusions and Risk of Chondrolysis: Intra-articular infusions of local anesthetics may cause chondrolysis. Ropivacaine Hydrochloride Injection is not approved for this use. Risk of Methemoglobinemia: Patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure. Immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue ropivacaine hydrochloride injection and any other oxidizing agents. Central Nervous System Toxicity: Careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness should be performed after each local anesthetic injection. Hepatic Disease: Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease are at a greater risk of developing toxic plasma concentrations. Adverse Reactions: Most common adverse reactions (incidence ≥ 5%) are hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain. Drug Interactions: Agents structurally related to amide-type local anesthetics: Concurrent use may cause additive effects. Please see accompanying full Prescribing Information for Ropivacaine Hydrochloride Injection, USP. Regadenoson Injection Indications Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Important Risk Information Contraindications: Do not administer regadenoson injection to patients with: Second- or third-degree AV block, or Sinus node dysfunction, unless these patients have a functioning artificial pacemaker. Myocardial Ischemia: Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example unstable angina or cardiovascular instability, who may be at greater risk. Cardiac resuscitation equipment and trained staff should be available before administration. Sinoatrial (SA) and Atrioventricular (AV) Nodal Block: Adenosine receptor agonists, including regadenoson injection, can depress the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia. Atrial Fibrillation/Atrial Flutter: New-onset or recurrent atrial fibrillation with rapid ventricular response and atrial flutter have been reported. Hypersensitivity, Including Anaphylaxis: Anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria and rashes have occurred. Have personnel and resuscitative equipment immediately available. Hypotension: Adenosine receptor agonists, including regadenoson injection, induce vasodilation and hypotension. The risk of serious hypotension may be higher in patients with autonomic dysfunction, stenotic valvular heart disease, pericarditis or pericardial effusions, stenotic carotid artery disease with cerebrovascular insufficiency, or hypovolemia. Hypertension: Adenosine receptor agonists, including regadenoson injection, may induce clinically significant increases in blood pressure particularly in patients with a history of hypertension and when the MPI includes low level exercise. Bronchoconstriction: Adenosine receptor agonists, including regadenoson injection, may induce dyspnea, bronchoconstriction and respiratory compromise, especially in patients with chronic obstructive pulmonary disease (COPD) or asthma. Resuscitative measures should be available. Seizure: Regadenoson injection may lower the seizure threshold. New onset or recurrence of convulsive seizures has occurred. Some seizures are prolonged and require urgent anticonvulsive management. Methylxanthine use is not recommended in patients who experience a seizure in association with regadenoson injection. Cerebrovascular Accident (Stroke): Hemorrhagic and ischemic cerebrovascular accidents have occurred. Adverse Reactions: The most common (incidence ≥ 5%) adverse reactions to regadenoson injection are dyspnea, headache, flushing, chest discomfort, dizziness, angina pectoris, chest pain, and nausea. Drug Interactions: Methylxanthines, e.g., caffeine, aminophylline and theophylline, interfere with the activity of regadenoson injection. Aminophylline may be used to attenuate severe and/or persistent adverse reactions to regadenoson injection. Dipyridamole may increase the activity of regadenoson injection. When possible, withhold dipyridamole for at least two days prior to regadenoson injection administration. Please see accompanying full Prescribing Information for Regadenoson Injection. This release includes forward-looking statements concerning Norepinephrine Bitartrate in 5% Dextrose Injection, Vasopressin in 0.9% Sodium Chloride Injection, Vancomycin Injection, USP in 5% Dextrose, Ropivacaine Hydrochloride Injection, USP and Regadenoson Injection pre-filled syringe, including potential benefits associated with the use of these products. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and Form 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements. Baxter is a registered trademark of Baxter International Inc. 1 Baxter data on > 2 Mercaldi CJ, Lanes S, Bradt J. Comparative risk of bloodstream infection in hospitalized patients receiving intravenous medication by open, point-of-care, or closed delivery systems. Am J Health-Syst Pharm. 2013;70:957-965. 3 Billstein-Leber M, Carrillo CJD, Cassano AT, Moline K, Robertson JJ. ASHP Guidelines on Preventing Medication Errors in Hospitals. Am J Health Syst Pharm. 2018;75(19):1493-1517. US-PH57-240005 (v1.0) 04/2024 View source version on businesswire.com: Contacts Media Contact Andrea Johnson, (224) 948-5353 media@baxter.com Investor Contact Clare Trachtman, (224) 948-3020 Source: Baxter International Inc. View this news release online at:

Drug Approval

21 Feb 2024

·www.prnewswire.com

ASSERTIO INVESTOR ALERT: Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $25,000 In Assertio To Contact Him Directly To Discuss Their Options

If you suffered losses exceeding $25,000 investing in Assertio stock or options between March 9, 2023 and November 8, 2023 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). You may also click here for additional information: . There is no cost or obligation to you. NEW YORK, Feb. 21, 2024 /PRNewswire/ -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Assertio Holdings, Inc. ("Assertio" or the "Company") (NASDAQ: ASRT) and reminds investors of the March 5, 2024 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi is a leading minority and Woman-owned national securities law firm with offices in New York, Pennsylvania, California and Georgia. Continue Reading Faruqi & Faruqi Logo (PRNewsfoto/Faruqi & Faruqi, LLP) As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (1) the Company's reliance on Indocin products to boost its net income was unsustainable given the risk of generic competition; (2) the Spectrum Acquisition was less valuable than Assertio had represented to investors; (3) accordingly, Assertio had overstated the positive impact the sale of Indocin products and the Spectrum Acquisition were likely to have on the Company's profitability; and (4) as a result, Defendants' public statements were materially false and/or misleading at all relevant times. In July 2023, Assertio acquired Spectrum Pharmaceuticals, Inc. ("Spectrum"), a biopharmaceutical company focused on novel and targeted oncology, along with Spectrum's injection asset Rolvedon (the "Spectrum Acquisition"). In a press release announcing the closing of the acquisition, Assertio's Chief Executive Officer ("CEO") Defendant Dan Peisert ("Peisert") was quoted as stating, in relevant part, "[w]e look forward to building on the successful early results in the [Rolvedon] Injection launch for the remainder of 2023, driving the business toward [its] goal of accretive contribution to our Adjusted EPS and operating cash flow in 2024." On August 3, 2023, Zydus Lifesciences Limited ("Zydus"), a generic pharmaceutical company, received approval from the U.S. Food and Drug Administration ("FDA") to manufacture and market 50mg indomethacin suppositories, the generic version of the Company's Indocin Suppositories. Specifically, the FDA granted Zydus 180-day Competitive Generic Therapies exclusivity to market the product. Following the FDA's decision, Assertio withdrew its 2023 financial outlook previously issued in May 2023. On this news, Assertio's stock price fell $2.44 per share, or 45.6%, to close at $2.91 per share on August 4, 2023 Then, on November 8, 2023, Assertio issued a press release announcing its financial results for its third quarter ("Q3") of 2023. Among other results, Assertio reported Q3 non-GAAP earnings-per-share of $0.01, missing consensus estimates by $0.09, and revenue of $35.63 million, missing consensus estimates by $14.8 million. Defendant Peisert called the Company's Q3 2023 results "disappointing," noting that "the loss of Indocin exclusivity and Rolvedon results below expectations [drove] significant charges to our net income" and that the Company was "learning" that "certain aspects" of its July 31, 2023 acquisition of Spectrum Pharmaceuticals Inc. "may not be everything we initially expected." On this news, Assertio's stock price fell $0.92 per share, or 43.19%, to close at $1.21 per share on November 9, 2023. On, January 3, 2024, Assertio issued a press release announcing that Defendant Peisert was stepping down from his role as the Company's CEO. On this news, Assertio's stock price fell $0.12 per share, or 10.96%, to close at $1.01 per share on January 4, 2024. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not. Faruqi & Faruqi, LLP also encourages anyone with information regarding Assertio's conduct to contact the firm, including whistleblowers, former employees, shareholders and others. Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP (). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner. SOURCE Faruqi & Faruqi, LLP

AcquisitionDrug ApprovalFinancial Statement

100 Deals associated with Indomethacin

External Link

KEGG	Wiki	ATC	Drug Bank
D00141	Indomethacin	C01EB03 S01BC01 M01AB01	DB00328

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Pain	US	Genus Lifesciences, Inc.	24 Feb 2014
Ductus Arteriosus, Patent	US	Fresenius Kabi USA LLC	17 Mar 2010
Inflammation	JP	Hisamitsu Pharmaceutical Co., Inc.	06 Oct 1989
Myalgia	JP	Teikoku Seiyaku Co. Ltd.	06 Oct 1989
Tennis Elbow	JP	Teikoku Seiyaku Co. Ltd.	06 Oct 1989
Arthritis, Gouty	US	Rising Pharmaceuticals, Inc.Startup	20 Apr 1984
Periarthritis	JP	Kowa Co., Ltd.	18 Mar 1980
Tenosynovitis	JP	Kowa Co., Ltd.	18 Mar 1980
Tumescence	JP	Kowa Co., Ltd.	18 Mar 1980
Pain	JP	Kowa Co., Ltd.	18 Mar 1980
Ankylosing Spondylitis	US	Zyla Life Sciences US LLC	10 Jun 1965
Bursitis	US	Zyla Life Sciences US LLC	10 Jun 1965
Osteoarthritis	US	Zyla Life Sciences US LLC	10 Jun 1965
Primary gout	US	Zyla Life Sciences US LLC	10 Jun 1965
Rheumatoid Arthritis	US	Zyla Life Sciences US LLC	10 Jun 1965
Shoulder Pain	US	Zyla Life Sciences US LLC	10 Jun 1965
Tendinopathy	US	Zyla Life Sciences US LLC	10 Jun 1965

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Low Back Pain	Phase 3	CN	Teikoku Seiyaku Co. Ltd.	10 Oct 2013
Low Back Pain	Phase 3	CN	Beijing Century Liwei Pharmaceutical Technology Development Co., Ltd.	10 Oct 2013
Soft Tissue Injuries	Phase 3	CN	Beijing Century Liwei Pharmaceutical Technology Development Co., Ltd.	10 Oct 2013
Soft Tissue Injuries	Phase 3	CN	Teikoku Seiyaku Co. Ltd.	10 Oct 2013
Soft tissue pain	Phase 3	CN	Teikoku Seiyaku Co. Ltd.	10 Oct 2013
Soft tissue pain	Phase 3	CN	Beijing Century Liwei Pharmaceutical Technology Development Co., Ltd.	10 Oct 2013
Pain, Postoperative	Phase 3	US	Iroko Pharmaceuticals LLC	01 Feb 2012
Toothache	Phase 2	US	Iroko Pharmaceuticals LLC	01 Aug 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04207060 (CTgov)	Phase 1/2	Pancreatitis, Chronic	27	Endoscopy for Pancreatic Function Testing+Indomethacin (Indomethacin)	qxrxczddbf(gpmeybrlqz) = qggxaczlvl ubsqlkkeib (asefielcyw, khdnoqontb - tquaaizfpi) View more	-	04 Sep 2024
				Placebo (Placebo)	qxrxczddbf(gpmeybrlqz) = nnjtaeevov ubsqlkkeib (asefielcyw, vmlalzmzbb - zjyrqchuwz) View more
DDW2024	Not Applicable	Post-ERCP Pancreatitis	-	Indomethacin	vdwzpmqtvd(fsaycxraqr) = bkhwqifnxn esriyskabx (wqitxuxxns )	-	21 May 2024
				No Indomethacin	vdwzpmqtvd(fsaycxraqr) = ntqclnfqlx esriyskabx (wqitxuxxns )
DDW2024	Not Applicable	Visible Lesion \| Pancreatitis	-	RECTAL INDOMETHACIN (No Prophylaxis)	eesuijliov(bwcmhdjhwj) = 1 case of acute renal failure was noted in the no prophylaxis group jeudfcrlju (ybvvdyvuek ) View more	-	20 May 2024
NCT02950259 (P212, CTgov)	Phase 1	Male Breast Neoplasms \| Triple Negative Breast Cancer \| Early Stage Breast Carcinoma	16	Multivitamin+Indomethacin+Omeprazole+Cyclophosphamide (IRX-2 Regimen -Early Stage Breast Cancer)	zdtxqbthzi(uqsdenyxdb) = uochxqzruu ayexzfrwmu (sflneeewzr, blajctpccz - lbgujoljav) View more	-	30 Jan 2024
				Multivitamin+Indomethacin+Omeprazole+Cyclophosphamide (IRX-2 Regimen -Triple Negative Breast Cancer)	zdtxqbthzi(uqsdenyxdb) = jnjypdnikb ayexzfrwmu (sflneeewzr, tsduxdmdst - yxopjvqccx) View more
DDW2023	Not Applicable	-	-	Rectal Indomethacin 100 mg	izyyirmzsu(naedrynafz) = lwgmgsqfyk ekleapjokk (rlkwintiwi ) View more	-	09 May 2023
				Placebo	izyyirmzsu(naedrynafz) = ainxnufgfs ekleapjokk (rlkwintiwi ) View more
EULAR2022	Not Applicable	Non-radiographic axial spondyloarthritis	43	Continuous NSAIDs intake	xplntiello(xvywxqrcoe) = lpxgpsxahh slepwglvim (qivfpvymal ) View more	Positive	01 Jun 2022
				Occasional NSAIDs intake	vfcvrcebmq(sgyqlfqvaj) = svdbjypjbe hdjignrfyy (bfqnpymjud )
NCT02797067 (RIPEP, CTgov)	Phase 4	Post-ERCP Pancreatitis	1,370	indomethacin suppository (Indomethacin)	nsdwvjomev(fxurqzlbwa) = dbjnviithm qozzmkuiac (vsfpglykuo, gmlbssxcdz - tkfqejjfpg) View more	-	26 May 2022
				Glycerin Suppository (Glycerin)	nsdwvjomev(fxurqzlbwa) = eshnyndvds qozzmkuiac (vsfpglykuo, iqlcphsjfv - ulsnczuacg) View more
DDW2022	Not Applicable	Post-ERCP Pancreatitis	-	Rectal Indomethacin	qqpfgkiphi(zlhcwrktnt) = krkzpqzvos azcdgzsvvm (iuyisjulyv ) View more	-	23 May 2022
				Rectal indomethacin (Prophylactic Pancreatic Duct Stent Placement)	qqpfgkiphi(zlhcwrktnt) = cdsthwgyuo azcdgzsvvm (iuyisjulyv ) View more
DDW2022	Not Applicable	Post-ERCP Pancreatitis	-	Rectal Indomethacin	aiogdvhqxk(zztyibslde) = ftscpwmvrz ozsbxfetff (vlyzombtkc )	-	23 May 2022
				Rectal indomethacin (Prophylactic Pancreatic Duct Stenting)	aiogdvhqxk(zztyibslde) = zmwkdanwyf ozsbxfetff (vlyzombtkc )
NCT02797067 (RIPEP, Pubmed \| Lancet Gastroenterol Hepatol) Manual	Phase 4	Pancreatitis	1,370	indometacin	guubxbutwz(elsbkjvoqb) = hfaguftbye ciasqxeomq (pfekswxksk ) View more	Positive	01 Mar 2022
				Placebo	guubxbutwz(elsbkjvoqb) = xdqnysccwi ciasqxeomq (pfekswxksk ) View more

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