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ACETAMINOPHEN

acetaminophen

Post-LOE

INTRAVENOUS · SOLUTION

12.1 Mechanism of Action The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions. 12.2 Pharmacodynamics Acetaminophen has been shown to have analgesic and antipyretic activities in animal and human studies. Single doses of acetaminophen injection up to 3000 mg and repeated doses of 1000 mg every 6 hours for 48 hours have not been shown to cause a significant effect on platelet aggregation. Acetaminophen does not have any immediate or delayed effects on small-vessel hemostasis. Clinical studies of both healthy subjects and patients with hemophilia showed no significant changes in bleeding time after receiving multiple doses of oral acetaminophen. 12.3 Pharmacokinetics Distribution The pharmacokinetics of acetaminophen injection have been studied in patients and healthy subjects up to 60 years old. The pharmacokinetic profile of acetaminophen has been demonstrated to be dose proportional in adults following administration of single doses of 500, 650, and 1000 mg. The maximum concentration (C max ) occurs at the end of the 15-minute intravenous infusion of acetaminophen injection. Compared to the same dose of oral acetaminophen, the C max following administration of acetaminophen injection is up to 70% higher, while overall exposure (area under the concentration time curve [AUC]) is very similar. Pharmacokinetic parameters of acetaminophen injection (AUC, C max , terminal elimination half-life [T 1/2 ], systemic clearance [CL], and volume of distribution at steady-state [Vss]) following administration of a single intravenous dose of 15 mg/kg in children and adolescents and 1000 mg in adults are summarized in Table 5. Table 5. Acetaminophen Injection Pharmacokinetic Parameters Subpopulations Mean (SD) AUC 0-6h (mcg × h/mL) C max (mcg/mL) T 1/2 (h) CL (L/h/kg) Vss (L/kg) Children 38 (8) 29 (7) 3.0 (1.5) 0.34 (0.10) 1.2 (0.3) Adolescents 41 (7) 31 (9) 2.9 (0.7) 0.29 (0.08) 1.1 (0.3) Adults 43 (11) 28 (21) 2.4 (0.6) 0.27 (0.08) 0.8 (0.2) The concentrations of acetaminophen observed in neonates greater than 32 weeks gestational age at birth treated with 12.5 mg/kg dose are similar to infants, children and adolescents treated with a 15 mg/kg dose, and similar to adults treated with a 1000 mg dose. At therapeutic levels, binding of acetaminophen to plasma proteins is low (ranging from 10% to 25%). Acetaminophen appears to be widely distributed throughout most body tissues except fat. Metabolism and Excretion Acetaminophen is primarily metabolized in the liver by first-order kinetics and involves three principal separate pathways: Conjugation with glucuronide, conjugation with sulfate, and oxidation via the cytochrome P450 enzyme pathway, primarily CYP2E1, to form a reactive intermediate metabolite (N-acetyl-p-benzoquinone imine or NAPQI). With therapeutic doses, NAPQI undergoes rapid conjugation with glutathione and is then further metabolized to form cysteine

2021

Excl: 2026 (exp)

Pipeline & Clinical Trials

e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study

Endotoxin-associated Sterile Peritonitis

N/A

Clinical Trials (1)

NCT01460056e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study

N/A

Prismaflex HF20

Acute Renal Failure (ARF)

N/A

Oxidized cellulose strip

Intra-operative Bleeding

N/A

Clinical Trials (1)

NCT01637025Oxidized Cellulose hEmostAsis evaluatioN

N/A

Pulsed lavage

Healthy

N/A

Clinical Trials (1)

NCT01457183Clinical Evaluation of Bedside Pulse Lavage Irrigation Device

N/A

Measure of quadriceps thickness with ultrasonography and albumin/prealbumin levels

Malnutrition

N/A

Clinical Trials (1)

NCT02564159Malnutrition Screening by Muscle Ultrasound in Patients Requiring Mechanical Ventilation in Intensive Care Unit

N/A

Quality of Life in Patients With Refractory Angina

Refractory Ischemia

N/A

Clinical Trials (1)

NCT00840437Quality of Life in Patients With Refractory Angina

N/A

OrthoADAPT

Rotator Cuff Tear

N/A

Clinical Trials (1)

NCT00957255Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

N/A

ModPG3 Investigational Device

Blood Pressure

N/A

Clinical Trials (1)

NCT05654714ModPG3 Adult/Ped ISO 81060-2:2018 Study Protocol

N/A

Inductigraft

Degenerative Disk Disease

N/A

Clinical Trials (1)

NCT01452022Performance of Inductigraft in Spinal Fusion

N/A

Continuous venovenous hemodiafiltration with high adsorption membrane

Hemodiafiltration

N/A

Clinical Trials (1)

NCT04033029Antibiotic Plasma Concentrations During Continuous Renal Replacement Therapy With a High Adsorption Membrane (oXiris®)

N/A

Hemofilter Life Span, ECLS And/or CRRT

Kidney Diseases

N/A

Clinical Trials (1)

NCT04193865Hemofilter Life Span, ECLS And/or CRRT

N/A

Vascular access catheter to support dialysis or CRRT

AKI - Acute Kidney Injury

N/A

Adhesive

Adhesive Wear Time

N/A

Clinical Trials (1)

NCT07256951Gen 2 Battrode Wear Study

N/A

Parenteral nutrition

Neoplasms

N/A

Clinical Trials (1)

NCT02828150Integrative Parenteral Nutrition in Cancer Patients

N/A

Veritas in Non-Bridging Ventral Hernia Repair

Hernia

N/A

Clinical Trials (1)

NCT01426477Veritas in Non-Bridging Ventral Hernia Repair

N/A

More concentrated parenteral nutrition solution

Nutrition Disorder, Infant

N/A

Clinical Trials (1)

NCT04085484Effects of Two Different Parenteral Nutrition Regimes on Nutrient Intakes, Growth and Plasma Electrolytes in Very Low Birth Weight Infants

N/A

Connex CVSM with Timmy3 module

Febrile Illness

N/A

Clinical Trials (1)

NCT06056011Timmy3 Module Clinical Accuracy ISO 80601-2-56:2017 + A1 2018

N/A

Physioneal

Kidney Failure,Chronic

N/A

Clinical Trials (1)

NCT00172211Comparison of Oxidative Stress and Insulin Resistance Before and After Using Physioneal in Peritoneal Dialysis Patients

N/A

Acute Kidney Injury

N/A

Clinical Trials (1)

NCT02424747Long-term Survival and Renal Outcomes in Critically Ill Patients After Acute Kidney Injury: Swedish Multi-centre Cohort Study

N/A

Comparison of Infection Rates Among Patients Using Two Catheter Access Devices

Catheter-Related Infections

N/A

Clinical Trials (1)

NCT00965198Comparison of Infection Rates Among Patients Using Two Catheter Access Devices

N/A

GamCath® central venous catheter

Hemodialysis

N/A

septeX

Rhabdomyolysis

N/A

FloSeal application

Benign Ovarian Tumor

N/A

Clinical Trials (1)

NCT01683877Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

N/A

Standard RRT initiation

Acute Kidney Injury

N/A

Clinical Trials (1)

NCT02568722Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)

N/A

FloSeal application

Gynecologic Cancer

N/A

Clinical Trials (1)

NCT01679483Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer

N/A

A Retrospective Study of Actifuse Synthetic Bone Graft Versus Other Bone Graft Substitutes in Patien

Lumbar Fusion

N/A

Clinical Trials (1)

NCT01833962A Retrospective Study of Actifuse Synthetic Bone Graft Versus Other Bone Graft Substitutes in Patients Requiring Lumbar Fusion

N/A

CELSTAT

Bleeding Active

N/A

Clinical Trials (1)

NCT02640235Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding

N/A

Heparin dose titration

Renal Failure Chronic Requiring Hemodialysis

N/A

Cova Patch

Cardiac Failure

N/A

Theranova 400 Dialyzer

Chronic Kidney Failure

N/A

Hemodynamic ABI Monitor

Traumatic Brain Injury

N/A

Zolderonic acid

Prostatic Neoplasms

N/A

Clinical Trials (1)

NCT00489905Study on Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer

N/A

Peripheral Intravenous Analysis

Infection

N/A

Clinical Trials (1)

NCT03736421Observational Study to Evaluate Peripheral IntraVenous Analysis (PIVA) in Euvolemic, Hypovolemic, and Hypervolemic Emergency Department Patients

N/A

Indirect Calorimetry measurement of Resting Energy Expenditure .

Mechanical Ventilation Complication

N/A

Clinical Trials (1)

NCT01479673TICACOS International

N/A

High Frequency Chest Wall Oscillation

Bronchiectasis

N/A

Clinical Trials (1)

NCT04017312A Pilot Study to Evaluate the Use of the Vest® System for Treatment of Bronchiectasis Patients in the Home Setting

N/A

Back Side of the Moon

Nutritional Deficiency

N/A

Clinical Trials (1)

NCT03724045Back Side of the Moon: Nutritional Therapy

N/A

Implementation of the KDIGO bundle)

Acute Kidney Injury (Nontraumatic)

N/A

Clinical Trials (1)

NCT05275218Effect of an Intervention to Prevent Acute Kidney Injury Versus Standard Care in High-risk Patients After Major Surgery

N/A

oXiris filter

Sepsis

N/A

Clinical Trials (1)

NCT03914586The Membrane Adsorbing OXiris Filter in Septic Patients With AKI

N/A

Discontinuation of using device

CHF

N/A

Clinical Trials (1)

NCT03207802Remotely Monitoring Patients With Chronic Conditions in Their Home

N/A

Ready-to-Use Parenteral Nutrition

Very Low Birth Weight Infant

N/A

Clinical Trials (1)

NCT06200324Clinical Outcomes of Ready-to-Use Parenteral Nutrition in Low Birth Weight Newborns in Colombia 2017-2023

N/A

Gambro HD-C4 Small Dialyzer

Hemodialysis

N/A

Unite Biomatrix

Venous Leg Ulcers

N/A

Clinical Trials (1)

NCT00953563The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

N/A

The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

Intraoperative Blood Loss

N/A

Clinical Trials (1)

NCT05258487The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

N/A

Theranova

Kidney Failure, Chronic

N/A

Clinical Trials (1)

NCT03448887Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration

N/A

Prismaflex HF20 CRRT Filter

Acute Kidney Injury in Pediatric Patients

N/A

Validation of a Sensor for Non-Invasive Measurements

CHF

N/A

Clinical Trials (1)

NCT03463148Validation of a Sensor for Non-Invasive Measurements

N/A

Adsorption membrane filter Oxiris™

Acute Kidney Injury

N/A

Clinical Trials (1)

NCT06253377Continuous Renal Replacement Therapy With Oxiris in Acute Kidney Injury and Sepsis

N/A

Assessment the activity of anti-Xa factor.

Assessment of Activity of Anti-Xa Factor in Patients Treated With Continuous Veno-venous Hemodiafiltration Receiving Anticoagulant Prophylaxis

N/A

Clinical Trials (1)

NCT04671160Impact of Continuous Veno-venous Hemodiafiltration on Efficacy of Administration of Prophylactic Doses of Enoxaparin or Fondaparinux in Critically Ill Patients.

N/A

Ease of Use and Blood Clotting for the Gambro Polyflux HD-C4 Big Dialyzer

Chronic Kidney Failure

N/A

HF20™

Pediatric Kidney Disease

N/A

Clinical Trials (1)

NCT04836026Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization

N/A

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