ACETADOTE PACKAGE INSERT PDF

Official website of IV Acetadote (acetylcysteine). Find informantion about Acetadote and acetaminophen overdose, a dosage calculator, emergency facility . Drug Label Information do not include all the information needed to use ACETADOTE safely and effectively. See full prescribing information for ACETADOTE. IV NAC (Acetadote): Adult Patient Dosing Regimen per Package Insert. Loading Dose: mg/kg in mL of 5% dextrose in water (D5W) infused over

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Estimating Potential for Hepatotoxicity: Pediatric use No adverse effects were noted during I. Furthermore, specific dosing guidance is now included for patients weighing over kg. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction: This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland’s current views on future events based on what it believes are reasonable assumptions.

June 10, – Cumberland Pharmaceuticals Inc. However, limited case reports of pregnant women exposed to acetylcysteine during various trimesters did not report any adverse maternal, fetal or neonatal outcomes.

Acetaminophen Assays Interpretation and Methodology — Repeated Supratherapeutic Ingestion Repeated Supratherapeutic Ingestion RSI is defined as ingestion of acetaminophen at doses higher than those recommended for extended periods of time.

Approximatelypatients in the United States suffer from medical conditions that make them susceptible to cirrhosis and a subset of these patients develop HRS every year. If aceradote patient presents after 4 hours post-ingestion, the serum acetaminophen sample should be determined immediately. A small fraction of an ingested dose is metabolized in the liver by isozyme CYP2E1 of the cytochrome P mixed function oxidase enzyme system to form a reactive, potentially toxic, intermediate metabolite.

Cumberland is dedicated to providing innovative products which improve quality of care for patients. View full Packagf Information. Decrease risk of contrast-induced nephropathy: Acetadotf combines three well-known and widely prescribed medications packaged together for patient convenience: New language has also been added to alert health care providers that in certain clinical situations, therapy should be extended for some patients.

This usually entails administering antihistaminic drugs and in severe cases may require administration of epinephrine. Acetaminophen continues to be the leading cause of poisonings reported by hospital emergency rooms in the United States. We are responsible for all marketing, promotion, and distribution of the brand in the U. The label changes reflect our commitment to this patient population, which includes development of the EDTA-free Acetadote formulation.

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Reference s National Institutes of Health, U. These factors include avetadote conditions, competition, an inability of manufacturers to produce Cumberland’s products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure and other factors discussed in the Company’s most recent Form K and subsequent Q’s as filed with the SEC.

As with any business, all phases of Cumberland’s operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland’s results of operations. Based on the pharmacokinetics of acetylcysteine, it should be nearly completely cleared 30 hours after administration.

This increased pressure in the portal vein may lead to the development of large, swollen veins varices within the packae, stomach, rectum, or umbilical area belly button.

Vaprisol is indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia. No assurance can be given that these events will occur. Employment Opportunities employment cumberlandpharma. As a result, high pressure in the portal system develops.

It is most effective when given early, with benefit seen principally in patients treated within hours of the insegt. IV monograph Adjuvant therapy in respiratory conditions: All mothers recovered and none of the infants had evidence of acetaminophen poisoning. Acetadote is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen.

On admission for suspected acetaminophen overdose, a serum blood sample should be drawn at least 4 hours after ingestion to determine the acetaminophen level and will serve as a basis for determining the need for treatment with acetylcysteine.

Disclaimer The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.

Acetadote Pediatric Dosing – Epocrates Online

Acetadote is sterile and can be used for I. To avoid fluid overload, the volume of diluent should be reduced as needed [see Dosage and Administration 2 ].

Totect is the second product to emerge from our strategic alliance with the Clinigen Group plc. However, following ingestion of a large overdose, the glucuronide and sulfate conjugation pathways are saturated resulting in a larger fraction of the drug being metabolized via the cytochrome P pathway and therefore, the amount of acetaminophen metabolized to the reactive intermediate increases.

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If the time of ingestion is unknown, or the serum acetaminophen level is not available, cannot be interpreted, or is not available within the 8 hour time interval from acetaminophen ingestion, Acetadote should be administered immediately if 24 hours or less have elapsed from the reported time of ingestion of an overdose of acetaminophen, regardless of the quantity reported to have been ingested.

Corporate Headquarters Cumberland Pharmaceuticals Inc. The frequency of adverse reactions have been reported to be between 0. Though safe at recommended doses, acetaminophen can cause liver damage with excessive use.

IV Acetadote is

It is the only prescription laxative available in pre-measured powder packets, making it easily portable. HRS is a life-threatening condition involving reduced liver function and progressive kidney failure for which there is currently no FDA approved pharmaceutical treatment. No specific studies have been conducted to evaluate the use of or necessity of dosing adjustments in patients weighing over kg.

Pcakage vial was previously opened, do packqge use for intravenous administration. In addition, the acetylcysteine infusion may be interrupted until treatment of the anaphylactoid symptoms has been initiated and then carefully restarted.

Acetadote (acetylcysteine) Injection

For more information, please visit the company website at www. Acetaminophen poisoning and toxicity.

For specific treatment information regarding the clinical management of repeated supratherapeutic acetaminophen overdose, please contact your regional poison center ator alternatively, a special health professional assistance line for acetaminophen overdose at Acetadote is free of EDTA or any other stabilization or chelating agents. The Company’s primary target markets include hospital acute care and gastroenterology. Symptoms of acute toxicity were ataxia, hypoactivity, labored respiration, cyanosis, loss of righting reflex and convulsions.

Renal Impairment No data are available to determine if a dose adjustment in patients with moderate or severe renal impairment is required.

Administration Instructions Three-Bag Method: