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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Elimination of acetylcysteine was slower in these infants than in adults; mean elimination half-life was 11 hours.

Acetadote&#; | Cumberland Pharmaceuticals

Acetadote is sterile and can be used for I. 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. The new indication states, “Acetadote is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen.

These factors include market 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. Acetylcysteine likely protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite.

Though safe at recommended doses, acetaminophen can cause liver damage with excessive use. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. It is most effective when given early, with benefit seen principally in patients treated within hours of the overdose. Based on the pharmacokinetics of acetylcysteine, it should be nearly completely cleared 30 hours after administration.

packzge If vial was previously opened, do not use for intravenous administration. 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 Single dose vial, preservative-free, discard unused ;ackage. It is the only prescription laxative available in pre-measured powder packets, making it easily portable.

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Acetylcysteine has been shown to reduce the extent of liver injury following packagge overdose. Therapy should continue until all doses are administered even though the acetaminophen plasma level has dropped below the toxic range. It combines three well-known and widely prescribed medications packaged together for patient convenience: The label changes reflect our commitment to this patient population, which includes development of the EDTA-free Acetadote formulation.

Under the terms of the agreement, we are responsible for all marketing, promotion, and distribution of the product in the U. Do not use previously opened vials for IV administration. Acetadote packate not contain Ethylene diamine tetraacetic acid EDTA or any other stabilization or chelating agents and is free of preservatives.

With a 3-dose, hour IV N-acetylcysteine infusion, Acetadote is the shortest FDA-approved treatment insetr for acetaminophen overdose. However, following ingestion of a large overdose, innsert 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.

As a result, we were able to achieve approval and stocking of the product at a core group of medical facilities around the U. Plasma or Serum Acetaminophen Concentration vs.

IV Acetadote is

Nursing mothers It is not known whether Acetadote is present in human milk. If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death. Recommended therapeutic doses of acetaminophen are not believed to saturate the glucuronide and sulfate conjugation pathways and therefore are not expected to result in the formation of sufficient reactive metabolite pwckage deplete glutathione stores.

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

Packag local search option of this data can be found here. To avoid fluid overload, the volume of diluent should be reduced as needed [see Dosage and Administration 2 ]. Indert is premixed and administered by IV infusion. If vial was previously opened, do not use for I. However, the reported history of the acetadlte of a drug ingested as an overdose is often inaccurate and is not a reliable guide to therapy of the overdose.

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Serious anaphylactoid reactions, including death. The increased formation of the reactive metabolite may deplete the hepatic stores of glutathione with subsequent binding of the metabolite to protein molecules within the hepatocyte resulting in cellular necrosis. Estimating Potential for Hepatotoxicity: 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. Pediatric use No adverse effects were noted during I.

Although several medications are used to treat the skin disease associated pqckage SSc, there is no universally effective treatment to improve the function of affected internal organs such as the lungs, heart, and gastrointestinal tract, hence the treatment of SSc remains an unmet need.

Draw a second level at 4 to 6 hours after the initial level. This increased pressure in the portal vein may lead to the development of large, swollen veins varices within the wcetadote, stomach, rectum, or umbilical area belly button. Portal hypertension, a complication of liver cirrhosis, is an increase in the blood pressure within a system of veins called the portal venous system. It is available as follows:. However, it does not appear to worsen the condition of patients and it should not be withheld, since the reported time of ingestion may not be correct.

HRS is a life-threatening condition involving reduced liver function and progressive kidney failure for which packagr is currently no FDA approved pharmaceutical treatment.

Current treatment of AERD remains a challenge, as novel and effective treatment modalities are lacking for this unmet medical need. Therefore, plasma or serum acetaminophen concentrations, packzge as early as possible, but no sooner than four hours following an acute overdose, are essential in assessing the potential risk of hepatotoxicity.