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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If you are a patient, caregiver or healthcare professional and need product related information, please visit our Products page, which will link you to product-specific websites. With an extended-release preparation, an acetaminophen level drawn less than acetqdote hours post-ingestion may be misleading. It is available as follows: As a result, we were able to achieve approval and stocking of the product at a core group of medical facilities around the U. Therefore, plasma or serum acetaminophen concentrations, determined as early as possible, but no sooner than four hours following an acute overdose, are essential in assessing the potential risk of hepatotoxicity.

If either falls above the toxicity line, acetylcysteine treatment should be initiated.

Single dose vial, preservative-free, discard unused portion. If the patient presents after 4 hours post-ingestion, the serum acetaminophen sample should be determined immediately.

Acetadote does not contain Ethylene diamine tetraacetic acid EDTA or any other stabilization or chelating agents and is free of preservatives. It is most effective when given early, with benefit seen principally in patients treated within hours of the overdose.

IV Acetadote is

It combines three well-known and widely prescribed medications packaged together for patient convenience: The Company’s primary target markets include hospital acute care and gastroenterology.

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If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death. We are responsible for all marketing, promotion, and distribution of the brand in the U. Acetadote is sterile and can be used for I.

The nomogram does not apply to patients with RSI. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. 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. Acetadote should be used with caution in patients with asthma, or where there is a history of bronchospasm.

Omeclamox-Pak is available in over 15, retail pharmacies nationwide and is available on many managed care plan formularies.

Acetadote&#; | Cumberland Pharmaceuticals

For full prescribing information, visit www. In the literature, the most frequently reported adverse reactions attributed to intravenous acetylcysteine administration were rash, urticaria and pruritus. The color of acetylcysteine injection may turn from essentially colorless to a slight pink or purple once the stopper is punctured. 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.

Based on data from the American Association of Poison Control Centers AAPCCacetaminophen was involved in more thanpoisoning exposures in the United States inincluding more thancases of acetaminophen in combination with other medications.

Vaprisol is indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia. Acetadote, introduced in the United States in and currently used in more than 3, hospitals across the U.

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Reproductive and developmental toxicity studies performed in rats at oral doses up to 6. Limited information is available regarding the dosing requirements of patients that weigh more than kg. The frequency of adverse reactions have been reported to be between 0.

This was a result of a dedicated effort during the year to focus on individual hospital formulary approvals for the product.

We acquired Vibativ from Theravance Biopharma in November No assurance can be given that these events will occur. No adverse sequelae developed in the three viable infants. This lifesaving antibiotic is designed for difficult to treat Gram-positive bacterial infections, including those that are classified as MRSA or multidrug-resistant.

Furthermore, specific dosing guidance is now included for patients weighing over kg. Hydrate patient with saline concurrently. These reactions usually occur 30 to 60 minutes after initiating the infusion and often resolve spontaneously despite continued infusion of acetylcysteine.

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.

Clin Tox ; Under the terms of the agreement, we are responsible for all marketing, acetadotte, and distribution of the product in the U. If vial was previously opened, do not use for I. To avoid fluid overload, the volume of diluent should be reduced as needed [see Dosage and Administration 2 ]. Elimination of acetylcysteine was slower in these infants than in adults; mean elimination half-life was 11 hours.