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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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IV Acetadote is

Please refer to the guidelines below for dose preparation based upon patient weight. Varices can rupture and bleed, resulting in potentially life-threatening complications. Acetaminophen inssert absorbed from the upper gastrointestinal tract with peak plasma levels occurring between 30 and 60 minutes after therapeutic doses and usually within 4 hours following an overdose.

It is a rare autoimmune disorder that affects the skin and internal organs. If a reaction to acetylcysteine involves more than simply flushing and erythema of the skin, it should be treated as an anaphylactoid reaction.

Inserr information is available regarding the dosing requirements of patients that weigh more than kg. Acetaminophen continues to be the leading cause of poisonings reported by hospital emergency rooms in the United States. Repeat dose if emesis occurs within 1 hour of administration.

The color change does not affect the quality of the product. For full prescribing information, visit www. 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.

There are no adequate and well-controlled studies in pediatric patients. Cumberland acquired the rights to ifetroban in early 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.

Treatment is often in a critical care setting.

If either falls above the toxicity line, acetylcysteine treatment should be initiated. The total volume administered should be adjusted for patients weighing less than 40 kg and for those requiring fluid restriction.

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No assurance can be given pcakage these events will occur. Administration Instructions Three-Bag Method: It is extensively metabolized in the liver to form principally the sulfate and glucoronide insertt which are excreted in the urine. It combines three well-known and widely prescribed medications packaged together for patient convenience: Disclaimer The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical aceadote.

It is available as follows:. If vial was previously opened, do not use for intravenous administration. 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.

Nursing women may consider resuming nursing 30 hours after administration. There are published reports on four pregnant women with acetaminophen toxicity, who were treated with oral or intravenous acetylcysteine at the time of delivery.

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. If vial was previously opened, do not use for I. Cumberland is dedicated to providing innovative products which improve quality of care for acetadore.

Acetadote (acetylcysteine) Injection

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

For specific treatment information regarding the clinical acettadote of acetaminophen overdose, please contact your regional poison center ator alternatively, a special health professional assistance line for acetaminophen overdose at Renal Impairment No data are available to determine if a dose adjustment in patients with moderate or severe renal impairment is required.

There are no adequate and well-controlled studies of Acetadote in pregnant women. Although several medications are used to treat the skin disease associated with SSc, there is no insett effective treatment to improve the function of acetadore internal organs such as the lungs, heart, and gastrointestinal tract, hence the treatment of SSc remains an unmet need. With an extended-release preparation, an acetaminophen level drawn less than 8 hours post-ingestion may be misleading.

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Draw a second level at 4 to 6 hours after the initial level.

For more information, please visit the company website at www. As a result, we were able to achieve approval and stocking of the product at a core group of medical facilities around the U. Acute flushing and erythema of the skin may occur in patients receiving acetylcysteine intravenously. We then initiated a shift in strategy to begin driving pull-through use and corresponding padkage of the product. The stopper in the Acetadote vial is formulated with a synthetic base-polymer and does not contain Natural Rubber Latex, Dry Natural Rubber, or blends of Natural Rubber.

Acetadote should be used with caution in patients with asthma, or where there is packagf history of bronchospasm.

Acetadote Pediatric Dosing – Epocrates Online

However, limited case reports of pregnant women exposed to acetylcysteine during various trimesters did not report any adverse maternal, fetal or neonatal outcomes. Pediatric use No adverse effects were noted during I. This increased pressure in the portal vein may lead to the development of large, swollen veins varices within the esophagus, stomach, rectum, or umbilical area belly button. It is the first FDA approved triple therapy combination medication to contain omeprazole as the proton pump inhibitor, which works to decrease the amount of acid the stomach produces.

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.