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The only acetylcysteine
oral solution with

LEMON-MINT
TASTE AND SMELL1

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Cetylev provides an alternative treatment experience for acetaminophen overdose patients by offering:

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*Provided as 500-mg and 2.5-g effervescent tablets that are dissolved in water. +Available in two strengths for customized and accurate weight-based dosing.
²An open-label, randomized, crossover study demonstrated the bioequivalence of Cetylev and 20% acetylcysteine oral solution

Indication

Cetylev is indicated to prevent or lessen hepatic injury after ingestion of a potentially hapatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).

Hypersensitivity reactions, including generalized urticaria have been observed in patients receiving oral acetylcysteine overdose. If hypersensitivity reactions occur, Cetylev should be discontinued unless it is deemed essential for patient management and the reactions can be otherwise controlled.

Risk of upper gastrointestinal hemorrhage may increase due to occasional severe and persistent vomiting as a symptom of acute acetaminophen overdose. Treatment with Cetylev may aggravate the vomiting and increase the risk of upper gastrointestinal hemorrhage in at risk patients (e.g., those with esophageal varices, peptic ulcers, etc.). Consider the risk/benefit for patients at risk of hemorrhage versus the risk of developing hepatic toxicity and treat with Cetylev as needed.

Cetylev tablets contain sodium. Consider the total sodium content from dietary and non-dietary sources in patients who may be sensitive to excess sodium intake, such as those with congestive heart failure, hypertension, or renal impairment.

Acetaminophen and acetylcysteine cross the placenta. Delaying treatment in pregnant women with acetaminophen overdose and potentially toxic acetaminophen plasma levels may increase the risk of maternal and fetal morbidity and and mortality.

There is no information regarding the presence of acetylcysteine in human milk, or the effects of acetylcysteine on the breastfed infant or on milk production. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Cetylev and any potential adverse effects on the breastfed infant from Cetylev or from the underlying maternal condition.

Please refer to the Cetylev prescribing information for Recommended Dosage and Preparation and Administration Instructions in Adults and Pediatrics for Acute Acetaminophen Ingestion. For assistance with specific Cetylev dosage and administration information for acute ingestion or specific Cetylev dosage and administration information in patients with RSI, consider contacting your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115.

Adverse Reactions

The most common adverse reactions were nausea, vomiting, other gastrointestinal symptoms, and rash with or without fever.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For further information, please see full Prescribing Information.

References:

1. Drugs@FDA. Drug Details. https://www.accessadata.fda.gov/scripts/oder/drugsat feda/index.cfm?fuseaction=Search.DrugDetails
Accessed April 25, 2016. 2. Green et al. (2016). Effervescent N-Acetylcysteine Tablets versus Oral Solution N-Acetylcysteine in Fasting Healthy Adults: An Open-Label, Randomized, Single Dose, Crossover, Relative Bioavailability Study, Current Therapeutics Research, 83, 1-7, doi: http://dx.doi.org/10.1016/j.curtheres.2016.06.001

Cetylev is a trademark of Arbor Pharmaceuticals.
©2016 Arbor Pharmaceuticals, LLC. All rights reserved. PP-CET-US-0093

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