1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CETYLEV
®
safely and effectively. See full prescribing information for
CETYLEV.
CETYLEV (acetylcysteine) effervescent tablets for oral solution
Initial U.S. Approval: 1963
----------------------------INDICATIONS AND USAGE---------------------------
CETYLEV is an antidote for acetaminophen overdose indicated to prevent or
lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of
acetaminophen in patients with acute ingestion or from repeated
supratherapeutic ingestion. (1)
-----------------------DOSAGE AND ADMINISTRATION-----------------------
Pre-Treatment Assessment Following Acute Ingestion (2.1):
Obtain a plasma or serum sample to assay for acetaminophen concentration at
least 4 hours after ingestion.
• If the time of acetaminophen ingestion is unknown:
o Administer a loading dose of CETYLEV immediately
o Obtain an acetaminophen concentration to determine the need for
continued treatment
• If the acetaminophen concentration cannot be obtained (or is unavailable or
uninterpretable) within the 8-hour time interval after acetaminophen
ingestion or there is clinical evidence of acetaminophen toxicity:
o Administer a loading dose of CETYLEV immediately and
continue treatment for a total of 17 doses.
• If the patient presents more than 8 hours after ingestion and the time of
acute acetaminophen ingestion is known:
o Administer a loading dose of CETYLEV immediately
o Obtain acetaminophen concentration to determine need for
continued treatment
• If the patient presents less than 8 hours after ingestion and the time of acute
acetaminophen ingestion is known and the acetaminophen concentration is
known:
o Use the Rumack-Matthew nomogram (Figure 1) to determine
whether or not to initiate treatment with CETYLEV (2.2)
Nomogram for Estimating Potential for Hepatotoxicity from Acute
Acetaminophen Ingestion (2.2):
• See the Full Prescribing Information for instructions on how to use the
nomogram to determine the need for loading and maintenance dosing.
Recommended Adult and Pediatric Dosage (2.3):
• CETYLEV is for oral administration only; not for nebulization or
intratracheal instillation
• Loading dose: 140 mg/kg
• Maintenance doses: 70 mg/kg repeated every 4 hours for a total of 17
doses.
• See Full Prescribing Information for weight-based dosage and preparation
and administration instructions.
Repeated Supratherapeutic Acetaminophen Ingestion (2.4):
• Obtain acetaminophen concentration and other laboratory tests to guide
treatment; Rumack-Matthew nomogram does not apply.
----------------------DOSAGE FORMS AND STRENGTHS---------------------
Effervescent tablets: 500 mg and 2.5 grams (3)
------------------------------CONTRAINDICATIONS-------------------------------
None (4)
------------------------WARNINGS AND PRECAUTIONS-----------------------
• Hypersensitivity Reactions, Including Urticaria: Discontinue CETYLEV
unless deemed essential to patient management and the reactions can be
otherwise controlled (5.1)
• Risk of Upper Gastrointestinal Hemorrhage: Consider the risk/benefit for
patients at risk of hemorrhage (e.g., those with esophageal varices, peptic
ulcers, etc.) versus the risk of developing hepatic toxicity, and treat with
CETYLEV accordingly.(5.2)
------------------------------ADVERSE REACTIONS-------------------------------
Most common adverse reactions are nausea and vomiting, other
gastrointestinal symptoms, and rash with or without fever. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Arbor
Pharmaceuticals LLC at 1- 866-516-4950 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Patient
Information.
Revised: 04/2017
_____________________________________________________________________________________________________________________________________
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Pre-Treatment Assessment and Testing Following Acute
Acetaminophen Ingestion
2.2 Nomogram for Estimating Potential for Hepatotoxicity from Acute
Acetaminophen Ingestion and Need for CETYLEV Treatment
2.3 Recommended Dosage and Preparation and Administration
Instructions in Adults and Pediatrics for Acute Acetaminophen
Ingestion
2.4 Recommendations for Repeated Supratherapeutic Acetaminophen
Ingestion
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
5.2 Risk of Upper Gastrointestinal Hemorrhage
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Patients Sensitive to High Sodium Intake
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not
listed.
Reference ID: 4083362