CETYLEV acetylcysteine tablet effervescent

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

acetylcysteine (UNII: WYQ7N0BPYC) (acetylcysteine - UNII:WYQ7N0BPYC)

Available from:

Arbor Pharmaceuticals

INN (International Name):

acetylcysteine

Composition:

acetylcysteine 500 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

CETYLEV- ACETYLCYSTEINE TABLET, EFFERVESCENT
ARBOR PHARMACEUTICALS
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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:
Administer a loading dose of CETYLEV immediately.
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:
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:
Administer a loading dose of CETYLEV immediately.
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:
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