Drugplain

Acetylcysteine 100 mg/mL

ACETYLCYSTEINE · SOLUTION · Fresenius Kabi USA, LLC

No Recall History
Plain English

Acetylcysteine oral solution is an antidote medication used primarily to treat acetaminophen (Tylenol) overdose by protecting the liver from damage. It works by replenishing a substance in your body that helps neutralize toxic effects of excessive acetaminophen.

Key Facts

Brand Name
Acetylcysteine
Generic Name
ACETYLCYSTEINE
NDC Code (Product)
63323-695
Manufacturer
Fresenius Kabi USA, LLC
Strength
100 mg/mL
Dosage Form
SOLUTION
Route
ORAL, RESPIRATORY (INHALATION)
Marketing Status
Application #
ANDA204674
Drug Class
Antidote [EPC]; Antidote for Acetaminophen Overdose [EPC]
Marketing Start
03/31/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea751 reports
off label use650 reports
drug ineffective643 reports
pneumonia612 reports
pyrexia500 reports
fatigue436 reports
nausea421 reports
diarrhoea338 reports
vomiting316 reports
hypertension309 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Acetylcysteine Injection is 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 (RSI). Acetylcysteine Injection 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 an acute ingestion or from repeated supratherapeutic ingestion (RSI) ( 1 ).

Dosage & Administration

2 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 acetylcysteine injection immediately. Obtain an acetaminophen concentration to determine 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 acetylcysteine injection immediately and continue treatment for a total of three doses over 21 hours. If the patient presents more than 8 hours after ingestion and the time of acute acetaminophen ingestion is known: Administer a loading dose of acetylcysteine injection 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 )…

Contraindications

4 CONTRAINDICATIONS Acetylcysteine is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine [see Warnings and Precautions ( 5.1 )] . Patients with a previous hypersensitivity reaction to acetylcysteine ( 4 ).

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions (> 2%) are rash, urticaria/facial flushing and pruritus ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the literature the most frequently reported adverse reactions attributed to intravenous acetylcysteine administration were rash, urticaria and pruritus. The frequency of adverse reactions has been reported to be between 0.2% and 21%, and they most commonly occur during the initial loading dose of acetylcysteine. Loading Dose/Infusion Rate Study In a randomized, open-label, multi-center clinical study conducted in Australia in patients with acetaminophen poisoning, the rates of hypersensitivity reactions between a 15-minute and 60-minute intravenous infusion for the 150 mg/kg loading dose of acetylcysteine were compared. The incidence…

Frequently Asked Questions

What is Acetylcysteine used for?

Acetylcysteine oral solution is an antidote medication used primarily to treat acetaminophen (Tylenol) overdose by protecting the liver from damage. It works by replenishing a substance in your body that helps neutralize toxic effects of excessive acetaminophen.

Is Acetylcysteine a controlled substance?

Acetylcysteine is not classified as a controlled substance by the DEA.

What is the generic name for Acetylcysteine?

The generic name for Acetylcysteine is ACETYLCYSTEINE. There are 2 other brand versions of ACETYLCYSTEINE.

What is the NDC code for Acetylcysteine 100 mg/mL?

The NDC (National Drug Code) for Acetylcysteine 100 mg/mL is 63323-695, listed by Fresenius Kabi USA, LLC.

Product NDC

63323-695

Package NDC

63323-695-04

Other Acetylcysteine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)