Acetylcysteine is an antidote sold in the U.S. under 2 brand and generic names, for amyloidosis, bronchiectasis and bronchitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Acetadote (application NDA021539). Other acetylcysteine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Pre-Treatment Assessment Following Acute Ingestion ( 2.1 ): Prior to initiating treatment with Acetylcysteine Injection, decide whether the three-bag or two-bag regimen will be used. 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 Acetylcysteine Injection immediately. o 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: o Administer a loading dose of Acetylcysteine Injection immediately and continue treatment for a total of three doses over 21 hours ( 2.5 ). • 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 Acetylcysteine Injection 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 revised Rumack-Matthew nomogram (Figure 1) to determine whether or not to initiate treatment with Acetylcysteine…
Most common adverse reactions (> 2%) are rash, urticaria/facial flushing and pruritus ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience The following clinically significant adverse reactions are described elsewhere in labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Fluid Overload [see Warnings and Precautions ( 5.2 )] 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 of drug-related…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Injectable | Generic | $1 | View → | |
| 2 | Not yet rated | Prescription | Solution | Generic | $1 | View → |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Acetylcysteine Injection 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 )