Acetylcysteine

DRUG INFORMATION

  ADULT
    - The total dose of Acetylcysteine Injection is 300 mg/kg given as 3 separate doses
      and administered over a total of 21 hours.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'dosage and
      administration', retrieved 2026-08-29
    - The total dose of Acetylcysteine Injection is 300 mg/kg given as 3 separate doses
      and administered over a total of 21 hrs.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'dosage and
      administration', retrieved 2026-08-29
    - The dose of Acetylcysteine Injection recommended in these patients should be a
      loading dose of 15,000 mg infused over one hour followed by a first maintenance
      dose of 5,000 mg over 4 hrs and a second maintenance dose of 10,000 mg over 16
      hrs.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - No adverse effects were noted during intravenous infusion with acetylcysteine at a
      mean rate of 4.2 mg/kg/h for 24 hours to 10 preterm newborns ranging in
      gestational age from 25 to 31 weeks and in weight from 500 to 1380 grams in one
      study or in 6 newborns ranging in gestational age from 26 to 30 weeks and in
      weight from 520 to 1335 grams infused with acetylcysteine at 0.1 to 1.3 mg/kg/h
      for 6 days.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'pediatric use',
      retrieved 2026-08-29
    - The total dose of Acetylcysteine Injection is 300 mg/kg given as 3 separate doses
      and administered over a total of 21 hours. Please refer to the guidelines below
      for dose preparation based upon patient weight. The total volume administered
      should be adjusted for patients less than 40 kg and for those requiring fluid
      restriction (see Tables 1 and 2).
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for acetylcysteine
      (Acetylcysteine), section 'dosage and administration', retrieved 2026-08-29
    - The total dose of Acetylcysteine Injection is 300 mg/kg given as 3 separate doses
      and administered over a total of 21 hours.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - The color change does not affect the quality of the product. 2.3 Renal Impairment
      No data are available to determine if a dose adjustment in patients with moderate
      or severe renal impairment is required. 2.4 Hepatic Impairment Although there was
      a threefold increase in acetylcysteine plasma concentrations in patients with
      hepatic cirrhosis, no data are available to determine if a dose adjustment in
      these patients is required.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'dosage and
      administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - In cases of suspected massive overdose, or with concomitant ingestion of other
      substances, or in patients with preexisting liver disease, the absorption and/or
      the half-life of acetaminophen may be prolonged, in such cases consideration
      should be given to the need for continued infusion of N-acetylcysteine beyond 21
      hours.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'dosage and
      administration', retrieved 2026-08-29
    - The color change does not affect the quality of the product. 2.3 Renal Impairment
      No data are available to determine if a dose adjustment in patients with moderate
      or severe renal impairment is required. 2.4 Hepatic Impairment Although there was
      a threefold increase in acetylcysteine plasma concentrations in patients with
      hepatic cirrhosis, no data are available to determine if a dose adjustment in
      these patients is required.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'dosage and
      administration', retrieved 2026-08-29
    - The published medical literature does not indicate that the dose of acetylcysteine
      in patients with hepatic impairment should be reduced.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'dosage and
      administration', retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Category B There are no adequate and well-controlled studies of
      Acetylcysteine Injection in pregnant women.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'pregnancy',
      retrieved 2026-08-29
    - However, limited case reports of pregnant women exposed to acetylcysteine during
      various trimesters did not report any adverse maternal, fetal or neonatal
      outcomes.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'pregnancy',
      retrieved 2026-08-29
    - There are published reports on four pregnant women with acetaminophen toxicity,
      who were treated with oral or intravenous acetylcysteine at the time of delivery.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - It is not known whether Acetylcysteine Injection is present in human milk.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'nursing
      mothers', retrieved 2026-08-29
    - Because many drugs are excreted in human milk, caution should be exercised when
      acetylcysteine is administered to a nursing woman.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'nursing
      mothers', retrieved 2026-08-29
    - Based on the pharmacokinetics of acetylcysteine, it should be nearly completely
      cleared 30 hours after administration.
      Source: US FDA label for acetylcysteine (Acetylcysteine), section 'nursing
      mothers', retrieved 2026-08-29