acetylcysteine solution HOSPIRA, INC.
ACETYLCYSTEINE Solution, USP 10% and 20%
WARNING: NOT FOR INJECTION
Acetylcysteine solution is for inhalation (mucolytic agent)
or oral administration (acetaminophen antidote), and available as sterile,
unpreserved solutions (not for injection).
is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine.
Chemically, it is N-acetyl-L-cysteine.
is a white crystalline powder which melts at 104°−110°C and
has a very slight odor. The structural formula for acetylcysteine is as follows:
Each mL of the 10% solution contains
acetylcysteine 100 mg; edetate disodium, dihydrate 0.25 mg.
mL of the 20% solution contains acetylcysteine 200 mg; edetate disodium, dihydrate
The solutions also contain sodium hydroxide
and may contain hydrochloric acid for pH adjustment, pH 7.0 (6.0 to 7.5).
Acetylcysteine Solution, USP is oxygen sensitive.
Acetylcysteine As A Mucolytic Agent
The viscosity of pulmonary mucous secretions depends on the
concentrations of mucoprotein and to a lesser extent deoxyribonucleic acid
(DNA). The latter increases with increasing purulence owing to the presence
of cellular debris. The mucolytic action of acetylcysteine is related to the
sulfhydryl group in the molecule. This group probably “opens”
disulfide linkages in mucous thereby lowering the viscosity. The mucolytic
activity of acetylcysteine is unaltered by the presence of DNA, and increases
with increasing pH. Significant mucolysis occurs between pH 7 and
Acetylcysteine undergoes rapid deacetylation in vivo to yield cysteine or oxidation to yield
Occasionally, patients exposed to the
inhalation of an acetylcysteine aerosol respond with the development of increased
airways obstruction of varying and unpredictable severity. Those patients
who are reactors cannot be identified a priori from a random patient population. Even when patients are known
to have reacted previously to the inhalation of an acetylcysteine aerosol,
they may not react during a subsequent treatment. The converse is also true;
patients who have had inhalation treatments of acetylcysteine without incident
may still react to a subsequent inhalation with increased airways obstruction.
Most patients with bronchospasm are quickly relieved by the use of a bronchodilator
given by nebulization. If bronchospasm progresses, the medication should be
INDICATIONS AND USAGE
Acetylcysteine is indicated as adjuvant therapy for patients
with abnormal, viscid, or inspissated mucous secretions in such conditions
Chronic bronchopulmonary disease
emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis,
bronchiectasis and primary amyloidosis of the lung)
(pneumonia, bronchitis, tracheobronchitis)
complications of cystic fibrosis
complications associated with surgery
Use during anesthesia
Atelectasis due to mucous obstruction
bronchial studies (bronchograms, bronchospirometry, and bronchial wedge catheterization)
Acetylcysteine is contraindicated in those patients who are
sensitive to it.
After proper administration of
acetylcysteine, an increased volume of liquified bronchial secretions may
occur. When cough is inadequate, the open airway must be maintained by mechanical
suction if necessary. When there is a mechanical block due to foreign body
or local accumulation, the airway should be cleared by endotracheal aspiration,
with or without bronchoscopy. Asthmatics under treatment with acetylcysteine
should be watched carefully. Most patients with bronchospasm are quickly relieved
by the use of a bronchodilator given by nebulization. If bronchospasm progresses,
this medication should be discontinued immediately.
With the administration of acetylcysteine, the patient may
initially notice a slight disagreeable odor that is soon noticeable. With
a face mask there may be a stickiness on the face after nebulization. This
is easily removed by washing with water.
conditions, a color change may occur in the solution of acetylcysteine in
the opened bottle. The light purple color is the result of a chemical reaction
which does not significantly affect the safety or mucolytic effectiveness
Continued nebulization of an acetylcysteine
solution with a dry gas will result in an increased concentration of the drug
in the nebulizer because of evaporation of the solvent. Extreme concentration
may impede nebulization and efficient delivery of the drug. Dilution of the
nebulizing solution with appropriate amounts of Sterile Water for Injection,
as a concentration occurs, will obviate this problem.
Drug stability and safety of acetylcysteine when mixed with
other drugs in a nebulizer have not been established.
Carcinogenesis, Mutagenesis, Impairment of Fertility
studies in laboratory animals have not been performed with acetylcysteine
alone, nor with acetylcysteine in combination with isoproterenol.
oral studies of acetylcysteine alone in rats (12 months of treatment followed
by 6 months of observation) at doses up to 1,000 mg/kg/day (5.2 times
the human mucolytic dose) provided no evidence of oncogenic activity.
data1 indicate that acetylcysteine is not mutagenic in the Ames
test, both with and without metabolic activation.
Impairment of Fertility
reproductive toxicity test to assess potential impairment of fertility was
performed with acetylcysteine (10%) combined with isoproterenol (0.05%) and
administered as an aerosol into a chamber of 12.43 cubic meters. The combination
was administered for 25, 30, or 35 minutes twice a day for 68 days before
mating, to 200 male and 150 female rats; no adverse effects were noted in
dams or pups. Females after mating were continued on treatment for the next
Reproductive toxicity studies of acetylcysteine
in the rat given oral doses of acetylcysteine up to 1,000 mg/kg (5.2 times
the human mucolytic dose) have also been reported in the literature1.
The only adverse effect observed was a slight non-dose-related reduction in
fertility at dose levels of 500 or 1,000 mg/kg/day (2.6 or 5.2 times the human
dose) in the Segment 1 study.
Teratogenic Effects: Pregnancy
In a teratology study of acetylcysteine
in the rabbit, oral doses of 500 mg/kg/day (2.6 times the human mucolytic
dose) were administered to pregnant does by intubation on days 6 through 16
of gestation. Acetylcysteine was found to be nonteratogenic under the conditions
In the rabbit, two groups (one of 14 and one
of 16 pregnant females) were exposed to an aerosol of 10% acetylcysteine and
0.05% isoproterenol hydrochloride for 30 or 35 minutes twice a day from the
6th through the 18th day of pregnancy. No teratogenic effects were observed
among the offspring.
Teratology and a perinatal and
postnatal toxicity study in rats were performed with a combination of acetylcysteine
and isoproterenol administered by the inhalation route. In the rat, two groups
of 25 pregnant females each were exposed to the aerosol for 30 and 35 minutes,
respectively, twice a day from the 6th through the 15th day of gestation.
No teratogenic effects were observed among the offspring.
the pregnant rat (30 rats per group), twice-daily exposure to an aerosol of
acetylcysteine and isoproterenol for 30 or 35 minutes from the 15th day of
gestation through the 21st day postpartum was without adverse effect on dams
Reproduction studies of acetylcysteinewith isoproterenol have been performed in rats and of acetylcysteine alone
in rabbits at doses up to 2.6 times the human dose. These have revealed no
evidence of impaired fertility or harm to the fetus due to acetylcysteine.
There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies may not always be predictive of human
responses, this drug should be used during pregnancy only if clearly needed.
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
when acetylcysteine is administered to a nursing woman.
Adverse effects have included stomatitis, nausea, vomiting,
fever, rhinorrhea, drowsiness, clamminess, chest tightness, and bronchoconstriction.
Clinically overt acetylcysteine induced bronchospasm occurs infrequently and
unpredictably even in patients with asthmatic bronchitis or bronchitis complicating
Acquired sensitization to acetylcysteine
have been reported rarely. Reports of sensitization in patients have not been
confirmed by patch testing. Sensitization has been confirmed in several inhalation
therapists who reported a history of dermal eruptions after frequent and extended
exposure to acetylcysteine.
Reports of irritation to
the tracheal and bronchial tracts have been received and although hemoptysis
has occurred in patients receiving acetylcysteine such findings are not uncommon
in patients with bronchopulmonary disease and a causal relationship has not
DOSAGE AND ADMINISTRATION
Solution 10% and 20% is available in glass vials containing 30 mL. The 20%
solution may be diluted to a lesser concentration with either Sodium Chloride
Inhalation Solution; Sodium Chloride Injection; or Sterile Water for Injection,
or Sterile Water for Inhalation. The 10% solution may be used undiluted.
Storage of Opened Vials
product does not contain an antimicrobial agent, and care must be taken to
minimize contamination of the sterile solution. If only a portion of the solution
in a vial is used, store the remainder in a refrigerator and use for inhalation
only within 96 hours.
Nebulization— Face Mask, Mouth Piece, Tracheostomy
nebulized into a face mask, mouth piece or tracheostomy, 1 to 10 mL of the
20% solution or 2 to 20 mL of the 10% solution may be given every 2 to 6 hours;
the recommended dose for most patients is 3 to 5 mL of the 20% solution or
6 to 10 mL of the 10% solution 3 to 4 times a day.
Nebulization — Tent, Croupette
special circumstances it may be necessary to nebulize into a tent or Croupette,
and this method of use must be individualized to take into account the available
equipment and the patient’s particular needs. This form of administration
requires very large volumes of the solution, occasionally as much as 300 mL
during a single treatment period.
If a tent or Croupette
must be used, the recommended dose is the volume of acetylcysteine (using
10% or 20%) that will maintain a very heavy mist in the tent or Croupette
for the desired period. Administration for intermittent or continuous prolonged
periods, including overnight, may be desirable.
used by direct instillation, 1 to 2 mL of a 10% or 20% solution may be given
as often as every hour.
When used for the routine nursing
care of patients with tracheostomy, 1 to 2 mL of a 10% to 20% solution may
be given every 1 to 4 hours by instillation into the tracheostomy.
may be introduced directly into a particular segment of the bronchopulmonary
tree by inserting (under local anesthesia and direct vision) a small plastic
catheter into the trachea. Two to 5 mL of the 20% solution may then be instilled
by means of a syringe connected to the catheter.
may also be given through a percutaneous intratracheal catheter. One to 2
mL of the 20% or 2 to 4 mL of the 10% solution every 1 to 4 hours may then
be given by a syringe attached to the catheter.
diagnostic bronchial studies, 2 or 3 administrations of 1 to 2 mL of the 20%
solution or 2 to 4 mL of the 10% solution should be given by nebulization
or by instillation intratracheally, prior to the procedure.
Administration of Aerosol
may be administered using conventional nebulizers made of plastic or glass.
Certain materials used in nebulization equipment react with acetylcysteine.
The most reactive of these are certain metals (notably iron and copper) and
rubber. Where material may come into contact with acetylcysteine solution,
parts made of the following acceptable materials should be used: glass, plastic,
aluminum, anodized aluminum, chromed metal, tantalum, sterling silver, or
stainless steel. Silver may become tarnished after exposure, but this is not
harmful to the drug action or to the patient.
tank gas (air) or an air compressor should be used to provide pressure for
nebulizing the solution. Oxygen may also be used but should be used with usual
precautions in patients with severe respiratory disease and CO2 retention.
is usually administered as fine nebulae, and the nebulizer used should be
capable of providing optimal quantities of a suitable range of particle sizes.
available nebulizers will produce nebulae of acetylcysteine satisfactory for
retention in the respiratory tract. Most of the nebulizers tested will supply
a high proportion of the drug solution as particles of less than 10 microns
in diameter. Mitchell2 has shown that particles less than 10 microns
should be retained in the respiratory tract satisfactorily.
intermittent positive pressure breathing devices nebulized acetylcysteine
with a satisfactory efficiency including: No: 40 De Vilbiss (The De Vilbiss
Co., Somerset, Pennsylvania) and the Bennett Twin-Jet Nebulizer (Puritan Bennett
Corp., Oak at 13th, Kansas City, Missouri).
solution may be inhaled directly from the nebulizer. Nebulizers may also be
attached to plastic face masks or plastic mouthpieces. Suitable nebulizers
may also be fitted for use with the various intermittent positive pressure
breathing (IPPB) machines. The nebulizing equipment should be cleaned immediately
after use because the residues may clog the smaller orifices or corrode metal
Hand bulbs are not recommended for routine use
for nebulizing acetylcysteine because their output is generally too small.
Also, some hand-operated nebulizers deliver particles that are larger than
optimum for inhalation therapy.
should not be placed directly into the chamber of a heated (hot pot) nebulizer. A heated nebulizer may be part of the nebulization assembly to
provide a warm saturated atmosphere if the acetylcysteine aerosol is introduced
by means of a separate unheated nebulizer. Usual precautions for administration
of warm saturated nebulae should be observed.
solution may be breathed directly from the nebulizer. Nebulizers may also
be attached to plastic face masks, plastic face tents, plastic mouth pieces,
conventional plastic oxygen tents, or head tents. Suitable nebulizers may
also be fitted for use with the various intermittent positive pressure breathing
The nebulizing equipment should be
cleaned immediately after use, otherwise the residues may occlude the fine
orifices or corrode metal parts.
When three-fourths of the initial
volume of acetylcysteine solution has been nebulized, a quantity of Sterile
Water for Injection (approximately equal to the volume of solution remaining),
should be added to the nebulizer. This obviates any concentration of the agent
in the residual solvent remaining after prolonged nebulization.
and chemical compatibility of acetylcysteine with certain other drugs that
might be concomitantly administered by nebulization, direct instillation,
or topical application, has been studied.
should not be mixed with certain antibiotics. For example, the antibiotics
tetracycline hydrochloride, oxytetracycline hydrochloride, and erythromycin
lactobionate were found to be incompatible when mixed in the same solution.
These agents may be administered from separate solutions if administration
of these agents is desirable.
The supplying of these
data should not be interpreted as a recommendation for combining acetylcysteine
with other drugs. The table is not presented as positive assurance that no
incompatibility will be present, since these data are based only on short-term
compatibility studies done in the Mead Johnson Research Center. Manufacturers
may change their formulations, and this could alter compatibilities. These
data are intended to serve only as a guide for
predicting compounding problems.
If it is deemed advisable
to prepare an admixture, it should be administered as soon as possible after
preparation. Do not store unused mixtures.
VITRO COMPATIBILITY1 TESTS OF
PRODUCT AND/OR AGENT
ANTIBACTERIALS (A parenteral form of each antibiotic was used)
Bacitracin2.3 (mix and use at once)
Chloramonenicol Sodium Succinate
(mix and use at once)
(mix and use at once)
Penicillin G Potassium2
(mix and use at once)
Polymyxin B Sulfate2
(mix and use at once)
13.3% (2 parts)
.33% (1 part)
13.3% (2 parts)
13.3% (2 parts)
.33% (1 part)
13.3% (2 parts)
.17% (1 part)
400 γ /mL
400 γ /mL
Dexamethasone Sodium Phosphate
Prednisolone Sodium Phosphate5
20% (1 part)
4.2% (1 part)
The rating, Incompatible,
is based on the formation of a precipitate, a change in clarity, immiscibility
or a rapid loss of potency of acetylcysteine or the active ingredient of the
PRODUCT AND/OR AGENT in the admixture.
The rating, Compatible, means that there was no significant
physical change in the admixture when compared with a control solution of
the PRODUCT AND/OR AGENT, and that there was no predicted chemical incompatibility.
All of the admixtures have been tested for short-term chemical compatibility
by assaying for the concentration of acetylcysteine after mixing.
The active ingredient in the PRODUCT AND/OR AGENT was also
assayed after mixing. Some of the admixtures developed minor physical changes
which were considered to be insufficient to rate the admixtures incompatible. These are listed in footnotes 3, 4, and 5.
A strong odor developed after storage for 24 hours at room
The admixture was a slightly darker shade of yellow than
a control solution of the PRODUCT AND/OR AGENT.
A light tan color developed after storage for 24 hours at
Entries are final concentrations. Values in parentheses relate
volumes of acetylcysteine solutions to volume of test solutions.
Acetylcysteine As An Antidote
For Acetaminophen Overdose
(Antidotal) Acetaminophen is rapidly absorbed from the upper
gastrointestinal tract with peak plasma levels occurring between 30 and 60
minutes after therapeutic doses and usually within 4 hours following
an overdose. The parent compound, which is nontoxic, extensively metabolized
in the liver to form principally the sulfate and glucuronide conjugates which
are also nontoxic and are rapidly excreted in the urine. A small fraction
of an ingested dose is metabolized in the liver by the cytochrome P-450 mixed
function oxidase enzyme system to form a reactive, potentially toxic, intermediate
metabolite which preferentially conjugates with hepatic glutathione to form
the nontoxic cysteine and mercapturic acid derivatives which are then excreted
by the kidney. Therapeutic doses of acetaminophen do not saturate the glucuronide
and sulfate conjugation pathways and do not result in the formation of sufficient
reactive metabolite to deplete glutathione stores. However, following ingestion
of a large overdose (150 mg/kg or greater) the glucuronide and sulfate conjugation
pathways are saturated resulting in a larger fraction of the drug being metabolized
via the P-450 pathway. The increased formation of reactive metabolite may
deplete the hepatic stores of glutathione with subsequent binding of the metabolite
to protein molecules within the hepatocyte resulting in cellular necrosis.
has been shown to reduce the extent of liver injury following acetaminophen
overdose. Its effectiveness depends on early administration, with benefit
seen principally in patients treated within 16 hours of the overdose. Acetylcysteine
probably protects the liver by maintaining or restoring the glutathione levels,
or by acting as an alternate substrate for conjugation with, and thus detoxification
of, the reactive metabolite.
INDICATIONS AND USAGE
Acetylcysteine, administered orally, is indicated as an antidote
to prevent or lessen hepatic injury which may occur following the ingestion
of a potentially hepatotoxic quantity of acetaminophen.
is essential to initiate treatment as soon as possible after the overdose
and, in any case, within 24 hours of ingestion.
There are no contraindications to oral administration of
acetylcysteine in the treatment of acetaminophen overdose.
Generalized urticaria has been observed rarely in patients
receiving oral acetylcysteine for acetaminophen overdose. If this occurs or
other allergic symptoms appear, treatment with acetylcysteine should be discontinued
unless it is deemed essential and the allergic symptoms can be otherwise controlled.
encephalopathy due to hepatic failure becomes evident, acetylcysteine treatment
should be discontinued to avoid further administration of nitrogenous substances.
There are no data indicating that acetylcysteine adversely influences hepatic
failure, but this remains a theoretical possibility.
Occasionally severe and persistent vomiting occurs as a symptom
of acute acetaminophen overdose. Treatment with oral acetylcysteine may aggravate
the vomiting. Patients at risk of gastric hemorrhage (e.g., esophageal varices,
peptic ulcers, etc.) should be evaluated concerning the risk of upper gastrointestinal
hemorrhage versus the risk of developing hepatic toxicity, and treatment with
acetylcysteine given accordingly.
Dilution of the acetylcysteine
(SEE PREPARATION OF ACETYLCYSTEINE FOR ORAL ADMINISTRATION) minimizes the
propensity of oral acetylcysteine to aggravate vomiting.
Oral administration of acetylcysteine, especially in the
large doses needed to treat acetaminophen overdose, may result in nausea,
vomiting and other gastrointestinal symptoms. Rash with or without mild fever
has been observed rarely.
DOSAGE AND ADMINISTRATION
of the quantity of acetaminophen reported to have been ingested, administer
acetylcysteine immediately if 24 hours or less have elapsed from the reported
time of ingestion of an overdose of acetaminophen. Do not await results of
assays for acetaminophen level before initiating treatment with acetylcysteine.
The following procedures are recommended:
The stomach should be emptied promptly by lavage or by inducing
emesis with syrup of ipecac. Syrup of ipecac should be given in a dose of
15 mL for children up to age 12, and 30 mL for adolescents and adults followed
immediately by drinking copious amounts of water. The dose should be repeated
if emesis does not occur in 20 minutes.
In the case of a mixed drug overdose activated charcoal may
be indicated. However, if activated charcoal has been administered, lavage
before administering acetylcysteine treatment. Activated charcoal adsorbs
acetylcysteine in vitro and may do
so in patients and thereby may reduce its effectiveness.
Draw blood for predetoxification acetaminophen plasma assay
and for baseline SGOT, SGPT, bilirubin, prothrombin time, creatinine, BUN,
blood sugar and electrolytes.
Administer the loading dose of acetylcysteine, 140 mg per
kg of body weight. (Prepare acetylcysteine for oral administration as described
in the Specific Dosage Guide and Preparation table.)
Determine subsequent action based on predetoxification plasma
acetaminophen information. Choose ONE of the following four courses of therapy.
Predetoxification plasma acetaminophen level is clearly in the toxic range
(See Acetaminophen Assays - Interpretation and Methodology below):
a first maintenance dose (70 mg/kg acetylcysteine) 4 hours after the loading
dose. The maintenence dose is then repeated at 4-hour intervals for a total
of 17 doses. Monitor hepatic and renal function and electrolytes throughout
the detoxification process.
B. Predetoxification acetaminophen
level could not be obtained:
Proceed as in A.
Predetoxification acetaminophen level is clearly in the nontoxic range (beneath
the dashed line on the nomogram) and you know that acetaminophen overdose
occured at least 4 hours before the predetoxification acetaminophen plasma
Discontinue administration of acetylcysteine.
Predetoxification acetaminophen level was in the non-toxic range, but time
of ingestion was unknown or less than 4 hours.
the level of acetaminophen at the time of the predetoxification assay may
not be a peak value (peak may not be achieved before 4 hours post-ingestion),
obtain a second plasma level in order to decide whether or not the full 17-dose
detoxification treatment is necessary.
If the patient vomits any oral dose within 1 hour of administration,
repeat that dose.
In the occasional instances where the patient is persistently
unable to retain the orally administered acetylcysteine, the antidote may
be administered by duodenal intubation.
Repeat SGOT, SGPT, bilirubin, prothrombin time, creatinine,
BUN, blood sugar and electrolytes daily if the acetaminophen plasma level
is in the potentially toxic range as discussed below.
Preparation of Acetylcysteine
For Oral Administration —Oral administration requires dilution
of the 20% solution with diet cola, or other diet soft drinks, to a final
concentration of 5% (see Dosage Guide and Preparation table). If administered
via gastric tube or Miller-Abbott tube, water may be used as the diluent.
The dilutions should be freshly prepared and utilized within one hour. Remaining
undiluted solutions in opened vials can be stored in the refrigerator up to
NOT APPROVED FOR PARENTERAL INJECTION.
Acetaminophen Assays — Interpretation and Methodology: The acute ingestion of acetaminophen in quantities of 150 mg/kg
or greater may result in hepatic toxicity. However, the reported history of
the quantity of a drug ingested as an overdose is often inaccurate and is
not a reliable guide to therapy of the overdose. THEREFORE,
PLASMA OR SERUM ACETAMINOPHEN CONCENTRATIONS, DETERMINED AS EARLY AS POSSIBLE,
BUT NO SOONER THAN FOUR HOURS FOLLOWING AN ACUTE OVERDOSE, ARE ESSENTIAL IN
ASSESSING THE POTENTIAL RISK OF HEPATOTOXICITY. IF AN ASSAY FOR ACETAMINOPHEN
CANNOT BE OBTAINED, IT IS NECESSARY TO ASSUME THAT THE OVERDOSE IS POTENTIALLY
of Acetaminophen Assays:
When results of the plasma acetaminophen assay are available
refer to the nomogram below to determine if plasma concentration is in the
potentially toxic range. Values above the solid line connecting 200 mcg/mL
at 4 hours with 50 mcg/mL at 12 hours are associated with a possibility of
hepatic toxicity if an antidote is not administered. (Do not wait for assay
results to begin acetylcysteine treatment.)
If the predetoxification plasma level is above the broken
line continue with maintenance doses of acetylcysteine. It is better to err
on the safe side and thus the broken line is placed 25% below the solid line
which defines possible toxicity.
If the predetoxification plasma level is below the broken
line described above, there is minimal risk of hepatic toxicity and acetylcysteine
treatment can be discontinued.
Acetaminophen Assay Methodology:
Assay procedures most suitable for determining
acetaminophen concentrations utilize high pressure liquid chromatography (HPLC)
or gas liquid chromatography (GLC). The assay should measure only parent acetaminophen
and not conjugated. The assay procedures listed below fulfill this requirement:
Selected techniques (non-inclusive)
Blair, D and Rumack, BH, Clin
Chem. 1977; 23(4):743−745.
Glynn, JP and Kendal, SE. Lancet 1975; 1(May 17):1147-1148.
SUPPORTIVE TREATMENT OF
Maintain fluid and electrolyte balance based on clinical
evaluation of state of hydration and serum electrolytes.
Treat as necessary for hypoglycemia.
Administer vitamin K1 if prothrombin time ratio
exceeds 1.5 or fresh frozen plasma if the prothrombin time ratio exceeds 3.0.
Diuretics and forced diuresis should be avoided (See table
on preceding page).
GUIDE AND PREPARATION
Doses in relation to body weight are:
Dose of Acetylcysteine**
90 − 99
80 − 89
70 − 79
60 − 69
50 − 59
40 − 49
30 − 39
66 − 86
20 − 29
44 − 64
90 − 99
80 − 89
70 − 79
60 − 69
50 − 59
40 − 49
30 − 39
66 − 86
20 − 29
44 − 64
**If patient weighs less than 20 kg (usually patients younger
than 6 years), calculate the doses of Acetylcysteine Solution. Each mL of
20% Acetylcysteine Solution, contains 200 mg of acetylcysteine. The loading
dose is 140 mg per kilogram of body weight. The maintenance dose is 70 mg/kg.
Three (3) mL of diluent are added to each mL of 20% Acetylcysteine Solution.
Do not decrease the proportion of diluent.
Estimating Potential for Hepatotoxicity:
following nomogram has been developed to estimate the probability that plasma
levels in relation to intervals post ingestion will result in hepatotoxicity.
from Rumack and Matthews, Pediatrics 1975;
Acetylcysteine Solution, USP is supplied in teartop vials
Cartons of 3
Cartons of 3
The 20% solution may be diluted to a lesser concentration
with either Sodium Chloride for Injection, Sodium Chloride for Inhalation,
Sterile Water for Injection, or Sterile Water for Inhalation. The 10% solution
may be used undiluted.
Store at 20 to 25°C (68
to 77°F). [See USP Controlled Room Temperature.]
in refrigerator 2° to 8°C (36° to 46°F) after opening.
Discard opened vial after 96 hours.
does not contain an antimicrobial agent, and care must be taken to minimize
contamination of the sterile solution. Dilutions of acetylcysteine should
be used freshly prepared and utilized within one hour. If only a portion of
the solution in a vial is used, store the remaining undiluted portion in a
refrigerator and use within 96 hours.
A change in color
may occur after opening; this does not change the efficacy of the drug.
Bonanomi L, Gazzaniga A. Toxicological, pharmacokinetic and
metabolic studies on acetylcysteine. Eur J Respir
Dis 1981; 61(suppl 111):45−51.