Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1321
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Acetylcysteine (Solution)
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General Acetylcysteine
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 This
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 When
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 In
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. Direct Instillation When
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. Acetylcysteine
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. Acetylcysteine
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 Bronchograms For
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 Materials Acetylcysteine
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. Nebulizing Gases Compressed
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 COretention. Apparatus Acetylcysteine
is usually administered as fine nebulae, and the nebulizer used should be
capable of providing optimal quantities of a suitable range of particle sizes. Commercially
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. Mitchellhas shown that particles less than 10 microns
should be retained in the respiratory tract satisfactorily. Various
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). The nebulized
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
parts. 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. Acetylcysteine
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. The nebulized
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
(IPPB) machines. The nebulizing equipment should be
cleaned immediately after use, otherwise the residues may occlude the fine
orifices or corrode metal parts. Prolonged
Nebulization 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. Compatibility The physical
and chemical compatibility of acetylcysteine with certain other drugs that
might be concomitantly administered by nebulization, direct instillation,
or topical application, has been studied. Acetylcysteine
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. Acetylcysteine As An Antidote
For Acetaminophen Overdose
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Acetylcysteine solution is for inhalation (mucolytic agent)
or oral administration (acetaminophen antidote), and available as sterile,
unpreserved solutions (not for injection). Acetylcysteine
is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine.
Chemically, it is N-acetyl-L-cysteine. The compound
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: Molecular
weight: 163.19 Each mL of the 10% solution contains
acetylcysteine 100 mg; edetate disodium, dihydrate 0.25 mg. Each
mL of the 20% solution contains acetylcysteine 200 mg; edetate disodium, dihydrate
0.5 mg. 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
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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
9. Acetylcysteine undergoes rapid deacetylation in vivo to yield cysteine or oxidation to yield
diacetylcystine. 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
discontinued immediately.
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Acetylcysteine is contraindicated in those patients who are
sensitive to it.
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Acetylcysteine Solution, USP is supplied in teartop vials
as follows: 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.] Store
in refrigerator 2��to 8��C (36��to 46��F) after opening.
Discard opened vial after 96 hours. Acetylcysteine solution
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.
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General: 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. Under certain
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
of acetylcysteine. 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.<br/>Drug Interactions: Drug stability and safety of acetylcysteine when mixed with
other drugs in a nebulizer have not been established.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis Carcinogenicity
studies in laboratory animals have not been performed with acetylcysteine
alone, nor with acetylcysteine in combination with isoproterenol. Long-term
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. Mutagenesis Published
dataindicate that acetylcysteine is not mutagenic in the Ames
test, both with and without metabolic activation. Impairment of Fertility A
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 aftermating were continued on treatment for the next
42 days. 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 literature.
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.<br/>Pregnancy:: Teratogenic Effects: Pregnancy
Category B 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
of study. 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. In
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
or newborns. 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.<br/>Nursing Mothers: 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.
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Acetylcysteine
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Acetylcysteine (Solution)
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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
bronchial asthma. 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
been established.
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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.
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Acetylcysteine is indicated as adjuvant therapy for patients
with abnormal, viscid, or inspissated mucous secretions in such conditions
as: Chronic bronchopulmonary disease (chronic
emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis,
bronchiectasis and primary amyloidosis of the lung) Acute
bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis) Pulmonary
complications of cystic fibrosis Tracheostomy care Pulmonary
complications associated with surgery Use during anesthesia Post-traumatic
chest conditions Atelectasis due to mucous obstruction Diagnostic
bronchial studies (bronchograms, bronchospirometry, and bronchial wedge catheterization)
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Acetylcysteine
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