ACETYLCYSTEINE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC)

Available from:

Hospira, Inc.

INN (International Name):

ACETYLCYSTEINE

Composition:

ACETYLCYSTEINE 100 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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) Acetylcysteine is contraindicated in those patients who are sensitive to it. 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. It is essential to initiate treatment as soon as

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETYLCYSTEINE- ACETYLCYSTEINE SOLUTION
HOSPIRA, INC.
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ACETYLCYSTEINE SOLUTION, USP
10% AND 20%
TEARTOP VIALS
_WARNING: NOT FOR INJECTION_
RX ONLY
_DESCRIPTION_
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
_CLINICAL PHARMACOLOGY_
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. Ev