ACETYLCYSTEINE inhalant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Regent, Inc.

INN (International Name):

ACETYLCYSTEINE

Composition:

ACETYLCYSTEINE 100 mg in 1 mL

Administration route:

RESPIRATORY (INHALATION)

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 po

Product summary:

Acetylcysteine is available in rubber stoppered glass vials containing 4, 10, or 30 mL. 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. Acetylcysteine solution is sterile and can be used for inhalation (mucolytic agent) or oral administration (acetaminophen antidote). Acetylcysteine solution is not for parenteral injection.  It is available as: Acetylcysteine 20% solution (200 mg acetylcysteine per mL). Sterile, not for injection. NDC 0517-7604-25           Cartons of twenty-five 4 mL vials NDC 0517-7610-03           Cartons of three 10 mL vials, plastic dropper NDC 0517-7630-03           Cartons of three 30 mL vials Acetylcysteine 10% solution (100 mg acetylcysteine per mL). Sterile, not for injection. NDC 0517-7504-25           Cartons of twenty-five 4 mL vials NDC 0517-7510-03           Cartons of three 10 mL vials, plastic dropper

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETYLCYSTEINE- ACETYLCYSTEINE INHALANT
AMERICAN REGENT, INC.
----------
ACETYLCYSTEINE SOLUTION, USP
STERILE
NOT FOR INJECTION
DESCRIPTION
Acetylcysteine is for inhalation (mucolytic agent) or oral
administration (acetaminophen antidote),
available as a sterile, unpreserved solution (NOT FOR INJECTION). The
solutions contain 20% (200
mg/mL) or 10% (100 mg/mL) acetylcysteine, with disodium edetate in
water for injection. Sodium
hydroxide and/or hydrochloric acid is added to adjust pH (range 6.0 -
7.5). Acetylcysteine is the N-
acetyl derivative of the naturally-occurring amino acid, L-cysteine.
The compound is a white crystalline
powder with the molecular formula C H NO S, a molecular weight of
163.2, and chemical name of N-
acetyl-L-cysteine. Acetylcysteine has the following structural
formula:
This product contains the following inactive ingredients:
disodium edetate, sodium hydroxide and water for injection.
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 mucus 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 ae