ACETYLCYSTEINE inhalant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

acetylcysteine (UNII: WYQ7N0BPYC) (acetylcysteine - UNII:WYQ7N0BPYC)

Available from:

Cardinal Health 107, LLC

INN (International Name):

acetylcysteine

Composition:

acetylcysteine 200 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 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.

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 55154-5731-5           Overbagged with five 4 mL vials Acetylcysteine 10% solution (100 mg acetylcysteine per mL). Sterile, not for injection. NDC 55154-5730-5           Overbagged with five 4 mL vials

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETYLCYSTEINE- ACETYLCYSTEINE INHALANT
CARDINAL HEALTH 107, LLC
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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.
5
9
3
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 acetylcy