ACETYLCYSTEINE solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Fresenius Kabi USA, LLC

INN (International Name):

ACETYLCYSTEINE

Sammensætning:

ACETYLCYSTEINE 100 mg in 1 mL

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Acetylcysteine Solution, USP 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 Solution, USP 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 trea

Produkt oversigt:

Acetylcysteine Solution, USP 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 is sterile, not for injection and can be used for inhalation (mucolytic agent) or oral administration (acetaminophen antidote). It is available as follows: Acetylcysteine 10% solution (100 mg acetylcysteine per mL). Sterile, not for injection. Product No. NDC No. Strength Acetylcysteine 20% solution (200 mg acetylcysteine per mL). Sterile, not for injection. Product No. NDC No. Strength STORAGE: Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (see USP Controlled Room Temperature). Store in refrigerator 2° - 8°C (36° - 46°F) after opening. Acetylcysteine 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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

ACETYLCYSTEINE- ACETYLCYSTEINE SOLUTION
FRESENIUS KABI USA, LLC
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ACETYLCYSTEINE
_SOLUTION, USP_
Sterile, Not For Injection
PRESERVATIVE FREE
DESCRIPTION:
Acetylcysteine Solution, USP 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 purified water. Sodium
hydroxide and/or
hydrochloric acid is added to adjust pH (range 6.0 to 7.5).
Acetylcysteine is the N-acetyl
derivative of the naturally-occurring amino acid, 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, purified water, and hydrochloric acid, if necessary.
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 re