ACETYLCYSTEINE- acetylcysteine solution solution

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Exela Pharma Sciences, LLC

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Acetylcysteine solution, USP is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as: 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 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.

Резиме производа:

Acetylcysteine Solution, USP is available in rubber stoppered glass vials containing 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. Acetylcysteine is sterile, not for injection 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 Solution, USP 20% (200 mg acetylcysteine per mL). Sterile, not for injection. NDC 51754-0105-8        Cartons of three 30 mL vials

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

ACETYLCYSTEINE- ACETYLCYSTEINE SOLUTION SOLUTION
EXELA PHARMA SCIENCES, LLC
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ACETYLCYSTEINE SOLUTION, USP 20% (200 MG/ML) STERILE, NOT FOR
INJECTION
DESCRIPTION
Acetylcysteine solution, USP is for inhalation (mucolytic agent) or
oral administration
(acetaminophen antidote), available as a sterile, unpreserved solution
(NOT FOR
INJECTION). The solution contains 20% (200 mg/mL) acetylcysteine, with
disodium
edetate in water for injection. The solution also contains sodium
hydroxide and may
contain hydrochloric acid 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
5
9
3
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