Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC)
American Regent, Inc.
ACETYLCYSTEINE
ACETYLCYSTEINE 100 mg in 1 mL
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
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 Прочитајте комплетан документ