देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC)
Hospira, Inc.
ACETYLCYSTEINE
ACETYLCYSTEINE 100 mg in 1 mL
ORAL
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
Acetylcysteine Solution, USP is supplied in teartop vials as follows: 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. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Store in refrigerator 2° to 8°C (36° to 46°F) after opening. Discard opened vial after 96 hours. Acetylcysteine solution 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. A change in color may occur after opening; this does not change the efficacy of the drug.
Abbreviated New Drug Application
ACETYLCYSTEINE- ACETYLCYSTEINE SOLUTION HOSPIRA, INC. ---------- ACETYLCYSTEINE SOLUTION, USP 10% AND 20% TEARTOP VIALS _WARNING: NOT FOR INJECTION_ RX ONLY _DESCRIPTION_ Acetylcysteine solution is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), and available as sterile, unpreserved solutions (not for injection). Acetylcysteine is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. Chemically, it is N-acetyl-L-cysteine. The compound is a white crystalline powder which melts at 104°−110°C and has a very slight odor. The structural formula for acetylcysteine is as follows: Molecular weight: 163.19 Each mL of the 10% solution contains acetylcysteine 100 mg; edetate disodium, dihydrate 0.25 mg. Each mL of the 20% solution contains acetylcysteine 200 mg; edetate disodium, dihydrate 0.5 mg. The solutions also contain sodium hydroxide and may contain hydrochloric acid for pH adjustment, pH 7.0 (6.0 to 7.5). Acetylcysteine Solution, USP is oxygen sensitive. 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 mucous 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. Ev पूरा दस्तावेज़ पढ़ें