How is Acetylcysteine Solutionsupplied?

Acetylcysteine Solution, USP (n-acetyl-l-cysteine) , is available in rubber stopped glass vials containing 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. Acetycysteine is sterile, not for injection and can be used for inhalation (mucolytic agent) or oral administration (acetaminophen antidote). It is available as follows: 10% Acetylcysteine Solution, USP (n-acetyl-l-cysteine) (100 mg acetylcysteine per mL). NDC 0054-3027-02....................................10 mL vials; carton of 3
NDC 0054-3025-02....................................30 mL vials; carton of 3 20% Acetylcysteine Solution, USP (n-acetyl-l-cysteine) (200 mg acetylcysteine per mL). NDC 0054-3028-02.....................................10 mL vials; carton of 3
NDC 0054-3026-02.....................................30 mL vials; carton of 3 Store unopened vials at controlled room temperature, 15° to 30°C (59° to 86°F). Acetylcysteine Solution, USP (n-acetyl-l-cysteine) 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. REFERENCES 1. Bonanomi L, Gazzaniga A. Toxicological pharmacokinetic and metabolic studies on acetylcysteine. Eur J Respir Dis 1981 61 (Suppl III):45-51. 2. Amer Rev Resp Dis 1960 82:627-639. Mfd. by Ben Venue Laboratories, Inc., Bedford, Ohio 44146. Revised March 2007. Mfd. for Boehringer Ingelheim Roxane Laboratories. FDA Rev date: 8/28/2000 Last reviewed on RxList: 5/29/2008
This monograph has been modified to include the generic and brand name in many instances.

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