Acetylcysteine Compositions and Methods of use Thereof

Abstract

A pharmaceutical composition and method for providing a reduction in side effects for human patients in need of therapy comprising the administration of a pharmaceutical composition comprising acetylcysteine is disclosed.

1 - 11 . (canceled) 
     
     
         12 . A method of treating acetaminophen overdose, comprising intravenously administering an acetylcysteine composition to a patient in need thereof via a 2-bag infusion regimen comprising a first dose of 200 mg/kg administered over from 3 to 5 hours followed by a second dose of 100 mg/kg over 16 hours. 
     
     
         13 . The method of  claim 12 , further comprising determining if the patient has achieved clinically significant improvement in liver function over the course of the 2-bag infusion regimen, and continuing the administration of acetylcysteine to the patient beyond 21 hours where the patient has not achieved clinically significant improvement in liver function. 
     
     
         14 . The method of  claim 12 , further comprising intravenously administering to the patient a third-dose of the acetylcysteine composition of 100 mg/kg over 16 hours following the second dose. 
     
     
         15 . The method of  claim 12 , further comprising intravenously administering to the patient the acetylcysteine composition at 6.25 mg/kg per hour following the second dose. 
     
     
         16 - 28 . (canceled) 
     
     
         29 . The method of  claim 13 , wherein clinically significant improvement in liver function is determined by the ALT level of the patient. 
     
     
         30 . The method of  claim 12 , further comprising intravenously administering to the patient following the second dose a third dose of the acetylcysteine composition of 200 mg/kg over 4 hours, followed by a fourth dose of the acetylcysteine composition of 100 mg/kg over 16 hours. 
     
     
         31 . The method of  claim 12 , further comprising repeating the 2-bag infusion regimen following the second dose. 
     
     
         32 . The method of  claim 12 , wherein the acetylcysteine composition contains less than 0.05% EDTA. 
     
     
         32 . The method of  claim 12 , wherein the acetylcysteine composition contains less than 0.05% chelating agents. 
     
     
         33 . The method of  claim 12 , further comprising diluting the acetylcysteine composition in an aqueous solution of at least one of 5% dextrose, 0.45% sodium chloride, 0.90% sodium chloride, and water for injection prior to administration. 
     
     
         34 . A method of treating acetaminophen overdose, comprising:
 intravenously administering 300 mg/kg of an acetylcysteine composition to a patient in need thereof;   determining if the patient has achieved clinically significant improvement in liver function over the course of the treatment; and   continuing the administration of the acetylcysteine composition to the patient beyond 21 hours where the patient has not achieved clinically significant improvement in liver function.   
     
     
         35 . The method of  claim 34 , wherein the continued administration comprises intravenously administering 100 mg/kg over 16 hours. 
     
     
         36 . The method of  claim 34 , wherein the continued administration comprises intravenously administering 6.25 mg/kg per hour. 
     
     
         37 . The method of  claim 34 , wherein clinically significant improvement in liver function is determined by the ALT level of the patient. 
     
     
         38 . The method of  claim 34 , wherein the continued administration comprises a first dose of 200 mg/kg over 3 to 5 hours, followed by a second dose of 100 mg/kg over 16 hours. 
     
     
         39 . The method of  claim 34 , wherein the acetylcysteine composition contains less than 0.05% EDTA. 
     
     
         40 . The method of  claim 34 , wherein the acetylcysteine composition contains less than 0.05% chelating agents. 
     
     
         41 . The method of  claim 34 , further comprising diluting the acetylcysteine composition in an aqueous solution of at least one of 5% dextrose, 0.45% sodium chloride, 0.90% sodium chloride, and water for injection prior to administration. 
     
     
         42 . The method of  claim 34 , wherein the 300 mg/kg of an acetylcysteine composition is administered as a dose of 200 mg/kg over 3 to 5 hours, followed by a second dose of 100 mg/kg over 16 hours. 
     
     
         43 . The method of  claim 34 , wherein the 300 mg/kg of an acetylcysteine composition is administered as a dose of 150 mg/kg over 60 minutes, followed by a second dose of 50 mg/kg over 4 hours, followed by a third dose of 100 mg/kg over 16 hours. 
     
     
         44 . The method of  claim 34 , wherein clinically significant improvement in liver function is determined by the AST level of the patient. 
     
     
         45 . The method of  claim 13 , wherein clinically significant improvement in liver function is determined by the AST level of the patient. 
     
     
         46 . The method of  claim 12 , wherein the first dose is administered over 4 hours. 
     
     
         47 . The method of  claim 12 , wherein the first dose is administered over 3 hours. 
     
     
         48 . The method of  claim 12 , wherein the first dose is administered over 5 hours.