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Claims for Patent: 8,722,738

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Claims for Patent: 8,722,738

Title:Acetycysteine 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.
Inventor(s): Pavliv; Leo (Cary, NC), Rock; Amy (Thompsons Station, TN)
Assignee: Cumberland Pharmaceuticals, Inc. (Nashville, TN)
Application Number:13/188,152
Patent Claims: 1. A method of treating acetaminophen overdose-induced liver injury, comprising intravenously administering an acetylcysteine composition to a patient in need thereof via a 2-bag infusion regimen comprising: administering a first dosage of 50 mg/kg of acetylcysteine per hour for 4 hours followed by administering a second dosage of 100 mg/kg of acetylcysteine over 16 hours.

2. The method of claim 1, 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.

3. The method of claim 1, further comprising intravenously administering to the patient a third dose of 100 mg/kg of acetylcysteine over 16 hours following the second dose.

4. The method of claim 1, further comprising intravenously administering to the patient 6.25 mg/kg of acetylcysteine per hour following the second dose.

5. The method of claim 2, wherein clinically significant improvement in liver function is determined by the ALT level of the patient.

6. The method of claim 1, further comprising repeating the 2-bag infusion regimen following the second dose.

7. The method of claim 1, wherein the acetylcysteine composition contains less than 0.05% EDTA.

8. The method of claim 1, wherein the acetylcysteine composition contains less than 0.05% chelating agents.

9. The method of claim 1, wherein the acetylcysteine composition is prepared 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.

10. The method of claim 2, wherein clinically significant improvement in liver function is determined by the AST level of the patient.

11. The method of claim 1, wherein the patient is in liver failure.

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: administering a first dosage of 50 mg/kg of acetylcysteine per hour for 4 hours followed by administering a second dosage of 100 mg/kg of acetylcysteine 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 100 mg/kg of acetylcysteine over 16 hours following the second dose.

15. The method of claim 12, further comprising intravenously administering to the patient 6.25 mg/kg of acetylcysteine per hour following the second dose.

16. The method of claim 13, wherein clinically significant improvement in liver function is determined by the ALT level of the patient.

17. The method of claim 12, further comprising intravenously administering to the patient following the second dose a third dose of 200 mg/kg of acetylcysteine over 4 hours, followed by a fourth dose of 100 mg/kg of acetylcysteine over 16 hours.

18. The method of claim 12, further comprising repeating the 2-bag infusion regimen following the second dose.

19. The method of claim 12, wherein the acetylcysteine composition contains less than 0.05% EDTA.

20. The method of claim 12, wherein the acetylcysteine composition contains less than 0.05% chelating agents.

21. The method of claim 12, wherein the acetylcysteine composition is prepared 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.
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