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Claims for Patent: 9,327,028

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Claims for Patent: 9,327,028

Title: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.
Inventor(s): Pavliv; Leo (Cary, NC), Rock; Amy (Thompsons Station, TN)
Assignee: Cumberland Pharmaceuticals, Inc. (Nashville, TN)
Application Number:14/225,345
Patent Claims: 1. A method of treating acetaminophen overdose in a patient, comprising: intravenously administering an acetylcysteine composition to the patient at a dosage of 300 mg/kg acetylcysteine over 20 or 21 hours; measuring the level of AST or ALT in the patient following the administration of 300 mg/kg acetylcysteine, determining whether acetylcysteine therapy should be continued based on the outcome of the AST or ALT level measurement, continuing the administration of the acetylcysteine composition to the patient via a 3-bag infusion regimen; wherein the continued administration comprises a first dosage of 150 mg/kg of acetylcysteine over 60 minutes, followed by a second dosage of 50 mg/kg of acetylcysteine over 4 hours, followed by a third dosage of 100 mg/kg of acetylcysteine over 16 hours.

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

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

4. The method of claim 1, wherein the acetylcysteine composition is prepared in an aqueous solution of 5% dextrose, 0.45% sodium chloride, 0.90% sodium chloride, or water for injection prior to administration.

5. The method of claim 1, wherein the 300 mg/kg of acetylcysteine is administered via a 2-bag infusion regimen comprising administering a first dosage of 200 mg/kg of acetylcysteine over 4 hours, followed by a second dosage of 100 mg/kg of acetylcysteine over 16 hours.

6. The method of claim 1, wherein the 300 mg/kg of acetylcysteine is administered via a 3-bag infusion regimen comprising administering a first dosage of 150 mg/kg of acetylcysteine over 60 minutes, followed by a second dosage of 50 mg/kg of acetylcysteine over 4 hours, followed by a third dosage of 100 mg/kg of acetylcysteine over 16 hours.

7. A method of treating acetaminophen overdose, comprising: intravenously administering an acetylcysteine composition to a patient in need thereof at a dosage of 300 mg/kg acetylcysteine over 20 or 21 hours; and continuing the administration of the acetylcysteine composition to the patient via a 3-bag infusion regimen, wherein the continued administration comprises a first dosage of 150 mg/kg of acetylcysteine over 60 minutes, followed by a second dosage of 50 mg/kg of acetylcysteine over 4 hours, followed by a third dosage of 100 mg/kg of acetylcysteine over 16 hours.

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

9. The method of claim 7, wherein the acetylcysteine composition contains less than 0.05% chelating agents.

10. The method of claim 7, wherein the 300 mg/kg of acetylcysteine is administered via a 2-bag infusion regimen comprising administering a first dosage of 200 mg/kg of acetylcysteine over 4 hours, followed by a second dosage of 100 mg/kg of acetylcysteine over 16 hours.

11. The method of claim 7, wherein the 300 mg/kg of acetylcysteine is administered via a 3-bag infusion regimen comprising administering a first dosage of 150 mg/kg of acetylcysteine over 60 minutes, followed by a second dosage of 50 mg/kg of acetylcysteine over 4 hours, followed by a third dosage of 100 mg/kg of acetylcysteine over 16 hours.
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