IP Library Granted Patent US 9,327,028
Granted Patent B2
US 9,327,028 · App. 14/225,345 · Granted May 3, 2016

Acetylcysteine compositions and methods of use thereof

Inventors: Leo Pavliv (Cary, NC); Amy Rock (Thompsons Station, TN)
Assignee: Cumberland Pharmaceuticals, Inc.
A61K47/02A61K9/0019A61K31/197A61K31/198
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Quick Facts
Patent No.
US 9,327,028
App. No.
14/225,345
Granted
May 3, 2016
Kind
B2
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.

Claims (18)

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.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 25, 2026
From: CUMBERLAND PHARMACEUTICALS INC.
To: APOTEX CORP.
Reel/Frame 075763/0709 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 18, 2014
From: PAVLIV, LEO; ROCK, AMY
To: CUMBERLAND PHARMACEUTICALS, INC.
Reel/Frame 032706/0947 →
Continuity (3)
Division 13188152 · Jul 21, 2011
Provisional Application 61366439 · Jul 21, 2010
Related Publication 20140206765A1 · Jul 24, 2014