REDUCED DOSE INTRAVENOUS ACETAMINOPHEN

• US 20180256523A1
• Filed: 05/14/2018
• Published: 09/13/2018
• Est. Priority Date: 11/13/2007
• Status: Active Grant

• Current Assignee: Mallinckrodt Hospital Products IP Ltd. (Mallinckrodt plc)
• Original Assignee: Mallinckrodt Ip (Mallinckrodt plc)
• Inventors: Royal, Mike Allan, Breitmeyer, James Bradley
• Granted Patent: US 10,383,834 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/18 Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
• CPC Class Codes: A61K 47/20 containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
• CPC Class Codes: A61K 47/22 Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

Described herein are compositions and methods for intravenous administration of acetaminophen at a single dose level of less than about 1000 mg for the treatment or prevention of pain (e.g., postoperative pain) and/or fever.

Claims

1-55. -55. (canceled)

56. A method of treating pain in a human subject weighing at least 50 kg comprising:

administering to the subject an intravenous acetaminophen formulation comprising about 650 mg of acetaminophen; and

repeating the administration of the intravenous acetaminophen formulation every four hours;

wherein the subject receives a maximum daily dose of less than 4000 mg of acetaminophen per day.

57. The method of claim 56, wherein intravenous acetaminophen formulation is a sterile solution.

58. The method of claim 56, wherein intravenous acetaminophen formulation can be stored at a temperature of less than 30 degrees Celsius for up to two years prior to administration.

59. The method of claim 56, wherein the intravenous acetaminophen formulation is administered to the subject over about 5 minutes to about 30 minutes.

60. The method of claim 56, wherein the intravenous acetaminophen formulation is administered to the subject over about 15 minutes.

61. The method of claim 56, wherein the subject is suffering from acute pain.

62. The method of claim 56, wherein the subject is suffering from postoperative pain.

63. The method of claim 56, wherein the intravenous acetaminophen formulation is a lyophilized powder that is reconstituted prior to administration to the subject.

64. A method of treating fever in a human subject weighing at least 50 kg comprising:

administering to the subject an intravenous acetaminophen formulation comprising about 650 mg of acetaminophen; and

repeating the administration of the intravenous acetaminophen formulation every four hours;

wherein the subject receives a maximum daily dose of less than 4000 mg of acetaminophen per day.

65. The method of claim 64, wherein intravenous acetaminophen formulation is a sterile solution.

66. The method of claim 64, wherein intravenous acetaminophen formulation can be stored at a temperature of less than 30 degrees Celsius for up to two years prior to administration.

67. The method of claim 64, wherein the intravenous acetaminophen formulation is administered to the subject over about 5 minutes to about 30 minutes.

68. The method of claim 64, wherein the intravenous acetaminophen formulation is administered to the subject over about 15 minutes.

69. The method of claim 64, wherein the intravenous acetaminophen formulation is a lyophilized powder that is reconstituted prior to administration to the subject.