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US-20260124196-A1 - LEVOCETIRIZINE AND MONTELUKAST IN THE TREATMENT OF SEPSIS AND SYMPTOMS THEREOF

US20260124196A1US 20260124196 A1US20260124196 A1US 20260124196A1US-20260124196-A1

Abstract

Certain embodiments described herein include methods and formulations for treating or preventing symptoms and conditions associated with sepsis. The methods and formulations include, but are not limited to, methods and formulations for delivering effective concentrations of levocetirizine and montelukast to a patient in need. The methods and formulations can comprise conventional and/or modified-release elements, providing for drug delivery to the patient.

Inventors

  • Bruce Chandler May

Assignees

  • IRR, Inc.

Dates

Publication Date
20260507
Application Date
20260105

Claims (19)

  1. 1 . A method of treating a patient with an infection, the method comprising administering to the patient an effective amount of a combination of levocetirizine and montelukast, wherein the patient is at risk of developing sepsis or septic shock from the infection.
  2. 2 . The method of claim 1 , wherein the infection is a viral infection.
  3. 3 . The method of claim 2 , wherein the viral infection is rhinovirus, coronavirus, influenza, human parainfluenza virus, human respiratory syncytial virus, adenovirus, enterovirus, metapneumovirus or Epstein Barr virus.
  4. 4 . The method of claim 1 , wherein the infection is a bacterial infection.
  5. 5 . The method of claim 4 , wherein the bacterial infection is caused at least in part from one or more of Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus , other streptococci species, anaerobic bacteria, or gram negative bacteria.
  6. 6 . The method of claim 1 , wherein the infection is a lung infection; appendicitis; an infection of the abdomen; an infection of the thin layer of tissue that lines the inside of the abdomen; an infection of the bladder, urethra, or kidneys; a urinary tract infection; an infection of the gallbladder or bile duct; a skin infection; an infection from an indwelling catheter or device; an infection following surgery; an infection of the brain or nervous system; a flu; a bone infection; or a cardiac infection.
  7. 7 . The method of claim 1 , wherein the patient has undergone surgery, and the infection is an infection following surgery.
  8. 8 . The method of claim 1 , wherein the method causes a decrease in severity in the signs or symptoms of sepsis including one or more of fever, mental confusion, diminished urine output, inadequate blood flow, nausea, vomiting, abdominal guarding, rebound pain upon removal of pressure from the abdomen, silent abdomen, pain, redness of the skin, oliguria, coagulopathy, tachycardia, rigors, myalgia, productive cough, tachypnea, sweats, dyspnea, cellulitis, borborygmus, loose stools, hemorrhagic colitis, pyelonephritis, pneumonia, obtundation, inflammation of the abdominal cavity lining, infection of the bile duct, intestinal infarction, petechiae, purpura, purpura fulminans, malaise, myalgia, arthralgia, headache, chills, rapid heart rate or rapid breathing.
  9. 9 . The method of claim 1 , wherein the method decreases hypotension.
  10. 10 . The method of claim 1 , wherein the patient is suffering from multiple organ dysfunction syndrome and/or treatment decreases mortality associated with multiple organ dysfunction syndrome.
  11. 11 . The method of claim 1 , wherein the method decreases coagulopathy.
  12. 12 . The method of claim 1 , wherein the combination of levocetirizine and montelukast is administered in a sequential manner.
  13. 13 . The method of claim 1 , wherein the combination of levocetirizine and montelukast is administered in a substantially simultaneous manner.
  14. 14 . The method of claim 1 , wherein the combination is administered to the patient by one or more of the routes consisting of enteral, intravenous, intraperitoneal, inhalation, intramuscular, subcutaneous and oral.
  15. 15 . The method of claim 1 , wherein the levocetirizine and montelukast are administered by the same route.
  16. 16 . The method of claim 1 , wherein the levocetirizine and montelukast are administered by different routes.
  17. 17 . The method of claim 1 , wherein the levocetirizine and/or the montelukast are provided as a slow release composition.
  18. 18 . The method of claim 1 , wherein the method further comprises administering to the patient an effective amount of one or more additional medications known for use in treating complications associated with sepsis.
  19. 19 . The method of claim 1 , wherein the method further comprises administering to the patient a steroid.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 17/925,798, filed Nov. 16, 2022, which is a U.S. national stage application of International Application No. PCT/US2021/032766, filed May 17, 2021, which claims the benefit of priority to U.S. Provisional Patent Application No. 63/026,983, filed May 19, 2020, the entirety of which is hereby incorporated by reference herein. FIELD The disclosure generally relates to treating sepsis patients with the combination of levocetirizine and montelukast. BACKGROUND Sepsis is a life-threatening condition that arises when a dysregulated host response to infection causes injury to its own tissues and organs. SUMMARY Embodiments of compositions for treating a patient suffering from sepsis or a symptom thereof are disclosed. In some embodiments, the method comprises administering to the patient an effective amount of a combination of levocetirizine and montelukast. In some embodiments, the treatment causes a decrease in severity of the signs (objective) or symptoms (subjective) of sepsis including one or more of fever, mental confusion, diminished urine output, inadequate blood flow, thrombocytopenia, nausea and/or vomiting, abdominal guarding, rebound pain upon removal of pressure from the abdomen, silent abdomen, pain, redness of the skin, oliguria, coagulopathy, tachycardia, rigors, myalgia, productive cough, tachypnoea, sweats, dyspnea, cellulitis, borborygmus, loose stools, hemorrhagic colitis, pyelonephritis, pneumonia, obtundation, inflammation of the abdominal cavity lining, infection of the bile duct, intestinal infarction, petechiae, purpura, purpura fulminans, malaise, myalgia, arthralgia, headache, chills, rapid heart rate, and rapid breathing. In some embodiments, the treatment decreases hypotension. In some embodiments, the treatment decreases toxic shock associated with sepsis. In some embodiments, the treatment decreases coagulopathy. In some embodiments, the combination of levocetirizine and montelukast is administered in a sequential manner. In some embodiments, the combination of levocetirizine and montelukast is administered in a substantially simultaneous manner. In some embodiments, the combination is administered to the patient by one or more of the routes consisting of enteral, intravenous, intraperitoneal, inhalation, intramuscular, subcutaneous and oral. In some embodiments, the levocetirizine and montelukast are administered by the same route. In some embodiments, the levocetirizine and montelukast are administered via different routes. In some embodiments, one or more of levocetirizine or montelukast are provided as a slow release composition. In some embodiments, the combination further comprises other medications known for use in treating sepsis and/or complications associated with sepsis. In some embodiments, the combination further comprises one or more antibiotics. In some embodiments, the combination further comprises a steroid. Some embodiments pertain to a method of treating a patient having a septic shock, the method comprising administering to the patient an effective amount of a combination of levocetirizine and montelukast. Some embodiments pertain to a composition for use in treating a patient having sepsis, the composition comprising a combination of levocetirizine and montelukast. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1A shows a diagram of displaying a number of causes of sepsis, including infection caused by a number of sources (e.g., bacterial, fungal, parasitic, viral, others) and/or systemic inflammatory response (SIRS) caused by a number of sources (e.g., trauma, burns, pancreatitis, others). In several embodiments, a composition for use in treating a patient having sepsis from any one or more of these sources is provided, the composition comprising a combination of levocetirizine and montelukast. FIG. 1B shows a diagram of a proposed anti-inflammatory mechanism of action of levocetirizine and montelukast utilizing a steroid model pathway. FIG. 2 is a diagram depicting a cell and embodiments of biological cascades involved in sepsis. FIG. 3 is a diagram depicting embodiments of procoagulant and anticoagulant pathways that may be affected during sepsis. In several embodiments, levocetirizine and montelukast block the activity of one or more of factors (as indicated in FIG. 3) within the procoagulant or anticoagulant pathways, as shown in FIG. 3. FIG. 4 is a diagram depicting possible pathophysiologic pathways leading to septic shock and organ failure. In several embodiments, levocetirizine and montelukast block the activity of one or more of steps (as indicated in FIG. 4) within these pathways. FIG. 5 is a CT Scan of the chest of a patient suffering from multiple septic emboli due to Lemierre's Syndrome. DETAILED DESCRIPTION Some examples described herein disclose the use of levocetirizine and montelukast as a medicament for the prevention or treatment of sepsis and/or com