Pharmaceutical composition comprising sulbactam and avibactam, and application thereof
The present application relates to a pharmaceutical composition comprising sulbactam or a pharmaceutically acceptable salt thereof, avibactam or a pharmaceutically acceptable salt thereof, and optionally a pharmaceutically acceptable carrier, wherein unit dose ratio of said sulbactam or the pharmaceutically acceptable salt thereof and said avibactam or the pharmaceutically acceptable salt thereof is about 8:1 to about 4:1, unit dose of said sulbactam or the pharmaceutically acceptable salt thereof is about 1 g-4 g, and unit dose of said avibactam or the pharmaceutically acceptable salt thereof is about 0.125 g-1 g. The present application also relates to methods of treating bacterial infections using said pharmaceutical composition.
1 . A pharmaceutical composition comprising sulbactam or a pharmaceutically acceptable salt thereof and avibactam or a pharmaceutically acceptable salt thereof, and optionally a pharmaceutically acceptable carrier, wherein unit dose ratio of said sulbactam or the pharmaceutically acceptable salt thereof to said avibactam or the pharmaceutically acceptable salt thereof is about 8:1 to about 4:1, unit dose of said sulbactam or the pharmaceutically acceptable salt thereof is about 1 g-4 g, and unit dose of said avibactam or the pharmaceutically acceptable salt thereof is about 0.125 g-1 g.
2 . The pharmaceutical composition of claim 1 , wherein the unit dose of said sulbactam or the pharmaceutically acceptable salt thereof is about 2 g.
3 . The pharmaceutical composition of claim 1 , wherein the unit dose of said avibactam or the pharmaceutically acceptable salt thereof is about 1 g.
4 . The pharmaceutical composition of claim 1 , wherein the unit dose of said avibactam or the pharmaceutically acceptable salt thereof is about 0.5 g.
5 . The pharmaceutical composition of claim 1 , which has a pH value of about 5 to about 7.3.
6 . A kit or an administration device, which comprises the pharmaceutical composition of claim 1 .
7 . A method for preventing, treating and/or alleviating bacterial infections, wherein said method comprises administering to a patient in need thereof sulbactam or a pharmaceutically acceptable salt thereof and avibactam or a pharmaceutically acceptable salt thereof, ratio of administration dosage of said sulbactam or the pharmaceutically acceptable salt thereof to said avibactam or the pharmaceutically acceptable salt thereof is about 8:1 to about 4:1 and the administration dosage of said sulbactam or the pharmaceutically acceptable salt thereof is about 4 g-12 g/day, and the administration dosage of said avibactam or the pharmaceutically acceptable salt thereof is about 0.5 g-3 g/day.
8 . The method of claim 7 , wherein dosing interval of said sulbactam or the pharmaceutically acceptable salt thereof is every 6 hours-8 hours.
9 . The method of claim 7 , wherein dosing frequency of said sulbactam or the pharmaceutically acceptable salt thereof is 2 times-4 times daily.
10 . The method of claim 9 , wherein the administration dosage of said sulbactam or the pharmaceutically acceptable salt thereof is 2 g each time.
11 . The method of claim 7 , wherein dosing interval of said avibactam or the pharmaceutically acceptable salt thereof is every 6 hours-8 hours.
12 . The method of claim 7 , wherein dosing frequency of said avibactam or the pharmaceutically acceptable salt thereof is 2 times-4 times daily.
13 . The method of claim 12 , wherein the administration dosage of said avibactam or the pharmaceutically acceptable salt thereof is 0.5 g each time.
14 . The method of claim 7 , which comprises intravenous injection.
15 . The method of claim 7 , wherein bacteria are resistant to one or more β-lactam antibiotics.
16 . The method of claim 7 , wherein bacteria comprise Acinetobacter baumannii.
17 . The method of claim 7 , which is used in combination with polymyxin.
18 . The method of claim 7 , which is used in combination with tigecycline.