Ready-to-use tranexamic acid intravenous solution
Ready-to-use, stable aqueous intravenous tranexamic acid compositions are provided.
1. An aqueous pharmaceutical composition in the form of a solution for parenteral administration comprising: 5 mg/ml tranexamic acid or a pharmaceutically acceptable salt thereof; and from 7.8 to 8.4 mg/ml sodium chloride, wherein the composition requires no dilution before administration and has a pH from 6.0 to 8.0.
2. The aqueous pharmaceutical composition of claim 1 , where the pH is from 7 to 8.
3. The aqueous pharmaceutical composition of claim 1 , where the pH is from 7.3 to 7.5.
4. The aqueous pharmaceutical composition of claim 1 , further comprising a pH adjuster.
5. The aqueous pharmaceutical composition of claim 4 , where the pH adjuster is selected from the group consisting of sodium hydroxide, hydrochloric acid, or a mixture thereof.
6. An aqueous pharmaceutical composition in the form of a solution for parenteral administration comprising: 10 mg/ml tranexamic acid or a pharmaceutically acceptable salt thereof; and from 6.8 to 7.5 mg/ml sodium chloride, wherein the composition requires no dilution before administration and has a pH from 6.0 to 8.0.
7. The aqueous pharmaceutical composition of claim 6 , where the pH is from 7 to 8.
8. The aqueous pharmaceutical composition of claim 6 , where the pH is from 7.3 to 7.5.
9. The aqueous pharmaceutical composition of claim 6 , further comprising a pH adjuster.
10. The aqueous pharmaceutical composition of claim 9 , where the pH adjuster is selected from the group consisting of sodium hydroxide, hydrochloric acid, or a mixture thereof.
11. The aqueous pharmaceutical composition of claim 1 , wherein the composition maintains at least about 95% of the tranexamic acid in undegraded form after storage for 180 days at 25° C.
12. The aqueous pharmaceutical composition of claim 6 , wherein the composition maintains at least about 95% of the tranexamic acid in undegraded form after storage for 180 days at 25° C.
13. A method for reducing or preventing hemorrhage associated with tooth extraction in a patient with coagulopathy comprising steps of:
(a) administering the composition of claim 1 to the patient immediately before tooth extraction; and
(b) administering the composition of claim 1 to the patient for 2 to 8 days following tooth extraction.
14. The method of claim 13 , wherein step (a) comprises intravenous administration of the composition at a dose of 10 mg tranexamic acid per kg body weight of the patient.
15. The method of claim 13 , wherein step (b) comprises intravenous administration of the composition at a dose of 10 mg tranexamic acid per kg body weight of the patient three to four times per day.
16. A method for reducing or preventing hemorrhage associated with tooth extraction in a patient with coagulopathy comprising steps of:
(a) administering the composition of claim 6 to the patient immediately before tooth extraction; and
(b) administering the composition of claim 6 to the patient for 2 to 8 days following tooth extraction.
17. The method of claim 16 , wherein step (a) comprises intravenous administration of the composition at a dose of 10 mg tranexamic acid per kg body weight of the patient.
18. The method of claim 16 , wherein step (b) comprises intravenous administration of the composition at a dose of 10 mg tranexamic acid per kg body weight of the patient three to four times per day.