Ready to use liquid formulation

1. A ready-to-use liquid formulation comprising:

lidocaine hydrochloride in an amount of about 10 mg/mL or about 20 mg/mL;

epinephrine hydrochloride in an amount of about 10 mcg/mL, based on epinephrine free base;

sodium chloride in an amount of about 7 mg/mL;

sodium metabisulfite in an amount of about 5.2 mcg/mL;

citric acid in an amount of about 0.2 mg/mL;

EDTA sodium in an amount of about 0.2 mg/mL;

a sufficient amount of sterile water for injection; and

a sufficient amount of a pH adjuster to obtain a pH of about 3.4.

2. The ready-to-use liquid formulation of claim 1 , wherein the pH adjuster is hydrochloric acid, sodium hydroxide, or a combination thereof.

3. A syringe containing about 5 mL of the ready-to-use liquid formulation of any one of claim 1 .

4. The syringe of claim 3 , wherein each of lidocaine and epinephrine has a potency of at least 90% after storage for about 3-months at a temperature of about 25° C.

5. A light-sensitive container comprising the syringe of claim 3 , wherein the light sensitive container has light transmission of less than 5% at any wavelength between 290 nm and 450 nm.

6. A ready-to-use liquid formulation consisting of:

lidocaine hydrochloride in an amount of about 10 mg/mL or about 20 mg/mL;

epinephrine hydrochloride in an amount of about 10 mcg/mL, based on epinephrine free base;

sodium chloride in an amount of about 7 mg/mL;

sodium metabisulfite in an amount of about 5.2 mcg/mL;

citric acid in an amount of about 0.2 mg/mL;

EDTA sodium in an amount of about 0.2 mg/mL;

a sufficient amount of sterile water for injection; and

a sufficient amount of a pH adjuster to obtain a pH of about 3.4.

7. The ready-to-use liquid formulation of claim 6 , wherein the pH adjuster is hydrochloric acid, sodium hydroxide, or a combination thereof.

8. A syringe containing about 5 mL of the ready-to-use liquid formulation of any one of claim 6 .

9. The syringe of claim 8 , wherein each of lidocaine and epinephrine has a potency of at least 90% after storage for about 3-months at a temperature of about 25° C.

10. A light-sensitive container comprising the syringe of claim 8 , wherein the light-sensitive container has a light transmission of less than 5% at any wavelength between 290 nm and 450 nm.

11. A method for providing procedural analgesia to a patient in need thereof, which comprises:

administering the ready-to-use liquid formulation of claim 1 to the patient.

12. The method of claim 11 , wherein the procedural analgesia is associated with a venipuncture, a shave removal, or a punch biopsy.

13. A process for preparing the ready-to-use liquid formulation of claim 1 , which comprises:

a) dissolving sodium chloride (43.4 g) and lidocaine HCl in a first container including sterile water for injection;

b) adding citric acid, EDTA sodium, and sodium metabisulfite in the first container of step a) and stirring to provide a dissolved solution;

c) adding the pH adjuster to the first container of step b) to obtain a pH of the solution of 2.5;

d) dissolving epinephrine in the first container of step c);

e) if necessary, adding 10% v/v hydrochloric acid to the first container of step d) to maintain the pH of the solution below 3.0;

f) adding an additional amount of sterile water to the first container of step e) and adding the pH adjuster to obtain a pH of from about 3.5;

g) transferring the solution of step f) to a second container; and

h) filtering the solution of step g) through a 0.22 micron filter.

14. A syringe product containing about 5 mL of the ready-to-use liquid formulation prepared by the process of claim 13 .

15. The syringe of claim 14 , wherein each of lidocaine and epinephrine has a potency of at least 90% after storage for about 3-months at a temperature of about 25° C.

16. A light-sensitive container comprising the syringe of claim of claim 14 , wherein the light-sensitive container has a light transmission of less than 5% at any wavelength between 290 nm and 450 nm.