Compositions comprising ephedrine or an ephedrine salt and methods of making and using same

1. A method of administering ephedrine sulfate to a subject having hypotension or an elevated risk of developing hypotension in need thereof, the method consisting essentially of:

drawing a shelf-stable ready-to-use ephedrine sulfate composition from a sterile premixed pharmaceutical product into a syringe; and

injecting the composition into the subject using the syringe,

wherein the shelf-stable ready-to-use ephedrine sulfate composition consists essentially of:

5 mg/mL+/−5% ephedrine sulfate;

9 mg/mL sodium chloride;

no preservative; and

water, and

wherein the shelf-stable ready-to-use ephedrine sulfate composition is prepared by a process comprising:

combining ephedrine sulfate, sodium chloride, and water to form a solution comprising 5 mg/mL+/−5% of ephedrine sulfate and 9 mg/mL sodium chloride;

filtering the solution comprising 5 mg/mL+/−5% of ephedrine sulfate and 9 mg/mL sodium chloride;

placing the filtered solution into depyrogenated glass vials; and

sealing the filled glass vials.

2. The method of claim 1 , wherein the step of sealing the filled glass vials comprises sealing the filled glass vials with coated rubber stoppers.

3. The method of claim 1 , wherein a pH level of the shelf-stable ready-to-use ephedrine sulfate composition is within 0.5 pH units of an initial pH level after storage at 25° C. and 60% relative humidity for 12 months.

4. The method of claim 1 , wherein a pH level of the shelf-stable ready-to-use ephedrine sulfate composition is within 0.5 pH units of an initial pH level after storage at 40° C. and 75% relative humidity for 6 months.

5. The method of claim 1 , wherein the shelf-stable ready-to-use ephedrine sulfate composition has an initial pH level of about 4.5 to about 7.

6. A method of administering ephedrine sulfate to a subject having hypotension or an elevated risk of developing hypotension in need thereof, the method comprising:

drawing a sterile, shelf-stable ready-to-use ephedrine sulfate pharmaceutical product comprising 5 mg/mL+/−5% ephedrine sulfate and no preservative from a sealed glass vial into a syringe; and

injecting the composition into the subject using the syringe,

wherein the sterile, shelf-stable ready-to-use ephedrine sulfate pharmaceutical product is prepared by a process comprising:

combining ephedrine sulfate, sodium chloride, and water to form a solution consisting essentially of 5 mg/mL+/−5% of ephedrine sulfate and 9 mg/mL sodium chloride and having an initial pH level;

thereafter filtering the solution through a membrane filter to form a filtered solution;

thereafter placing the filtered solution into depyrogenated glass vials; and

sealing the filled glass vials.

7. The method of claim 6 , wherein the step of sealing the filled glass vials comprises sealing the filled glass vials with coated rubber stoppers.

8. The method of claim 6 , wherein the initial pH level is about 4.5 to about 7.

9. The method of claim 8 , wherein a pH level of the shelf-stable ready-to-use ephedrine sulfate composition is within 0.5 pH units of the initial pH level after storage at 25° C. and 60% relative humidity for 12 months.

10. The method of claim 8 , wherein a pH level of the shelf-stable ready-to-use ephedrine sulfate composition is within 0.5 pH units of the initial pH level after storage at 40° C. and 75% relative humidity for 6 months.