EPINEPHRINE DOSING REGIMENS

• US 20070203247A1
• Filed: 02/28/2007
• Published: 08/30/2007
• Est. Priority Date: 02/28/2006
• Status: Abandoned Application

• Current Assignee: Sciele Pharma Incorporated
• Original Assignee: Sciele Pharma Incorporated
• Inventors: Phillips, Elaine, Malone, Greg
• Application Number:
  US11/680,533
• Publication Number:
  US 20070203247A1
• Time in Patent Office: Days
• US Class Current: 514/649
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

The present invention relates to methods for administering a first dose of epinephrine solution and an optional second dose of epinephrine solution. Also provided herein are kits useful in these methods.

Claims

1. A method of treating an allergic emergency in a patient, comprising injecting into a patient in need thereof a first dose of an epinephrine solution comprising less than about 0.15 mg of epinephrine and optionally subsequently injecting into the patient a second dose of an epinephrine solution, wherein the first and second doses are administered from a single device.

2. The method of claim 1, wherein the amount of epinephrine in the first dose is about the same as the amount of epinephrine in the second dose.

3. The method of claim 2, wherein the amount of epinephrine in the first dose is about 0.1 mg.

4. The method of claim 2, wherein the amount of epinephrine in the first dose is about 0.05 mg.

5. The method of claim 1, wherein the amount of epinephrine in the first dose is greater than the amount of epinephrine in the second dose.

6. The method of claim 5, wherein the amount of epinephrine in the second dose is about 0.1 mg.

7. The method of claim 5, wherein the amount of epinephrine in the second dose is about 0.05 mg.

8. The method of claim 1, wherein the amount of epinephrine in the first dose is less than the amount of epinephrine in the second dose.

9. The method of claim 8, wherein the amount of epinephrine in the second dose is at least about 0.15 mg.

10. The method of claim 8, wherein the amount of epinephrine in the second dose is at least about 0.3 mg.

11. The method of claim 1, wherein the first dose is automatically injected.

12. The method of claim 11, wherein the second dose is automatically injected.

13. The method of claim 11, wherein the second dose is manually injected.

14. The method of claim 1, wherein the first dose is manually injected.

15. The method of claim 14, wherein the second dose is automatically injected.

16. The method of claim 14, wherein the second dose is manually injected.

17. The method of claim 1, wherein the second dose is injected less than about 30 minutes after the first dose.

18. The method of claim 17, wherein the second dose is injected less than about 20 minutes after the first dose.

19. The method of claim 17, wherein the second dose is injected less than about 10 minutes after the first dose

20. The method of claim 17, wherein the second dose is injected between about 2 to about 10 minutes after the first dose.

21. The method of claim 1, wherein the patient weighs between about 5 to about 15 Kg.

22. The method of claim 1, wherein the concentration of the epinephrine solution in the first dose is about 1 mg/ml.

23. The method of claim 1, wherein the concentration of the epinephrine solution in the first dose is about 0.5 mg/ml.

24. A method of treating allergic emergency in a patient, comprising injecting into a patient in need thereof a first dose of an epinephrine solution comprising at least about 0.5 mg of epinephrine and optionally subsequently injecting into the patient a second dose of an epinephrine solution, wherein the first and second doses are administered from a single device.

25. The method of claim 24, wherein the amount of epinephrine in the first dose is about the same as the amount of epinephrine in the second dose.

26. The method of claim 25, wherein the amount of epinephrine in the first dose is about 0.5 mg.

27. The method of claim 25, wherein the amount of epinephrine in the first dose is between about 0.5 mg to about 1.0 mg.

28. The method of claim 25, wherein the amount of epinephrine in the first dose is about 0.75 mg.

29. The method of claim 24, wherein the amount of epinephrine in the first dose is greater than the amount of epinephrine in the second dose.

30. The method of claim 29, wherein the amount of epinephrine in the second dose is about 0.5 mg.

31. The method of claim 29, wherein the amount of epinephrine in the second dose is about 0.3 mg.

32. The method of claim 29, wherein the amount of epinephrine in the second dose is about 0.15 mg.

33. The method of claim 29, wherein the amount of epinephrine in the second dose is less than about 0.15 mg.

34. The method of claim 24, wherein the amount of epinephrine in the first dose is less than the amount of epinephrine in the second dose.

35. The method of claim 24, wherein the first dose is automatically injected.

36. The method of claim 35, wherein the second dose is automatically injected.

37. The method of claim 35, wherein the second dose is manually injected.

38. The method of claim 24, wherein the first dose is manually injected.

39. The method of claim 38, wherein the second dose is automatically injected.

40. The method of claim 38, wherein the second dose is manually injected.

41. The method of claim 24, wherein the second dose is injected less than about 30 minutes after the first dose.

42. The method of claim 41, wherein the second dose is injected less than about 20 minutes after the first dose.

43. The method of claim 41, wherein the second dose is injected less than about 10 minutes after the first dose.

44. The method of claim 41, wherein the second dose is injected within about 2 to about 10 minutes after the first dose.

45. The method of claim 24, wherein the patient weighs between about 50 Kg to about 100 Kg.

46. The method of claim 24, wherein the concentration of the first dose of epinephrine solution is 1 mg/ml.

47. The method of claim 24, wherein the concentration of the first dose of epinephrine solution is 0.5 mg/ml.

48. A kit or packaging system for treating an allergic emergency, comprising a first injectable dosage form comprising an epinephrine solution comprising less than about 0.15 mg of epinephrine and a second injectable dosage form comprising an epinephrine solution.

49. The kit or packaging system according to claim 48, further comprising an article for holding said first and second injectable dosage forms and written instructions for administering said first and second injectable dosage forms.

50. The kit or packaging system according to claim 48, wherein said first and second injectable dosage forms are administered from a single device.

51. A kit or packaging system for treating an allergic emergency, comprising a first injectable dosage form comprising an epinephrine solution comprising at least about 0.5 mg of epinephrine and a second injectable dosage form comprising an epinephrine solution.

52. The kit or packaging system according to claim 51, further comprising an article for holding said first and second injectable dosage forms and written instructions for administering said first and second injectable dosage forms.

53. The kit or packaging system according to claim 51, wherein said first and second injectable dosage forms are administered from a single device.

54. A drug delivery device containing an epinephrine solution, wherein the device is capable of delivering a first dose of an epinephrine solution comprising less than about 0.15 mg of epinephrine and optionally a second dose of an epinephrine solution.

55. A drug delivery device containing an epinephrine solution, wherein the device is capable of delivering a first dose of an epinephrine solution comprising about 0.5 mg of the epinephrine and optionally second dose of an epinephrine solution.