Bibliographic Details
| Title: |
REDUCED DOSE INTRAVENOUS ACETAMINOPHEN |
| Document Number: |
20090143474 |
| Publication Date: |
June 4, 2009 |
| Appl. No: |
12/270796 |
| Application Filed: |
November 13, 2008 |
| Abstract: |
Described herein are compositions and methods for intravenous administration of acetaminophen at a single dose level of less than about 1000 mg for the treatment or prevention of pain (e.g., postoperative pain) and/or fever. |
| Inventors: |
Royal, Mike Allan (San Diego, CA, US); Breitmeyer, James Bradley (Rancho Santa Fe, CA, US) |
| Assignees: |
CADENCE PHARMACEUTICALS, INC. (San Diego, CA, US) |
| Claim: |
1. A pharmaceutical composition comprising about 500 mg to about 1000 mg of acetaminophen and at least one antioxidant, wherein the pharmaceutical composition is provided as a formulation suitable for intravenous administration. |
| Claim: |
2. The pharmaceutical composition of claim 1, wherein the at least one antioxidant comprises cysteine hydrochloride monohydrate, thiolyglycolic acid, thiolacetic acid, dithiothreitol, reduced glutathione, thiourea, alpha-thioglycerol, cysteine, acetylcysteine, or mercaptoethane sulfonic acid, ascorbic acid ascorbic acid derivatives, an organic compound having at least one thiol, an alkyl polyhydroxylated compound, or a cycloalkyl polyhydroxylated compound. |
| Claim: |
3. The pharmaceutical composition of claim 2, wherein the at least one antioxidant comprises cysteine hydrochloride monohydrate. |
| Claim: |
4. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is provided as a solution |
| Claim: |
5. The pharmaceutical composition of claim 4, wherein the solution has a volume of about 30 ml to about 200 ml. |
| Claim: |
6. The pharmaceutical composition of claim 1, further comprising a buffering agent. |
| Claim: |
7. The pharmaceutical composition of claim 6, wherein the buffering agent comprises disodium phosphate dehydrate. |
| Claim: |
8. The pharmaceutical composition of claim 6, wherein the pharmaceutical composition has a pH from about 4 to about 8 when in solution. |
| Claim: |
9. The pharmaceutical composition of claim 8, wherein the pharmaceutical composition has a pH of about 5 to about 6 when in solution. |
| Claim: |
10. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition has an osmolality from about 250 mOsm/L to about 400 mOsm/L when in solution. |
| Claim: |
11. The pharmaceutical composition of claim 10, wherein the acetaminophen is present in an amount of about 600 to about 700 mg. |
| Claim: |
12. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises an isotonicity agent. |
| Claim: |
13. The pharmaceutical composition of claim 12, wherein the isotonicity agent is dextrose, mannitol, or lactose. |
| Claim: |
14. The pharmaceutical composition of claim 13, wherein the isotonicity agent is mannitol. |
| Claim: |
15. The pharmaceutical composition of claim 1, further comprising EDTA. |
| Claim: |
16. The pharmaceutical composition of claim 1, further comprising at least one analgesic agent other than acetaminophen. |
| Claim: |
17. The pharmaceutical composition of claim 16, wherein the at least one analgesic agent other than acetaminophen comprises an anilide, an opioid, an NSAID, a cannabinoid, a pyrazolone, or a barbiturate. |
| Claim: |
18. The pharmaceutical composition of claim 17, wherein the at least one analgesic other than acetaminophen comprises an opioid. |
| Claim: |
19. The pharmaceutical composition of claim 1, wherein the composition is free of polyethylene glycol or a derivative thereof. |
| Claim: |
20. The pharmaceutical composition of claim 1, wherein the composition is free of sulfites. |
| Claim: |
21. A method for the treatment or prevention of pain or fever in a subject in need thereof, comprising administering to the subject, by an intravenous route of administration, a pharmaceutical composition comprising about 500 mg to about 1000 mg of acetaminophen. |
| Claim: |
22. The method of claim 21, wherein the pharmaceutical composition is administration is repeated at least once with an interval of about 3 to about 8 hours and the subject receives a total of about 3 to about 5 grams of acetaminophen. |
| Claim: |
23. The method of claim 21, wherein the pharmaceutical composition is administered at least six times in a period of twenty four hours. |
| Claim: |
24. The method of claim 21, wherein the pharmaceutical composition comprises at least one antioxidant. |
| Claim: |
25. The method of claim 24, wherein the at least one antioxidant comprises cysteine hydrochloride monohydrate, thiolyglycolic acid, thiolacetic acid, dithiothreitol, reduced glutathione, thiourea, α-thioglycerol, cysteine, acetylcysteine, or mercaptoethane sulfonic acid, ascorbic acid ascorbic acid derivatives, an organic compound having at least one thiol, an alkyl polyhydroxylated compound, or a cycloalkyl polyhydroxylated compound. |
| Claim: |
26. The method of claim 25, wherein the at least one antioxidant comprises cysteine hydrochloride monohydrate. |
| Claim: |
27. The method of claim 21, further comprising a buffering agent. |
| Claim: |
28. The method of claim 24, wherein the buffering agent comprises disodium phosphate dehydrate. |
| Claim: |
29. The method of claim 21, wherein the pharmaceutical composition has a pH between about 4 to about 8. |
| Claim: |
30. The method of claim 29, wherein the pharmaceutical composition has a pH of between about 5 and about 6. |
| Claim: |
31. The method of claim 21, wherein the pharmaceutical composition has an osmolality of between about 200 mOsm/L to about 400 mOsm/L. |
| Claim: |
32. The pharmaceutical composition of claim 31, wherein the acetaminophen is present in the solution in an amount of about 600 to about 700 mg. |
| Claim: |
33. The method of claim 21, wherein the pharmaceutical composition further comprises an isotonicity agent. |
| Claim: |
34. The method of claim 33, wherein the isotonicity agent is dextrose, mannitol, or lactose. |
| Claim: |
35. The method of claim 34, wherein the isotonicity agent is mannitol. |
| Claim: |
36. The method of claim 21, further comprising EDTA. |
| Claim: |
37. The method of claim 21, wherein the pharmaceutical composition further comprises at least one analgesic agent other than acetaminophen. |
| Claim: |
38. The method of claim 37, wherein the at least one analgesic agent other than acetaminophen comprises an anilide, an opioid, an NSAID, a cannabinoid, a pyrazolone, or a barbiturate. |
| Claim: |
39. The method of claim 38, wherein the at least one analgesic other than acetaminophen comprises an opioid. |
| Claim: |
40. The method of claim 21, wherein the subject is suffering from a fever. |
| Claim: |
41. The method of claim 21, wherein the subject is unconscious, sedated, fasting, nauseous, or unable to be administered a pharmaceutical composition by an oral route. |
| Claim: |
42. The method of claim 21, wherein the pharmaceutical composition is administered after a surgical intervention on the subject. |
| Claim: |
43. The method of claim 21, wherein the pharmaceutical composition is administered within 3 hours of a surgical intervention on the subject. |
| Claim: |
44. The method of claim 43, wherein the pharmaceutical composition is administered within 1 hour of a surgical intervention on the subject. |
| Claim: |
45. The method of claim 21, wherein the pharmaceutical composition is administered postoperatively. |
| Claim: |
46. The method of claim 21, further comprising administering to the subject at least one analgesic agent other than acetaminophen. |
| Claim: |
47. The method of claim 46, wherein the at least one analgesic agent other than acetaminophen comprises an anilide, an opioid, an NSAID, a cannabinoid, a pyrazolone, or a barbiturate. |
| Claim: |
48. The method of claim 21, wherein the subject is suffering from an infection. |
| Claim: |
49. A method for reducing or preventing pain or fever in a subject in need thereof, comprising administering to the subject, by an intravenous route of administration, a pharmaceutical composition in solution comprising: about 600 mg to about 700 mg of acetaminophen, cysteine hydrochloride monohydrate, disodium phosphate dehydrate, and mannitol, wherein the solution has a pH of about 5 to about 6, and an osmolality of about 200-400 mOsm/L. |
| Claim: |
50. The method of claim 49, wherein the pharmaceutical composition has an acetaminophen concentration of about 0.5% (w/v) to about 10% (w/v). |
| Claim: |
51. The method of claim 50, wherein the acetaminophen concentration is about 1% (w/v). |
| Claim: |
52. The method of claim 49, wherein the pharmaceutical composition further comprises EDTA. |
| Claim: |
53. The method of claim 49, wherein the subject is suffering from postoperative pain. |
| Claim: |
54. The method of claim 21, wherein the level of pain the subject is suffering from is reduced. |
| Claim: |
55. The method of claim 21, wherein the pharmaceutical composition is administered as a pretreatment. |
| Current U.S. Class: |
514/629 |
| Current International Class: |
61; 61 |
| Accession Number: |
edspap.20090143474 |
| Database: |
USPTO Patent Applications |
