Claims
- 1. A method of treating a disease associated with the use of antibiotics in a patient in need thereof, said method comprising administering to said patient ramoplanin in an amount and for a duration effective to treat said disease.
- 2. The method of claim 1, wherein said disease is caused by the presence of a bacterium selected from the group consisting of Clostridium difficile, Staphylococcus aureus, and Clostridum perfringens.
- 3. The method of claim 2, wherein said Clostridium difficile is resistant to metronidazole and/or vancomycin.
- 4. The method of claim 1, wherein said disease is selected from the group consisting of antibiotic-associated diarrhea, colitis, and pseudomembranous colitis.
- 5. The method of claim 1, further comprising administering to said patient a corticosteroid.
- 6. The method of claim 5, wherein said corticosteroid is algestone, 6-alphafluoroprednisolone, 6-alpha-methylpredniso lone, 6-alpha-methylprednisolone 21 acetate, 6-alpha-methylprednisolone 21-hemisuccinate sodium salt, 6-alpha,9-alphadifluoroprednisolone 21-acetate 17-butyrate, amcinafal, beclomethasone, beclomethasone dipropionate, beclomethasone dipropionate monohydrate, 6-betahydroxycortisol, betamethasone, betamethasone-17-valerate, budesonide, clobetasol, clobetasol propionate, clobetasone, clocortolone, clocortolone pivalate, cortisone, cortisone acetate, cortodoxone, deflazacort, 21-deoxycortisol, deprodone, descinolone, desonide, desoximethasone, dexamethasone, dexamethasone-21-acetate, dichlorisone, diflorasone, diflorasone diacetate, diflucortolone, doxibetasol, fludrocortisone, flumethasone, flumethasone pivalate, flumoxonide, flunisolide, fluocinonide, fluocinolone acetonide, 9-fluorocortisone, fluorohydroxyandrostenedione, fluorometholone, fluorometholone acetate, fluoxymesterone, flupredidene, fluprednisolone, flurandrenolide, formocortal, halcinonide, halometasone, halopredone, hyrcanoside, hydrocortisone, hydrocortisone acetate, hydrocortisone butyrate, hydrocortisone cypionate, hydrocortisone sodium phosphate, hydrocortisone sodium succinate, hydrocortisone probutate, hydrocortisone valerate, 6-hydroxydexamethasone, isoflupredone, isoflupredone acetate, isoprednidene, meclorisone, methylprednisolone, methylprednisolone acetate, methylprednisolone sodium succinate, paramethasone, paramethasone acetate, prednisolone, prednisolone acetate, prednisolone metasulphobenzoate, prednisolone sodium phosphate, prednisolone tebutate, prednisolone-21-hemisuccinate free acid, prednisolone-21-acetate, prednisolone-21 (beta-D-glucuronide), prednisone, prednylidene, procinonide, tralonide, triamcinolone, triamcinolone acetonide, triamcinolone acetonide 21-palmitate, triamcinolone diacetate, or triamcinolone hexacetonide.
- 7. The method of claim 6, wherein said corticosteroid is budesonide.
- 8. The method of claim 1, further comprising administering to said patient one or more compounds selected from detoprofen, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, meclofenameate, mefenamic acid, meloxicam, nabumeone, naproxen sodium, oxaprozin, piroxicam, sulindac, tolmetin, celecoxib, rofecoxib, aspirin, choline salicylate, salsalte, cyclosporine, azathioprine, methotrexate, leflunomide, cyclophosphamide, hydroxychloroquine, sulfasalazine, D-penicillamine, minocycline, etanercept, infliximab, sulfasalazine, olsalazine, balsalazide, azathioprine, 6-mercaptopurine, or methotrexate.
- 9. The method of claim 1, further comprising administering to said patient bismuth, diphenoxylate, atropine, kaolin, pectin, loperamide, or paragoric.
- 10. The method of claim 1, wherein said ramoplanin is administered in an amount between 50 mg and 1 g.
- 11. The method of claim 10, wherein said ramoplanin is administered in an amount between 200 and 400 mg once or twice daily.
- 12. The method of claim 1, wherein said ramoplanin is administered one to four times daily for three to fifteen days.
- 13. The method of claim 1, wherein said ramoplanin is administered orally.
- 14. The method of claim 1, further comprising administering to said patient vancomycin, bacitracin, or metronidazole.
- 15. A method of inhibiting or preventing the onset of an antibiotic-associated condition in a patient in need thereof, said method comprising administering to said patient ramoplanin in an amount and for a duration sufficient to inhibit onset of said antibiotic associated condition.
- 16. The method of claim 15, wherein said antibiotic-associated condition is caused by the presence of a bacterium selected from the group consisting of Clostridium difficile, Staphylococcus aureus, and Clostridum perfringens.
- 17. The method of claim 26, wherein said Clostridium difficile is resistant to metronidazole and/or vancomycin.
- 18. The method of claim 15, wherein said antibiotic-associated condition is selected from the group consisting of antibiotic-associated diarrhea, colitis, and pseudomembranous colitis.
- 19. The method of claim 15, wherein said ramoplanin is administered in an amount between 50 mg and 1 g.
- 20. The method of claim 15, wherein said ramoplanin is administered in an amount between 200 and 400 mg once or twice daily.
- 21. The method of claim 15, wherein said ramoplanin is administered one to four times daily for three to fifteen days.
- 22. The method of claim 15, wherein said ramoplanin is administered orally.
- 23. The method of claim 15, further comprising administering to said patient vancomycin, bacitracin, or metronidazole.
- 24. A method of treating or inhibiting relapse of an antibiotic-associated condition selected from the group consisting of antibiotic-associated diarrhea, colitis, and pseudomembranous colitis in a patient, said method comprising administering to said patient ramoplanin in an amount and for a duration effective to inhibit relapse of said antibiotic-associated condition.
- 25. The method of claim 24, wherein said patient has been treated with vancomycin or metronidazole within sixty days of said relapse.
- 26. The method of claim 24, wherein said ramoplanin is administered in an amount between 50 mg and 1 g.
- 27. The method of claim 26, wherein said ramoplanin is administered in an amount between 200 and 400 mg once or twice daily.
- 28. The method of claim 24, wherein said ramoplanin is administered one to four times daily for three to fifteen days.
- 29. The method of claim 24, wherein said ramoplanin is administered orally.
- 30. A method of treating a disease caused by a bacterial infection of the colon, said method comprising administering to a patient in need thereof an effective amount of ramoplanin in a pharmaceutical formulation that maintains the integrity of the formulation during passage through the gastrointestinal tract and permits release of said ramoplanin into the colon or other portion of the gastrointestinal tract.
- 31. The method of claim 30, wherein the bacterial infection is a Clostridium difficile, Staphylococcus aureus, or Clostridium perfringens infection.
- 32. The method of claim 31, wherein said Clostridium difficile is resistant to metronidazole and/or vancomycin.
- 33. The method of claim 30, further comprising administering to said patient a corticosteroid.
- 34. The method of claim 33, wherein said corticosteroid is algestone, 6-alphafluoroprednisolone, 6-alpha-methylprednisolone, 6-alpha-methylprednisolone 21 acetate, 6-alpha-methylprednisolone 21-hemisuccinate sodium salt, 6-alpha,9-alphadifluoroprednisolone 21-acetate 17-butyrate, amcinafal, beclomethasone, beclomethasone dipropionate, beclomethasone dipropionate monohydrate, 6-betahydroxycortisol, betamethasone, betamethasone-17-valerate, budesonide, clobetasol, clobetasol propionate, clobetasone, clocortolone, clocortolone pivalate, cortisone, cortisone acetate, cortodoxone, deflazacort, 21-deoxycortisol, deprodone, descinolone, desonide, desoximethasone, dexamethasone, dexamethasone-21-acetate, dichlorisone, diflorasone, diflorasone diacetate, diflucortolone, doxibetasol, fludrocortisone, flumethasone, flumethasone pivalate, flumoxonide, flunisolide, fluocinonide, fluocinolone acetonide, 9-fluorocortisone, fluorohydroxyandrostenedione, fluorometholone, fluorometholone acetate, fluoxymesterone, flupredidene, fluprednisolone, flurandrenolide, formocortal, halcinonide, halometasone, halopredone, hyrcanoside, hydrocortisone, hydrocortisone acetate, hydrocortisone butyrate, hydrocortisone cypionate, hydrocortisone sodium phosphate, hydrocortisone sodium succinate, hydrocortisone probutate, hydrocortisone valerate, 6-hydroxydexamethasone, isoflupredone, isoflupredone acetate, isoprednidene, meclorisone, methylprednisolone, methylprednisolone acetate, methylprednisolone sodium succinate, paramethasone, paramethasone acetate, prednisolone, prednisolone acetate, prednisolone metasulphobenzoate, prednisolone sodium phosphate, prednisolone tebutate, prednisolone-21-hemisuccinate free acid, prednisolone-21-acetate, prednisolone-21 (beta-D-glucuronide), prednisone, prednylidene, procinonide, tralonide, triamcinolone, triamcinolone acetonide, triamcinolone acetonide 21-palmitate, triamcinolone diacetate, or triamcinolone hexacetonide.
- 35. The method of claim 34, wherein said corticosteroid is budesonide.
- 36. The method of claim 30, further comprising administering to said patient one or more compounds selected from detoprofen, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, meclofenameate, mefenamic acid, meloxicam, nabumeone, naproxen sodium, oxaprozin, piroxicam, sulindac, tolmetin, celecoxib, rofecoxib, aspirin, choline salicylate, salsalte, cyclosporine, azathioprine, methotrexate, leflunomide, cyclophosphamide, hydroxychloroquine, sulfasalazine, D-penicillamine, minocycline, etanercept, infliximab, sulfasalazine, olsalazine, balsalazide, azathioprine, 6-mercaptopurine, or methotrexate.
- 37. The method of claim 30, further comprising administering to said patient bismuth, diphenoxylate, atropine, kaolin, pectin, loperamide, or paragoric.
- 38. The method of claim 30, wherein the disease is antibiotic-associated diarrhea or pseudomembranous colitis.
- 39. The method of claim 30, wherein said ramoplanin is administered in an amount between 50 mg and 1 g.
- 40. The method of claim 39, wherein said ramoplanin is administered in an amount between 200 and 400 mg once or twice daily.
- 41. The method of claim 30, wherein said ramoplanin is administered one to four times daily for three to fifteen days.
- 42. The method of claim 30, wherein said ramoplanin is administered orally.
- 43. The method of claim 30, further comprising administering to said patient vancomycin, bacitracin, or metronidazole.
- 44. A method for preventing sporulation of Clostridium difficile or Clostridium perfringens in a patient, said method comprising administering to said patient ramoplanin in an amount and for a duration effective to prevent sporulation of Clostridium difficile or Clostridium perfringens.
- 45. The method of claim 44, wherein said Clostridium difficile is resistant to metronidazole and/or vancomycin.
- 46. The method of claim 44, wherein said ramoplanin is administered in an amount between 50 mg and 1 g.
- 47. The method of claim 44, wherein said ramoplanin is administered in an amount between 200 and 400 mg once or twice daily.
- 48. The method of claim 44, wherein said ramoplanin is administered one to four times daily for three to fifteen days.
- 49. The method of claim 48, wherein said ramoplanin is administered orally.
- 50. The method of claim 44, further comprising administering to said patient vancomycin, bacitracin, or metronidazole.
- 51. A kit comprising (i) ramoplanin, (ii) a second compound that is useful for the treatment of diseases associated with the use of antibiotics, and (iii) instructions for administering said ramoplanin and said second compound to a patient diagnosed as having a disease associated with the use of antibiotics.
- 52. The kit of claim 51, wherein the disease is antibiotic-associated diarrhea or pseudomembranous colitis.
- 53. The kit of claim 51, wherein said second compound is a corticosteroid.
- 54. The kit of claim 53, wherein said corticosteroid is algestone, 6-alphafluoroprednisolone, 6-alpha-methylprednisolone, 6-alpha-methylprednisolone 21 acetate, 6-alpha-methylprednisolone 21-hemisuccinate sodium salt, 6-alpha,9-alphadifluoroprednisolone 21-acetate 17-butyrate, amcinafal, beclomethasone, beclomethasone dipropionate, beclomethasone dipropionate monohydrate, 6-betahydroxycortisol, betamethasone, betamethasone-17-valerate, budesonide, clobetasol, clobetasol propionate, clobetasone, clocortolone, clocortolone pivalate, cortisone, cortisone acetate, cortodoxone, deflazacort, 21-deoxycortisol, deprodone, descinolone, desonide, desoximethasone, dexamethasone, dexamethasone-21-acetate, dichlorisone, diflorasone, diflorasone diacetate, diflucortolone, doxibetasol, fludrocortisone, flumethasone, flumethasone pivalate, flumoxonide, flunisolide, fluocinonide, fluocinolone acetonide, 9-fluorocortisone, fluorohydroxyandrostenedione, fluorometholone, fluorometholone acetate, fluoxymesterone, flupredidene, fluprednisolone, flurandrenolide, formocortal, halcinonide, halometasone, halopredone, hyrcanoside, hydrocortisone, hydrocortisone acetate, hydrocortisone butyrate, hydrocortisone cypionate, hydrocortisone sodium phosphate, hydrocortisone sodium succinate, hydrocortisone probutate, hydrocortisone valerate, 6-hydroxydexamethasone, isoflupredone, isoflupredone acetate, isoprednidene, meclorisone, methylprednisolone, methylprednisolone acetate, methylprednisolone sodium succinate, paramethasone, paramethasone acetate, prednisolone, prednisolone acetate, prednisolone metasulphobenzoate, prednisolone sodium phosphate, prednisolone tebutate, prednisolone-21-hemisuccinate free acid, prednisolone-21-acetate, prednisolone-21 (beta-D-glucuronide), prednisone, prednylidene, procinonide, tralonide, triamcinolone, triamcinolone acetonide, triamcinolone acetonide 21-palmitate, triamcinolone diacetate, or triamcinolone hexacetonide.
- 55. The kit of claim 54, wherein said corticosteroid is budesonide.
- 56. The kit of claim 51, wherein said second compound is detoprofen, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, meclofenameate, mefenamic acid, meloxicam, nabumeone, naproxen sodium, oxaprozin, piroxicam, sulindac, tolmetin, celecoxib, rofecoxib, aspirin, choline salicylate, salsalte, cyclosporine, azathioprine, methotrexate, leflunomide, cyclophosphamide, hydroxychloroquine, sulfasalazine, D-penicillamine, minocycline, etanercept, infliximab, sulfasalazine, olsalazine, balsalazide, azathioprine, 6-mercaptopurine, or methotrexate.
- 57. The kit of claim 51, wherein said second compound is bismuth, diphenoxylate, atropine, kaolin, pectin, loperamide, or paragoric.
- 58. A pharmaceutical composition comprising (i) ramoplanin, (ii) a second compound that is useful for the treatment of diseases associated with the use of antibiotics, and (iii) a pharmaceutically acceptable excipient, wherein said ramoplanin and said second compound are present in amounts that, when administered to a patient, a disease associated with the use of antibiotics.
- 59. The composition of claim 58, wherein the disease is antibiotic-associated diarrhea or pseudomembranous colitis.
- 60. The composition of claim 58, wherein said second compound is a corticosteroid.
- 61. The composition of claim 60, wherein said corticosteroid is algestone, 6-alpha-fluoroprednisolone, 6-alpha-methylprednisolone, 6-alpha-methylprednisolone 21-acetate, 6-alpha-methylprednisolone 21-hemisuccinate sodium salt, 6-alpha,9-alpha-difluoroprednisolone 21-acetate 17-butyrate, amcinafal, beclomethasone, beclomethasone dipropionate, beclomethasone dipropionate monohydrate, 6-betahydroxycortisol, betamethasone, betamethasone-17-valerate, budesonide, clobetasol, clobetasol propionate, clobetasone, clocortolone, clocortolone pivalate, cortisone, cortisone acetate, cortodoxone, deflazacort, 21-deoxycortisol, deprodone, descinolone, desonide, desoximethasone, dexamethasone, dexamethasone-21-acetate, dichlorisone, diflorasone, diflorasone diacetate, diflucortolone, doxibetasol, fludrocortisone, flumethasone, flumethasone pivalate, flumoxonide, flunisolide, fluocinonide, fluocinolone acetonide, 9-fluorocortisone, fluorohydroxyandrostenedione, fluorometholone, fluorometholone acetate, fluoxymesterone, flupredidene, fluprednisolone, flurandrenolide, formocortal, halcinonide, halometasone, halopredone, hyrcanoside, hydrocortisone, hydrocortisone acetate, hydrocortisone butyrate, hydrocortisone cypionate, hydrocortisone sodium phosphate, hydrocortisone sodium succinate, hydrocortisone probutate, hydrocortisone valerate, 6-hydroxydexamethasone, isoflupredone, isoflupredone acetate, isoprednidene, meclorisone, methylprednisolone, methylprednisolone acetate, methylprednisolone sodium succinate, paramethasone, paramethasone acetate, prednisolone, prednisolone acetate, prednisolone metasulphobenzoate, prednisolone sodium phosphate, prednisolone tebutate, prednisolone-21-hemisuccinate free acid, prednisolone-21-acetate, prednisolone-21 (beta-D-glucuronide), prednisone, prednylidene, procinonide, tralonide, triamcinolone, triamcinolone acetonide, triamcinolone acetonide 21-palmitate, triamcinolone diacetate, or triamcinolone hexacetonide.
- 62. The composition of claim 61, wherein said corticosteroid is budesonide.
- 63. The composition of claim 58, wherein said second compound is detoprofen, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, meclofenameate, mefenamic acid, meloxicam, nabumeone, naproxen sodium, oxaprozin, piroxicam, sulindac, tolmetin, celecoxib, rofecoxib, aspirin, choline salicylate, salsalte, cyclosporine, azathioprine, methotrexate, leflunomide, cyclophosphamide, hydroxychloroquine, sulfasalazine, D-penicillamine, minocycline, etanercept, infliximab, sulfasalazine, olsalazine, balsalazide, azathioprine, 6-mercaptopurine, or methotrexate.
- 64. The composition of claim 58, wherein said second compound is bismuth, diphenoxylate, atropine, kaolin, pectin, loperamide, or paragoric.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims benefit of U.S. Provisional Application Nos. 60/385,902 (filed Jun. 6, 2002) and 60/469,803 (filed May 12, 2003), each of which is hereby incorporated by reference.
Provisional Applications (2)
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Number |
Date |
Country |
|
60385902 |
Jun 2002 |
US |
|
60469803 |
May 2003 |
US |