Claims for Patent: 6,468,967

Summary for Patent: 6,468,967

Title:	Methods for administration of antibiotics
Abstract:	The invention provides methods for administering a therapeutically effective amount of daptomycin while minimizing skeletal muscle toxicity. The methods provide daptomycin administration at a dosing interval of 24 hours or greater. This long dosing interval minimizes skeletal muscle toxicity and allows for higher peak concentrations of daptomycin, which is related to daptomycin's efficacy. The invention also provides methods of administering lipopeptide antibiotics other than daptomycin while minimizing skeletal muscle toxicity by administering a therapeutically effective amount of the lipopeptide antibiotic at a dosage interval that does not result in muscle toxicity. The invention also provides methods of administering quinupristin/dalfopristin while minimizing skeletal muscle toxicity by administering a therapeutically effective amount of quinupristin/dalfopristin at a dosage interval that does not result in muscle toxicity.
Inventor(s):	Oleson, Jr.; Frederick B. (Concord, MA), Tally; Francis P. (Lincoln, MA)
Assignee:	Cubist Pharmaceuticals, Incorporated (Lexington, MA)
Application Number:	09/406,568
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,468,967
Patent Claims:	1. A method for administering daptomycin, comprising the step of administering to a human patient in need thereof a therapeutically effective amount of daptomycin in a dose of 3 to 75 mg/kg of daptomycin at a dosage interval that minimizes skeletal muscle toxicity, wherein the daptomycin dose is repeatedly administered at a dosage interval of once every 24 hours to once every 48 hours. 2. The method according to claim 1, wherein daptomycin is administered at a dosage interval of once every 24 hours or once every 48 hours. 3. The method according to claim 1, wherein the dose is 3 to 12 mg/kg. 4. The method according to claim 3, wherein the dose is 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 mg/kg. 5. The method according to claim 4, wherein the dose is 4, 6, 8 or 10 mg/kg. 6. The method according to claim 1, wherein the dose is 10 to 25 mg/kg. 7. The method according to claim 6, wherein the dose is 10, 11, 12, 13, 14, 15, 16, 20 or 25 mg/kg. 8. The method according to claim 1, wherein an antibiotic other than daptomycin is co-administered with daptomycin. 9. The method according to claim 8, wherein said antibiotic is selected from the group consisting of penicillins and related drugs, carbapenems, cephalosporins and related drugs, aminoglycosides, bacitracin, gramicidin, mupirocin, chloramphenicol, thiamphenicol, fusidate sodium, lincomycin, clindamycin, macrolides, novobiocin, polymyxins, rifamycins, spectinomycin, tetracyclines, vancomycin, teicoplanin, streptogramins, anti-folate agents, sulfonamides, trimethoprim and its combinations, pyrimethamine, synthetic antibacterials, nitrofuirans, methenamine mandelate, methenamine hippurate, nitroimidazoles, quinolones, fluoroquinolones, isoniazid, ethambutol, pyrazinamide, para-aminosalicylic acid (PAS), cycloserine, capreomycin, ethionamide, prothionamide, thiacetazone and viomycin. 10. The method according to claim 8, wherein said antibiotic is selected from the group consisting of imipenen, amikacin, netilmicin, fosfomycin, gentamicin and teicoplanin. 11. The method according to claim 8, wherein said administering is via oral, subcutaneous or intravenous administration. 12. A method for administering daptomycin, comprising the step of administering to a human patient in need thereof a therapeutically effective amount of daptomycin at a dose of 3 to 75 mg/kg of daptomycin at a dosage interval that minimizes skeletal muscle toxicity, wherein the daptomycin dose is repeatedly administered at a dosage interval of once every 24 hours. 13. The method according to claim 12, wherein the dose is 3 to 12 mg/kg. 14. The method according to claim 13, wherein the dose is 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 mg/kg. 15. The method according to claim 14, wherein the dose is 4, 6, 8 or 10 mg/kg. 16. The method according to claim 14, wherein the dose is 4 mg/kg administered once every 24 hours. 17. The method according to claim 14, wherein the dose is 6 mg/kg administered once every 24 hours. 18. The method according to claim 13, wherein the dose is 25 to 75 mg/kg. 19. The method according to claim 18, wherein the dose is 25, 50 or 75 mg/kg. 20. The method according to claim 12, wherein the dose is 10 to 25 mg/kg. 21. The method according to claim 20, wherein the dose is 10, 11, 12, 13, 14, 15, 16, 20 or 25 mg/kg. 22. The method according to either of claims 1 or 12, wherein said administering is via oral, subcutaneous or intravenous administration. 23. The method according to either of claims 1 or 12, wherein the daptomycin is administered for 3 days to 6 months. 24. The method according to either of claims 1 or 12, wherein the daptomycin is administered for 7 to 28 days. 25. The method according to either of claims 1 or 12, wherein the daptomycin is administered for 7 to 14 days. 26. A method for treating or eradicating a bacterial infection in a human patient in need thereof, comprising the step of administering a therapeutically effective amount of daptomycin in a dose of 3 to 75 mg/kg to the patient at a dosage interval that minimizes skeletal muscle toxicity, wherein the daptomycin dose is repeatedly administered at the dosage interval of once every 24 hours to once every 48 hours until said bacterial infection is treated or eradicated. 27. The method according to claim 26, wherein the dose is 3 to 12 mg/kg. 28. The method according to claim 26, wherein the dose is 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 mg/kg. 29. The method according to claim 26, wherein an antibiotic other than daptomycin is co-administered with daptomycin. 30. The method according to claim 29, wherein said antibiotic is selected from the group consisting of penicillins and related drugs, carbapenems, cephalosporins and related drugs, aminoglycosides, bacitracin, gramicidin, mupirocin, chloramphenicol, thiamphenicol, fusidate sodium, lincomycin, clindamycin, macrolides, novobiocin, polymyxins, rifamycins, spectinomycin, tetracyclines, vancomycin, teicoplanin, streptogramins, anti-folate agents, sulfonamides, trimethoprim and its combinations, pyrimethamine, synthetic antibacterials, nitrofurans, methenamine mandelate, methenamine hippurate, nitroimidazoles, quinolones, fluoroquinolones, isoniazid, ethambutol, pyrazinamide, para-aminosalicylic acid (PAS), cycloserine, capreomycin, ethionamide, prothionamide, thiacetazone and viomycin. 31. The method according to claim 29, wherein said antibiotic is selected from the group consisting of imipenen, amikacin, netilmicin, fosfomycin, gentamicin and teicoplanin. 32. The method according to any one of claims 26 or 29, wherein said administering is via oral, subcutaneous or intravenous administration. 33. The method according to any one of claims 26 or 29, wherein said administering is once every 24 hours. 34. The method according to claim 33, wherein the dose is 4 mg/kg. 35. The method according to claim 33, wherein the dose is 6 mg/kg. 36. The method according to claim 33, wherein the daptomycin is administered for 3 days to 6 months. 37. The method according to claim 33, wherein the daptomycin is administered for 7 to 28 days. 38. The method according to claim 33, wherein the daptomycin is administered for 7 to 14 days. 39. The method according to either of claims 26 or 29, wherein the daptomycin is administered for 3 days to 6 months. 40. The method according to either of claims 26 or 29, wherein the daptomycin is administered for 7 to 28 days. 41. The method according to either of claims 26 or 29, wherein the daptomycin is administered for 7 to 14 days. 42. The method according to claim 16, wherein said administering is via intravenous administration. 43. The method according to claim 17, wherein said administering is via intravenous administration. 44. The method according to claim 34, wherein said administering is via intravenous administration. 45. The method according to claim 35, wherein said administering is via intravenous administration.