Levodopa fractionated dose composition and use
There is provided a convenient new treatment of Parkinson disease by a frequent administration of optimal levodopa doses mimicking a continuous intravenous or infusion treatment, thus mitigating motor complications; and a new carbidopa/levodopa pharmaceutical unit form providing said new treatment.
1. A method for the treatment of Parkinson's disease or related levodopa (LD)-responsive disorders, comprising orally administering to a patient in need thereof, carbidopa/levodopa (CD/LD) at an effective dose to simulate continuous intravenous administration of LD, up to 9 times per day,
wherein the effective dose comprises CD within a range of 6.25 mg to 18.75 mg and LD within a range of 25 mg to 75 mg, and
wherein entacapone is not concurrently administered.
2. The method of claim 1 , wherein the effective dose comprises CD within a range of 6.25 mg to 8.3 mg and LD within a range of 25 mg to 33.3 mg.
3. The method of claim 1 , wherein the patient is administered from one to six unit doses as the effective dose, each unit dose comprising a carbidopa/levodopa amount selected from the group consisting of carbidopa-6.25 mg/levodopa-25 mg and carbidopa-8.3 mg/levodopa-33.3 mg.
4. The method of claim 1 , wherein said patient is a newly diagnosed patient at the initial stage of Parkinson's disease.
5. The method of claim 1 , wherein said patient is a parkinsonian patient previously administered a standard treatment with carbidopa/levodopa (CD/LD).
6. The method of claim 5 , wherein said patient suffers from motor response complications.
7. The method of claim 1 , wherein the effective dose is administered from 5 to 9 times per day.
8. The method of claim 7 , wherein the effective dose is administered from 5 to 6 times per day.
9. The method of claim 1 , wherein the effective dose to simulate continuous intravenous administration of LD provides a constant plasma concentration range of the LD for full efficacy with no motor response complications.
10. The method of claim 1 , wherein the blood plasma concentration range of LD in the patient is within a physiologic range in comparison to when the patient is not treated with the effective dose of CD/LD.
11. A method for the treatment of Parkinson's disease or levodopa (LD)-responsive disorders in a patient who is hypersensitive to LD, comprising orally administering to the patient, carbidopa/levodopa (CD/LD) at an effective dose to simulate continuous intravenous administration of LD, up to 9 times per day,
wherein the effective dose comprises CD within a range of 6.25 mg to 18.75 mg and LD within a range of 25 mg to 75 mg, and
wherein entacapone is not concurrently administered.
12. The method of claim 11 wherein the effective dose comprises CD within a range of 6.25 mg to 8.3 mg and LD within a range of 25 mg to 33 mg.
13. The method of claim 11 , wherein the patient is administered from one to six unit doses as the effective dose, each unit dose comprising a carbidopa/levodopa amount selected from the group consisting of carbidopa-6.25 mg/levodopa-25 mg and carbidopa-8.3 mg/levodopa-33.3 mg.
14. The method of claim 11 , wherein the patient is a minor child.
15. The method of claim 11 , wherein the LD-responsive disorder is generalized dystonia.
16. The method of claim 11 , wherein the effective dose is administered two times a day (b.i.d.) or three times a day (t.i.d.).
17. The method of claim 11 , wherein the effective dose comprises a carbidopa/levodopa amount of carbidopa-12.5 mg/levodopa-50 mg, and the effective dose is administered two times a day (b.i.d.).
18. A method of treating, alleviating, or delaying the onset of, motor response complications related to Parkinson's disease or related levodopa (LD)-responsive disorder, comprising orally administering to a patient in need thereof, carbidopa/levodopa (CD/LD) at an effective dose to simulate continuous intravenous administration of LD, up to 9 times per day,
wherein the effective dose comprises CD within a range of 6.25 mg to 18.75 mg and LD within a range of 25 mg to 75 mg, and
wherein entacapone is not concurrently administered.
19. The method of claim 18 , wherein the effective dose comprises CD within a range of 6.25 mg to 8.3 mg and LD within a range of 25 mg to 33. mg.
20. The method of claim 18 , wherein the patient is administered from one to six unit doses as the effective dose, each unit dose comprising a carbidopa/levodopa amount selected from the group consisting of carbidopa-6.25 mg/levodopa-25 mg and carbidopa-8.3 mg/levodopa-33.3 mg.
21. The method of claim 18 , wherein the effective dose is administered from 5 to 9 times per day.
22. The method of claim 21 , wherein the effective dose is administered from 5 to 6 times per day.
23. The method of claim 18 , wherein the effective dose to simulate continuous intravenous administration of LD provides a constant plasma concentration range of the LD for full efficacy with no motor response complications.
24. The method of claim 1 , wherein the effective dose to simulate continuous intravenous administration of LD provides a constant plasma concentration range of the LD for full efficacy with reduced motor response complications in comparison to when the patient is not treated with the effective dose of CD/LD.
25. The method of claim 11 , wherein the effective dose to simulate continuous intravenous administration of LD provides a constant plasma concentration range of the LD for full efficacy with reduced motor response complications in comparison to when the patient is not treated with the effective dose of CD/LD.
26. The method of claim 6 , wherein said method relieves said motor response complications.
27. The method of claim 1 , wherein said method delays the onset of motor response complications.
28. The method of claim 1 , wherein the effective dose comprises CD 6.25 mg and LD 75 mg.
29. The method of claim 1 , wherein the effective dose comprises CD 8.3 mg and LD 33.3 mg.