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Carbidopa and Levodopa (Carbidopa / Levodopa) - Summary

 



SUMMARY

CARBIDOPA AND LEVODOPA TABLETS USP

Carbidopa and levodopa tablets are a combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water.

Carbidopa and levodopa tablets are indicated in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), post-encephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. This product is indicated in these conditions to permit the administration of lower doses of levodopa with reduced nausea and vomiting, with more rapid dosage titration, with a somewhat smoother response, and with supplemental pyridoxine (vitamin B6).

In some patients a somewhat smoother antiparkinsonian effect results from therapy with carbidopa and levodopa than with levodopa. However, patients with markedly irregular ("on‑off") responses to levodopa have not been shown to benefit from carbidopa and levodopa therapy.

Although the administration of carbidopa permits control of parkinsonism and Parkinson's disease with much lower doses of levodopa, there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting, permitting more rapid titration, and providing a somewhat smoother response to levodopa.

Certain patients who responded poorly to levodopa have improved when carbidopa and levodopa was substituted. This is most likely due to decreased peripheral decarboxylation of levodopa which results from administration of carbidopa rather than to a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa in parkinsonian syndromes.

In considering whether to give this combination product to patients already on levodopa who have nausea and/or vomiting, the practitioner should be aware that, while many patients may be expected to improve, some do not. Since one cannot predict which patients are likely to improve, this can only be determined by a trial of therapy. It should be further noted that in controlled trials comparing carbidopa and levodopa with levodopa, about half of the patients with nausea and/or vomiting on levodopa improved spontaneously despite being retained on the same dose of levodopa during the controlled portion of the trial.


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NEWS HIGHLIGHTS

Published Studies Related to Carbidopa and Levodopa (Carbidopa / Levodopa)

Lack of pharmacokinetic interactions between transdermal rotigotine and oral levodopa/carbidopa. [2009.09]
This open-label phase I trial assessed potential pharmacokinetic interactions between oral levodopa/carbidopa and transdermal rotigotine treatment at steady state. Twenty-four participants with idiopathic restless legs syndrome (12 per group) received levodopa/carbidopa (100 mg/25 mg bid) and rotigotine (initial dose 2 mg/24 h for 3 days, followed by 4 mg/24 h) in a randomized sequence as monotherapy and in combination during hospitalization for 13 days...

Reducing dosing frequency of carbidopa/levodopa: double-blind crossover study comparing twice-daily bilayer formulation of carbidopa/levodopa (IPX054) versus 4 daily doses of standard carbidopa/levodopa in stable Parkinson disease patients. [2009.07]
OBJECTIVE: We compared IPX054, a bilayer tablet of immediate- and extended-release carbidopa/levodopa (CD/LD) given twice daily to standard CD/LD given 4 times daily in patients with stable Parkinson disease (PD)... CONCLUSIONS: In stable PD patients, no difference was detected between twice-daily treatment with IPX054 and CD/LD given 4 times daily. In this group, substitution with IPX054 reduced dosing frequency while maintaining CD/LD efficacy. In clinical practice, this ease of administration may offer improved treatment compliance.

Comparison of pharmacokinetic profile of levodopa throughout the day between levodopa/carbidopa/entacapone and levodopa/carbidopa when administered four or five times daily. [2009.05]
OBJECTIVES: To compare plasma levodopa concentrations after repeated doses of levodopa/carbidopa/entacapone (LCE) and levodopa/carbidopa (LC)... CONCLUSIONS: The present results on the differences in levodopa PK between LCE and LC provide a basis to evaluate the relationship of levodopa PK and the induction of motor complications in an on-going study in early Parkinson's disease using similar dosing regimens.

Long-term outcome of early versus delayed rasagiline treatment in early Parkinson's disease. [2009.03.15]
The purpose of this study to compare the long-term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early-start group) or placebo for 6 months followed by rasagiline (delayed-start group) in the TEMPO study...

Levodopa/carbidopa in the treatment of amblyopia. [2009.03]
PURPOSE: To evaluate the role of levodopa/carbidopa in the treatment of amblyopia... CONCLUSION: Levodopa/carbidopa improves visual acuity in patients with amblyopia and maintains improved visual acuity, especially in patients younger than 8 years.

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Clinical Trials Related to Carbidopa and Levodopa (Carbidopa / Levodopa)

Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers [Completed]

Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers [Completed]

Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers [Completed]

Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone Under Fasting Conditions in Healthy Volunteers [Completed]

Efficacy of Levodopa/Carbidopa/Entacapone vs. Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing Off [Active, not recruiting]
The study will evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in patients with Parkinson's disease and early wearing off with levodopa

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Page last updated: 2009-10-20

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