PARCOPA SUMMARY
PARCOPA®
(carbidopa-levodopa orally disintegrating tablets)
RX ONLY
PARCOPA™ (carbidopa-levodopa orally disintegrating tablets) is a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. PARCOPA™ is an orally administered formulation of carbidopa-levodopa which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.
PARCOPA™ is indicated in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. PARCOPA™ 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-levodopa than with levodopa. However, patients with markedly irregular ("on-off") responses to levodopa have not been shown to benefit from carbidopa-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-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 PARCOPA™ 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-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 Parcopa (Carbidopa / Levodopa)
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.
Efficacy of levodopa and carbidopa on visual function in patients with non-arteritic anterior ischaemic optic neuropathy. [2005.03]
The benefit of levodopa and carbidopa therapy in improving visual function in patients with non-arteritic anterior ischaemic neuropathy (NAION) was evaluated. Twenty-four subjects with NAION were randomly selected to receive either levodopa-carbidopa or a placebo... Levodopa and carbidopa had no therapeutic effect on visual recovery in our patients with NAION.
Randomized controlled pilot trial of cabergoline, hydergine and levodopa/carbidopa: Los Angeles Cocaine Rapid Efficacy Screening Trial (CREST). [2005.03]
AIM: This study tested three dopaminergic medications against a common unmatched placebo condition: hydergine 1 mg three times daily (n = 15); levodopa/carbidopa 25/100 mg three times daily (n = 15); cabergoline 0.5 mg per week (n = 15); and placebo three times daily (n = 15) as potential pharmacotherapies for cocaine dependence... CONCLUSIONS: These results, combined with the apparent safety of cabergoline when used with this population, provide empirical support for conducting a larger study of the medication.
Treatment of end-of-dose wearing-off in parkinson's disease: stalevo (levodopa/carbidopa/entacapone) and levodopa/DDCI given in combination with Comtess/Comtan (entacapone) provide equivalent improvements in symptom control superior to that of traditional levodopa/DDCI treatment. [2005]
The aim of this study was to evaluate the efficacy of the new optimised levodopa, Stalevo (levodopa, carbidopa and entacapone) in patients with Parkinson's disease experiencing end-of-dose wearing-off. Treatment with Stalevo was compared to treatment with traditional immediate-release levodopa and dopa-decarboxylase inhibitor (DDCI) formulations along with adjunct entacapone (Comtess/Comtan)...
Concurrent administration of donepezil HCl and levodopa/carbidopa in patients with Parkinson's disease: assessment of pharmacokinetic changes and safety following multiple oral doses. [2004.11]
AIM: The use of acetylcholinesterase inhibitors for the treatment of comorbid Alzheimer's disease in Parkinson's disease (PD) patients stabilized on a levodopa regimen may potentially disrupt cholinergic balance. This randomized, double-blind, crossover study investigated the safety of, and possible drug-drug interaction between, donepezil HCl and levodopa/carbidopa... CONCLUSIONS: No clinically significant drug-drug interactions between donepezil HCl and levodopa/carbidopa were observed at steady state. The small changes in the pharmacokinetics of levodopa did not result in any change in motor symptoms. Co-administration of the two drugs led to a small increase in adverse events compared with administration of levodopa/carbidopa alone in PD patients. These adverse events, however, were consistent with donepezil's cholinomimetic effect, and their incidence was comparable to that observed following the administration of donepezil HCl alone.
Clinical Trials Related to Parcopa (Carbidopa / Levodopa)
A Single Center, Randomized, Double-Blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease [Completed]
To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a
faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single
dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease.
Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are
eligible if taking a stable dose of < 200 mg carbidopa and < 2000 mg levodopa daily. At both
treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or
conventional) are administered. The dose is the same as the subject's prestudy regimen. The
primary efficacy variable, time to onset of action, is the first postdose time when a 30%
decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by
a rater blinded to the active treatment received by the subject.
Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study [Recruiting]
To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth,
works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.
A Multicenter, Open-Label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease [Completed]
The objective of this trial was to assess subject preference for PARCOPA, carbidopa/levodopa
Orally Disintegrating Tablets (ODT), compared with conventional carbidopa/levodopa tablets,
in subjects with stable Parkinson's disease.
Comparison of IPX054, Immediate-Release Carbidopa-Levodopa, and Controlled-Release Carbidopa-Levodopa in Subjects With Parkinson's Disease [Recruiting]
The objective of this study is to compare the pharmacokinetics and pharmacodynamics of
IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa
controlled-release tablets in subjects with idiopathic Parkinson's disease.
A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy Subjects [Completed]
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Page last updated: 2009-10-20
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