"The US Food and Drug Administration (FDA) has approved an extended-release capsule formulation of carbidopa-levodopa (Rytary, IPX066, Impax Pharmaceuticals) for the treatment of Parkinson's disease (PD), postencephalitic parkinsonism, an"...
The patient should be informed that SINEMET is an immediate-release formulation of carbidopa-levodopa that is designed to begin release of ingredients within 30 minutes. It is important that SINEMET (carbidopa-levodopa) be taken at regular intervals according to the schedule outlined by the physician. The patient should be cautioned not to change the prescribed dosage regimen and not to add any additional antiparkinson medications, including other carbidopa-levodopa preparations, without first consulting the physician.
Patients should be advised that sometimes a 'wearing-off effect may occur at the end of the dosing interval. The physician should be notified if such response poses a problem to lifestyle.
Patients should be advised that occasionally, dark color (red, brown, or black) may appear in saliva, urine, or sweat after ingestion of SINEMET (carbidopa-levodopa) . Although the color appears to be clinically insignificant, garments may become discolored.
The patient should be advised that a change in diet to foods that are high in protein may delay the absorption of levodopa and may reduce the amount taken up in the circulation. Excessive acidity also delays stomach emptying, thus delaying the absorption of levodopa. Iron salts (such as in multivitamin tablets) may also reduce the amount of levodopa available to the body. The above factors may reduce the clinical effectiveness of the levodopa or carbidopa-levodopa therapy.
Patients should be alerted to the possibility of sudden onset of sleep during daily activities, in some cases without awareness or warning signs, when they are taking dopaminergic agents, including levodopa. Patients should be advised to exercise caution while driving or operating machinery and that if they have experienced somnolence and/or sudden sleep onset, they must refrain from these activities. (See PRECAUTIONS, General.)
There have been reports of patients experiencing intense urges to gamble, increased sexual urges, and other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone and that are generally used for the treatment of Parkinson's disease, including SINEMET (carbidopa-levodopa) . Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges or other urges while being treated with SINEMET (carbidopa-levodopa) . Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges, or other intense urges while taking SINEMET (carbidopa-levodopa) . Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking SINEMET (carbidopa-levodopa) .
NOTE: The suggested advice to patients being treated with SINEMET (carbidopa-levodopa) is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
Last reviewed on RxList: 3/28/2011
This monograph has been modified to include the generic and brand name in many instances.
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