"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 most common adverse reactions reported with SINEMET (carbidopa-levodopa) have included dyskinesias, such as choreiform, dystonic, and other involuntary movements, and nausea.
The following other adverse reactions have been reported with SINEMET (carbidopa-levodopa) :
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Psychotic episodes including delusions, hallucinations, and paranoid ideation, neuroleptic malignant syndrome (NMS, see WARNINGS), bradykinetic episodes ("on-off" phenomenon), confusion, agitation, dizziness, somnolence, dream abnormalities including nightmares, insomnia, paresthesia, headache, depression with or without development of suicidal tendencies, dementia, pathological gambling, increased libido including hypersexuality, impulse control symptoms. Convulsions also have occurred; however, a causal relationship with SINEMET (carbidopa-levodopa) has not been established.
Urinary tract infection, urinary frequency, dark urine.
Decreased hemoglobin and hematocrit; abnormalities in alkaline phosphatase, SCOT (AST), SGPT (ALT), lactic dehydrogenase, bilirubin, blood urea nitrogen (BUN), Coombs test; elevated serum glucose; white blood cells, bacteria, and blood in the urine.
Other adverse reactions that have been reported with levodopa alone and with various carbidopa-levodopa formulations, and may occur with SINEMET (carbidopa-levodopa) are:
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Ataxia, extrapyramidal disorder, falling, anxiety, gait abnormalities, nervousness, decreased mental acuity, memory impairment, disorientation, euphoria, blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time), trismus, increased tremor, numbness, muscle twitching, activation of latent Homer's syndrome, peripheral neuropathy.
Pharyngeal pain, cough.
Read the Sinemet (carbidopa-levodopa) Side Effects Center for a complete guide to possible side effects
Caution should be exercised when the following drugs are administered concomitantly with SINEMET (carbidopa-levodopa) .
Symptomatic postural hypotension occurred when SINEMET (carbidopa-levodopa) was added to the treatment of a patient receiving antihypertensive drugs. Therefore, when therapy with SINEMET (carbidopa-levodopa) is started, dosage adjustment of the antihypertensive drug may be required.
For patients receiving MAO inhibitors (Type A or B), see CONTRAINDICATIONS. Concomitant therapy with selegiline and carbidopa-levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa-levodopa alone (see CONTRAINDICATIONS).
Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and isoniazid may reduce the therapeutic effects of levodopa. In addition, the beneficial effects of levodopa in Parkinson's disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with SINEMET (carbidopa-levodopa) should be carefully observed for loss of therapeutic response.
Iron salts may reduce the bioavailability of levodopa and carbidopa. The clinical relevance is unclear.
Although metoclopramide may increase the bioavailability of levodopa by increasing gastric emptying, metoclopramide may also adversely affect disease control by its dopamine receptor antagonistic properties.
Read the Sinemet Drug Interactions Center for a complete guide to possible interactions
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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