Sixteen patients completed the study. Additionally, mean value of Cmax for levodopa was increased by 24% in elderly patients (≥ 65 yr) compared to young patients (< 65 yr) (see The AUC of carbidopa was increased in elderly subjects (n=10, 65-76 yr) by 29% compared to young subjects (n=24, 23-64 yr) following IV administration of 50 mg levodopa with carbidopa (50 mg). It is important that SINEMET CR be taken at regular intervals according to the schedule outlined by the physician. �U��N9zf���o�r@��AMP�����ב��

1895 37 0000007210 00000 n There was a decrease in the number of live pups delivered by rats receiving approximately two times the maximum recommended human dose of carbidopa and approximately five times the maximum recommended human dose of levodopa during organogenesis. The adverse experience frequency profile of SINEMET CR did not differ substantially from that of SINEMET, as shown in Table 1.Abnormal laboratory findings occurring at a frequency of 1% or greater in approximately 443 patients who received SINEMET CR and 475 who received SINEMET during controlled clinical trials included: decreased hemoglobin and hematocrit; elevated serum glucose; white blood cells, bacteria and blood in the urine.The adverse experiences observed in patients in uncontrolled studies were similar to those seen in controlled clinical studies.Other adverse experiences reported overall in clinical trials in 748 patients treated with SINEMET CR, listed by body system in order of decreasing frequency, include:Asthenia, fatigue, abdominal pain, orthostatic effects.Palpitation, hypertension, hypotension, myocardial infarction.Chorea, somnolence, falling, anxiety, disorientation, decreased mental acuity, gait abnormalities, extrapyramidal disorder, agitation, nervousness, sleep disorders, memory impairment.Decreased white blood cell count and serum potassium; increased BUN, serum creatinine and serum LDH; protein and glucose in the urine.The following adverse experiences have been reported in postmarketing experience with SINEMET CR:Angioedema, urticaria, pruritus, bullous lesions (including pemphigus-like reactions).Increased tremor, peripheral neuropathy, psychotic episodes including delusions and paranoid ideation, pathological gambling, increased libido including hypersexuality, impulse control symptoms.Other adverse reactions that have been reported with levodopa alone and with various carbidopa levodopa formulations and may occur with SINEMET CR are:Gastrointestinal bleeding, development of duodenal ulcer, sialorrhea, bruxism, hiccups, flatulence, burning sensation of tongue.Hemolytic and non-hemolytic anemia, thrombocytopenia, leukopenia, agranulocytosis.Ataxia, depression with suicidal tendencies, dementia, euphoria, convulsions (however, a causal relationship has not been established); bradykinetic episodes, numbness, muscle twitching, blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time), trismus, activation of latent Horner's syndrome, nightmares.Faintness, hoarseness, malaise, hot flashes, sense of stimulation, bizarre breathing patterns.Abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), bilirubin, Coombs test, uric acid.Management of acute overdosage with SINEMET CR is the same as with levodopa.
Caution should be exercised when interpreting the plasma and urine levels of catecholamines and their metabolites in patients on levodopa or carbidopa levodopa therapy. xref

Consider discontinuing SINEMET CR in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.). The occurrence of dyskinesias may require dosage reduction.Hallucinations and psychotic-like behavior have been reported with dopaminergic medications. It is designated chemically as (—)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Note: although not in the package insert, the drug has a coating that is intended to release the drug over approximately 3 hours. Symptomatic postural hypotension has occurred when carbidopa levodopa preparations were added to the treatment of patients receiving some antihypertensive drugs. 0000009875 00000 n It belongs to a class of drugs known as azole antifungals.

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