Levodopa has been detected in human milk. Caution should be exercised when carbidopa and levodopa extended-release tablet is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established. Use of the drug in patients below the age of 18 is not recommended.
In the clinical efficacy trials for carbidopa and levodopa tablets, almost half of the patients were older than 65, but few were older than 75. No overall meaningful differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals to adverse drug reactions such as hallucinations cannot be ruled out. There is no specific dosing recommendation based upon clinical pharmacology data as carbidopa and levodopa tablets and carbidopa and levodopa extended-release tablets are titrated as tolerated for clinical effect.
In controlled clinical trials, patients predominantly with moderate to severe motor fluctuations while on carbidopa and levodopa tablets were randomized to therapy with either carbidopa and levodopa tablets or carbidopa and levodopa extended-release tablets. The adverse experience frequency profile of carbidopa and levodopa extended-release tablets did not differ substantially from that of carbidopa and levodopa, as shown in Table 1.
Table 1: Clinical Adverse Experiences Occurring in 1% or Greater of Patients
|Carbidopa and Levodopa Extended-Release Tablets n=491||Carbidopa and Levodopa Tablets n=524|
|Urinary tract infection||2.2||2.3|
|Upper respiratory infection||1.8||1|
Abnormal laboratory findings occurring at a frequency of 1% or greater in approximately 443 patients who received carbidopa and levodopa extended-release tablets and 475 who received carbidopa and levodopa tablets 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 carbidopa and levodopa extended-release tablets, listed by body system in order of decreasing frequency, include:
Body as a Whole
Asthenia, fatigue, abdominal pain, orthostatic effects.
Palpitation, hypertension, hypotension, myocardial infarction.
Gastrointestinal pain, dysphagia, heartburn.
Chorea, somnolence, falling, anxiety, disorientation, decreased mental acuity, gait abnormalities, extrapyramidal disorder, agitation, nervousness, sleep disorders, memory impairment.
Cough, pharyngeal pain, common cold.
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 carbidopa and levodopa extended-release tablets:
Cardiac irregularities, syncope.
Taste alterations, dark saliva.
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.
Alopecia, flushing, dark sweat.
Other adverse reactions that have been reported with levodopa alone and with various carbidopa levodopa formulations and may occur with carbidopa and levodopa extended-release tablets are:
Gastrointestinal bleeding, development of duodenal ulcer, sialorrhea, bruxism, hiccups, flatulence, burning sensation of tongue.
Hemolytic and non-hemolytic anemia, thrombocytopenia, leukopenia, agranulocytosis.
Weight gain, edema.
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.
Malignant melanoma (see also CONTRAINDICATIONS), increased sweating.
Oculogyric crises, mydriasis, diplopia.
Urinary retention, priapism.
Faintness, hoarseness, malaise, hot flashes, sense of stimulation, bizarre breathing patterns.
Abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), bilirubin, Coombs test, uric acid.
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