SINEMET CR SIDE EFFECTS
- Generic Name: carbidopa-levodopa sustained release
- Brand Name: Sinemet CR
- Drug Class: Decarboxylase Inhibitors
SIDE EFFECTS
In controlled clinical trials, patients predominantly with moderate to severe motor fluctuations while on SINEMET were randomized to therapy with either SINEMET or SINEMET CR. The adverse experience frequency profile of SINEMET CR did not differ substantially from that of SINEMET, as shown in Table 1.
Table 1: Clinical Adverse Experiences Occurring in 1% or Greater of Patients
| Adverse Experience | SINEMET CR n=491 % |
SINEMET n=524 % |
| Dyskinesia | 16.5 | 12.2 |
| Nausea | 5.5 | 5.7 |
| Hallucinations | 3.9 | 3.2 |
| Confusion | 3.7 | 2.3 |
| Dizziness | 2.9 | 2.3 |
| Depression | 2.2 | 1.3 |
| Urinary tract infection | 2.2 | 2.3 |
| Headache | 2.0 | 1.9 |
| Dream abnormalities | 1.8 | 0.8 |
| Dystonia | 1.8 | 0.8 |
| Vomiting | 1.8 | 1.9 |
| Upper respiratory infection | 1.8 | 1.0 |
| Dyspnea | 1.6 | 0.4 |
| ‘On-Off’ phenomena | 1.6 | 1.1 |
| Back pain | 1.6 | 0.6 |
| Dry mouth | 1.4 | 1.1 |
| Anorexia | 1.2 | 1.1 |
| Diarrhea | 1.2 | 0.6 |
| Insomnia | 1.2 | 1.0 |
| Orthostatic hypotension | 1.0 | 1.1 |
| Shoulder pain | 1.0 | 0.6 |
| Chest pain | 1.0 | 0.8 |
| Muscle cramps | 0.8 | 1.0 |
| Paresthesia | 0.8 | 1.1 |
| Urinary frequency | 0.8 | 1.1 |
| Dyspepsia | 0.6 | 1.1 |
| Constipation | 0.2 | 1.5 |
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:
Body as a Whole
Asthenia, fatigue, abdominal pain, orthostatic effects.
Cardiovascular
Palpitation, hypertension, hypotension, myocardial infarction.
Gastrointestinal
Gastrointestinal pain, dysphagia, heartburn.
Metabolic
Weight loss.
Musculoskeletal
Leg pain.
Nervous System/Psychiatric
Chorea, somnolence, falling, anxiety, disorientation, decreased mental acuity, gait abnormalities, extrapyramidal disorder, agitation, nervousness, sleep disorders, memory impairment.
Respiratory
Cough, pharyngeal pain, common cold.
Skin
Rash.
Special Senses
Blurred vision.
Urogenital
Urinary incontinence.
Laboratory Tests
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:
Cardiovascular
Cardiac irregularities, syncope.
Gastrointestinal
Taste alterations, dark saliva.
Hypersensitivity
Angioedema, urticaria, pruritus, bullous lesions (including pemphigus-like reactions).
Nervous System/Psychiatric
Increased tremor, peripheral neuropathy, psychotic episodes including delusions and paranoid ideation, pathological gambling, increased libido including hypersexuality, impulse control symptoms.
Skin
Alopecia, flushing, dark sweat.
Urogenital
Dark urine.
Other adverse reactions that have been reported with levodopa alone and with various carbidopa levodopa formulations and may occur with SINEMET CR are:
Cardiovascular
Phlebitis.
Gastrointestinal
Gastrointestinal bleeding, development of duodenal ulcer, sialorrhea, bruxism, hiccups, flatulence, burning sensation of tongue.
Hematologic
Hemolytic and non-hemolytic anemia, thrombocytopenia, leukopenia, agranulocytosis.
Hypersensitivity
Henoch-Schönlein purpura.
Metabolic
Weight gain, edema.
Nervous System/Psychiatric
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.
Skin
Malignant melanoma, increased sweating.
Special Senses
Oculogyric crises, mydriasis, diplopia.
Urogenital
Urinary retention, priapism.
Miscellaneous
Faintness, hoarseness, malaise, hot flashes, sense of stimulation, bizarre breathing patterns.
Laboratory Tests
Abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), bilirubin, Coombs test, uric acid.
SRC: NLM .