Medication Safety Issues
Sound-alike/look-alike issues:
Sinemet may be confused with Janumet, Serevent
International issues:
Zimox: Brand name for carbidopa and levodopa [Greece], but also the brand name for amoxicillin [Italy]
Zimox [Greece] may be confused with Diamox which is a brand name for acetazolamide [Canada and multiple international markets]
Storage/Stability
Oral formulations: Store at 25?C (77?F); excursions permitted between 15?C to 30?C (59?F to 86?F). Protect from light and moisture.
Intestinal suspension (Duopa): Store in freezer at -20?C (-4?F). Fully thaw in refrigerator at 2?C to 8?C (36?F to 46?F) prior to use; protect from light. To ensure controlled thawing, remove the cartons containing the seven individual cassettes from the transport box and separate the cartons from each other. Assign a 12-week, use-by date based on the time the cartons are put in the refrigerator to thaw (may take up to 96 hours to thaw). Once thawed, the individual cartons may be packed in a closer configuration within the refrigerator. Cassettes are for single use only and should be discarded daily following infusion (up to 16 hours). Do not re-use opened cassettes.
Intestinal gel (Duodopa [Canadian product]): Store in refrigerator at 2?C to 8?C (36?F to 46?F). Keep in outer carton to protect from light. Cassettes are for single use only and should be discarded daily following infusion (up to 16 hours).
Adverse Reactions
>10%:
Cardiovascular: Orthostatic hypotension (enteral suspension: 70% to 73%; oral: 1% to 5%)
Central nervous system: Dizziness (2% to 19%), headache (oral : 1% to 17%), depression (enteral suspension: 11%; oral: 1% to 2%)
Gastrointestinal: Nausea (enteral suspension: 30%; oral: 3% to 20%), constipation (enteral suspension: 22%; oral: ?6%)
Neuromuscular & skeletal: Dyskinesia (2% to 17%), increased creatine phosphokinase (enteral suspension: ?17%)
Renal: Increased blood urea nitrogen (enteral suspension: ?13%)
1% to 10%:
Cardiovascular: Hypertension (enteral suspension: 8%), peripheral edema (enteral suspension: 8%), ischemia (oral: ?2%), chest pain (oral: ?1%)
Central nervous system: Insomnia (oral: 1% to 9%), anxiety (2% to 8%), confusion (2% to 8%), abnormal dreams (oral: ?6%), polyneuropathy (enteral suspension: 5%), sleep disorder (enteral suspension: 5%), hallucination (?5%), psychosis (?5%), dystonia (oral: ?2%), on-off phenomenon (oral: 1% to 2%), paresthesia (oral: ?1%)
Dermatologic: Skin rash (enteral suspension: 5%)
Endocrine & metabolic: Increased serum glucose (?1%)
Gastrointestinal: Xerostomia (oral: 1% to 7%), diarrhea (?5%), dyspepsia (?5%), vomiting (oral: 2% to 5%), anorexia (oral: 1%)
Genitourinary: Bacteriuria (enteral suspension: 5%; oral: ?1%), urinary tract infection (oral: 2%), hematuria (oral: ?1%), urinary frequency (oral: ?1%)
Hematologic & oncologic: Leukocyturia (enteral suspension: 5%; oral: ?1%), decreased hematocrit (oral: ?1%), decreased hemoglobin (oral: ?1%)
Neuromuscular & skeletal: Back pain (oral: ?2%), muscle cramps (oral: ?1%), shoulder pain (oral: ?1%)
Respiratory: Atelectasis (enteral suspension: 8%), oropharyngeal pain (enteral suspension: 8%), upper respiratory tract infection (enteral suspension: 8%; oral: 1% to 2%), dyspnea (oral: ?2%)
Miscellaneous: Fever (enteral suspension: 5%)
<1%, postmarketing, and/or case reports: Abdominal distress, abdominal pain, abnormal behavior, abnormal gait, abnormality in thinking, agitation, agranulocytosis, alopecia, anemia, angioedema, asthenia, ataxia, blepharospasm, blurred vision, bruxism, bullous rash (including pemphigus-like reactions), cardiac arrhythmia, common cold, cough, decreased mental acuity, decreased serum potassium, delirium, delusions, dementia, diaphoresis, diplopia, discoloration of saliva, discoloration of sweat, disorientation, drowsiness, duodenal ulcer, dysgeusia, dysphagia, edema, euphoria, extrapyramidal reaction, falling, fatigue, flatulence, flushing, gastrointestinal hemorrhage, glossopyrosis, glycosuria, heartburn, hemolytic anemia, Henoch-Schonlein purpura, hiccups, hoarseness, Horner syndrome (reactivation), hot flash, hypotension, impulse control disorder, increased lactate dehydrogenase, increased libido (including hypersexuality), increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate transaminase, increased serum bilirubin, increased tremors, increased uric acid, leukopenia, lower extremity pain, malaise, malignant melanoma, memory impairment, muscle twitching, mydriasis, myocardial infarction, narcolepsy, nervousness, neuroleptic malignant syndrome, nightmares, numbness, oculogyric crisis, palpitations, paranoia, pathological gambling, peripheral neuropathy, phlebitis, positive direct Coombs test, priapism, proteinuria, pruritus, seizure, sense of stimulation, sialorrhea, suicidal ideation, suicidal tendencies, syncope, thrombocytopenia, trismus, urinary incontinence, urinary retention, urine discoloration, urticaria, weight gain, weight loss
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