Medical Editor: John P. Cunha, DO, FACOEP
Duopa (carbidopa and levodopa) is a combination of an inhibitor of aromatic amino acid decarboxylation and an aromatic amino acid used to treat motor fluctuations in patients with advanced Parkinson's disease. Common side effects of Duopa include complication of device insertion, nausea, depression, swelling of legs and feet, high blood pressure, upper respiratory tract infection, mouth and throat pain, incision site redness, constipation, involuntary muscle movements, confusion, anxiety, dizziness, sleep problems, fever, rash, diarrhea, and indigestion.
The maximum recommended daily dose of Duopa is 2000 mg of the levodopa component (i.e., one cassette per day) administered over 16 hours. Duopa may interact with MAO inhibitors, high blood pressure medications, phenothiazines, butyrophenones, risperidone, metoclopramide, papaverine, isoniazid, iron salts or multi-vitamins containing iron salts, and high protein diets. Tell your doctor all medications and supplements you use. During pregnancy, Duopa should be administered only if prescribed. This drug may pass into breast milk. Consult your doctor before breastfeeding.
Our Duopa (carbidopa and levodopa) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are discussed below and elsewhere in labeling:
- Gastrointestinal and Gastrointestinal Procedure-Related Risks [see WARNINGS AND PRECAUTIONS]
- Falling Asleep During Activities of Daily Living and Somnolence [see WARNINGS AND PRECAUTIONS]
- Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
- Hallucinations/Psychosis/Confusion [see WARNINGS AND PRECAUTIONS]
- Impulse Control/Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
- Depression and Suicidality [see WARNINGS AND PRECAUTIONS]
- Withdrawal-Emergent Hyperpyrexia and Confusion [see WARNINGS AND PRECAUTIONS]
- Dyskinesia [see WARNINGS AND PRECAUTIONS]
- Neuropathy [see WARNINGS AND PRECAUTIONS]
- Cardiovascular Ischemic Events [see WARNINGS AND PRECAUTIONS]
- Melanoma [see WARNINGS AND PRECAUTIONS]
- Laboratory Test Abnormalities [see WARNINGS AND PRECAUTIONS]
- Glaucoma [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical studies are run under widely varying conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical studies, 416 patients with advanced Parkinson’s disease received DUOPA. 338 patients were treated with DUOPA for more than 1 year, 233 patients were treated with DUOPA for more than 2 years, and 162 patients were treated with DUOPA for more than 3 years.
In a 12-week, active-controlled clinical trial (Study 1), a total of 71 patients with advanced Parkinson’s disease were enrolled and had a PEG-J procedure. Of these, 37 patients received DUOPA and 34 received oral immediate-release carbidopa-levodopa.
The most common adverse reactions for DUOPA (incidence at least 7% greater than oral immediaterelease carbidopa-levodopa) were: complication of device insertion, nausea, depression, peripheral edema, hypertension, upper respiratory tract infection, oropharyngeal pain, atelectasis, and incision site erythema.
Table 3 lists the incidence of adverse reactions occurring in the DUOPA-treated group (requiring at least 2 patients in this group) in Study 1 when the incidence was numerically greater than that for oral immediate-release carbidopa-levodopa.
Table 3. Adverse Reactions in Study 1 for DUOPA in Patients with Advanced Parkinson’s
(n = 37)
|Oral immediate-release carbidopa-levodopaa
(n = 34)
|Complication of device insertion||57||44|
|Incision site erythema||19||12|
|Post procedural discharge||11||3|
|Upper respiratory tract infection||8||0|
|Excessive granulation tissue||5||0|
|White blood cells urine positive||5||0|
|aAll patients in the clinical trial regardless of treatment arm received a PEG-J.|
Procedure And Device- Related Adverse Reactions
The most common adverse reactions associated with complications due to naso-jejunal (NJ) insertion were: oropharyngeal pain, abdominal distention, abdominal pain, abdominal discomfort, pain, throat irritation, gastrointestinal injury, esophageal hemorrhage, anxiety, dysphagia, and vomiting.
The most common adverse reactions associated with complications due to PEG-J insertion were: abdominal pain, abdominal discomfort, abdominal distension, flatulence, or pneumoperitoneum.
Additional adverse reactions that were co-reported with complication of naso-jejunal and PEG-J insertion included upper abdominal pain, duodenal ulcer, duodenal ulcer hemorrhage, erosive duodenitis, erosive gastritis, gastrointestinal hemorrhage, intussusception, peritonitis, post-operative abscess, and small intestine ulcer.
Read the entire FDA prescribing information for Duopa (Carbidopa and Levodopa Enteral Suspension)
© Duopa Patient Information is supplied by Cerner Multum, Inc. and Duopa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.