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SAFETY
| Switching from IR CD/LD to CREXONT | Double-blind phase | ||
|---|---|---|---|
| CREXONT (n=589) | CREXONT (n=256) | IR CD/LD (n=250) | |
| Nausea | 5% | 4% | 1% |
| Anxiety | 2% | 3% | 0.0% |
| Dizziness | 3% | 2% | 1% |
| Dyskinesia | 7% | 2% | 0.4% |
| Constipation | 2% | 2% | 0.4% |
| Headache | 2% | 1% | 0% |
| Vomiting | 2% | 1% | 0% |
| Insomnia | 2% | 1% | 0.4% |
Switching from IR CD/LD to Crexont
| CREXONT (n=589) | |
|---|---|
| Nausea | 5% |
| Anxiety | 2% |
| Dizziness | 3% |
| Dyskinesia | 7% |
| Constipation | 2% |
| Headache | 2% |
| Vomiting | 2% |
| Insomnia | 2% |
Double-blind phase
| CREXONT (n=256) | IR CD/LD (n=250) | |
|---|---|---|
| Nausea | 4% | 1% |
| Anxiety | 3% | 0% |
| Dizziness | 2% | 1% |
| Dyskinesia | 2% | 0.4% |
| Constipation | 2% | 0.4% |
| Headache | 1% | 0% |
| Vomiting | 1% | 0% |
| Insomnia | 1% | 0.4% |
Established safety profile
CREXONT® (carbidopa and levodopa) extended-release capsules is a prescription medication for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults.
Do not take CREXONT with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors.
Do not take CREXONT with other carbidopa-levodopa preparations without consulting your healthcare provider.
CREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. Avoid activities that require alertness such as driving and operating machinery until you know how CREXONT affects you.
The most common side effects that may occur with CREXONT are nausea and anxiety.
It is important to avoid sudden discontinuation or rapid dose reduction of CREXONT. If you are discontinuing CREXONT, work with your healthcare provider to taper the dose over time to reduce the risk of fever or confusion.
You may take CREXONT with or without food, but taking it with food may decrease or delay its effect. Consider taking the first dose of the day about 1 to 2 hours before eating.
Swallow CREXONT whole. Do not chew, divide, or crush the capsules.
Do not take CREXONT with alcohol.
Tell your healthcare provider if you:
CREXONT® (carbidopa and levodopa) extended-release capsules is a prescription medication for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals, LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please read the full Prescribing Information. For more information talk to your healthcare provider.
CREXONT® (carbidopa and levodopa) extended-release capsules is a prescription medication for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults.
Do not take CREXONT with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors.
Do not take CREXONT with other carbidopa-levodopa preparations without consulting your healthcare provider.
CREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. Avoid activities that require alertness such as driving and operating machinery until you know how CREXONT affects you.
The most common side effects that may occur with CREXONT are nausea and anxiety.
It is important to avoid sudden discontinuation or rapid dose reduction of CREXONT. If you are discontinuing CREXONT, work with your healthcare provider to taper the dose over time to reduce the risk of fever or confusion.
You may take CREXONT with or without food, but taking it with food may decrease or delay its effect. Consider taking the first dose of the day about 1 to 2 hours before eating.
Swallow CREXONT whole. Do not chew, divide, or crush the capsules.
Do not take CREXONT with alcohol.
Tell your healthcare provider if you:
CREXONT® (carbidopa and levodopa) extended-release capsules is a prescription medication for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals, LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please read the full Prescribing Information. For more information talk to your healthcare provider.
CREXONT® is a registered trademark of Amneal Pharmaceuticals LLC. © 2024 Amneal Pharmaceuticals LLC.
Distributed by Amneal Specialty, a division of Amneal Pharmaceuticals LLC.
All rights reserved. PP-IPX203-US-0026 08/2024
This is intended for residents of the United States only. Any product discussed herein may have different product labeling in different countries. Please read the full Prescribing Information and discuss it with your doctor or healthcare professional.
