safety

CREXONT was generally well-tolerated

Side effects that occurred in ≥2% of participants while switching from IR CD/LD to CREXONT and also occurred at a higher rate than IR CD/LD in the double-blind part of the study

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%
0.0%
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 was studied for over a year in adults with Parkinson’s disease, which established its well-understood safety profile

Indication & Important Safety Information

INDICATION

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.

IMPORTANT SAFETY INFORMATION

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:

  • Have any heart conditions, especially if you have had a heart attack or irregular heartbeats
  • Experience hallucinations or abnormal thoughts and behaviors
  • Have an inability to control urges to gamble, have increased sexual urges, or experience other intense urges
  • Have thoughts of suicide or have attempted suicide
  • Have abnormal involuntary movements that appear or get worse during treatment
  • Have ever had a peptic ulcer or glaucoma
  • Become or intend to become pregnant. Based on animal data, CREXONT may cause fetal harm
  • Are breastfeeding during therapy

INDICATION

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.

Indication & Important Safety Information

INDICATION

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.

IMPORTANT SAFETY INFORMATION

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:

  • Have any heart conditions, especially if you have had a heart attack or irregular heartbeats
  • Experience hallucinations or abnormal thoughts and behaviors
  • Have an inability to control urges to gamble, have increased sexual urges, or experience other intense urges
  • Have thoughts of suicide or have attempted suicide
  • Have abnormal involuntary movements that appear or get worse during treatment
  • Have ever had a peptic ulcer or glaucoma
  • Become or intend to become pregnant. Based on animal data, CREXONT may cause fetal harm
  • Are breastfeeding during therapy

INDICATION

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.