Safety - Crexont Site

	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

Double-blind phase

CREXONT (n=589)

CREXONT (n=256)

IR CD/LD (n=250)

Nausea

Anxiety

0.0%

Dizziness

Dyskinesia

0.4%

Constipation

0.4%

Headache

Vomiting

Insomnia

0.4%

	CREXONT (n=589)
Nausea	5%
Anxiety	2%
Dizziness	3%
Dyskinesia	7%
Constipation	2%
Headache	2%
Vomiting	2%
Insomnia	2%

CREXONT (n=589)

Nausea

Anxiety

Dizziness

Dyskinesia

Constipation

Headache

Vomiting

Insomnia

	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%

CREXONT (n=256)

IR CD/LD (n=250)

Nausea

Anxiety

Dizziness

Dyskinesia

0.4%

Constipation

0.4%

Headache

Vomiting

Insomnia

0.4%

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.

Your doctor should evaluate vitamin B6 levels before and during treatment with carbidopa/levodopa therapies as seizures associated with low levels of vitamin B6 have been reported. Traditional anti-seizure medications were not effective, and seizures were only resolved after vitamin B6 administration. Other symptoms of vitamin B6 deficiency include depression, confusion, cracked corners of the mouth, swollen tongue, skin inflammation, low red blood cell count, and/or numbness, tingling, or weakness in the extremities. Your doctor may advise you to take vitamin B6 as necessary.

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

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Global Patient Safety at 1-877- 835-5472, or 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 was generally well-tolerated

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

Helpful support and resources for CREXONT

INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

CREXONT was generally well-tolerated

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

Helpful support and resources for CREXONT

INDICATION

IMPORTANT SAFETY INFORMATION

Está a punto de abandonar nuestro sitio.

You are now leaving this site