Resources
Explore helpful resources
For your practice
Review the access and educational materials below to better support your practice.
Access Tip Sheet
See useful suggestions for writing a Letter of Medical Necessity, Letter of Appeal, or Letter of Medical Exception.
Letter of Medical Necessity
Download and utilize this sample Letter of Medical Necessity to help your patients obtain authorization for CREXONT® (carbidopa and levodopa) extended-release capsules. This comprehensive template can help streamline the process for your office staff.
Letter of Appeal
Download this Letter of Appeal template to assist in reversing a payer denial for CREXONT.
Letter of Medical Exception
When CREXONT is nonformulary with your patient’s insurance, download this sample Letter of Medical Exception to request coverage based on their clinical needs.
Latest formulary wins!
Amneal is working with insurers to include CREXONT on their formularies, making it available to more patients
CVS and Aetna
Dosing and educational resources
See the dosing and online resources below.
The Expert Institute for Parkinson's Disease
Discover a robust online resource about PD with insights from experts in the field.
CD/LD=carbidopa/levodopa; IR=immediate-release; PD=Parkinson’s disease.
For your patients
Share these materials with your patients to help them learn about CREXONT.
Considering CREXONT Brochure
Help your patients learn essential details about how CREXONT works and how it may benefit them.
Newsletter: THRIVE
Tell your patients about the THRIVE newsletters, which cover topics for people living with PD and their care partners.
Connect with Amneal to ask questions
IMPORTANT SAFETY INFORMATION
Indications and Usage
CREXONT® (carbidopa and levodopa) extended-release capsules for oral use is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults.Dosage and Administration
- Levodopa-naïve patients: Starting dose is 35 mg carbidopa/140 mg levodopa taken orally twice daily for the first three days; thereafter, dosage may be increased gradually as needed
- For patients converting to CREXONT from immediate-release carbidopa/levodopa, dosages are not substitutable on a 1:1 basis. See full prescribing information Section 2.2 for instructions
- For patients converting from Rytary® (carbidopa and levodopa) extended-release capsules, initiate CREXONT on an approximately 1:1 mg basis using the levodopa component for conversion
- CREXONT may be taken up to four times daily. The maximum recommended daily dosage is 525 mg carbidopa/2100 mg levodopa
- CREXONT may be taken with or without food. Capsules should not be chewed, divided or crushed
- CREXONT should not be taken with alcohol
Contraindications
Nonselective MAO inhibitors.Warnings and Precautions
- CREXONT may cause falling asleep during activities of daily living, somnolence or dizziness. Patients should avoid activities that require alertness such as driving and operating machinery until they know how CREXONT affects them
- It is important to avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal symptoms such as high fever or confusion. Patients who are discontinuing CREXONT should taper off with healthcare provider guidance
- Consider dose reductions or stopping CREXONT in patients with hallucinations or impulse control disorders (e.g., gambling, sexual urges, or uncontrolled spending)
- Consider dose reduction in patients with dyskinesia
- Patients with a major psychotic disorder should not be treated with CREXONT
- Monitor patients with a history of cardiovascular disease for cardiac function
- Monitor patients with a history of peptic ulcer for upper GI hemorrhage
- Monitor patients with glaucoma for increased intraocular pressure
Adverse Reactions
The most common adverse reactions (incidence ≥ 3% and greater than immediate-release CD/LD) are nausea and anxiety.Drug Interactions
Iron salts and dopamine D2 antagonists, including metoclopramide, may reduce the effectiveness of CREXONT.Use in Specific Populations
Pregnancy: Based on animal data, CREXONT may cause fetal harm. There are no adequate data on the developmental risk associated with the use of CREXONT in pregnant women.Breastfeeding: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CREXONT.
Geriatric patients: There were no differences in safety outcomes between patients less than 65 years of age, 65-75 years of age, or 75 years and older.
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 see full Prescribing Information for CREXONT.
Content is for guidance only. Please use clinical judgment when prescribing CREXONT. Dosage is individualized for each patient.
