Crexont Dosage

2.1 Dosage in Patients Naïve to Levodopa Therapy

The recommended starting dosage of CREXONT in levodopa-naïve patients is 35 mg carbidopa / 140 mg levodopa taken orally twice daily for the first three days. Thereafter, dosage may be increased gradually as needed to a maximum daily dosage of 525 mg carbidopa / 2100 mg levodopa divided up to four times daily.

Dosage in Patients Converting from Immediate-Release Carbidopa-Levodopa to CREXONT

The dosages of immediate-release carbidopa-levodopa products are not substitutable on a 1:1 basis with the dosages of CREXONT.

To convert patients from immediate-release carbidopa-levodopa to CREXONT, follow these steps:

Step 1: Determine the patient’s total daily dosage of immediate-release levodopa.

Step 2: Determine the patient’s most frequent single dose of immediate-release levodopa. If more than one dose corresponds to the most frequent, use the highest of the doses.

Step 3: Find the values from Step 1 and Step 2 in Table 1 (below) to determine the recommended starting CREXONT dosage of levodopa and dosing frequency.

Step 4: After one to three days, adjust the dose or frequency as needed based on the patient’s clinical response and tolerability. Dosage may be increased gradually as needed to a maximum daily dosage of 525 mg carbidopa / 2100 mg levodopa divided up to four times daily.

Table 1: Conversion from Immediate-Release Carbidopa-Levodopa to CREXONT

For patients currently treated with carbidopa and levodopa plus a catechol-O-methyl transferase (COMT) inhibitor (e.g., entacapone or opicapone), the initial total daily dose of levodopa in CREXONT may need to be increased if the COMT inhibitor is discontinued.

Use of CREXONT in combination with other levodopa products has not been studied.

Dosage for Patients Converting from Extended-Release Carbidopa-Levodopa (Rytary) to CREXONT

For patients converting from RYTARY (extended-release carbidopa-levodopa), initiate CREXONT on an approximately 1:1 mg basis using the levodopa component for conversion.

2.4 Administration Information

Swallow CREXONT whole with or without food. CREXONT should not be taken with alcohol. A high-fat, high-calorie meal may delay the absorption of levodopa to reach the peak plasma concentration by about 2 hours.

Do not chew, divide, or crush CREXONT capsules.

2.5 Discontinuation of CREXONT

Avoid sudden discontinuation or rapid dose reduction of CREXONT. The daily dose of CREXONT should be tapered at the time of treatment discontinuation.