CREXONT

The pharmacokinetics of CREXONT were evaluated following single doses in healthy subjects and following single and multiple doses in patients with Parkinson’s disease. CREXONT shows dose proportional pharmacokinetics for both carbidopa and levodopa over the carbidopa/levodopa dosage strength range of 35 mg/140 mg to 87.5 mg/350 mg.

AbsorptionCarbidopa Following oral dosing of CREXONT, the maximum concentration occurred at approximately 2.5 hours. The bioavailability of carbidopa from CREXONT re...

The effectiveness of CREXONT for the treatment of Parkinson’s disease was established in an active-controlled, multicenter, 20-week clinical trial (Study 1; NCT03670953). Study 1 consisted of a 3-week dose adjustment period of immediate-release carbidopa-levodopa treatment prior to a 4-week conversion period to CREXONT, which was followed by a 13-week, double-blind, double-dummy, randomized, parallel group period comparing CREXONT to immediate-release carbidopa-levodopa. Study 1 enrolled 630 (506 randomized) patients (Hoehn & Yahr Stages I-IV) who had been maintained on a stable regimen of at ...

The following serious adverse reactions are discussed below and elsewhere in the labeling: Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.1) ] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.2) ] Cardiovascular Ischemic Events [see Warnings and Precautions (5.3) ] Hallucinations/Psychosis [see Warnings and Precautions (5.4) ] Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.5) ] Dyskinesia [see...

CREXONT is contraindicated in patients currently taking a nonselective monoamine oxidase (MAO) inhibitor or have recently (within 2 weeks) taken a nonselective MAO inhibitor. Hypertension can occur if these drugs are used concurrently [see Drug Interactions (7.1) ] . Nonselective MAO inhibitors (4)

May cause falling asleep during activities of daily living. ( 5.1 ) Avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal-emergent hyperpyrexia and confusion. ( 5.2 ) Cardiovascular Events: Monitor patients with a history of cardiovascular disease. ( 5.3 ) Hallucinations/Psychosis may occur. ( 5.4 ) Impulse Control Disorders: Consider dose reduction or stopping CREXONT if occurs. ( 5.5 ) May cause or exacerbate dyskinesia: Consider dose reduction. ( 5.6 ) 5.1 Fall...

7 DRUG INTERACTIONS Iron salts and dopamine D2 antagonists, including metoclopramide, may reduce the effectiveness of CREXONT. ( 7.2 , 7.3 ) 7.1 Monoamine Oxidase (MAO) Inhibitors Nonselective MAO Inhibitors The use of nonselective MAO inhibitors (e.g., phenelzine and tranylcypromine) with CREXONT is contraindicated [see Contraindications (4) ] . Discontinue use of any nonselective MAO inhibitors ...