Carbidopa/levodopa sustained-release capsule instructions and marketing details

[drug name]

Common name: Carbidopa/L-dopa sustained-release capsules

English name: carbidopa and levodopa

Product name:CREXONT

【Indications】

Carbidopa/Levodopa sustained-release capsules are mainly used to treat the following diseases:

1.Parkinson's disease: Used to improve the motor symptoms of patients with Parkinson's disease, such as tremor, muscle stiffness, bradykinesia and postural instability.

2.Parkinson's syndrome: used to treat Parkinson's syndrome caused by encephalitis, carbon monoxide or manganese poisoning.

[Drug ingredients and mechanism of action]

Carbidopa/Levodopa extended-release capsules are composed of two active ingredients:

1.Levodopa (Levodopa): Levodopa is the precursor of dopamine. It can enter the brain through the blood-brain barrier and be converted into dopamine in the brain, thereby supplementing the lack of dopamine in the brains of patients with Parkinson's disease and improving motor function.

2.Carbidopa (Carbidopa): Carbidopa is a peripheral dopa decarboxylase inhibitor that can inhibit the peripheral metabolism of levodopa and reduce its conversion into dopamine, thereby increasing the proportion of levodopa entering the brain and reducing peripheral side effects (such as nausea, vomiting, etc.).

And the design of sustained-release capsules allows the drug to be slowly released in the gastrointestinal tract, thereby extending the duration of drug efficacy, reducing the number of medication doses, and stabilizing blood drug concentration.

【Usage and Dosage】

Usually start with a low dose and gradually adjust based on the patient's condition and tolerance. The recommended initial dose for adults is 1 capsules 1 times a day (carbidopa 25mg/levodopa 100mg). According to the patient's response, the dose can be gradually increased, usually the daily dose does not exceed 8 tablets (carbidopa200mg/L-dopa800mg).

Sustained-release capsules should be swallowed whole and should not be chewed or crushed. It is recommended to take them with meals to reduce gastrointestinal discomfort. If a dose is missed, it should be taken as soon as possible, but if it is close to the time of the next dose, skip the missed dose and do not double the dose.

【Adverse reactions】

1.Common adverse reactions: uncontrolled muscle movement, dry mouth, anxiety, headache, dizziness, drop in blood pressure, insomnia, strange dreams, muscle contraction, nausea, vomiting, constipation, etc., mostly mild to moderate.

2.Serious adverse reactions:

Stomach bleeding: bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Allergic reaction: hives, difficulty breathing, swelling of face, lips, tongue, or throat.

Nervous system reactions: Very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeat, shaking, feeling like you might pass out.

Psychiatric symptoms: Depression, anxiety, panic attacks, sleep problems, impulsivity, irritability, agitation, aggression, talkativeness, thoughts of suicide or harming yourself.

3.Risk of long-term use:Long-term use may lead to"End-of-dose phenomenon" (gradual weakening of drug effect) or "switching phenomenon" (sudden worsening or relief of symptoms).

【Notes】

1.Contraindications:

Contraindicated for those allergic to carbidopa or levodopa.

Use with caution in patients with narrow-angle glaucoma, severe cardiovascular disease, or mental illness.

2.Special groups:

Pregnant and lactating women: The safety has not yet been determined and should be used under the guidance of a doctor.

Elderly patients: The dose needs to be adjusted carefully to avoid adverse reactions.

3.Drug interactions:

Concomitant use with monoamine oxidase inhibitors (MAOIs) may result in hypertensive crisis.

Concomitant use with antipsychotics may reduce the efficacy of levodopa.

4.Monitoring and adjustment:

Long-term use requires regular monitoring of liver and kidney function, blood routine and electrocardiogram.

Adjust dosage according to changes in condition and adverse reactions.

Carbidopa/levodopa sustained-release capsules, are currently available in the United States with approval from the U.S. Food and Drug Administration (FDA) on August 7, 2024. Due to the short time on the market, specific price information has not been clear yet. Patients can pay attention to the official website of the FDA or relevant pharmaceutical news to obtain the latest updates.

Reference link: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217186s000lbl.pdf