INDICATIONS AND USAGE（适应症）

Dopalevo is indicated for the treatment of Parkinson's disease.

Dopalevo can be used:

To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products.

To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.

DOSAGE（服用剂量）

Dopalevo should be used as a substitute for patients already stabilized on equivalent doses of carbidopa/levodopa and entacapone. However, some patients who have been stabilized on a given dose of carbidopa/levodopa may be treated with Dopalevo if a decision has been made to add entacapone (see below). Therapy should be individualized and adjusted according to the desired therapeutic response.

The optimum daily dosage of Dopalevo must be determined by careful titration in each patient.

Clinical experience with daily doses above 1,600 mg of entacapone is limited. The maximum recommended daily dose of Dopalevo depends on the strength used. The maximum number of tablets to be used in a 24-hour period is less with the highest strength (Dopalevo 200) than with lower strengths. Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 mg per day to 100 mg per day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting.

Converting Patients from Carbidopa, Levodopa, and Entacapone to Dopalevo

Patients currently treated with entacapone 200 mg with each dose of non-extended release carbidopa/levodopa tablet, can switch to the corresponding strength of Dopalevo containing the same amounts of levodopa and carbidopa. For example, patients receiving one tablet of carbidopa/levodopa 25 mg/100 mg and one tablet of entacapone 200 mg at each administration can switch to a single Dopalevo 100 tablet (containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone).

Converting Patients from Carbidopa and Levodopa Products to Dopalevo

There is no experience in transferring patients currently treated with extended release formulations of carbidopa/levodopa, or carbidopa/levodopa products that are not combined in a 1:4 ratio of carbidopa to levodopa.

Patients with a history of moderate or severe dyskinesias or taking more than 600 mg of the levodopa component per day are likely to require a reduction in their daily levodopa dose when entacapone is added. Because dose adjustment of the individual carbidopa or levodopa component is not possible with fixed-dose products, initially titrate patients to a dose that is tolerated and that meets their individual therapeutic need using a separate carbidopa/levodopa tablet (1:4 ratio) plus an entacapone tablet. Once the patient's individual dose of carbidopa/levodopa plus entacapone dose has been established using two separate tablets; switch the patient to a corresponding single tablet of Dopalevo.

When less levodopa is required, reduce the total daily dosage of carbidopa/levodopa either by decreasing the strength of Dopalevo at each administration or by decreasing the frequency of administration by extending the time between doses.

ADVERSE REACTIONS（不良反应）

Falling Asleep During Activities of Daily Living and Somnolence

Hypotension/Orthostatic Hypotension and Syncope

Dyskinesia

Depression and suicidality

Hallucinations/Psychotic-Like Behavior

Impulse Control and/or Compulsive Behaviors

Withdrawal-Emergent Hyperpyrexia and Confusion

Diarrhea and Colitis

Rhabdomyolysis

Peptic Ulcer Disease

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/5edfc3e7-f80d-47ee-897a-c02ff4eb3e74/spl-doc?hl=Stalevo

Dopalevoinformation