STALEVO® (carbidopa, levodopa and entacapone) tablets are indicated to treat patients with idiopathic Parkinson's disease:

1. To substitute (with equivalent strength of each of the 3 components) for immediate-release carbidopa/levodopa and entacapone previously administered as individual products.
   
   
2. To replace immediate-release carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing off" (only for patients taking a total daily dose of levodopa of 600 mg or less and not experiencing dyskinesia).

STALEVO is supplied as tablets in 3 strengths: STALEVO 50, containing 12.5 mg carbidopa, 50 mg levodopa, and 200 mg entacapone; STALEVO 100, containing 25 mg carbidopa, 100 mg levodopa, and 200 mg entacapone; and STALEVO 150, containing 37.5 mg carbidopa, 150 mg levodopa, and 200 mg entacapone.

STALEVO is contraindicated for use concomitantly with nonselective monoamine oxidase (MAO) inhibitors, with selegiline at doses >10 mg/day, in patients with narrow-angle glaucoma, and in patients with suspicious, undiagnosed skin lesions or a history of melanoma.

Because STALEVO contains entacapone, it should not be used concurrently with COMTAN® (entacapone).

The most common side effects of STALEVO therapy are dopaminergic in nature (eg, dyskinesia, nausea). These side effects may be manageable with alteration in the drug-dosing schedule, ie, extending the dosing interval, reducing the number of doses per day, or changing to a STALEVO strength containing less levodopa. However, rapid withdrawal or abrupt reduction of STALEVO therapy should be avoided.

Other common side effects include diarrhea, hyperkinesia, urine discoloration, hypokinesia, abdominal pain, dizziness, constipation, fatigue, pain, and hallucinations.

Other less frequent side effects can include: other mental disturbances, orthostatic hypotension, rhabdomyolysis, severe diarrhea, dark saliva, and symptoms resembling neuroleptic malignant syndrome.

Drugs metabolized by the COMT enzymes (eg, isoproterenol, epinephrine) should be used with caution in patients receiving STALEVO.

STALEVO should be used with caution in patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, and in patients with a history of myocardial infarction or peptic ulcer.

For more information about STALEVO, please read the full prescribing information.