Stalevo (Carbidopa/Levodopa/Entacapone)

<br><font color = "#666666" size= "1"> *Dispensed from a jurisdiction where Stalevo 050 (Carbidopa, Levodopa, & Entacapone) is approved for sale.</font> <br><br>Stalevo 050 (Carbidopa, Levodopa, & Entacapone) is a new therapy for people with Parkinson's disease (PD). In addition to carbidopa and levodopa (active ingredients in levodopa (active ingredients in Sinemet®*),Stalevo 050 (Carbidopa, Levodopa, & Entacapone) contains entacapone (active ingredient in COMTAN®), a substance that enhances the benefits of levodopa.

Levodopa is the most widely prescribed treatment for PD. In clinical studies, the combination of entacapone, carbidopa, and levodopa provided longer control of PD symptoms compared with carbidopa and levodopa alone. This means that when you take Stalevo (Carbidopa, Levodopa, & Entacapone), you may get more out of your daily activities over a longer period of time.

Stalevo (Carbidopa, Levodopa, & Entacapone) can be used instead of carbidopa/levodopa and COMTAN by patients taking those medicines as separate tablets. Depending on your levodopa dose and side effects, Stalevo 050 (Carbidopa, Levodopa, & Entacapone) can also be used to replace carbidopa/levodopa when the benefits of levodopa aren't lasting as long as they used to.

The most common Stalevo side effects are dopaminergic in nature (eg, dyskinesia, nausea). These Stalevo 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 otherwise they may result in Stalevo side effects. Other common Stalevo side effects include diarrhea, hyperkinesia, urine discoloration, hypokinesia, abdominal pain, dizziness, constipation, fatigue, pain, and hallucinations. Other less frequent Stalevo 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 otherwise they may result in Stalevo side effects. 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. 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).

Levodopa enters the brain and helps replace the missing dopamine, which allows people with PD to function better. That's why your healthcare professional may have prescribed a levodopa therapy for you. By increasing the amount of dopamine in the brain, levodopa helps control PD symptoms and helps you to perform daily activities such as dressing, walking, and handling utensils. How long after starting a levodopa medicine does it begin to wear off? Each person with PD is different, so the timing varies. Most people on levodopa will experience wearing off. Studies have shown that almost half of those taking traditional levodopa will experience wearing off within 1 or 2 years. You may be experiencing wearing off if you have 1 or more of the following symptoms between levodopa doses: Slowness of movement (bradykinesia) Tremors Feeling of internal tremors Decreased manual dexterity Inability to move (akinesia) in the early morning Sudden muscle spasms (dystonia) "Pins and needles" feeling (paresthesia) Pain Shortness of breath Voice softness Constipation How effective is STALEVO? STALEVO extends the benefits of levodopa and can significantly improve the control of Parkinson's symptoms. STALEVO may deliver smoother and steadier levels of levodopa to the brain in an extended, more consistent manner. Clinical studies evaluating the addition of entacapone to carbidopa/levodopa (the 3 ingredients in STALEVO) have shown that the majority of patients have better control of symptoms for longer periods of time each day. How long does it take before STALEVO starts working? For many people, STALEVO begins working right away—often with the first dose—helping to provide more consistent control of symptoms. However, some people may not notice the benefits of STALEVO for a few days. How is STALEVO taken? Your healthcare professional will provide you with specific instructions on how to take STALEVO. If you have any questions or are uncertain about how much STALEVO to take, or when to take it, talk to your healthcare professional. 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 STALEVO 150, containing 37.5 mg carbidopa, 150 mg levodopa, and 200 mg entacapone Only 1 STALEVO tablet should be taken at each scheduled dose. No more than 8 tablets should be taken per day. STALEVO tablets should not be crushed or broken in half.