Carbidopa, entacapone, and levodopa (Stalevo) is a combination medicine used to treat Parkinson symptoms such as muscle stiffness, tremors, spasms, and poor muscle control.

Stalevo may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have narrow-angle glaucoma.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Swallow the tablet whole and do not crush, chew, or break it.

Take only a single tablet at each dosing time. Do not take more than 1 tablet at a time or take a portion of a broken tablet. Combining more than one tablet or tablet portions may cause an overdose.

Take your doses at regular intervals to keep a steady amount of the drug in your body at all times. Ask your doctor about whether you should take Stalevo with or without food.

Tell your doctor if the effects of this medicine seem to wear off quickly in between doses.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated from vomiting or diarrhea. Drink plenty of liquids if you are ill.

Do not take any other medications for Parkinson's disease that your doctor has not prescribed.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Stalevo.

Do not stop using Stalevo suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Parkinson's Disease:

Converting from Carbidopa, Levodopa, and Entacapone:
-Switch to combination tablet that provides equivalent dose

Converting from Carbidopa and Levodopa:
-Patients with moderate to severe dyskinesias taking levodopa doses of 600 mg or more are likely to require a reduction in levodopa dose when entacapone is added
-Titrate patients to a dose using separate carbidopa/levodopa tablets plus entacapone, then switch to corresponding single combination tablet
-When less levodopa is required, reduce dose by either decreasing tablet strength or extending time between doses

Concomitant Administration with Other Anti-Parkinson Drugs:
-Dose adjustment of concomitant medications or this drug may be needed

MAXIMUM DAILY DOSE:
-Stalevo(R) 50, 75, 100, 125 and 150: Do not exceed 8 tablets in 24-hours
-Stalevo (R) 200: Do not exceed 6 tablets in 24-hours

Comments:
-Conversions from carbidopa/levodopa are based on carbidopa/levodopa products combined in a 1:4 ratio; there is no experience switching patients from products that are not combined in a 1:4 ratio or from extended-release formulations.
-Optimum dose should be determined by careful titration; therapy should be individualized and adjusted according to the desired therapeutic response.

Use: For the treatment of Parkinson's disease:
--As a substitute for equivalent strengths of each component;
--Or to replace carbidopa/levodopa therapy in patients experiencing signs and symptoms of end-of-dose "wearing-off" when the total daily dose of levodopa is 600 mg or less and dyskinesias are not present.

You should not take carbidopa, entacapone, and levodopa if you are allergic to carbidopa, entacapone, or levodopa, or if you have:

• narrow-angle glaucoma.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you have ever had:

• glaucoma;

• depression or other mental illness;

• a stomach ulcer; or

• liver disease.

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Ask your doctor about skin symptoms to watch for.

Tell your doctor if you are pregnant or breastfeeding.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include rapid heartbeats and feeling light-headed.

Avoid driving or hazardous activity until you know how carbidopa, entacapone, and levodopa will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid taking iron supplements without your doctor's advice. Also avoid increasing the amount of protein in your diet (protein sources include meat, eggs, and cheese). Taking iron or eating too much protein can make it harder for your body to digest and absorb Stalevo.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Carbidopa, entacapone, and levodopa may cause serious side effects. Call your doctor at once if you have:

• worsening symptoms such as tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

• depressed mood, thoughts about hurting yourself;

• hallucinations, unusual behaviors;

• severe nausea and vomiting;

• severe or ongoing diarrhea, diarrhea that is watery;

• unexplained muscle pain, tenderness, or weakness;

• a light-headed feeling, like you might pass out;

• fluid build-up in or around the lungs--pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold, clammy skin, anxiety, rapid heartbeats; or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats.

carbidopa, entacapone, and levodopa may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.

Common side effects of carbidopa, entacapone, and levodopa may include:

• involuntary muscle movement;

• diarrhea;

• nausea, vomiting, stomach pain;

• discolored urine; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Stalevo with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can affect Stalevo. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.