Carbidopa, entacapone, and levodopa

Carbidopa, entacapone, and levodopa (Stalevo) is a combination medicine that helps treat symptoms of Parkinson's disease, including muscle stiffness, tremors, spasms, and difficulty with muscle control.

Stalevo may also be used for reasons not mentioned in this medication guide.

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

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

Take only one tablet at each dosing time. Do not take more than 1 tablet at a time or take part of a broken tablet. Taking more than one tablet or parts of a tablet may lead to an overdose.

Take your doses at regular times to maintain a steady level of the drug in your body. Ask your doctor if you should take Stalevo with food or on an empty stomach.

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

Call your doctor if you experience vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated due to vomiting or diarrhea. Drink plenty of fluids if you are unwell.

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

This medicine can affect the results of certain medical tests. Inform any doctor treating you that you are using Stalevo.

Do not stop using Stalevo suddenly, as it may cause 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.

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

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

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 taken 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.

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 right away 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, watery diarrhea;
• unexplained muscle pain, tenderness, or weakness;
• feeling light-headed, 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 happens.

You may notice that your sweat, urine, or saliva is dark in color, such as red, brown, or black. This is not a harmful side effect, but it may stain 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.

Usual Adult Dose for Parkinson's Disease:

Converting from Carbidopa, Levodopa, and Entacapone: -Switch to combination tablet that provides equivalent doseConverting 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 dosesConcomitant Administration with Other Anti-Parkinson Drugs: -Dose adjustment of concomitant medications or this drug may be neededMAXIMUM 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.

Take the medicine as soon as you remember, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same 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 doing dangerous activities until you know how carbidopa, entacapone, and levodopa will affect you. Your reactions could be impaired. Avoid getting up too quickly from a sitting or lying position, or you may feel dizzy.

Do not take iron supplements without your doctor's advice. Also, do not increase 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.

Using Stalevo with other medications that cause drowsiness can make this effect stronger. Consult your doctor before taking opioid medication, a sleeping pill, a muscle relaxer, or medication for anxiety or seizures.

Many medications can interact with Stalevo. This includes both prescription and over-the-counter medicines, vitamins, and herbal products. Not all potential interactions are included here. Inform your doctor about all your current medications and any new medications you start or stop using.