Stalevo

Stalevo is a prescription medication used to treat symptoms of Parkinson's disease. Parkinson's symptoms, including tremors (shaking), stiffness, and slowness of movement, are caused by a lack of dopamine, a natural substance usually found in the brain.

It is a single product containing 3 medications: levodopa, carbidopa, and entacapone. Levodopa is in a class of medications called central nervous system agents. It is converted to dopamine in the brain. Carbidopa is in a class of medications called decarboxylase inhibitors. It works by preventing levodopa from being broken down before it reaches the brain. Entacapone belongs to a class of drugs called catechol-O-methyltransferase (COMT) inhibitors. It works by allowing more of the levodopa and carbidopa to reach the brain. It reduces the "wearing-off" symptoms at the end of the carbidopa/levodopa dose.

This combination medication comes in regular (immediate-release) tablet forms to be taken by mouth. The dose is individualized on the basis of a patient's symptoms. It may be taken up to 8 times a day, with or without food.

Common side effects include nausea, diarrhea, abdominal pain, votiming, dry mouth, and abnormal movements.

Stalevo can cause drowsiness, dizziness, and blurred vision. Do not drive or operate heavy machinery until you know how Stalevo affects you.

Stalevo is a prescription medication used to treat symptoms of Parkinson's disease.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Serious side effects have been reported with Stalevo. See the "Stalevo Precautions" section.

Common side effects include:

• dizziness
• nausea
• vomiting
• loss of appetite
• diarrhea
• dry mouth constipation
• changes in sense of taste
• forgetfulness or confusion
• nervousness
• nightmares
• difficulty sleeping
• headaches
• weakness
• increased sweating
• drowsiness
• abnormal or impaired movement

This is not a complete list of Stalevo side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medications you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ampicillin
• antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
• antihistamines
• apomorphine (Zydis)
• bitolterol (Tornalate)
• chloramphenicol (AK-Chlor, Chloromycetin)
• cholestyramine (Cholybar, Questran, Questran Light, others)
• dobutamine (Dobutrex)
• epinepehrine (AsthmaHaler, EpiPen Auto-Injector, Primatene Mist, others)
• erythromycin (E-Mycin, E-Base, E.E.S., others)
• haloperidol (Haldol)
• ipratropium (Atrovent)
• iron pills and vitamins containing iron
• isocarboxazid (Marplan)
• isoetharine (Aldomet)
• isoniazid (INH, Nydrazid)
• medications for high blood pressure, irritable bowel disease, mental illness, motion sickness, nausea, ulcers, or urinary problems
• metoclopramide (Reglan)
• papaverine (Pavabid)
• phenelzine (Nardil)
• phenytoin (Dilantin)
• probenicid (Benemid)
• rasagiline (Azilect)
• rifampin (Rifadin, Rimactane)
• risperidone (Risperdal)
• selegiline (Eldepryl)
• sleeping pills or other medications that cause sleepiness
• tranylcypromine (Parnate)

This is not a complete list of Stalevo drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Stalevo.

• difficulty breathing
• hallucinations
• high fever
• confusion
• muscle stiffness
• weakness
• falling asleep during activities of daily living
• changes in blood pressure
• irregular heartbeat
• problems with impulse control
• increased risk of skin cancer (melanoma)

Stalevo can cause drowsiness, dizziness, and blurred vision. Do not drive or operate heavy machinery until you know how Stalevo affects you.

Do not take Stalevo if you:

• are allergic to Stalevo or any of its ingredients
• are taking or have recently stopped taking a monoamine oxidase inhibitor (MAOI)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Stalevo, there are no specific foods that you must exclude from your diet when receiving this medication.

However, tell your doctor if you plan on changing your diet to include foods that are high in protein, such as meat, poultry, and dairy products, since these foods can affect the way your body uses the medication.

Before taking Stalevo, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Stalevo or to any of its ingredients
• have or have had glaucoma
• have or have had melanoma (skin cancer) or a skin growth that has not been diagnosed
• have or have had hormone problems
• have asthma or emphysema
• have mental illess
• have diabetes
• have or have had ulcers
• have had a heart attack
• have an irregular heart beat
• have blood vessel, heart, kidney, liver, or lung disease
• are pregnant or breastfeeding
• have phenylketonuria
• have a history of alcoholism

Tell your doctor about all the medicines you take inclyding prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when medication is taken during pregnancy.

Stalevo falls into category C. In animal stidues, pregnancy animals were given this medication and had some babies born with problems. No well-controlled studies have bene done in humans. Therefore, this medication may be used if the potential benefits to the mother outweight the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Levodopa, one of the components of Stalevo, has been detected in human breast milk. It is not known if carbidopa and entacapone are excreted in human breast milk. Caution should be exercised when Sinemet is given to a nursing woman. 

Take Stalevo exactly as prescribed.

This combination medication comes in regular (immediate-release) tablet form to be taken by mouth. It may be taken up to 8 times a day, depending on the dosage of carbidopa/levodopa. Stalevo may be taken with or without food.

Do not crush, chew, or break Stalevo tablets. Swallow tablets whole.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Stalevo at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of Stalevo will depend on the dose of carbidopa/levodopa that you are taking.

If you take too much Stalevo, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Stalevo is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

• Store Stalevo at room temperature.
• Keep this and all medications out of the reach of children.