Stalevo

The active ingredients in Stalevo are carbidopa, levodopa, and entacapone. Carbidopa is a dopa decarboxylase inhibitor, levodopa is a dopamine replacement, and entacapone is a catechol-O-methyltransferase (COMT) inhibitor. In individuals with Parkinson's disease, the brain does not have enough dopamine, which makes it hard for people to move their bodies the way they want to. Levodopa helps increase the levels of dopamine in the brain, while carbidopa and entacapone block enzymes so that more levodopa can get to the brain and turn into dopamine.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Stalevo. However, the following is a synopsis of the general guidelines for the use of Stalevo:

• Take this medication exactly as directed by your physician.
• Each time you take Stalevo, take only one tablet. Taking more than one at a time increases your risk of side effects.
• You can take Stalevo with or without food. However, avoid taking it with a meal high in fat, calories, or protein. This can slow down how fast your body absorbs the medication.

The most common side effects of Stalevo seen in clinical trials include:

• Involuntary movements (dyskinesia).
• Abdominal pain.
• Nausea.
• Diarrhea.
• Vomiting.
• Dry mouth.
• Drowsiness.
• Changes in the color of your urine.
• Dizziness.

Some individuals may experience serious side effects while using Stalevo. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Withdrawal symptoms after treatment changes - high fevers, sweating, confusion, irregular pulse, muscle stiffness, changes in breathing.
• Rhabdomyolysis - soreness, muscle pain, and muscle cramps.
• Depression and suicidal thoughts.
• Severe allergic reaction - hives, itching, swelling, rash, and trouble breathing.
• Orthostatic hypotension - dizziness, lightheadedness, and fainting.
• Hallucinations.
• Compulsive behaviors.
• Serious eye problems - sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Diarrhea - dehydration, weight loss, and low potassium levels.

These are not all of the possible side effects of Stalevo. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Stalevo, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Mental health or behavioral problems (psychosis).
• Peptic ulcer.
• Colitis.
• Sleep problems.
• Other movement disorders.
• Eye problems.
• Neuroleptic malignant syndrome (NMS).
• Low blood pressure (hypotension).
• Hepatic (liver) problems.
• Unusual urges.

• Previous allergic reaction/hypersensitivity to levodopa, carbidopa, or entacapone, or any of the other ingredients of Stalevo.
• Narrow-angle glaucoma.
• Currently taking a nonselective monoamine oxidase inhibitor (MAOI).

Stalevo starts to work about 30 minutes after your first dose.

When Stalevo is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Nonselective MAO inhibitor (monoamine oxidase inhibitor) within the past 2 weeks (phenelzine, tranylcypromine).
• Epinephrine.
• Methyldopa.
• Apomorphine.
• Tricyclic antidepressant (amitriptyline, nortriptyline).
• Antipsychotic medication.
• Isoniazid or rifampin.
• Phenytoin.
• Papaverine.
• Iron supplements or other products (multivitamins) containing iron.
• Probenecid.
• Bile acid sequestrant (cholestyramine).
• Erythromycin.
• Other medication that causes dizziness and sleepiness (prescription pain medicines, sleep medicines, medicines for anxiety).
• Other medications containing carbidopa or levodopa.

Stalevo tablets are film-coated and come in the following strengths:

• Stalevo 50:12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone.
• Stalevo 75: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone.
• Stalevo 100: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone.
• Stalevo125: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone.
• Stalevo 150: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone.
• Stalevo 200: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone.

Store this medication at room temperature and keep it out of reach of children.

Orion Corporation is the pharmaceutical company that manufactures Stalevo.

There are no lower-cost generics available for the brand-name Stalevo.

Do not stop or adjust your use of this medication without first consulting with your doctor. It may be necessary to reduce the dose of Stalevo gradually to prevent side effects and the effects of the medication from “wearing off” and keep the symptoms of Parkinson's disease from worsening.

It is unknown if or how Stalevo could affect pregnancy or harm an unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Levodopa, one of the medicines in carbidopa/levodopa/entacapone, is known to pass into breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.