STALEVO

STALEVO is the brand name for carbidopa, levodopa and entacapone and is available as an oral tablet.

STALEVO is available as STALEVO 50 (12.5 mg per 50 mg per 200 mg), STALEVO 75 (18.75 mg per 75 mg per 200 mg), STALEVO 100 (25 mg per 100 mg per 200 mg), STALEVO 125 (31.25 mg per 125 mg per 200 mg), STALEVO 150 (37.5 mg per 150 mg per 200 mg), and STALEVO 200 (50 mg per 200 mg per 200 mg) oral tablets.

STALEVO is a dopa decarboxylase inhibitor / dopamine replacement / COMT inhibitor and is used to treat Parkinson’s disease (PD).

STALEVO is a combination of three medications: carbidopa, levodopa, and entacapone. By working together, these medications help relieve symptoms of Parkinson’s disease (PD), which occur due to low dopamine levels in the brain. Levodopa is a dopamine replacement.

Levodopa travels into your brain, where it’s converted into dopamine. It helps relieve PD symptoms by restoring dopamine in your brain. Carbidopa is a dopa decarboxylase inhibitor and entacapone is a catechol-O-methyltransferase (COMT) inhibitor.

Dopa decarboxylase and COMT are proteins in your body that break down levodopa before it can travel into your brain. By blocking these proteins, carbidopa and entacapone prevent levodopa from breaking down.

This raises the level of levodopa in your body and allows more levodopa to travel into your brain to be converted into dopamine. Levodopa and dopamine can then reach and remain at higher levels in your brain, which enhances the medications’ ability to relieve PD symptoms.

STALEVO is dosed on your response to your previous medication regimen for PD.

For people previously taking Sinemet (carbidopa / levodopa) tablets plus an entacapone (Comtan) tablet: The dose will typically stay the same. You can switch directly to the combination tablet that contains the same amount of carbidopa, levodopa, and entacapone.

For people previously taking Sinemet (carbidopa / levodopa) tablets alone: You will typically start taking entacapone (Comtan) tablets along with your Sinemet (carbidopa / levodopa) tablets. Your provider will slowly adjust your dose until your PD symptoms are controlled. Once they find a dose that works for you, they will prescribe a Stalevo tablet that matches this dose.

STALEVO is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if you are taking a nonselective monoamine oxidase (MAO) inhibitor or have narrow-angle glaucoma.

Common side effects of STALEVO:

• Involuntary movements
• Nausea
• Muscle spasms
• Diarrhea
• Changes in the color of your urine
• Slow muscle movement
• Stomach pain
• Dizziness
• Vomiting
• Dry mouth

Serious side effects are rare with STALEVO. Contact your healthcare provider immediately if you experience any of the following.

• Neuroleptic malignant syndrome (NMS): very high fevers, confusion, irregular pulse, sweating, muscle stiffness, changes in blood pressure
• Severe muscle damage (rhabdomyolysis): muscle aches, soreness, cramping, dark-colored urine

The following medications may interact with STALEVO:

• Drugs metabolized by COMT: use with caution.
• Anti-hypertensive agents: dose adjustment may be required
• Tricyclic antidepressants: risk of hypertension and dyskinesia reported
• during concomitant use with carbidopa/levodopa.
• Dopamine D2 receptor antagonists, isoniazid, phenytoin, papaverine and iron salts: may reduce efficacy of STALEVO
• Drugs that interfere with biliary excretion, glucuronidation and intestinal beta-glucuronidase: dose adjustment of STALEVO may be required
• Drugs metabolized by CYP2C9 (e.g., coumadin): dose adjustment of STALEVO may be required; monitor INR when initiating STALEVO in patients on coumadin

Orion Pharma

Based on animal data, STALEVO may cause fetal harm. You should talk to your healthcare provider before taking this medication if you are pregnant. STALEVO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.