Carbidopa Entacapone Levodopa

Carbidopa, Entacapone, and Levodopa is a combination medicine used to treat Parkinson’s symptoms such as muscle stiffness, tremors, spasms, and poor muscle control. 

• Carbidopa, Entacapone, and Levodopa are available under various brand names: Stalevo 100, Stalevo 125, Stalevo 150, Stalevo 200, Stalevo 50, Stalevo 75 

Common side effects of Carbidopa, Entacapone, and Levodopa include:

• involuntary muscle movement.
• diarrhea.
• nausea, vomiting, stomach pain.
• discolored urine; or
• dry mouth.

Serious side effects of Carbidopa, Entacapone, and Levodopa include:

• hives. 
• difficulty breathing. 
• swelling of your face, lips, tongue, or throat.
• 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.
• 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.
• daytime sleepiness and drowsiness.
• increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine.
• sweat, urine, or saliva appears dark in color, such as red, brown, or black. 

Rare side effects of Carbidopa, Entacapone, and Levodopa include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 5 0mg/12.5 mg/200 mg
• 75 mg/18.75 mg/200 mg
• 100 mg/25 mg/200 mg
• 125 mg/31.25 mg/200 mg
• 150 mg/37.5 mg/200 mg
• 200 mg/50 mg/200 mg

Parkinson disease: 

Adult dosage

• Oral: Dose should be individualized based on therapeutic response; doses may be adjusted by changing strength or adjusting interval.
• Fractionated doses are not recommended and only 1 tablet should be given at each dosing interval. 
• maximum daily dose: 8 tablets of Stalevo 50, 75, 100, 125, or 150, or 6 tablets of Stalevo 200. 
• Patients receiving below 70 to 100 mg of the carbidopa component may experience nausea and vomiting.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Carbidopa, Entacapone, and Levodopa have severe interactions with the following drugs:
  • isocarboxazid
  • lonafarnib
  • phenelzine
  • phenelzine
  • procarbazine
  • selegiline
  • selegiline transdermal
  • tranylcypromine
• Carbidopa, Entacapone, and Levodopa have serious interactions with at least 29 other drugs.
• Carbidopa, Entacapone, and Levodopa have moderate interactions with at least 167 other drugs.
• Carbidopa, Entacapone, and Levodopa have minor interactions with at least 21 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to carbidopa, entacapone, or levodopa.
• 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. 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Carbidopa, Entacapone, and Levodopa?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Carbidopa, Entacapone, and Levodopa?”

Cautions

• 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.
• People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Ask your doctor about skin symptoms to watch for.
• Avoid driving or hazardous activity until you know how this medicine 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.

Pregnancy and Lactation

• Tell your doctor if you are pregnant. 
• There are no adequate data on developmental risk associated with use of drug in pregnant women
• Lactation
  • Tell your doctor if you are breastfeeding.
  • Levodopa has been detected in human milk after administration of carbidopa-levodopa; there are no data on presence of entacapone or carbidopa in human milk, effects of levodopa, carbidopa, or entacapone on breastfed infant, or on milk production; however, inhibition of lactation may occur because levodopa decreases secretion of prolactin; carbidopa and entacapone are excreted in rat milk; in lactating rat, oral administration of radiolabeled entacapone resulted in levels of entacapone and/or metabolites in milk up to 2 to 3 times that in plasma;
  • Consider developmental and health benefits of breastfeeding along with mother’s clinical need for drug and any potential adverse effects on breastfed infant or from underlying maternal condition