Stalevo

What is Stalevo?

Stalevo is a prescription medicine that is used to treat Parkinson’s disease.

Description

Stalevo is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease.

Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α- hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C₁₀H₁₄N₂O₄·H₂ O, and its structural formula is:

Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3.

Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C₉H₁₁NO₄, and its structural formula is:

Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl- 2-propenamide. Its empirical formula is C₁₄H₁₅N₃O₅ and its structural formula is:

Stalevo is supplied as tablets in 6 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

Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Stalevo 50, Stalevo 100, and Stalevo 150 also contain yellow iron oxide.

Before taking Stalevo, tell your doctor:

• If you are allergic to Stalevo; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Glaucoma, a skin lump or growth, or a history of skin cancer.
• If you have taken certain drugs for depression or Parkinson’s disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Stalevo with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Stalevo?

• Tell all of your health care providers that you take Stalevo. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Stalevo affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Stalevo.
• This medicine may “wear off” as the time for your next dose gets closer. Tell your doctor if this happens and it bothers you.
• It may take a few months to see the full effect.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• The chance of a type of skin cancer called melanoma may be raised in people with Parkinson’s disease. It is not known if Stalevo may also raise the chance. Have skin exams while you take Stalevo. Talk with your doctor.
• A dark color (red, brown, or black) may show up in your saliva, urine, or sweat. This is not harmful but may discolor your clothes.
• If diarrhea or throwing up happens, talk with the doctor. You will need to make sure to avoid dehydration and electrolyte problems.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Stalevo while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Stalevo best taken?

Use Stalevo as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Swallow whole. Do not chew, break, or crush.
• If you take an iron product or a multivitamin that has iron, ask your doctor or pharmacist how to take it with Stalevo. Iron may lower how well your body is able to absorb Stalevo.
• Diets high in protein, fat, or calories may lower how well your body absorbs Stalevo; tell your doctor if you have a diet like this or if you will be changing your diet. Talk with your doctor.
• Do not stop taking Stalevo all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop Stalevo, you will want to slowly stop it as ordered by your doctor.
• Keep taking Stalevo even when you are not having symptoms.
• Keep a diary of your signs.
• Keep taking Stalevo as you have been told by your doctor or other health care provider, even if you feel well.
• Take Stalevo at the same time of day.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Stalevo that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• Change in how you act.
• Hallucinations (seeing or hearing things that are not there).
• Very bad dizziness or passing out.
• Feeling confused.
• Very upset stomach or throwing up.
• Severe diarrhea.
• Diarrhea that will not go away.
• Throwing up blood or throw up that looks like coffee grounds.
• Black, tarry, or bloody stools.
• Very bad belly pain.
• Muscle pain or weakness.
• A skin lump or growth.
• Change in color or size of a mole.
• Strong urges that are hard to control (such as eating, gambling, sex, or spending money).
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• Chest pain or pressure.
• Shortness of breath.
• Fever or chills.
• Sore throat.
• Any unexplained bruising or bleeding.
• Some people have fallen asleep during activities like driving, eating, or talking. Some people did not feel sleepy and felt alert right before falling asleep. This has happened up to 1 year after Stalevo was started. If you fall asleep during activities, do not drive or do other tasks or actions that call for you to be alert while you take Stalevo. Call your doctor right away if this happens or you feel very sleepy.
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.

What are some other side effects of Stalevo?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Diarrhea.
• Constipation.
• Dizziness.
• Feeling sleepy.
• Dry mouth.
• Headache.
• Not able to sleep.
• Upset stomach or throwing up.
• Back pain.
• Belly pain.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Stalevo?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

SRC: NLM .