Stalevo

DRUG DESCRIPTION

Stalevo® (carbidopa, levodopa and entacapone) 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-(?-hydrazino-(?-methyl-?-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4•H2O, and its structural formula is

Carbidopa Structural Formula Illustration

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-?-amino-?-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is

Entacapone, an inhibitor of catechol-O-methyltransferase (COMT), 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® (carbidopa, levodopa and entacapone) is supplied as tablets in six strengths: Stalevo (carbidopa, levodopa and entacapone) ® 50, containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone; Stalevo (carbidopa, levodopa and entacapone) ® 75, containing 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone; Stalevo (carbidopa, levodopa and entacapone) ® 100, containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone; Stalevo (carbidopa, levodopa and entacapone) ® 125, containing 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone; Stalevo (carbidopa, levodopa and entacapone) ® 150, containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone; Stalevo (carbidopa, levodopa and entacapone) ® 200, containing 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone.

The inactive ingredients of the Stalevo (carbidopa, levodopa and entacapone) ® tablet are corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Stalevo (carbidopa, levodopa and entacapone) ® 50, Stalevo (carbidopa, levodopa and entacapone) ® 100, and Stalevo (carbidopa, levodopa and entacapone) ® 150 also contain yellow iron oxide.

What are the possible side effects of carbidopa, entacapone, and levodopa?

You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • nausea, sweating, feeling like you might pass out (especially when you first start...

Read All Potential Side Effects and See Pictures of Stalevo »

What are the precautions when taking carbidopa, levodopa and entacapone (Stalevo)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow-angle).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, glaucoma (wide-angle), breathing problems, heart disease (especially history of heart attack), kidney disease, ulcers, mental/mood disorders (e.g., depression, schizophrenia), blood disorders.

To minimize dizziness and...

Read All Potential Precautions of Stalevo »


Stalevo Consumer (continued)

SIDE EFFECTS: Diarrhea, nausea, vomiting, headache, dizziness, drowsiness, stomach upset, loss of appetite, dry mouth, or difficulty sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: involuntary movements (especially twitching of the eyelid), fainting or falling, difficulty swallowing, stomach/abdominal pain, persistent diarrhea, vision changes (including blurred vision).

Tell your doctor immediately if any of these unlikely but serious side effects occur: black/tarry stools, muscle pain, change in the amount of urine, mental/mood changes (such as confusion, hallucinations, thoughts of suicide, compulsive behavior including urge to gamble), signs of infection (e.g., persistent sore throat).

Seek immediate medical attention if any of these highly unlikely but very serious side effects occur: chest pain, high fever, severe muscle stiffness, fast heartbeat, fast breathing, increased sweating.

This medication may cause the saliva, urine, or sweat to turn a dark color. This is harmless; however, it may discolor clothing.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow-angle).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, glaucoma (wide-angle), breathing problems, heart disease (especially history of heart attack), kidney disease, ulcers, mental/mood disorders (e.g., depression, schizophrenia), blood disorders.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before you have surgery with a general anesthetic, including dental surgery, tell the doctor or dentist you are taking this medication.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

Levodopa passes into breast milk. It is unknown if carbidopa or entacapone pass into breast milk. Consult your doctor before breast-feeding.


Stalevo Patient Information Including Side Effects

Brand Names: Stalevo 100, Stalevo 125, Stalevo 150, Stalevo 200, Stalevo 50, Stalevo 75

Generic Name: carbidopa, entacapone, and levodopa (Pronunciation: KAR bi DOE pa, en TAK a pone, LEE voe DOE pa)

  • What is carbidopa, entacapone, and levodopa (Stalevo)?
  • What are the possible side effects of carbidopa, entacapone, and levodopa?
  • What is the most important information I should know about carbidopa, entacapone, and levodopa?
  • What should I discuss with my healthcare provider before taking carbidopa, entacapone, and levodopa?
  • How should I take carbidopa, entacapone, and levodopa?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking carbidopa, entacapone, and levodopa?
  • What other drugs will affect carbidopa, entacapone, and levodopa?
  • Where can I get more information?

What is carbidopa, entacapone, and levodopa (Stalevo)?

Levodopa is converted to a chemical called dopamine (DOE pa meen) in the brain. Symptoms of Parkinson's disease may be caused by low levels dopamine in the brain.

Carbidopa helps prevent the breakdown of levodopa before it can reach the brain and take effect.

When used with carbidopa, entacapone, and levodopa (Atamet, Parcopa, Sinemet), entacapone increases levels of levodopa in the body.

The combination of carbidopa, entacapone, and levodopa is used to treat Parkinson symptoms such as muscle stiffness, tremors, spasms, and poor muscle control.

Carbidopa, entacapone, and levodopa may also be used for other purposes not listed in this medication guide.

What are the possible side effects of carbidopa, entacapone, and levodopa?

You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • nausea, sweating, feeling like you might pass out (especially when you first start taking this medication);
  • depression, confusion, hallucinations, unusual thoughts or behavior, thoughts about hurting yourself;
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, neck, arms, or legs;
  • tremor (uncontrolled shaking);
  • muscle pain, tenderness, or weakness with fever or flu symptoms;
  • fast, pounding, or uneven heartbeats;
  • tight feeling in your chest, trouble breathing;
  • easy bruising or bleeding;
  • bloody or tarry stools, coughing up blood;
  • pain or burning when you urinate; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling.

Less serious side effects may include:

  • stomach pain or upset, loss of appetite, constipation;
  • dry mouth, changes in your sense of taste;
  • unusual skin changes;
  • dizziness or drowsiness;
  • headache, blurred vision;
  • sleep problems (insomnia), strange dreams;
  • agitation or anxiety;
  • muscle cramps, back pain; or
  • mild skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about carbidopa, entacapone, and levodopa?

Do not take this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) within the past 14 days.

You should not take this medication if you are allergic to carbidopa (Lodosyn), entacapone (Comtan), or levodopa (Larodopa), or if you have narrow-angle glaucoma, unusual skin lesions, or a history of skin cancer.

Tell your doctor about all of your medical conditions, especially heart disease, high blood pressure, asthma or other breathing problems, liver or kidney disease, a hormonal disease, an ulcer, glaucoma, or mental illness. Also tell your doctor about all the medications you use.

It may take up to several weeks of using carbidopa, entacapone, and levodopa before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment. Also tell your doctor if the effects of this medication seem to wear off quickly in between doses.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking carbidopa, entacapone, and levodopa.

Do not stop using carbidopa, entacapone, and levodopa without first talking to your doctor.

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