Sinemet CR

DRUG DESCRIPTION

SINEMET® CR (carbidopa-levodopa) is a sustained-release combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome.

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

SINEMET CR (carbidopa-levodopa sustained release) is supplied as sustained-release tablets containing either 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, magnesium stearate, and hypromellose. SINEMET CR (carbidopa-levodopa sustained release) 25-100 and SINEMET CR (carbidopa-levodopa sustained release) 50-200 also contain FD&C Blue #2/lndigo Carmine AL and FD&C Red #40/Allura Red AC AL.

The 50-200 tablet is supplied as an oval, compressed tablet that is dappled-purple in color and is coded "521" on one side and plain on the other. The 25-100 tablet is supplied as an oval, compressed tablet that is dappled-purple in color and is coded "601" on one side and plain on the other. The SINEMET CR (carbidopa-levodopa sustained release) tablet is a polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. SINEMET CR (carbidopa-levodopa sustained release) 25-100 is available to facilitate titration when 100 mg steps are required.

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 Sinemet CR »

What are the precautions when taking carbidopa-levodopa sustained release (Sinemet CR)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to carbidopa or levodopa; 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: certain eye problem (narrow-angle glaucoma).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders, breathing problems (e.g., asthma, emphysema), certain eye problem (wide-angle glaucoma), heart or blood vessel problems (e.g., arrhythmias, heart attack, angina), kidney disease,...

Read All Potential Precautions of Sinemet CR »


Sinemet CR Consumer (continued)

SIDE EFFECTS: Dizziness, nausea, vomiting, trouble sleeping, and headache 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.

This medication may cause your urine, sweat or saliva to turn red, brown, or black. This is harmless, but your clothes may become discolored.

Tell your doctor immediately if any of these unlikely but serious side effects occur: greatly increased eye blinking/twitching, irregular heartbeat, fainting, mental/mood changes (e.g., confusion, depression, hallucinations, thoughts of suicide), worsening of involuntary movements/spasms.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), tingling of the hands/feet, vision changes (e.g., blurred/double vision).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizures, vomit that looks like coffee grounds, black/tarry stools.

Abruptly stopping or reducing the dose of this medication may rarely cause a serious (sometimes fatal) condition (neuroleptic malignant syndrome). Seek immediate medical attention if any of these rare but very serious side effects occur: fast/shallow breathing, confusion, severe dizziness/fainting, high fever, unusual muscle stiffness, unusual sweating.

For males, in the very unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention or permanent problems could occur.

A very serious allergic reaction 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 carbidopa or levodopa; 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: certain eye problem (narrow-angle glaucoma).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders, breathing problems (e.g., asthma, emphysema), certain eye problem (wide-angle glaucoma), heart or blood vessel problems (e.g., arrhythmias, heart attack, angina), kidney disease, liver disease, mental/mood disorders (e.g., depression, schizophrenia), peptic ulcer, seizure.

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

To minimize lightheadedness, get up slowly when rising from a sitting or lying position.

Before having surgery, tell your doctor or dentist that 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 may pass into breast milk and affect milk production. Consult your doctor before breast-feeding.


Sinemet CR 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 (Sinemet CR)?
  • 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 (Sinemet CR)?

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.

Related Drug Centers
  • Stalevo
  • Sinemet CR


Related Drugs Index: