Generic Name: carbidopa/levodopa
(KAR-bi-DOE-pa/lee-voe-DOE-pa)

Brand Names: Sinemet®

Classification: Antidyskinetic

Issue Date: 2000

Sinemet is used for treating symptoms associated with Parkinson disease and parkinsonism-like symptoms caused by other conditions. It may also be used for other conditions as determined by your doctor.

Sinemet is an antidyskinetic combination. Levodopa is transformed by the body and the brain into a substance that helps to decrease tremors and other symptoms of Parkinson disease. Carbidopa helps levodopa to reach the brain.

Some medical conditions may interact with Sinemet. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• If you are pregnant, planning to become pregnant, or are breast-feeding
• If you are taking any prescription
• If you are taking nonprescription medicine such as herbal or dietary supplement
• If you have allergies to medicines, foods, or other substances
• If you have an irregular heartbeat, heart disease
• If you have an ulcer
• If you have a mental or mood disorders, seizures
• If you have blood pressure problems
• If you have asthma, lung problems
• If you have liver or kidney problems
• If you have blood or hormone problems
• If you have stomach or intestinal bleeding
• You are allergic to any ingredient in Sinemet
• You have narrow-angle glaucoma
• You have undiagnosed skin growths
• You have skin cancer, or a history of skin cancer
• If you have a history of heart attack
• You have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Some MEDICINES MAY INTERACT with Sinemet. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Butyrophenones
• haloperidol
• isoniazid
• papaverine
• phenothiazines
• chlorpromazine
• phenytoin
• risperidone because they may decrease Sinemet's effectiveness
• MAO inhibitors
• (eg, phenelzine) risk of severe high blood pressure may be increased
• Tricyclic antidepressants
• (eg, amitriptyline) risk of high blood pressure or unusual muscle movements may increase
• Metoclopramide because side effects may occur
• Blood pressure medicines or selegiline because risk of severe dizziness on standing may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sinemet may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Use Sinemet as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Sinemet by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
• Carefully follow the dosing schedule given to you by your health care provider. It may take several weeks to a few months to notice benefit from use because the dose is carefully adjusted over time.


• If you are also taking iron salts (eg, ferrous sulfate), do not take them within 2 hours before or 2 hours after taking Sinemet. Check with your doctor if you have questions.


• Take Sinemet on a regular schedule to get the most benefit from it. Taking Sinemet at the same times each day will help you to remember to take it.


• Continue to take Sinemet even if you feel well. Do not miss any doses.


• If you have been taking levodopa, do not start taking Sinemet until at least 12 hours after your final dose of levodopa.


• If you miss a dose of Sinemet, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Sinemet.

Sinemet may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Sinemet with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Sinemet; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Sinemet may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Tell your doctor or dentist that you take Sinemet before you receive any medical or dental care, emergency care, or surgery.

Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Sinemet. Symptoms may include:

• fever
• stiff muscles
• confusion
• abnormal thinking
• fast or irregular heartbeat
• and sweating

Contact your doctor at once if you have any of these symptoms.

Diabetes patients - Sinemet may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Sinemet may cause the results of some tests for urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.

Do not suddenly stop taking Sinemet. Some conditions may become worse when Sinemet is suddenly stopped. Your dose may need to be slowly lowered by your doctor to avoid side effects. Gradually increase physical activity as your symptoms improve.

A dark color (red, brown, or black) may appear in your saliva, urine, or sweat after taking Sinemet. This is not harmful.

The effects of Sinemet might start to wear off between doses. Talk with your doctor if Sinemet stops working well or if your condition worsens.

Sinemet may affect certain lab test results. Make sure your doctors and lab personnel know you use Sinemet. Lab tests, including complete blood cell counts and liver function tests, may be performed while you use Sinemet. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Sinemet with caution in ELDERLY patients; they may be more sensitive to its effects.

Sinemet should not be used in CHILDREN; safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sinemet while pregnant. It is not known if Sinemet is found in breast milk. If you are or will be breast-feeding while you are using Sinemet, check with your doctor. Discuss any possible risks to your baby.

If you miss a dose of Sinemet, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose of the medication to catch up.

Side Effects

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

• confusion
• constipation
• diarrhea
• dizziness
• drowsiness
• dry mouth
• headache
• increased sweating
• loss of appetite
• nausea
• taste changes
• trouble sleeping
• upset stomach
• urinary tract infection
• vomiting

Seek medical attention right away if any of these SEVERE side effects occur:

• Severe allergic reactions:
• rash
• hives
• itching
• difficulty breathing
• tightness in the chest
• swelling of the mouth, face, lips, or tongue
• black, tarry stools
• blood in vomit
• chest pain
• confusion
• depression
• fast or irregular heartbeat
• fever
• hallucinations
• mental or mood changes
• muscle pain or unusual stiffness
• severe abdominal pain
• severe lightheadedness or fainting
• sore throat
• thoughts of suicide
• unexplained fever or sweating
• unusual bruising or bleeding
• unusual or painful movements or spasms of the face, eyelids, mouth, tongue, arms, hands, or legs
• vision changes (blurred/double vision); yellowing of the skin or eyes

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some MEDICINES MAY INTERACT with Sinemet. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Butyrophenones
• haloperidol
• isoniazid
• papaverine
• phenothiazines
• chlorpromazine
• phenytoin
• risperidone because they may decrease Sinemet's effectiveness
• MAO inhibitors
• (eg, phenelzine) risk of severe high blood pressure may be increased
• Tricyclic antidepressants
• (eg, amitriptyline) risk of high blood pressure or unusual muscle movements may increase
• Metoclopramide because side effects may occur
• Blood pressure medicines or selegiline because risk of severe dizziness on standing may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sinemet may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.