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Carbidopa/Levodopa Sustained-Release Tablets

Generic Name: Carbidopa/Levodopa Sustained-Release Tablets (CAR-bih-doe-puh/LEE-voe-doe-puh)
Brand Name: Sinemet CR

Carbidopa/Levodopa Sustained-Release Tablets is used for:

Treating symptoms associated with Parkinson disease and parkinsonism-like symptoms caused by other conditions. It may also be used to treat certain conditions as determined by your doctor.

Carbidopa/Levodopa Sustained-Release Tablets is an antidyskinetic combination. Levodopa is transformed by the body and the brain into a substance which helps to decrease tremors and other symptoms of Parkinson disease. Carbidopa helps levodopa to reach the brain.

Do NOT use Carbidopa/Levodopa Sustained-Release Tablets if:

you are allergic to any ingredient in Carbidopa/Levodopa Sustained-Release Tablets
you have narrow-angle glaucoma, undiagnosed skin growths, skin cancer, or a history of skin cancer
you have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Carbidopa/Levodopa Sustained-Release Tablets:

Some medical conditions may interact with Carbidopa/Levodopa Sustained-Release Tablets. 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 or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have an irregular heartbeat, heart disease, ulcer, mental/mood disorders, seizures, blood pressure problems, asthma, lung problems, liver or kidney problems, blood or hormone problems, stomach or intestinal bleeding, glaucoma, or history of heart attack

Some MEDICINES MAY INTERACT with Carbidopa/Levodopa Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Butyrophenones, (eg, haloperidol), isoniazid, papaverine, phenothiazines (eg, phenergan), phenytoin, or risperidone because they may decrease Carbidopa/Levodopa Sustained-Release Tablets"s effectiveness
MAO inhibitors (eg, phenelzine) because risk of severe high blood pressure may be increased
Tricyclic antidepressants (eg, amitriptyline) because risk of high blood pressure or unusual muscle movements may be increased
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 Carbidopa/Levodopa Sustained-Release Tablets 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.

How to use Carbidopa/Levodopa Sustained-Release Tablets:

Use Carbidopa/Levodopa Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Carbidopa/Levodopa Sustained-Release Tablets 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.
Swallow whole. Do not break, crush, or chew before swallowing.
If you are also taking iron salts (eg, ferrous sulfate), do not take them within 2 hours before or 2 hours after taking Carbidopa/Levodopa Sustained-Release Tablets. Check with your doctor if you have questions.
Take Carbidopa/Levodopa Sustained-Release Tablets on a regular schedule to get the most benefit from it. Taking Carbidopa/Levodopa Sustained-Release Tablets at the same times each day will help you to remember to take it.
Continue taking Carbidopa/Levodopa Sustained-Release Tablets even if you feel better. Do not miss any doses.
If you have been taking levodopa, do not start taking Carbidopa/Levodopa Sustained-Release Tablets until at least 12 hours after your final dose of levodopa.
If you miss a dose of Carbidopa/Levodopa Sustained-Release Tablets, 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 Carbidopa/Levodopa Sustained-Release Tablets.

Important safety information:

Carbidopa/Levodopa Sustained-Release Tablets may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Carbidopa/Levodopa Sustained-Release Tablets 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 Carbidopa/Levodopa Sustained-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Tell your doctor or dentist that you take Carbidopa/Levodopa Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
Diabetes patients -- Carbidopa/Levodopa Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Diabetes patients - Carbidopa/Levodopa Sustained-Release Tablets 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.
Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Carbidopa/Levodopa Sustained-Release Tablets. 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.
Do not suddenly stop taking Carbidopa/Levodopa Sustained-Release Tablets. Some conditions may become worse when Carbidopa/Levodopa Sustained-Release Tablets is suddenly stopped. Your dose may need to be slowly lowered by your doctor to avoid side effects.
Carbidopa/Levodopa Sustained-Release Tablets 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.
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 Carbidopa/Levodopa Sustained-Release Tablets. This is not harmful.
The effects of Carbidopa/Levodopa Sustained-Release Tablets might start to wear off between doses. Talk with your doctor if Carbidopa/Levodopa Sustained-Release Tablets stops working well or if your condition worsens.
Carbidopa/Levodopa Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Carbidopa/Levodopa Sustained-Release Tablets.
Lab tests, including complete blood cell counts and liver function tests, may be performed while you use Carbidopa/Levodopa Sustained-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Carbidopa/Levodopa Sustained-Release Tablets with caution in ELDERLY; they may be more sensitive to its effects.
Carbidopa/Levodopa Sustained-Release Tablets should not be used in CHILDREN; safety and effectiveness in children 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 Carbidopa/Levodopa Sustained-Release Tablets while pregnant. It is not known if Carbidopa/Levodopa Sustained-Release Tablets is found in breast milk. If you are or will be breast-feeding while you are using Carbidopa/Levodopa Sustained-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Carbidopa/Levodopa Sustained-Release Tablets:

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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Carbidopa/Levodopa Sustained-Release Tablets:

Store Carbidopa/Levodopa Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Carbidopa/Levodopa Sustained-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Carbidopa/Levodopa Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
This medicine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Carbidopa/Levodopa Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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