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Carbidopa/ levodopa sustained-release tablets

Generic Name: carbidopa/levodopa (KAR-bi-DOE-pa/LEE-voe-DOE-pa)
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 for other 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 that 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 inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

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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 a history of heart problems (eg, irregular heartbeat) or heart attack, blood pressure problems, endocrine problems, fainting, lung problems (eg, asthma), kidney or liver problems, neuroleptic malignant syndrome (NMS), a severe muscle problem called rhabdomyolysis, glaucoma or increased pressure in the eye, stomach or intestinal problems (eg, ulcers, bleeding), or mood or mental problems (eg, depression)

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:

  • MAOIs (eg, phenelzine) because the risk of severe high blood pressure may be increased
  • Tricyclic antidepressants (eg, amitriptyline) because the risk of high blood pressure or unusual muscle movements may be increased
  • Metoclopramide because side effects may occur
  • Blood pressure medicines or selegiline because the risk of severe dizziness when standing may be increased
  • Butyrophenones, (eg, haloperidol), isoniazid, papaverine, phenothiazines (eg, chlorpromazine), phenytoin, or risperidone because they may decrease carbidopa/levodopa sustained-release tablets's effectiveness

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 with or without food.
  • 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 carbidopa/levodopa sustained-release tablets whole. Do not break, crush, or chew before swallowing. Some strengths of carbidopa/levodopa sustained-release tablets may be broken in half. If you have difficulty swallowing the tablet whole or if your doctor tells you to break the tablet in half, ask your pharmacist if your strength of medicine may be broken in half.
  • 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.
  • Diets that are high in protein may decrease your body's ability to absorb carbidopa/levodopa sustained-release tablets. Discuss any questions or concerns with your doctor. Tell your doctor if you have a diet that is high in protein, or if you will be changing your diet to include more protein.
  • Continue to take 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.
  • Do not suddenly stop taking carbidopa/levodopa sustained-release tablets without checking with your doctor. Side effects may occur. They may include fever, stiff muscles, confusion, abnormal thinking, fast or irregular heartbeat, and sweating.
  • 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.
  • 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.
  • 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 cause the results of some tests for urine glucose or urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
  • Carbidopa/levodopa sustained-release tablets may cause mental or mood changes. Contact your doctor at once if any new or worsening symptoms such as depressed mood; anxious, restless, or irritable behavior; or unusual changes in mood or behavior occur. Contact your doctor right away if any signs of suicidal thoughts or actions occur.
  • You may experience an increase in involuntary movements while taking carbidopa/levodopa sustained-release tablets. Check with your doctor if this occurs.
  • 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.
  • Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if carbidopa/levodopa sustained-release tablets also increases the risk of melanoma. You may need to have skin exams while you are using carbidopa/levodopa sustained-release tablets. Tell your doctor if you notice any unusual skin growths or a change in the appearance of a mole. Discuss any questions or concerns with your doctor.
  • Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while taking carbidopa/levodopa sustained-release tablets. Tell your doctor right away if you notice such effects.
  • 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.
  • 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, 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 the 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 taking carbidopa/levodopa sustained-release tablets while you are 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 taking 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; new or increased involuntary movements; 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 or 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, 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.
  • Carbidopa/levodopa sustained-release tablets 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take carbidopa/levodopa sustained-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about carbidopa/levodopa sustained-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to carbidopa/levodopa sustained-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using carbidopa/levodopa sustained-release tablets.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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