Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Parcopa
  2. Sinemet 10-100
  3. Sinemet 25-100
  4. Sinemet 25-250
  5. Sinemet CR

Canadian Brand Name

  1. Sinemet 10010
  2. Sinemet 10025
  3. Sinemet 25025
  4. Sinemet CR 10025
  5. Sinemet CR 20050

Descriptions


Carbidopa and levodopa combination is used to treat Parkinson's disease, sometimes called shaking palsy or paralysis agitans. Parkinson's disease is a disorder of the central nervous system (brain and spinal cord).

Dopamine is a naturally occurring substance in the brain that helps provide control of movement and activities such as walking and talking. In patients with Parkinson's disease, there is not enough dopamine in some parts of the brain. Levodopa enters the brain and helps replace the missing dopamine, which allows people to function better. By increasing the amount of dopamine in the brain, levodopa helps control symptoms and helps you to perform daily activities such as dressing, walking, and handling utensils.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet
  • Tablet, Disintegrating
  • Tablet, Extended Release

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of levodopa and carbidopa combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of Lodosyn® have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of Lodosyn® in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving Lodosyn®.

No information is available on the relationship of age to the effects of carbidopa and levodopa combination in geriatric patients.

Pregnancy

Information about this carbidopa-and-levodopa-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Clorgyline
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Methylene Blue
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Toloxatone
  • Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bupropion
  • Isoniazid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bromperidol
  • Droperidol
  • Droxidopa
  • Fosphenytoin
  • Indinavir
  • Iron
  • Kava
  • Metoclopramide
  • Phenylalanine
  • Phenytoin
  • Sapropterin
  • Spiramycin
  • Tyrosine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • High Protein Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma or
  • Depression, history of or
  • Dyskinesia (abnormal muscle movements) or
  • Endocrine disease or
  • Heart attack, history of or
  • Heart or blood vessel disease, severe or
  • Heart rhythm problems (eg, ventricular tachycardia) or
  • Kidney disease or
  • Liver disease or
  • Lung disease, severe or
  • Peptic ulcer, history of or
  • Psychosis (mental disorder), or history of or
  • Wide-angle glaucoma (eye pressure problem)—Use with caution. May make these conditions worse.
  • Melanoma (skin cancer), suspicious or a history of or
  • Narrow angle glaucoma (eye pressure problem) or
  • Skin lesions, undiagnosed (rashes that involve changes in color or texture of the skin)—Should not be used in patients with these conditions.
  • Phenylketonuria (PKU)—The oral disintegrating tablet contains phenylalanine, which can make this condition worse.

Proper Use

Take this medicine exactly as directed, and every time that you are supposed to take it. It is important that you do not stop taking your medicine unless ordered by your doctor. It is also important to not start taking other medicines for your Parkinson's disease without first talking with your doctor.

You may experience a “wearing-off” effect towards the end of the dosing interval. You should tell your doctor if you have problems with this that affect your every day life. Your doctor may want to adjust your dose.

Since protein may interfere with the body's response to carbidopa and levodopa, high protein diets should be avoided. Intake of normal amounts of protein should be spaced equally throughout the day, or taken as directed by your doctor.

If you are taking multivitamin tablets or plan to start taking them, discuss this first with your doctor. Iron salts (in vitamins) may keep this medicine from working properly.

Sinemet® tablet or Parcopa® disintegrating tablet begins to release its ingredients 30 minutes after you take it.

Swallow the sustained release tablet whole. Do not crush, break, or chew it.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not remove the tablet from the bottle until you are ready to take it. Place the tablet on the top of your tongue, where it will melt quickly.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For Parkinson's disease:
    • For oral dosage form (disintegrating tablets):
      • Adults—
        • For patients starting on carbidopa and levodopa treatment: At first, one tablet three or four times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 8 tablets per day.
        • For patients taking levodopa already: Levodopa should be discontinued at least 12 hours before starting Parcopa®. The starting dose is one tablet three or four times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 8 tablets per day.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (sustained release tablets):
      • Adults—
        • For patients switching from Sinemet® to Sinemet® CR: The starting dose is based on the amount of Sinemet® you are currently taking per day. Your doctor may adjust your dose as needed.
        • For patients taking levodopa already: Levodopa should be discontinued at least 12 hours before starting Sinemet® CR. The starting dose is one tablet two times a day. Your doctor may adjust your dose as needed.
        • For patients not taking levodopa: At first, one tablet two times a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • Adults—
        • For patients starting on carbidopa and levodopa treatment: At first, one tablet three or four times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
        • For patients taking levodopa already: Levodopa should be discontinued at least 12 hours before starting Lodosyn® plus levodopa or Sinemet®. The starting dose is one tablet three or four times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
        • For patients taking carbidopa and levodopa already: 25 milligrams (mg) of Lodosyn® per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to allow changes in your dose and to check for any unwanted effects.

Do not take this medicine if you have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine, tranylcypromine, Nardil®, Parnate®) in the past 2 weeks.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Check with your doctor right away if you are having convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause dizziness, drowsy, trouble in controlling movements, or trouble in concentrating or seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away.

If you develop any unusual or strange thoughts and behavior while receiving this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

It is possible that a dark color (red, brown, or black) may appear in saliva, urine, or sweat after taking this medicine. The color may cause some of your garments to become discolored. This is normal and nothing to worry about.

It is possible that you may become nauseous, especially when you are first starting your medicine.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having problems with gambling or an increased interest in sex while using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Twitching, twisting, uncontrolled repetitive movements of tongue, lips, face, arms, or legs

Less common

  1. Bladder pain
  2. bloody or cloudy urine
  3. chest pain
  4. confusion
  5. difficult, burning, or painful urination
  6. discouragement
  7. feeling sad or empty
  8. frequent urge to urinate
  9. inability to move the eyes
  10. increased blinking or spasms of the eyelid
  11. irritability
  12. lack of appetite
  13. loss of interest or pleasure
  14. lower back or side pain
  15. seeing, hearing, or feeling things that are not there
  16. sticking out of tongue
  17. tiredness
  18. trouble concentrating
  19. trouble in breathing, speaking, or swallowing
  20. trouble sleeping
  21. uncontrolled twisting movements of the neck, trunk, arms, or legs
  22. unusual facial expressions

Incidence not known

  1. Anxiety
  2. black, tarry stools
  3. bluish color
  4. blurred vision
  5. changes in skin color
  6. chest discomfort
  7. chills
  8. convulsions
  9. cough or hoarseness
  10. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  11. dry mouth
  12. false beliefs that cannot be changed by facts
  13. fast, irregular, pounding, or racing heartbeat or pulse
  14. feelings about hurting oneself or others
  15. fever with or without chills
  16. general feeling of tiredness or weakness
  17. high fever
  18. hyperventilation
  19. increased in sexual ability, desire, drive, or performance
  20. increased interest in sexual intercourse
  21. increased sweating
  22. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  23. loss of bladder control
  24. lower back or side pain
  25. nausea
  26. pain
  27. pain or discomfort in the arms, jaw, back, or neck
  28. restlessness
  29. seeing, hearing, or feeling things that are not there
  30. severe muscle stiffness
  31. shaking
  32. sore throat
  33. sores, ulcers, or white spots on the lips or in the mouth
  34. swelling of the foot or leg
  35. swollen glands
  36. tenderness
  37. tiredness
  38. unusual bleeding or bruising
  39. unusual tiredness or weakness
  40. unusually pale skin
  41. vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  1. Acid or sour stomach
  2. back or shoulder pain
  3. belching
  4. body aches or pain
  5. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  6. diarrhea
  7. difficulty having a bowel movement (stool)
  8. ear congestion
  9. headache
  10. heartburn
  11. indigestion
  12. loss of voice
  13. muscle cramps
  14. nasal congestion
  15. runny nose
  16. sneezing
  17. stomach discomfort, upset, or pain
  18. unusual dreams
  19. weight loss

Incidence not known

  1. Abdominal or stomach distress
  2. bad, unusual, or unpleasant (after) taste
  3. belching
  4. change in taste
  5. dark sweat
  6. double vision
  7. enlarged pupils
  8. feeling of warmth
  9. hair loss or thinning of the hair
  10. lack or loss of strength
  11. redness of the face, neck, arms, and occasionally, upper chest
  12. seeing double
  13. skin rash, hives or welts, itching

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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