Generic Name: carbidopa/levodopa/entacapone (KAR-bi-DOE-pa/LEE-voe-DOE-pa/en-TAK-a-pone)
Brand Name: Stalevo
Carbidopa/levodopa/entacapone is used for:
Treating symptoms of Parkinson disease.
Carbidopa/levodopa/entacapone is an antidyskinetic combination of dopamine-enhancing medicines. It works by increasing the amount of dopamine in the brain. By increasing the amount of dopamine in the brain, the chemicals of the brain become more balanced and the symptoms of this disease are lessened.
Do NOT use carbidopa/levodopa/entacapone if:
- you are allergic to any ingredient in carbidopa/levodopa/entacapone
- you have narrow-angle glaucoma, skin growths of unknown cause, skin cancer, or a history of skin cancer
- you have taken furazolidone or certain monoamine oxidase inhibitors (MAOIs) (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/entacapone:
Some medical conditions may interact with carbidopa/levodopa/entacapone. 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 a 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, or mood or mental problems (eg, depression)
- if you have stomach or intestinal problems (eg, ulcers), or biliary or gallbladder problems
Some MEDICINES MAY INTERACT with carbidopa/levodopa/entacapone. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Furazolidone, MAOIs (eg, phenelzine), selegiline, or tricyclic antidepressants (eg, amitriptyline) because serious side effects (eg, headache, very high blood pressure, abnormal heartbeat) may occur
- Ampicillin, chloramphenicol, cholestyramine, erythromycin, metoclopramide, probenecid, rifampin, or sympathomimetics (eg, phenylephrine) because they may increase the risk of carbidopa/levodopa/entacapone's side effects
- Apomorphine, butyrophenones (eg, haloperidol), hydantoins (eg, phenytoin), isoniazid, metoclopramide, papaverine, phenothiazines (eg, chlorpromazine), or risperidone because they may decrease carbidopa/levodopa/entacapone's effectiveness
- Medicines for blood pressure because the risk of their side effects may be increased by carbidopa/levodopa/entacapone
- Digoxin and iron salts (eg, ferrous sulfate) because their effectiveness may be decreased by carbidopa/levodopa/entacapone
This may not be a complete list of all interactions that may occur. Ask your health care provider if carbidopa/levodopa/entacapone 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/entacapone:
Use carbidopa/levodopa/entacapone as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take carbidopa/levodopa/entacapone by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Swallow carbidopa/levodopa/entacapone whole. Do not break, crush, or chew before swallowing.
- Take carbidopa/levodopa/entacapone at least 4 hours before or after taking iron salts (eg, ferrous sulfate).
- Diets that are high in protein may decrease your body's ability to absorb carbidopa/levodopa/entacapone. 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.
- Do not suddenly stop taking carbidopa/levodopa/entacapone 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/entacapone, 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/entacapone.
Important safety information:
- Carbidopa/levodopa/entacapone may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use carbidopa/levodopa/entacapone 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/entacapone; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Carbidopa/levodopa/entacapone 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.
- Diets high in protein may prevent your body's ability to absorb carbidopa/levodopa/entacapone. Dietary protein should be eaten evenly throughout the day.
- Gradually increase physical activity as your symptoms improve.
- A "wearing-off" effect may occur before you need to take your next dose of carbidopa/levodopa/entacapone. If this effect becomes bothersome, contact your doctor.
- Carbidopa/levodopa/entacapone may cause diarrhea. It typically begins within 4 to 12 weeks of starting carbidopa/levodopa/entacapone, but may occur during the first week or many months after starting it. Rare cases of prolonged diarrhea caused by colitis (inflammation of the large intestine) have occurred in patients taking carbidopa/levodopa/entacapone. Contact your doctor if you have severe, persistent, or watery diarrhea.
- If diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- Carbidopa/levodopa/entacapone may discolor the saliva, urine, or sweat a dark color (red, brown, or black). This is normal and not a cause for concern.
- Carbidopa/levodopa/entacapone may cause nausea, especially when you first start to take it. Check with your doctor if nausea persists or is severe.
- Carbidopa/levodopa/entacapone 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/entacapone. Check with your doctor if this occurs.
- NMS is a possibly fatal syndrome that can be caused by carbidopa/levodopa/entacapone. 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.
- Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while using carbidopa/levodopa/entacapone. Tell your doctor right away if you notice such effects.
- 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/entacapone also increases the risk of melanoma. You may need to have skin exams while you are using carbidopa/levodopa/entacapone. Discuss any questions or concerns with your doctor.
- Tell your doctor or dentist that you take carbidopa/levodopa/entacapone before you receive any medical or dental care, emergency care, or surgery.
- Diabetes patients - Carbidopa/levodopa/entacapone 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/entacapone may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking carbidopa/levodopa/entacapone.
- Lab tests, including complete blood cell counts and heart, liver, and kidney function, may be performed while you use carbidopa/levodopa/entacapone. 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/entacapone with extreme caution in the ELDERLY; they may be more sensitive to its effects.
- Carbidopa/levodopa/entacapone 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/entacapone while you are pregnant. It is not known if carbidopa/levodopa/entacapone is found in breast milk. If you are or will be breast-feeding while you use carbidopa/levodopa/entacapone, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of carbidopa/levodopa/entacapone:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Change in taste; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; upset stomach.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; dark urine; depression with thoughts of suicide; fainting; fast or irregular heartbeat; fever; hallucinations; lack of response to environment; mental or mood changes; muscle pain, stiffness, or rigidity; new or increased involuntary movements; paranoia; seizures; severe or persistent dizziness; severe, persistent, or watery diarrhea; shortness of breath; stomach pain; trouble sleeping; unusual or painful movements of the face, eyelids, mouth, tongue, arms, hands, or legs; unusual skin growths or change in the appearance of a mole; unusual sweating; vomiting; 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. Symptoms may include agitation; confusion; dark urine or trouble urinating; fast or irregular heartbeat; high blood pressure; insomnia; muscle spasms; restlessness.Proper storage of carbidopa/levodopa/entacapone:
Store carbidopa/levodopa/entacapone at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Protect from heat, moisture, and light. Keep in a tight, light-resistant container. Do not store in the bathroom. Keep carbidopa/levodopa/entacapone out of the reach of children and away from pets.
- If you have any questions about carbidopa/levodopa/entacapone, please talk with your doctor, pharmacist, or other health care provider.
- Carbidopa/levodopa/entacapone 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/entacapone 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/entacapone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to carbidopa/levodopa/entacapone. 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/entacapone.
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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