IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
CARBIDOPA/LEVODOPA/ENTACAPONE - ORAL
COMMON BRAND NAME(S): Stalevo
USES: This combination medication is used to treat symptoms of Parkinson's disease (such as shakiness, stiffness, difficulty moving). Parkinson's disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain. Levodopa changes into dopamine in the brain, helping to control movement. Carbidopa and entacapone prevent the breakdown of levodopa in the bloodstream so more levodopa can enter the brain. Carbidopa can also reduce some of levodopa's side effects such as nausea and vomiting.
HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 3 to 4 times a day. Take only one tablet for each dose. Swallow the tablet whole. Do not crush, chew, or split the tablet. Doing so may cause you to get the wrong dose and may also cause staining of the mouth, dentures, and saliva. See also Side Effects section.
Taking this medication with food may help to decrease nausea. It is best to avoid a high-protein diet (it decreases the amount of levodopa that your body takes in) during treatment, unless directed otherwise by your doctor. Also avoid taking this medication with a high-fat, high-calorie meal since this can slow down the time it begins to work by about 2 hours.
Separate your dose of this medication by as many hours as possible from any iron supplements or products containing iron (such as multivitamins with minerals) you may take. Iron can reduce the amount of this medication absorbed by the body. Consult your doctor or pharmacist for more details.
The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
Some patients may experience a "wearing-off" (worsening of symptoms) before the next dose is due. An "on-off" effect might also occur, in which sudden short periods of stiffness occur. If these effects occur, contact your doctor for possible dose adjustments that may help to lessen this effect.
Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased. (See also Side Effects section.)
Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Diarrhea, nausea, vomiting, dizziness, lightheadedness, drowsiness, stomach upset, loss of appetite, trouble sleeping, headache, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
This medication may cause saliva, urine, or sweat to turn a dark color. This effect is harmless, but your clothes may be stained.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Some people taking this medication have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with this medication, including up to 1 year after starting the medication. If you experience increased sleepiness or fall asleep during the day, do not drive or do other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.
Tell your doctor right away if you have any serious side effects, including: new/worsening movements you can't control/spasms, greatly increased eye blinking/twitching, fainting, diarrhea that doesn't stop, vision changes (such as blurred vision), eye pain, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds, muscle pain/tenderness/weakness, change in the amount of urine, mental/mood changes (such as confusion, hallucinations, thoughts of suicide), signs of infection (such as sore throat that doesn't go away), easy bleeding/bruising, unusual tiredness, tingling of the hands/feet, unusual strong urges (such as increased gambling, increased sexual urges).
Get medical help right away if you have any very serious side effects, including: chest pain.
Suddenly stopping or reducing the dose of this medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, unusual muscle stiffness, severe confusion, sweating, fast/irregular heartbeat, rapid breathing.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to carbidopa, levodopa, or entacapone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, glaucoma, breathing problems (such as asthma), heart disease (such as heart attack, irregular heartbeat), kidney disease, stomach/intestinal ulcer, mental/mood disorders (such as depression, schizophrenia), blood disorders, seizures, sleep disorders.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. See also Side Effects section.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
Levodopa passes into breast milk. It is unknown if carbidopa or entacapone pass into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: antipsychotic drugs (such as chlorpromazine, haloperidol, thioridazine), certain drugs used to treat high blood pressure (such as methyldopa, reserpine), tetrabenazine.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. However, certain MAO inhibitors (rasagiline, selegiline) may be used with careful monitoring by your doctor. Ask your doctor when to start or stop taking this medication.
Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and narcotic pain relievers (such as codeine, hydrocodone).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
This medication may interfere with certain laboratory tests (including urine catecholamine/glucose/ketone tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fast/irregular heartbeat, mental/mood changes (such as agitation).
NOTES: Do not share this medication with others.
Laboratory and/or medical tests (such as heart/kidney/liver function, complete blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
People with Parkinson's disease may have an increased risk for developing skin cancer (melanoma). Tell your doctor promptly if you have a mole that gets bigger or looks different, or if you have other unusual skin changes. Ask your doctor if you should have regular skin exams.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.
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