Pronunciation:

lee-voe-DOE-pa, kar-bi-DOE-pa, en-TAK-a-pone

Brand Names:

• Stalevo 100
• Stalevo 125
• Stalevo 150
• Stalevo 200
• Stalevo 50
• Stalevo 75

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antiparkinsonian

Pharmacologic—

Dopamine Precursor

Uses of This Medicine:

Carbidopa, entacapone, and levodopa combination is used to treat Parkinson's disease, sometimes called shaking palsy. 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 (a component of this medicine) 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 a combination of three different medicines. This medicine is known as a levodopa therapy. The difference between this medicine and other levodopa treatments is that this medicine contains entacapone. Entacapone helps levodopa last longer by blocking a substance called COMT enzyme. This enzyme breaks down levodopa before it reaches the brain. When less levodopa is broken down, more is available to the brain. Increased availability of levodopa may lead to smoother and steadier levels of dopamine in the brain, which may provide better symptom control for longer periods each day. This may lead to improvement in daily activities.

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

Before Using This Medicine:

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.

Children—

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

Older adults—

Appropriate studies performed to date in elderly patients up to age 75 years have not demonstrated geriatric-specific problems that would limit the usefulness of carbidopa, entacapone, and levodopa combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, and cardiovascular insufficiency, which may require extra caution.

Breast-feeding—

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.

Other medicines—

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.

• Bromopride
• Clorgyline
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Sulpiride
• 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.

• Amisulpride
• Apomorphine
• Bitolterol
• Bupropion
• Desipramine
• Dobutamine
• Dopamine
• Epinephrine
• Fluvastatin
• Glimepiride
• Glipizide
• Glyburide
• Haloperidol
• Irbesartan
• Isoetharine
• Isoniazid
• Isoproterenol
• Losartan
• Macimorelin
• Methyldopa
• Metoclopramide
• Nateglinide
• Norepinephrine
• Olanzapine
• Rosiglitazone
• Sapropterin
• Tolbutamide
• Venlafaxine
• Voriconazole
• Warfarin

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.

• Droxidopa
• Fosphenytoin
• Indinavir
• Iron
• Kava
• Phenylalanine
• Phenytoin
• 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
• Biliary obstruction or blockage or
• Colitis (inflammation of the colon) or
• Depression, history of or
• Dyskinesia (abnormal muscle movements) or
• Endocrine or metabolic disease or
• Heart attack, history of or
• Heart or blood vessel disease, severe or
• Heart rhythm problems (eg, ventricular tachycardia) or
• Hypotension (low blood pressure) or
• Kidney disease or
• Liver disease or
• Lung disease, severe or
• Psychosis (mental disorder), or history of or
• Wide-angle glaucoma (eye pressure problem)—Use with caution. May make these conditions worse.

• Melanoma (skin tumor), 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.

• Peptic ulcer, history of—May increase risk of stomach or bowel hemorrhage.

Proper Use of This Medicine:

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.

Swallow the tablet whole. Do not crush, chew, or break it. You may take the tablet with or without food.

Since protein may interfere with the body's response to 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.

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.

This medicine begins to release its ingredients 30 minutes after you take it.

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.

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 oral dosage forms (capsules or tablets):
  • For Parkinson's disease:
    • Adults—The starting dose is usually the same as the current dose you are taking. If you are starting this medicine for the first time, your doctor may want to start you on a carbidopa and levodopa combination with entacapone and gradually switch you over to this combination. Do not use more than 6 to 8 tablets in a 24-hour period.
    • 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 While Using This Medicine:

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, isocarboxazid [Marplan®], phenelzine [Nardil®] or tranylcypromine [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, drowsiness, trouble in controlling movements, or trouble in concentrating or seeing clearly. It may even cause you to fall asleep without warning while you drive, talk, or eat. 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.

Dizziness, lightheadedness, or fainting may occur with this medicine, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may also help. If this problem continues or gets worse, check with your doctor.

This medicine will add to the effects of other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medications, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

This medicine may cause diarrhea, and in some cases it can be severe. It can occur months after starting this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

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.

Check with your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These may be symptoms of a condition called rhabdomyolysis.

Check with your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while being treated with this medicine.

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.

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 of This Medicine:

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-Entacapone

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

Incidence not known-Carbidopa and Levodopa and/or Levodopa alone

Bleeding gums

bloody or black, tarry stools

bloody or cloudy urine

change in size, shape, or color of an existing mole

changes in skin color

chest pain, discomfort, or tightness

constipation

constricted pupil

convulsions

cough

difficult or labored breathing

difficulty with speaking

drooling

drooping eyelid (ptosis)

facial dryness

fast, irregular, or pounding heartbeat

fever with or without chills

general feeling of illness

hallucinations (seeing, hearing, or feeling things that are not there)

hoarseness

large, flat, blue, or purplish patches in the skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of appetite

loss of bladder control

lower abdominal or stomach pain

lower back or side pain

mole that leaks fluid or bleeds

muscle cramps or spasms

muscle pain or stiffness

muscle trembling, jerking, or stiffness

nausea

pain

painful or difficult urination

pinpoint red spots on the skin

raised red swellings on the skin, the buttocks, legs, or ankles

restlessness

severe mental changes

shakiness and unsteady walk

shuffling walk

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sweating

swollen glands

trembling, or other problems with muscle control or coordination

unusual bleeding or bruising

unusual tiredness or weakness

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:

More common-Entacapone

Absence of or decrease in body movement

diarrhea

dizziness

urine discoloration

Less common-Entacapone

Acid or sour stomach

anxiety

belching

bitter, sour, or unusual taste in the mouth

bloated

burning feeling in the chest or stomach

dry mouth

excess air or gas in the stomach or intestines

fear

full feeling

heartburn

hyperventilation

increased sweating

indigestion

irritability

lack or loss of strength

passing gas

restlessness

sleepiness or unusual drowsiness

stomach discomfort or upset

swollen mouth and tongue

tenderness in the stomach area

trouble sleeping

urge to have bowel movement

Incidence not known-Carbidopa and Levodopa and/or Levodopa alone

Being forgetful

bladder pain

blurred vision

body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning and upper abdominal or stomach pain

burning sensation of the tongue

clenching, gnashing, or grinding teeth

confusion about identity, place, and time

dark saliva

dark sweat

decreased mental acuity

difficulty swallowing

discouragement

double vision

ear congestion

enlarged pupils

excessive watering of the mouth

fainting

false or unusual sense of well-being

feeling like you will pass out

feeling of warmth

feeling sad or empty

flushing

hair loss

headache

hiccups

hives or welts

increased blinking

increased interest in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

lack of appetite

large, hard skin blisters

leg pain

loss of voice

muscle spasm, especially of the neck and back

nasal congestion

nightmares

numbness

pain in the chest below the breastbone

painful or prolonged erection of the penis

pharyngeal pain

pounding in the ears

problems with memory or speech

redness of the face, neck, arms, and occasionally upper chest

runny nose

sense of stimulation

skin rash

sleeplessness

slow movement

slow or fast heartbeat

slow reflexes

sneezing

swelling

tremor, increased

trouble concentrating

trouble recognizing objects

trouble thinking and planning

urinary frequency

urinary retention

weight gain

weight loss

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.