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Entacapone (Oral route)

Pronunciation:

en-TAK-a-pone

Brand Names:

  • Comtan

Dosage Forms:

  • Tablet

Classifications:

Therapeutic—

Antiparkinsonian

Pharmacologic—

Catechol-O-Methyltransferase Inhibitor

Uses of This Medicine:

Entacapone is used in combination with levodopa/carbidopa to treat Parkinson's disease, sometimes referred to as shaking palsy. Some patients experience signs and symptoms of end-of-dose “wearing-off” effect despite taking levodopa/carbidopa. Entacapone enhances the effect of levodopa/carbidopa. By improving muscle control, this medicine allows more normal movements of the body.

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—

Studies on this medicine have been done only in adult patients. There is no identified potential use of entacapone in children.

Older adults—

Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. In studies done to date that included elderly people, entacapone did not cause different side effects or problems in older people than it did in younger adults.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

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 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.

  • Apomorphine
  • Bitolterol
  • Desipramine
  • Dobutamine
  • Dopamine
  • Epinephrine
  • Iproniazid
  • Isocarboxazid
  • Isoetharine
  • Isoproterenol
  • Linezolid
  • Methyldopa
  • Nialamide
  • Norepinephrine
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Tranylcypromine
  • Venlafaxine

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

  • Liver problems—Side effects of entacapone may be increased because of a slower removal from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor, to help your condition as much as possible. Do not take more or less of it, and do not take it more or less often than your doctor ordered.

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.

Entacapone is always used in combination with levodopa/carbidopa (Sinemet); never alone.

The number of times a day you take the tablets depends on how often you take levodopa/carbidopa (Sinemet).

  • For oral dosage form (tablets):
    • For Parkinson's disease:
      • Adults—200 mg with each levodopa/carbidopa (Sinemet) dose. Entacapone may be taken up to 8 times a day, but the total daily dose is usually not more than 1600 mg..
      • 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 important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

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

Nausea may occur, especially when you first start taking this medicine. Also, an increase in body movements and twitching, twisting, or uncontrolled movements of the tongue, lips, face, arms or legs may occur. Your doctor may need to adjust your dose of levodopa/carbidopa if these movements occur.

This medicine may cause some people to become dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If you should have this problem, check with your doctor.

Hallucinations (seeing, hearing, or feeling things that are not there) may occur in some patients.

Entacapone may cause your urine to turn brownish orange. This effect is harmless and will go away after you stop taking the medicine.

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 as soon as possible if any of the following side effects occur:

More common
Absence of or decrease in body movements
hyperactivity
increase in body movements
seeing, hearing, or feeling things that are not there
twitching
twisting
uncontrolled repetitive movements of tongue, lips, face, arms, or legs
Less common
Fever or chills
cough or hoarseness
lower back or side pain
painful or difficult urination
Rare
Confusion
muscle cramps
pain
shortness of breath
stiffness
weakness
unusual tiredness

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
Abdominal pain
constipation
diarrhea
dizziness
fatigue
nausea
Less common
Acid or sour stomach
anxiety
belching
bruising
burning feeling in chest or stomach
heartburn
difficult or labored breathing
dry mouth
indigestion
insomnia
irritability
loss of strength or energy
muscle pain or weakness
nervousness
passing gas
sleepiness or unusual drowsiness
small, red spots on skin
stomach discomfort, upset or pain
sweating increased
restlessness
tenderness in stomach area
tightness in chest
tremor
shortness of breath
unusual or unpleasant (after) taste
unusual weak feeling
wheezing

This medicine may cause your urine to turn brownish orange. This effect is harmless and will go away after you stop taking the medicine.

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.


Last Updated: 4/4/2014

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