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Stalevo

(levodopa - carbidopa - entacapone)

How does this medication work? What will it do for me?

Levodopa - carbidopa - entacapone is a combination medication that is used to treat Parkinson's disease. Levodopa helps to control the symptoms of Parkinson's disease by correcting the chemical imbalance in the brain that produces symptoms.

Levodopa can be used alone, but adding carbidopa lowers the amount of levodopa that is needed and may reduce some of the side effects (such as nausea and vomiting) that are associated with levodopa. When entacapone is added to levodopa and carbidopa, it slows the speed at which the body breaks down levodopa. This results in more constant amounts of levodopa in the body, reducing the "wearing off" effect that some people experience.

This combination medication is used to replace immediate-release levodopa - carbidopa when the person is experiencing the end-of-dose "wearing off," or as a replacement for levodopa - carbidopa and entacapone being taken separately.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The daily dose of levodopa - carbidopa - entacapone tablets is based on how well the medication reduces the symptoms of Parkinson's disease, and how the side effects are tolerated. The dose of levodopa - carbidopa that a person is taking before starting this medication is the starting dose for this combination product.

This medication can be taken with or without food. Swallow the tablets whole. Do not crush or chew the tablets.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than one hour until your next dose, take the missed dose, wait one hour and then take the next dose. Afterwards, continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

50 mg/12.5 mg/200 mg
Each brownish- or greyish-red, round, convex, unscored, film-coated tablet, marked with "LCE 50" on one side, contains levodopa 50 mg, carbidopa 12.5 mg, and entacapone 200 mg. Nonmedicinal ingredients: croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, maize starch, mannitol, polysorbate 80, povidone, red iron oxide, sucrose, titanium dioxide, and yellow iron oxide.

75 mg/18.75 mg/200 mg
Each light brownish red, oval-shaped, unscored, film-coated tablet, marked with "LCE 75" on one side, contains levodopa 75 mg, carbidopa 18.75 mg, and entacapone 200 mg. Nonmedicinal ingredients: croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, maize starch, mannitol, polysorbate 80, povidone, red iron oxide, sucrose, and titanium dioxide.

100 mg/25 mg/200 mg
Each brownish- or greyish-red, oval-shaped, unscored, film-coated tablet, marked with "LCE 100" on one side, contains levodopa 100 mg, carbidopa 25 mg, and entacapone 200 mg. Nonmedicinal ingredients: croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, maize starch, mannitol, polysorbate 80, povidone, red iron oxide, sucrose, titanium dioxide, and yellow iron oxide.

125 mg/31.25 mg/200 mg
Each light brownish red, oval-shaped, unscored, film-coated tablet, marked with "LCE 125" on one side, contains levodopa 125 mg, carbidopa 31.25 mg, and entacapone 200 mg. Nonmedicinal ingredients: croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, maize starch, mannitol, polysorbate 80, povidone, red iron oxide, sucrose, and titanium dioxide.

150 mg/37.5 mg/200 mg
Each brownish- or greyish-red, elongated-ellipse shaped, unscored, film-coated tablet, marked with "LCE 150" on one side, contains levodopa 150 mg, carbidopa 37.5 mg, and entacapone 200 mg. Nonmedicinal ingredients: croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, maize starch, mannitol, polysorbate 80, povidone, red iron oxide, sucrose, titanium dioxide, and yellow iron oxide.

Who should NOT take this medication?

Do not take this medication if you :

  • are allergic to levodopa, carbidopa, entacapone, or any ingredients of the medication
  • are taking or have taken a nonselective monoamine oxidase inhibitors (MAOIs) within the last 2 weeks (e.g., phenelzine, tranylcypromine)
  • cannot take sympathomimetic amines (e.g., epinephrine)
  • have a previous history of neuroleptic malignant syndrome or rhabdomyolysis
  • have active heart disease, blood related diseases, endocrine disease, liver disease, lung disease, or kidney disease
  • have been diagnosed as having pheochromocytoma (tumour of the adrenal gland)
  • have liver impairment
  • have narrow angle glaucoma
  • have undiagnosed skin lesions or a history of melanoma (skin cancer)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • back or leg pain
  • bitter taste or a burning sensation of the tongue
  • change in colour of urine, sweat, nails
  • constipation
  • diarrhea
  • dizziness or lightheadedness when rising from a lying or sitting position
  • dry mouth
  • fatigue
  • flatulence (passing gas)
  • flushing of skin
  • headache
  • heartburn or indigestion
  • general feeling of discomfort or illness
  • generalized pain
  • increased sweating
  • loss of appetite
  • nausea
  • nightmares
  • trouble sleeping
  • uncontrolled movements
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abnormal thinking (holding false beliefs that cannot be changed by fact)
  • agitation
  • anxiety
  • clenching or grinding of teeth
  • clumsiness or unsteadiness
  • compulsive behaviour (e.g., gambling, spending)
  • confusion
  • difficult urination
  • difficulty opening mouth
  • difficulty swallowing
  • false sense of well-being
  • fast, irregular, or pounding heartbeat
  • feeling faint
  • forgetfulness
  • hallucinations (e.g., seeing or hearing things that aren't there)
  • increased hand tremor
  • loss of bladder control
  • muscle or joint pain/aches
  • muscle rigidity
  • numbness or tingling sensations
  • signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, cuts that don't stop bleeding)
  • signs of depression (e.g., changes in sleeping or appetite, loss of interest in activities, poor concentration, feelings of guilt)
  • signs of fluid retention (e.g., rapid weight gain and swelling)
  • signs of infection (fever, severe chills, sore throat, or mouth ulcers)
  • signs of inflammation of the colon (digestive system; e.g., severe diarrhea, weight loss)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of a urinary tract infection such as difficult or painful urination, or blood in the urine
  • signs of low blood pressure (e.g., dizziness and lightheadedness)
  • signs of muscle breakdown (e.g., muscle weakness, pain, bruising, confusion)
  • skin rash
  • sudden onset of sleep
  • unusual and uncontrolled muscle movement of the body (including face, tongue, arms, hands, head, upper body)
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vision changes (e.g., blurred vision, dilated (large) pupils, double-vision)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • convulsions (seizures)
  • high blood pressure
  • inability to move eyes
  • prolonged, painful, inappropriate penile erection
  • signs of a serious allergic reaction (i.e., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
  • signs of bleeding in the stomach (e.g., bloody or black, tarry stools, stomach pain, vomiting blood, or material that looks like coffee grounds)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Behavioural and mood changes: This medication has been known to cause mood swings, changes in behaviour and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You may notice compulsive behaviour, such as gambling, increased sexual activity or inappropriate spending. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, contact your doctor as soon as possible. If you notice compulsive behaviour or signs of depression in a family member, ensure that they see their doctor.

Bleeding: Carbamazepine may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Diarrhea: Diarrhea is a common side effect of this medication. It may appear as early as the first week of starting treatment or many months after starting treatment. For some people, the diarrhea causes weight loss. If you notice any weight loss or have excessive diarrhea, contact your doctor.

Drowsiness/reduced alertness: This medication may cause low blood pressure or dizziness and lightheadedness when rising from a lying or sitting position. Avoid driving or operating machinery until you know how this medication affects you.

Glaucoma: This medication may cause symptoms of glaucoma to get worse by increasing the pressure in the eye. If you have chronic wide-angle glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease: If you have heart disease (e.g., history of heart attack, arrhythmia), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: This medication has been reported to reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney disease: If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Melanoma: People with Parkinson's disease may be at increased risk of developing melanoma (a type of skin cancer). It is not known if this increased risk is due to Parkinson's disease or to the medications used to treat Parkinson's disease. Your doctor will monitor you for skin cancer while you are taking this medication. Talk to your doctor if you have any concerns.

Neuroleptic malignant syndrome (NMS): Very rarely, levodopa - carbidopa - entacapone can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.

Peptic (stomach) ulcer: There is a possibility of stomach bleeding for people with a history of peptic ulcer who take levodopa - carbidopa - entacapone. If you have peptic ulcers or a history of peptic ulcers, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you notice bloody or black tarry stools, stomach pain, vomiting blood or material that looks like coffee grounds, contact your doctor immediately.

Prostate cancer: Men who take this medication may have a slightly higher risk of developing prostate cancer. It is not known if this increased risk is due to o the medication or some other factor. While taking this medication, it is important for men to keep appointments for regular prostate cancer screening. Talk to your doctor if you have any concerns.

Rhabdomyolysis (muscle breakdown): Occasionally, this medication may cause rapid breakdown of muscle tissue. If you notice signs of muscle weakness or pain, high body temperature, unexpected bruising, confusion, or difficulty passing urine, contact your doctor immediately.

Seizures: If you have seizures or a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stopping this medication: Stopping this medication too quickly can cause potentially life-threatening side effects. Before stopping this medication, discuss the risks and benefits with your doctor. Do not stop taking this medication until you have spoken with your doctor first.

Sudden onset of sleep: There are reports of people who take levodopa - carbidopa - entacapone combinations falling asleep with no warning or drowsiness. If you have a sleep disorder, discuss this with your doctor. If you experience drowsiness while taking this medication, avoid driving or using machinery.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast feeding: Levodopa passes into breast milk. It is not known if carbidopa or entacapone pass into breast milk. If you are a breast-feeding mother and are taking levodopa - carbidopa - entacapone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between levodopa - carbidopa - entacapone and any of the following:

  • adrenaline
  • alcohol
  • ampicillin
  • antihistamines (e.g., cetirizine, diphenhydramine, hydroxyzine)
  • antipsychotics (e.g., haloperidol, quetiapine, risperidone)
  • azelastine
  • baclofen
  • barbiturates (e.g., butalbital, phenobarbital)
  • benzodiazepines (sedatives; e.g., clonazepam, diazepam, lorazepam)
  • blood pressure medications (e.g., ACE inhibitors, beta-blockers, diuretics)
  • buprenorphine
  • buspirone
  • chloramphenicol
  • cholestyramine
  • cyclobenzaprine
  • dobutamine
  • dopamine
  • epinephrine
  • glycopyrrolate
  • iron (e.g., ferrous sulfate, multivitamins)
  • isoniazid
  • isoproterenol
  • MAO inhibitors (e.g., phenelzine, tranylcypromine)
  • methyldopa
  • methylphenidate
  • metoclopramide
  • mirtazapine
  • narcotic pain relievers (e.g., codeine, fentanyl, hydromorphone, morphine)
  • noradrenaline
  • papaverine
  • paroxetine
  • phenothiazines (e.g., chlorpromazine, perphenazine, promethazine)
  • pramipexole
  • pyridoxine
  • ropinirole
  • scopolamine
  • seizure medications (e.g., carbamazepine, gabapentin, phenytoin)
  • selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, sertraline)
  • tramadol
  • tricyclic antidepressants (e.g., amitriptyline, desipramine)
  • venlafaxine
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Stalevo

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