Stalevo 150

Name: Stalevo 150

What is the most important information I should know about Stalevo 150 (carbidopa, entacapone, and levodopa)?

You should not use this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

You should not take this medication if you are allergic to carbidopa (Lodosyn), entacapone (Comtan), or levodopa (Larodopa), or if you have narrow-angle glaucoma, unusual skin lesions, or a history of skin cancer.

Tell your doctor about all of your medical conditions, especially heart disease, high blood pressure, asthma or other breathing problems, liver or kidney disease, a hormonal disease, an ulcer, glaucoma, or mental illness. Also tell your doctor about all the medications you use.

It may take up to several weeks of using carbidopa, entacapone, and levodopa before your symptoms improve. Talk with your doctor if your symptoms do not improve or if the effects of this medication seem to wear off quickly in between doses.

Do not stop using carbidopa, entacapone, and levodopa without first talking to your doctor.

How should I take Stalevo 150 (carbidopa, entacapone, and levodopa)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your medicine at regular intervals to keep a steady amount of the drug in your body at all times.

Drink plenty of liquids while you are taking this medication.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after a few weeks of treatment. Also tell your doctor if the effects of this medication seem to wear off quickly in between doses.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Do not stop using carbidopa, entacapone, and levodopa without first talking to your doctor. You may need to use less and less before you stop the medication completely.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using carbidopa, entacapone, and levodopa.

Store at room temperature away from moisture and heat.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include weakness, loss of coordination, trouble breathing, fainting, or seizure (convulsions).

What should I avoid while taking Stalevo 150 (carbidopa, entacapone, and levodopa)?

Carbidopa, entacapone, and levodopa may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid taking iron supplements or eating a diet that is high in protein (protein sources include meat, eggs, and cheese). These things can make it harder for your body to digest and absorb carbidopa, entacapone, and levodopa.

Stalevo 150 (carbidopa, entacapone, and levodopa) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • nausea, sweating, feeling like you might pass out (especially when you first start taking this medication);

  • depression, confusion, hallucinations, unusual thoughts or behavior, thoughts about hurting yourself;

  • worsening symptoms such as tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

  • severe or ongoing diarrhea, extreme thirst, increased urination, weight loss, leg discomfort, muscle weakness or limp feeling, uneven heart rate;

  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

  • fast, pounding, or uneven heartbeats;

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling;

  • tight feeling in your chest, new or worsening cough, fever, trouble breathing;

  • easy bruising or bleeding, bloody or tarry stools, coughing up blood;

  • pain or burning when you urinate; or

  • unexplained muscle pain, tenderness, or weakness.

Less serious side effects may include:

  • stomach pain or upset, loss of appetite, constipation;

  • dry mouth, changes in your sense of taste;

  • unusual skin changes. mild rash or itching;

  • dizziness or drowsiness, headache, blurred vision;

  • muscle cramps, back pain; or

  • agitation or anxiety, sleep problems (insomnia), strange dreams.

You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Stalevo 150 (carbidopa, entacapone, and levodopa)?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by carbidopa, entacapone, and levodopa. Tell your doctor if you regularly use any of these other medicines, or any other Parkinson's medications.

Tell your doctor about all other medicines you use, especially:

  • apomorphine (Apokyn);

  • cholestyramine (Prevalite, Questran);

  • dobutamine (Dobutrex);

  • epinephrine (Epi-Pen, and others);

  • isoniazid (for treating tuberculosis);

  • isoproterenol (Isuprel, Medihaler-Iso);

  • methyldopa (Aldomet);

  • metoclopramide (Reglan);

  • papaverine (Pavabid, Papacon, Pavagen, Pavacot);

  • phenytoin (Dilantin);

  • probenecid (Benemid);

  • blood pressure medication;

  • an antibiotic such as ampicillin, chloramphenicol, erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole, and others), or rifampin (Rifadin, Rifater, Rifamate);

  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others; or

  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), prochlorperazine (Compazine), risperidone (Risperdal), and others.

This list is not complete and other drugs may interact with carbidopa, entacapone, and levodopa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Before Using Stalevo 150

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.

Pediatric

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.

Geriatric

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.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal 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.

Interactions with 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.

  • Amisulpride
  • 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.

  • Apomorphine
  • Bitolterol
  • Bupropion
  • Desipramine
  • Dobutamine
  • Dopamine
  • Epinephrine
  • Fluvastatin
  • Glimepiride
  • Glipizide
  • Glyburide
  • Irbesartan
  • Isoetharine
  • Isoniazid
  • Isoproterenol
  • Losartan
  • Methyldopa
  • Nateglinide
  • Norepinephrine
  • Rosiglitazone
  • 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
  • Metoclopramide
  • Phenylalanine
  • Phenytoin
  • Spiramycin
  • Tyrosine

Interactions with Food/Tobacco/Alcohol

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.

For the Consumer

Applies to carbidopa / entacapone / levodopa: oral tablet

Along with its needed effects, carbidopa / entacapone / levodopa 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 while taking carbidopa / entacapone / levodopa:

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 of carbidopa / entacapone / levodopa 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

For Healthcare Professionals

Applies to carbidopa / entacapone / levodopa: oral tablet

Nervous system

Nervous system side effects most commonly reported with carbidopa-levodopa-entacapone have included dyskinesias (choreiform, dystonic, and involuntary movements) and headache. Hyperkinesia, hypokinesia, and dizziness have been reported with entacapone.

Convulsions have also been reported; however, a causal relationship with carbidopa-levodopa has not been established.[Ref]

Ocular

Ocular side effects reported with various carbidopa-levodopa products have included blurred vision, dilated pupils, diplopia, and oculogyric crisis.[Ref]

Psychiatric

Psychiatric side effects have included reports of psychotic episodes (including delusions, hallucinations, and paranoid ideation), agitation, anxiety, confusion, dream abnormalities including nightmares, depression (with or without development of suicidal tendencies), somnolence, and dementia.[Ref]

Respiratory

Respiratory side effects have included dyspnea, upper respiratory infection, pharyngeal pain, cough, pharyngitis, and rhinitis.[Ref]

Cardiovascular

Cardiovascular side effects have included reports of cardiac irregularities, myocardial infarction, and orthostatic effects (hypotension, hypertension, and syncope), and palpitations.[Ref]

Dermatologic

Dermatologic side effects have included rash, increased sweating, alopecia, dark sweat, and malignant melanoma.[Ref]

Gastrointestinal

Gastrointestinal (GI) side effects have included dark saliva, GI bleeding, development of duodenal ulcer, abdominal pain, anorexia, nausea, vomiting, diarrhea, constipation, dyspepsia, dry mouth, dysphagia, sialorrhea, flatulence, gastritis, taste alterations, heartburn, and hiccups.[Ref]

Hematologic

Hematologic side effects have included hemolytic and nonhemolytic anemia, agranulocytosis, thrombocytopenia, leukopenia, and purpura. Laboratory abnormalities reported have included decreased hemoglobin and hematocrit, serum potassium, Coombs' test, lactic dehydrogenase, bilirubin, and blood urea nitrogen (BUN); and elevated serum glucose.[Ref]

Hypersensitivity

Hypersensitivity side effects have included angioedema, urticaria, pruritus, and Henoch-Schonlein purpura, bullous lesions (with pemphigus- like reactions).[Ref]

Musculoskeletal

Musculoskeletal side effects have included asthenia, fatigue, back pain, shoulder pain, leg pain, and muscle cramps.[Ref]

Genitourinary

Genitourinary side effects have included dark urine, blood in the urine, urinary incontinence, urinary retention, urinary tract infection, and priapism,[Ref]

Hepatic

Hepatic side effects have included abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), and lactic dehydrogenase.[Ref]

Renal

Renal side effects have included increases in serum creatinine and uric acid.[Ref]

Metabolic

Metabolic side effects have included edema, weight gain, and weight loss.[Ref]

Some side effects of Stalevo 150 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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