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Novartis Pharmaceuticals Corporation
Serious side effects have been reported with Stalevo.
- difficulty breathing
- high fever
- muscle stiffness
- falling asleep during activities of daily living
- changes in blood pressure
- irregular heartbeat
- problems with impulse control
- increased risk of skin cancer (melanoma)
Stalevo can cause drowsiness, dizziness, and blurred vision. Do not drive or operate heavy machinery until you know how Stalevo affects you.
Do not take Stalevo if you:
- are allergic to Stalevo or any of its ingredients
- are taking or have recently stopped taking a monoamine oxidase inhibitor (MAOI)
Stalevo and Lactation
Tell your doctor if you are breastfeeding or plan to breastfeed.
Levodopa, one of the components of Stalevo, has been detected in human breast milk. It is not known if carbidopa and entacapone are excreted in human breast milk. Caution should be exercised when Sinemet is given to a nursing woman.
If you take too much Stalevo, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.
If Stalevo is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.
What are some things I need to know or do while I take Stalevo?
- Tell all of your health care providers that you take Stalevo. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
- To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Stalevo.
- If you have high blood sugar (diabetes), talk with your doctor about which glucose tests are best to use.
- This medicine may "wear off" as the time for your next dose gets closer. Tell your doctor if this happens and it bothers you.
- It may take a few months to see the full effect.
- Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
- The chance of a type of skin cancer called melanoma may be raised in people with Parkinson's disease. It is not known if this medicine may also raise the chance. Have skin exams while you take Stalevo. Talk with your doctor.
- If you are 65 or older, use this medicine with care. You could have more side effects.
- Do not give to a child. Talk with your doctor.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Stalevo while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How is this medicine (Stalevo) best taken?
Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take with or without food. Take with food if it causes an upset stomach.
- Swallow whole. Do not chew, break, or crush.
- Avoid a high protein diet. Keep protein use the same from day to day.
- Do not take iron products within 2 hours of Stalevo.
- Do not stop taking this medicine all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop Stalevo (levodopa, carbidopa, and entacapone), you will want to slowly stop it as ordered by your doctor.
- Take even during sign-free periods.
- Keep a diary of your signs.
- Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
- Take Stalevo at the same time of day.
- To gain the most benefit, do not miss doses.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
Indications and Usage for Stalevo
Stalevo, a combination drug consisting of levodopa, carbidopa (dopa decarboxylase inhibitor), and entacapone (catechol-O-methyltransferase-COMT inhibitor) is indicated for the treatment of Parkinson's disease.
Stalevo can be used:
- To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products.
- To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.
For Healthcare Professionals
Applies to carbidopa / entacapone / levodopa: oral tablet
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 side effects reported with various carbidopa-levodopa products have included blurred vision, dilated pupils, diplopia, and oculogyric crisis.[Ref]
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 side effects have included dyspnea, upper respiratory infection, pharyngeal pain, cough, pharyngitis, and rhinitis.[Ref]
Cardiovascular side effects have included reports of cardiac irregularities, myocardial infarction, and orthostatic effects (hypotension, hypertension, and syncope), and palpitations.[Ref]
Dermatologic side effects have included rash, increased sweating, alopecia, dark sweat, and malignant melanoma.[Ref]
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 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 side effects have included angioedema, urticaria, pruritus, and Henoch-Schonlein purpura, bullous lesions (with pemphigus- like reactions).[Ref]
Musculoskeletal side effects have included asthenia, fatigue, back pain, shoulder pain, leg pain, and muscle cramps.[Ref]
Genitourinary side effects have included dark urine, blood in the urine, urinary incontinence, urinary retention, urinary tract infection, and priapism,[Ref]
Hepatic side effects have included abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), and lactic dehydrogenase.[Ref]
Renal side effects have included increases in serum creatinine and uric acid.[Ref]
Metabolic side effects have included edema, weight gain, and weight loss.[Ref]
Some side effects of Stalevo may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.