Indications 

Stalevo 100 is an oral medication used to treat symptoms of Parkinson’s disease. It is specifically indicated for the treatment of adult patients with Parkinson’s disease who experience end-of-dose motor fluctuations that are not stabilized on levodopa/dopa therapy alone. These fluctuations refer to a pattern of symptoms that occur when the effects of levodopa wear off, leading to a return of Parkinson’s symptoms. 

Stalevo contains three active ingredients: carbidopa, entacapone, and levodopa. Carbidopa helps prevent the breakdown of levodopa in the bloodstream, allowing more of it to reach the brain and be converted into dopamine. Levodopa is a precursor to dopamine, a neurotransmitter that is deficient in individuals with Parkinson’s disease. Entacapone helps prolong the effect of levodopa by inhibiting the enzyme that breaks it down in the body. 

Use and Dosage 

Stalevo 100 comes in the form of a tablet to be typically taken orally, with or without food as directed by your doctor, usually 3 to 4 times a day. Swallow the tablet whole with a glass of water. Do not crush, chew, or break the tablet unless instructed to do so by your healthcare professional. Breaking or crushing the tablet may affect the way the medication is released and absorbed in your body. 

Stalevo 100 should be taken as prescribed by a healthcare professional. The dosage and frequency of administration will depend on individual factors such as the severity of symptoms and response to treatment.  

If a dose of Stalevo 100 is missed, it is recommended to take the missed dose as soon as possible. However, if it is close to the time for the next scheduled dose, skip the missed dose and continue with the regular dosing schedule. 

Side Effects 

Common Side Effects  

• Anxiety  
• Back pain  
• Blurred vision  
• Changes in your sense of taste  
• Constipation  
• Diarrhea  
• Difficulty sleeping (insomnia) 
• Dizziness  
• Drowsiness  
• Dry mouth  
• Headache  
• Loss of appetite  
• Muscle cramps  
• Nausea  
• Skin rash or itching  
• Stomach pain or upset  
• Strange dreams  
• Unusual skin changes  
• Vomiting  

Serious Side Effects 

• Black or tarry stools 
• Blurred vision 
• Change in the amount of urine 
• Chest pain 
• Confusion 
• Diarrhea 
• Difficulty breathing 
• Easy bleeding or bruising 
• Eye pain 
• Fainting 
• Fast or irregular heartbeat 
• Fever 
• Greatly increased eye blinking or twitching 
• Hallucinations 
• Hives 
• Mood changes 
• Muscle pain tenderness or weakness 
• New or worsening muscle spasm 
• Persistent sore throat 
• Rapid breathing  
• Severe abdominal pain 
• Severe confusion 
• Severe dizziness 
• Sweating 
• Swelling of your face lips tongue or throat 
• Thoughts of suicide 
• Tingling of the hands or feet 
• Unusual muscle stiffness 
• Unusual strong urges (increased gambling sexual urges) 
• Unusual tiredness 
• Vision changes 
• Vomit that looks like coffee grounds Agitation  

Cautions 

• Hyperpyrexia and Confusion: Stalevo 100 may be associated with a syndrome characterized by hyperpyrexia (high fever) and confusion. This syndrome can potentially lead to rhabdomyolysis, a condition where muscle tissue breaks down.  
• Drug Interactions: Stalevo 100 can interact with other medications, including prescription drugs, nonprescription drugs, and herbal supplements.  
• Dosage Adjustments: The dosage of Stalevo 100 may need to be adjusted in certain situations, such as in patients with liver or kidney impairment. Your healthcare provider will determine the appropriate dosage for your specific condition. 
• Sleep Disorders: Stalevo 100 may cause sleep disorders, including sudden sleep onset, in patients with Parkinson’s disease. Caution should be exercised while driving or operating machinery, as Stalevo 100 can cause drowsiness or sudden episodes of falling asleep. 
• Pregnancy and Breastfeeding: The use of Stalevo 100 during pregnancy or breastfeeding should be discussed with a healthcare provider. The potential risks and benefits need to be carefully considered. 
• Cardiovascular Effects: The tablet may have cardiovascular effects, including hypotension (low blood pressure) and orthostatic hypotension (a drop in blood pressure upon standing). Patients with a history of cardiovascular disease should be closely monitored while taking Stalevo 100. 
• Hallucinations and Psychotic Behavior: It has been associated with hallucinations and psychotic-like behavior. Patients may experience vivid dreams, illusions, or a sense of presence that is not there.  
• Melanoma and Other Malignant Melanomas: There have been reports of an increased risk of melanoma and other malignant melanomas in patients treated with Stalevo 100. Regular skin examinations are recommended, and any suspicious skin lesions should be promptly evaluated by a healthcare provider. 
• Dyskinesia: Stalevo 100 may cause or exacerbate dyskinesia, which refers to abnormal involuntary movements. Patients should be monitored for the development or worsening of these movements and appropriate adjustments to the medication may be necessary. 
• Withdrawal Symptoms: Abrupt discontinuation or sudden dose reduction of the tablet may lead to withdrawal symptoms, including fever, muscular rigidity, and altered consciousness.  
• Impulse Control Disorders: It has been associated with impulse control disorders, such as compulsive gambling, increased libido, and binge eating. Patients and their caregivers should be vigilant for any changes in behavior and report them to a healthcare provider.