Generic Stalevo ( Carbidopa/Entacapone/Entacapone )

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Stalevo is a triple-combination medication used to treat Parkinson's disease in people who experience "wearing-off" effects, where the benefit of each levodopa dose doesn't last until the next one. It combines levodopa, the mainstay of Parkinson's treatment, with carbidopa and entacapone, two agents that help more levodopa reach the brain.
The usual dose is one tablet taken up to 10 times per day, depending on your individual needs and your doctor's instructions. The maximum daily dose of entacapone is 2,000 mg, which equals 10 tablets of the 200 mg strength.
The administration form is film-coated tablets containing 25 mg carbidopa, 100 mg levodopa, and 200 mg entacapone. The tablets can be taken with or without food. Do not crush or chew them.
Stalevo does not work overnight. It is usually prescribed for people already taking levodopa/carbidopa who need better symptom control. The improvement in "wearing-off" may be noticeable within the first few days, but the full benefit takes a few weeks of steady dosing.
Alcohol should be avoided during treatment. It can increase the drowsiness and dizziness that Stalevo can cause, and it may worsen some of the side effects of the medication.
The most common side effects are uncontrolled movements (dyskinesias), which occur in about 19% of patients. Nausea and diarrhea are also common, affecting about 15% and 12% of patients respectively.
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Common Use Stalevo

Stalevo is a combination of levodopa, carbidopa, and entacapone. Levodopa is a natural substance that crosses into the brain and is converted into dopamine, which helps relieve the tremor, stiffness, and slowness of movement seen in Parkinson's disease. Carbidopa and entacapone both work by blocking enzymes that break down levodopa before it reaches the brain. Carbidopa blocks aromatic amino acid decarboxylase, mainly in the gut, while entacapone blocks catechol-O-methyltransferase (COMT) throughout the body. Together, these three agents deliver more levodopa to the brain and help smooth out the "wearing-off" effect that many people develop after several years of treatment. Health Canada has approved Stalevo for the treatment of patients with idiopathic Parkinson's disease who experience end-of-dose "wearing-off" fluctuations while taking their regular levodopa/carbidopa doses.

Basic Stalevo Information

• INN (International Nonproprietary Name): Levodopa, carbidopa, entacapone
• Brand names available in Canada: Stalevo® (Sandoz Canada Incorporated). There is no generic version currently marketed in Canada.
• ATC Code: N04BA03 (levodopa, decarboxylase inhibitor, and COMT inhibitor)
• Forms and dosages: Film-coated tablets – 50/12.5/200 mg, 75/18.75/200 mg, 100/25/200 mg, 125/31.25/200 mg, and 150/37.5/200 mg. The 25/100/200 mg strength refers to 25 mg carbidopa, 100 mg levodopa, and 200 mg entacapone.
• Manufacturers in Canada: Sandoz Canada Incorporated (DIN 02305933 for 50/12.5/200 mg, DIN 02305941 for 100/25/200 mg, DIN 02305968 for 150/37.5/200 mg, DIN 02337827 for 75/18.75/200 mg, DIN 02337835 for 125/31.25/200 mg). The original brand was marketed by Novartis Pharmaceuticals Canada Inc.
• Registration status in Canada: Approved by Health Canada. The 100/25/200 mg strength is listed under DIN 02305941, with a status of "Marketed" as of 2020-07-24. All five strengths are listed in the Drug Product Database.
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Take Stalevo exactly as your doctor prescribes. The dose depends on your previous levodopa/carbidopa regimen. A patient taking 100/25 mg levodopa/carbidopa four times a day with 200 mg entacapone can switch to one Stalevo 100/25/200 mg tablet four times a day instead. The optimal daily dose should be determined by using one of the available tablet strengths. The maximum recommended daily dose is 10 tablets of the 200 mg entacapone strength, which equals 2,000 mg of entacapone per day. Take only one Stalevo tablet per dose administration. Take the tablets with or without food. If you have been told to avoid a high-protein diet, continue to follow that advice, as protein can interfere with levodopa absorption. Do not stop taking Stalevo suddenly without talking to your doctor. Stopping abruptly can cause a condition called neuroleptic malignant syndrome, with high fever, muscle rigidity, and confusion. Your doctor will taper the dose gradually if you need to stop. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once.

Precautions

Stalevo can cause drowsiness, and some people may suddenly fall asleep without warning while taking it. Do not drive or operate machines if you experience excessive drowsiness or a sudden sleep onset episode. Contact your doctor if this happens. Studies of people with Parkinson's disease show they may be at increased risk of developing melanoma. Your doctor should perform periodic skin examinations. In one study, prostate cancer was reported more frequently in patients taking Stalevo compared to those taking levodopa/carbidopa alone. Men should have regular prostate examinations during treatment. Stalevo is not recommended for early-stage Parkinson's disease. Tell your doctor if you have ever had a heart attack, asthma, or other heart, blood vessel, or lung disease. Also tell your doctor if you have liver problems, severe kidney problems, hormone-related diseases, inflammatory bowel disease, trouble urinating, an enlarged prostate, prostate cancer, elevated PSA levels, stomach ulcers, convulsions, or a severe mental disorder. If you feel depressed, have suicidal thoughts, or notice unusual changes in behaviour, contact your doctor. Stalevo can cause low blood pressure when standing up, especially if you take other medicines that lower blood pressure. Some people develop impulse control disorders while taking Stalevo, including addictive gambling, excessive eating or spending, or an abnormally high sex drive. If you or your family notices these behaviours, tell your doctor. Do not take iron supplements or multivitamins containing iron at the same time as Stalevo. Wait at least 2 to 3 hours between them.

Contraindications

Do not take Stalevo if you have had an allergic reaction to levodopa, carbidopa, entacapone, or any of the inactive ingredients in the tablet. Stalevo is contraindicated in patients with liver impairment. Do not take it if you have narrow-angle glaucoma. It should not be used in patients with untreated heart, kidney, lung, blood, or hormonal disease. Stalevo is contraindicated in patients with pheochromocytoma, a tumour of the adrenal gland, because it may cause severe hypertensive reactions. Do not take Stalevo if you are taking or have been treated in the last two weeks with certain antidepressants, including both MAO-A and MAO-B inhibitors simultaneously, or non-selective MAO inhibitors. It is also contraindicated in patients with a history of neuroleptic malignant syndrome (NMS) or rhabdomyolysis not caused by injury. Do not take Stalevo if you have been told you should not take sympathomimetic drugs such as isoproterenol, amphetamines, epinephrine, or cough and cold medications containing drugs related to epinephrine.

Possible Side Effects

The most common side effect of Stalevo is dyskinesia, which are uncontrolled movements including choreiform, dystonic, and other involuntary movements. Dyskinesia occurs in approximately 19% of patients. Gastrointestinal symptoms are also common, with nausea affecting about 15% of patients and diarrhea about 12%. Other common side effects include dizziness, muscle pain, and harmless reddish-brown discoloration of urine. Some patients experience mental changes including paranoid ideation and psychotic episodes. Gastrointestinal bleeding, development of duodenal ulcer, hypertension, phlebitis, and leucopenia have been reported. Ataxia, numbness, increased hand tremor, muscle twitching, muscle cramp, and trismus can occur. Rhabdomyolysis has been reported in rare cases, secondary to severe dyskinesias or neuroleptic malignant syndrome. If you develop severe muscle rigidity, violent jerking, tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in blood pressure, seek medical attention immediately. If you experience diarrhea, your doctor may follow up on your weight to prevent excessive weight loss. Some patients experience excessive daytime sleepiness and episodes of sudden sleep onset.

Drug Interaction

Stalevo can increase the effects and side effects of certain medicines. These include medicines used to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, and venlafaxine. Do not take Stalevo and iron supplements at the same time. If you take iron supplements or multivitamins containing iron, wait at least 2 to 3 hours between taking them and taking Stalevo. Iron salts can reduce the absorption of entacapone and levodopa. Drugs that are metabolized by COMT, such as methyldopa, dobutamine, apomorphine, and isoproterenol, may interact with entacapone. Stalevo can enhance the blood pressure-lowering effects of antihypertensive agents, so your doctor may need to adjust the dose of those medicines. Tricyclic antidepressants and dopamine D2 receptor antagonists such as antipsychotics can also interact with Stalevo. Isoniazid can reduce the effectiveness of levodopa. Tell your doctor and pharmacist about every medication you take, including over-the-counter products, vitamins, and herbal supplements.

Missed Dose

If you miss a dose of Stalevo, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss several doses in a row, contact your doctor before restarting. Missing doses can cause your Parkinson's symptoms to return or worsen, so try to take the medication at the same times each day.

Overdose

Overdose with Stalevo can cause severe drowsiness, confusion, agitation, and involuntary movements. In severe cases, it can cause dangerously low blood pressure, fast or irregular heartbeat, and breathing problems. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and monitoring of vital signs. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store Stalevo tablets at room temperature between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit). Keep the container tightly closed and protect it from light and moisture. Do not store in the bathroom or near a sink. Keep out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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