entacapone – oral, Comtan

Medication Uses How To Use Side Effects Precautions Drug Interactions Overdose Notes Missed Dose Storage USES: This medication is used with other medications (levodopa/carbidopa) to treat Parkinson’s disease. Entacapone belongs to a class of drugs known as COMT inhibitors. Many people taking levodopa for Parkinson’s have problems with the effects of the levodopa wearing off between scheduled doses, causing symptoms to return or worsen. Entacapone blocks a certain natural substance (COMT enzyme) that breaks down the levodopa in the body. This effect allows the levodopa to last longer in the system so that it doesn’t wear off before the next dose. HOW TO USE: Take this medication by mouth with or without food, usually with each prescribed dose of levodopa/carbidopa (up to 8 times daily) or as directed by your doctor. Dosage is based on your medical condition, liver function, and response to therapy. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not suddenly stop taking this medication unless instructed to do so by your doctor. Doing so may cause your Parkinson’s symptoms to become much worse. Tell your doctor if your condition persists or worsens (such as your Parkinson’s symptoms are not controlled). SIDE EFFECTS: Nausea, vomiting, diarrhea, unwanted/uncontrolled movements, increased sweating, drowsiness, tiredness, dry mouth, gas, and abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Lightheadedness or dizziness upon standing may also occur, especially during the first few weeks of treatment. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that your doctor has prescribed this medication because the benefit is greater than the risk of side effects. Many people using this medication may develop serious side effects, but with frequent visits to your doctor, this risk can be minimized. Some people using this medication have reported falling asleep suddenly during their usual daily activities. In some cases, sleep occurred without any feelings of drowsiness beforehand. Therefore, do not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk is increased with use of alcohol or other medications that can make you drowsy. Your urine may turn brownish-orange. This effect is harmless. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, unusual urges, fever, muscle stiffness, persistent diarrhea. Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, sore/painful muscles, muscle weakness, trouble breathing, pain with breathing. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling, severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking entacapone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcoholism, liver problems, low blood pressure. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Older adults may be more sensitive to the side effects of this drug, especially drowsiness and confusion. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding. DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor or pharmacist give you the best care, be sure to tell your doctor or pharmacist about all the products you use before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor’s approval. Some of the products that may interact with this drug include: certain MAO inhibitors. Other MAO inhibitors may be used cautiously with close monitoring by your doctor. If you are taking rasagiline or selegiline for Parkinson’s disease, ask your doctor if you should continue taking it. Entacapone can slow down the removal of other drugs from your body, thereby affecting how they work. These affected drugs include apomorphine, dobutamine, and methyldopa. Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines, drugs for sleep or anxiety, muscle relaxants, and narcotic pain relievers. Check the labels on all your medicines because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

QUESTION

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. NOTES: Do not share this medication with others. Laboratory and/or medical tests should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Keep all medical and lab test appointments. People with Parkinson’s disease may have an increased risk for developing skin cancer. Tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams. MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. Brief storage is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product. Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.