ENTACAPONE

Drugs metabolized by COMT: When taken with Entacapone, drugs metabolized by COMT, can change heart rate (ventricular tachycardia).  Monitor and caution is a must.

Falling asleep while performing activities of daily living: Patients with Parkinson’s disease treated with entacapone, which increases plasma levodopa levels, or with levodopa have reported suddenly falling asleep without prior warning of sleepiness while engaged in activities of daily living. Before initiating treatment with Comtan, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase this risk such as concomitant use of sedating medications and the presence of sleep disorders.

Check with your doctor immediately if any of these side effects occur when taking entacapone:

• Difficulty breathing
• Seeing or hearing things that are not there (hallucinations)
• High fever with or without chills
• Confusion
• Muscle stiffness
• Weakness with or without fever
• Symptoms of allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Tell your doctor if any of these symptoms are severe or do not go away:

• Dizziness, 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.
• Diarrhea
• Upset stomach
• Movements you cannot control
• Stomach pain
• drowsiness

Some people taking entacapone have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand.

Your urine may turn brownish-orange. This effect is harmless.

Precautions

General:

Older adults may be more sensitive to the side effects of this drug, especially drowsiness and confusion.

• Allergy: Before taking entacapone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
• Dosage of levodopa and other anti-parkinsonian medications may have to be adjusted to prevent levodopa-induced side effects.
• Low blood pressure, fainting: Reports of syncope were generally more frequent in patients in both treatment groups who had an episode of documented hypotension.
• Hallucinations and psychotic-like: Patients with a major psychotic disorder should ordinarily not be treated with entacapone because of the risk of exacerbating psychosis. In addition, certain medications used to treat psychosis may exacerbate the symptoms of Parkinson’s disease and may decrease the effectiveness of entacapone.
• Impulse control and compulsive behavior: Patients treated with anti-Parkinson medications can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and other intense urges. Physicians should consider dose reduction or stopping entacapone if a patient develops such urges while taking entacapone.

Pregnancy Risk: Category C (Use in pregnancy only if benefit justifies the potential risk to the fetus)

Breastfeeding warning: Use is contraindicated

 Interactions

• Some of the products that may interact with this drug include: certain MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, tranylcypromine).
• Other MAO inhibitors (selegiline, rasagiline) 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. This is not a complete list.
• Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).

Overdose

If overdose is suspected, contact a poison control center or take the patient to the emergency room immediately.

Symptoms of overdose may include severe drowsiness, coma, confusion, agitation.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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. 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.

Brands

Available Brands:

Comtan [ Novartis Healthcare ]

Stalev [Novartis Healthcare]- entacapone + levodopa combination