Zelapar

Zelapar is used to help control the symptoms of Parkinson's disease. Zelapar  belongs to a group of drugs called monamine oxidase (MAO) inhibitors, which affect levels of certain natural substances in the brain. These substances are involved with motor control.

This medication is available as an orally disintegrating tablet. It is taken in the morning before breakfast and without liquid.

Common side effects of Zelapar  include redness in the application area, a large and sudden increase in blood pressure (hypertensive crisis), and low blood pressure (hypotension).  Do not drive or operate machinery until you know how Zelapar  will affect you.

Zelapar is used to help control the symptoms of Parkinson's disease.

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

• Valeant Pharmaceuticals North America LLC

• Zelapar can cause a sudden, large increase in blood pressure (‘‘hypertensive crisis’’) if you eat certain foods and drinks during treatment. See “Drug Precautions”. A hypertensive crisis can lead to stroke and death. Symptoms of a hypertensive crisis include the sudden onset of severe headache, nausea, stiff neck, a fast heartbeat or a change in the way your heart beats (palpitations), a lot of sweating, and confusion. If you suddenly have these symptoms, get medical care right away.
• Zelapar can cause serious and potentially life-threatening reactions if used with certain other medicines. See “Zelapar Drug Precautions”.
• Zelapar may worsen your depression, give you suicidal thoughts, or cause unusual changes in behavior.  Call your doctor right away if you feel worse with Zelapar.
• Zelapar may cause a mental condition called mania or hypomania (mental condition which causes high moods) in people who have a history of mania.
• Zelapar can cause low blood pressure. Lie down if you feel dizzy, faint, or lightheaded. Change your position slowly if low blood pressure is a problem for you. Tell your doctor if you have these symptoms. You may need a lower dose of Zelapar.

The most common side effects with Zelapar include the following dizziness, nausea, pain, headache, insomnia, runny nose, involuntary movement, back pain, mouth inflammation, and upset stomach.

These are not all the side effects of Zelapar. For more information, ask your doctor or pharmacist.

Zelapar can cause serious and potentially life-threatening reactions if used with certain other medicines. Do not take the following medicines while using Zelapar, and for 2 weeks after stopping Zelapar:

• other medicines to treat depression (antidepressants) including other MAOI medicines
• medicine which contains selegiline (such as Eldepryl)
• St. John’s wort (a herbal supplement)
• Demerol (meperidine), or medicines that contain meperidine (a narcotic pain medicine) or the pain medicines tramadol, methadone, or propoxyphene
• Tegretol (carbamazepine), or other medicines that contain carbamazepine (a seizure medicine)
• Trileptal (oxcarbazepine), or other medicines that contain oxcarbazepine (a seizure medicine)
• Cold or cough preparations that contain dextromethorphan
• Flexeril or other medicines that contain cyclobenzaprine (a medicine used to treat muscle spasms)
• decongestant medicines, found in many products to treat cold symptoms
• over-the-counter diet pills or herbal weight-loss products
• any herbal or dietary supplement that contains tyramine
• medicines called amphetamines, also called stimulants or “uppers”
• BuSpar (buspirone), an anxiety medicine

Some of these medicines will have to be stopped for at least a week before you can start using Zelapar. Be sure to tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

This is not a complete list of Zelapar drug interactions. Ask your doctor or pharmacist for more information.

• Zelapar contains a medicine called a monoamine oxidase inhibitor, also called a MAOI. MAOI medicines, including Zelapar, can cause a sudden, large increase in blood pressure (hypertensive crisis) if you eat foods and drinks that contain high amounts of tyramine. A hypertensive crisis can be a life-threatening condition. See "Zelapar Side Effects" for signs and symptoms of a hypertensive crisis.
  • You must avoid (not eat or drink) certain foods and drinks while using Zelapar and for 2 weeks after stopping Zelapar.
  • See "Zelapar Food Interactions" section for more information regarding foods to avoid.

• Zelapar can cause serious and potentially life-threatening reactions if used with certain other medicines. Do not take the following medicines while using Zelapar, and for 2 weeks after stopping Zelapar: 
       ▪ other medicines to treat depression (antidepressants) including other MAOI medicines
       ▪ medicine which contains selegiline (such as Eldepryl)
       ▪ St. John’s wort (a herbal supplement)
       ▪ Demerol (meperidine), or medicines that contain meperidine (a narcotic pain medicine) or the pain medicines tramadol, methadone, or propoxyphene
       ▪ Tegretol (carbamazepine), or other medicines that contain carbamazepine (a seizure medicine)
       ▪ Trileptal (oxcarbazepine), or other medicines that contain oxcarbazepine (a seizure medicine)
       ▪ Cold or cough preparations that contain dextromethorphan
       ▪ Flexeril or other medicines that contain cyclobenzaprine (a medicine used to treat muscle spasms)
       ▪ decongestant medicines, found in many products to treat cold symptoms
       ▪ over-the-counter diet pills or herbal weight-loss products
       ▪ any herbal or dietary supplement that contains tyramine
       ▪ medicines called amphetamines, also called stimulants or “uppers”
       ▪ BuSpar (buspirone HCl), an anxiety medicine
• Some of these medicines will have to be stopped for at least a week before you can start using Zelapar.
• Do not use Zelapar if you are allergic to anything in this medication
• You must not eat foods or drink beverages that contain high amounts of tyramine while using Zelapar. 
• Do not take other medicines while using Zelapar or for 2 weeks after you stop using it unless your doctor has told you it is okay. See “Zelapar Drug Precautions".
• Do not drive or operate dangerous machinery until you know how Zelapar affects you. Zelapar may reduce your judgment, ability to think, or coordination.
• Drinking alcoholic beverages is not recommended while using Zelapar.
• Zelapar is not to be used if you are also taking meperidine (Demerol). This contraindication is often extended to other opioid medications.

Tyramine is a naturally occurring compound found in some cheeses and other foods that may cause dangerously high blood pressure in people taking monoamine oxidase inhibitors (MAOIs) like Zelapar. You must not eat foods or drink beverages that contain high amounts of tyramine.

You should avoid eating very large amounts of foods containing high amounts of tyramine such as:

• cheese (particularly strong or aged varieties)
• sour cream
• Chianti wine
• sherry
• beer (including non-alcoholic beer)
• liqueurs
• pickled herring
• anchovies
• caviar
• liver
• canned figs
• raisins
• bananas
• avocados (particularly if overripe)
• chocolate
• soy sauce
• sauerkraut
• the pods of broad beans (fava beans)
• yeast extracts
• yogurt
• meat extracts
• meat prepared with tenderizers
• dry sausage

Some of the signs and symptoms of dangerously high blood pressure (hypertensive crisis) are:

• severe headache
• vision problems
• confusion
• stupor (mental numbness)
• coma
• seizures
• chest pain
• unexplained nausea or vomiting
• stroke-like symptoms (sudden numbness or weakness - especially on one side of the body)

Get emergency medical help if you experience these symptoms.

Tell your doctor about all your medical conditions, including if you:

• have any heart problems
• have or had manic episodes (a mental condition that causes “high” moods)
• have or had seizures (convulsions or “fits”)
• tend to get dizzy or faint
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Zelapar passes into your milk or if it can harm your baby.

This medication is also available as an orally disintegrating tablet. It is taken in the morning before breakfast and without liquid.

Treatment should be started with Zelapar 1.25 mg given once a day for at least 6 weeks. After 6 weeks, the dose may be increased to 2.5 mg given once a day if a desired benefit has not been achieved.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep Zelapar and all medicines out of the reach of children and away from pets.