Zelapar

Generic name: selegiline (oral)
Brand names: Eldepryl, Zelapar
Drug classes: Dopaminergic antiparkinsonism agents, Monoamine oxidase inhibitors

What is Zelapar?

Zelapar is a prescription medicine that is used to treat Parkinson’s disease. Zelapar may be given to you for other reasons.

Description

ZELAPAR Orally Disintegrating Tablets contain selegiline hydrochloride, a levorotatory acetylenic derivative of phenethylamine. Selegiline hydrochloride is described chemically as: (-)-(R)-N, α-dimethyl-N-2-propynylphenethylamine hydrochloride and its structural formula is:

Its empirical formula is C13H17N∙HCl, representing a molecular weight of 223.74. Selegiline hydrochloride is a white to almost white crystalline powder that is freely soluble in water and in methanol, slightly soluble in acetone.

ZELAPAR Orally Disintegrating Tablets are available for oral administration (not to be swallowed) in a strength of 1.25 mg. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: aspartame, citric acid, gelatin, glycine, mannitol, opatint yellow, purified water, and grapefruit flavor.

Mechanism of Action

Selegiline is an irreversible inhibitor of monoamine oxidase (MAO), which regulates the metabolic degradation of catecholamines and serotonin in the central nervous system and peripheral tissues. At recommended doses, selegiline is selective for MAO type B (MAO-B), the major form in the brain. Inhibition of MAO-B activity, by blocking the catabolism of dopamine, may result in increased dopamine levels; however, there is evidence that selegiline may act through other mechanisms to increase dopaminergic activity.

Before taking Zelapar, tell your doctor:

• If you are allergic to Zelapar; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have an adrenal gland tumor called pheochromocytoma.
• If you are using another drug that has the same drug in it.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Zelapar, like certain drugs that are used for low mood (depression) or other mood problems, pain, seizures, weight loss, and the common cold. There are many drugs that must not be taken with Zelapar.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson’s disease like rasagiline in the last 14 days. Taking Zelapar within 14 days of those drugs can cause very bad high blood pressure.
• If you have taken fluoxetine within the last 5 weeks. Do not start Zelapar if you have taken fluoxetine within the last 5 weeks.
• If you have any of these health problems: Kidney disease or liver disease.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Zelapar with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Zelapar?

• Tell all of your health care providers that you take Zelapar. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Zelapar affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not stop taking Zelapar all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop Zelapar, you will want to slowly stop it as ordered by your doctor.
• Check blood pressure and heart rate as the doctor has told you.
• Some foods and drinks, like cheese and red wine, may cause sudden, severe high blood pressure when you are taking Zelapar. This effect can be deadly. Talk with your doctor about your risk for this effect. Get a list of foods and drinks to avoid. Avoid these foods and drinks for as long as your doctor has told you after Zelapar is stopped.
• The chance of a type of skin cancer called melanoma may be raised in people with Parkinson’s disease. It is not known if Zelapar may also raise the chance. Have skin exams while you take Zelapar. Talk with your doctor.
• Avoid drinking alcohol while taking Zelapar.
• Some people taking the oral form of Zelapar have fallen asleep during activities like driving, eating, or talking. Some people did not feel sleepy and felt alert right before falling asleep. This has happened up to 1 year after Zelapar was started. If you fall asleep during activities, do not drive or do other tasks or actions that call for you to be alert while you take Zelapar. Call your doctor right away if this happens or you feel very sleepy.
• If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
• A severe and sometimes deadly problem called serotonin syndrome may happen if you take Zelapar with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.
• If you are 65 or older, use Zelapar with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Zelapar while you are pregnant.

How is Zelapar best taken?

Use Zelapar as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take before breakfast.
• Do not take Zelapar out of the blister pack until you are ready to take it. Take Zelapar right away after opening the blister pack. Do not store the removed drug for future use.
• Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your tongue and let it dissolve. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.
• Do not eat or drink for at least 5 minutes before or after taking Zelapar.
• Keep using Zelapar as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Zelapar that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• Shakiness, trouble moving around, or stiffness.
• Feeling confused.
• Mental, mood, or behavior changes that are new or worse.
• Hallucinations (seeing or hearing things that are not there).
• Strong urges that are hard to control (such as eating, gambling, sex, or spending money).
• A skin lump or growth.
• Change in color or size of a mole.
• Shortness of breath.
• Muscle pain or weakness.
• Neck stiffness.
• Chest pain or pressure.
• Fast, slow, or abnormal heartbeat.
• Sweating a lot.
• Larger pupils.
• If bright lights bother your eyes.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Mouth sores.
• Very bad pain when swallowing.

What are some other side effects of Zelapar?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy.
• Headache.
• Dry mouth.
• Upset stomach or throwing up.
• Trouble sleeping.
• Diarrhea or constipation.
• Nose or throat irritation.
• Back pain.
• Runny or stuffy nose.
• Mouth irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Zelapar?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Use oral disintegrating tablets within 3 months of opening pouch.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

• NDC 0187-0453-02
  Rx onlyZelapar®
  (selegiline HCL)
  Orally Disintegrating Tablets

  60 Tablets
  1.25 mg

  Contents:
  Clear child-resistant pouch containing 6 sachetpouches.
  Each sachet pouch contains 10 tablets

  BAUSCH HEALTH

SRC: NLM .