Zelapar

DRUG DESCRIPTION

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

ZELAPAR® selegiline hydrochloride) Structural Formula Illustration

Its empirical formula is C13H17N·HCl, representing a molecular weight of 223.75. Selegiline hydrochloride is a white to almost white crystalline powder that is freely soluble in water, chloroform, and methanol.

ZELAPAR® (selegiline hydrochloride) 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: gelatin, mannitol, glycine, aspartame, citric acid, yellow iron oxide, and grapefruit flavor.

What are the possible side effects of selegiline (Eldepryl, Zelapar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking selegiline and call your doctor at once if you have any of these serious side effects:

  • sudden and severe headache, confusion, blurred vision, problems with speech or balance, nausea, vomiting, chest pain, seizure (convulsions), and sudden numbness or weakness (especially on one side of the body);
  • feeling light-headed, fainting;
  • ...

Read All Potential Side Effects and See Pictures of Zelapar »

What are the precautions when taking selegiline hydrochloride (Zelapar)?

Before taking selegiline, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), high blood pressure, history of severe/frequent headaches, peptic ulcer.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, diabetes,...

Read All Potential Precautions of Zelapar »


Zelapar Consumer (continued)

SIDE EFFECTS: Dizziness, abdominal pain, dry mouth, nausea, stomach upset, trouble sleeping, and headache may occur. Redness, pain, and swelling of the mouth/throat may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If you are also taking levodopa, you may experience more side effects from the levodopa when taking selegiline. Tell your doctor immediately if any of these side effects occur: nausea, shakiness, muscle stiffness, mental/mood changes such as hallucinations/abnormal dreams. Your doctor may need to change your medication or dose. Do not stop or change the dose of your levodopa without talking with your doctor first.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, loss of balance, mental/mood changes (e.g., agitation, confusion, depression, hallucinations), worsening muscle stiffness/twitching, changes in sexual ability/interest, increased shaking (tremor), swollen ankles/legs, difficulty urinating, unusual weight gain.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds.

This drug may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Many drug and food interactions can increase this risk. (See also Drug Interactions section.) Seek immediate medical attention if any of these serious side effects occur: frequent/severe headache, fast/slow/irregular/pounding heartbeat, chest pain, neck stiffness/soreness, severe nausea/vomiting, sweating/clammy skin (sometimes with fever), widened pupils, vision changes (e.g., double/blurred vision), sudden sensitivity to light (photophobia).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), 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 selegiline, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), high blood pressure, history of severe/frequent headaches, peptic ulcer.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, diabetes, personal/family history of mental/mood disorders (e.g., schizophrenia, bipolar disorder), family history of high blood pressure, heart disease (e.g., coronary artery disease, history of chest pain), kidney disease, liver disease, history of peptic ulcer, overactive thyroid (hyperthyroidism).

This drug may make you dizzy. 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.

To minimize dizziness and the risk of fainting, get up slowly when rising from a sitting or lying position.

Before having surgery, tell your doctor or dentist you are taking this medication. You may need to stop taking this drug beforehand. Follow your doctor's instructions carefully.

This medicine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this drug safely.

The elderly may be more sensitive to the effects of this drug, especially dizziness from low blood pressure.

During pregnancy, selegiline should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Zelapar Patient Information Including Side Effects

Brand Names: Eldepryl, Zelapar

Generic Name: selegiline (oral) (Pronunciation: se LE ji leen)

  • What is selegiline (Zelapar)?
  • What are the possible side effects of selegiline (Zelapar)?
  • What is the most important information I should know about selegiline (Zelapar)?
  • What should I discuss with my healthcare provider before using selegiline (Zelapar)?
  • How should I take selegiline (Zelapar)?
  • What happens if I miss a dose (Zelapar)?
  • What happens if I overdose (Zelapar)?
  • What should I avoid while using selegiline (Zelapar)?
  • What other drugs will affect selegiline (Zelapar)?
  • Where can I get more information?

What is selegiline (Zelapar)?

Selegiline prevents the breakdown of a chemical in your brain called dopamine (DO pa meen). Low levels of this chemical are associated with Parkinson's disease.

Selegiline is used together with other medicines to treat symptoms of Parkinson's disease.

Selegiline may also be used for other purposes not listed in this medication guide.

What are the possible side effects of selegiline (Zelapar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking selegiline and call your doctor at once if you have any of these serious side effects:

  • sudden and severe headache, confusion, blurred vision, problems with speech or balance, nausea, vomiting, chest pain, seizure (convulsions), and sudden numbness or weakness (especially on one side of the body);
  • feeling light-headed, fainting;
  • hallucinations;
  • feeling restless, agitated, or irritable;
  • twitching muscle movements; or
  • painful or difficult urination.

Less serious side effects may include:

  • dizziness, weakness;
  • sleep problems (insomnia);
  • runny or stuffy nose;
  • back pain;
  • constipation; or
  • mouth sores or ulcers, pain with swallowing (while using Zelapar).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about selegiline (Zelapar)?

There are many other medicines that can cause serious medical problems if you take them together with selegiline. Tell your doctor about all other prescription and over-the-counter medications you use, including vitamins, minerals, and herbal products.

While taking selegiline, do not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while using selegiline?" section of this leaflet. Eating tyramine while you are using selegiline can raise your blood pressure to dangerous levels and cause life-threatening symptoms.

You should become very familiar with the list of foods to avoid while you are using selegiline.

Do not stop taking selegiline suddenly or you may have harmful side effects. Keep taking the medicine as prescribed. Talk with your doctor before stopping the medication.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking selegiline.

Related Drug Centers
  • Eldepryl
  • Zelapar


Related Drugs Index: