Eldepryl

Selegiline comes as a capsule and an orally disintegrating (dissolving) tablet to take by mouth. The capsule is usually taken twice a day with breakfast and with lunch. The orally disintegrating tablet is usually taken once a day before breakfast without food, water, or other liquids. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take selegiline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. If you take too much selegiline, you may experience a sudden and dangerous increase in your blood pressure.

If you are taking the orally disintegrating tablet, do not remove the blister that contains the tablets from the outer pouch until you are ready to take a dose. When it is time for your dose, remove the blister card from the outer pouch and use dry hands to peel open one blister. Do not try to push the tablet through the foil. Place the tablet on your tongue and wait for it to dissolve. Do not swallow the tablet. Do not eat or drink anything for 5 minutes before you take the tablet and for 5 minutes after you take the tablet.

If you are taking the orally disintegrating tablet, your doctor may start you on a low dose of selegiline and increase your dose after six weeks.

Tell your doctor if you experience nausea, stomach pain, or dizziness. Your doctor may decrease your dose of levodopa/carbidopa during your treatment with selegiline, especially if you experience these symptoms or other unusual symptoms. Follow these directions carefully and ask your doctor or pharmacist if you do not know how much medication you should take. Do not change the doses of any of your medications unless your doctor tells you that you should.

Selegiline may help to control the symptoms of PD, but it will not cure the condition. Do not stop taking selegiline without talking with your doctor. If you suddenly stop taking medications for Parkinson's disease such as selegiline, you may experience fever, sweating, stiff muscles, and loss of consciousness. Call your doctor if you experience these or other unusual symptoms after you stop taking selegiline.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.

• Eldepryl 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.
• Eldepryl can cause serious and potentially life-threatening reactions if used with certain other medicines. See “Eldepryl Drug Precautions”.
• Eldepryl may worsen your depression, give you suicidal thoughts, or cause unusual changes in behavior.  Call your doctor right away if you feel worse with Eldepryl.
• Eldepryl may cause a mental condition called mania or hypomania (mental condition which causes high moods) in people who have a history of mania.
• Eldepryl 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 Eldepryl.

The most common side effects with Eldepryl 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 Eldepryl. For more information, ask your doctor or pharmacist.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended. Do not change your doses or medication schedule without your doctor's advice.

Selegiline capsules are usually taken twice a day, at breakfast and lunch. Follow your doctor's instructions.

The disintegrating tablet form of selegiline (Zelapar) should be taken once a day before breakfast and without any liquid.

While you are using selegiline and for 14 days after you stop, you must not eat foods listed in the "What should I avoid while using selegiline?" section of this leaflet. Eating these foods while you are using selegiline can raise your blood pressure to dangerous levels.

Foods that you MAY eat include:

• fresh meat, poultry, or fish (including lunch meat, hot dogs, breakfast sausage, and cooked sliced ham);

• any vegetables except broad bean pods (fava beans);

• processed cheese, mozzarella, ricotta, cottage cheese;

• pizza made with cheeses low in tyramine;

• soy milk, yogurt; or

• Brewer's or baker's yeast.

To take selegiline orally disintegrating tablets (Zelapar):

• Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.

• Using dry hands, remove the tablet and place it on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves.

• Do not drink or eat anything for at least 5 minutes after taking a Zelapar orally disintegrating tablet.

Do not stop taking selegiline suddenly or you may have harmful side effects. For best results, keep taking the medicine as prescribed.

Store this medicine at room temperature away from moisture and heat.

Keep each Zelapar tablet in the foil blister pack until you are ready to take it. Throw away any Zelapar tablets not used within 3 months after you have opened the pouch containing the blister pack.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe headache, hallucinations, vision problems, sweating, cool or clammy skin, fast or uneven heart rate, feeling light-headed, fainting, or seizure (convulsions).

Contraindications

• Known hypersensitivity to selegiline or any ingredient in the formulation.1 2

• Concomitant administration of meperidine and possibly other opiates.1 2 (See Specific Drugs and Foods under Interactions.)

Warnings/Precautions

Warnings

Selectivity for MAO-B is relative.1 2 3 At dosage of 10 mg daily, selegiline hydrochloride inhibits cerebral MAO-B while having little effect on MAO-A in the GI tract and liver.1 2 4 5 22 32 84 At high dosages (e.g., 30–40 mg daily), the selectivity usually diminishes and the drug will inhibit MAO-B and MAO-A.1 2 4 5 22 32

Hypertensive crises following ingestion of foods containing large amounts of tyramine (i.e., cheese reaction) have occurred in patients receiving nonselective MAO inhibitors.123 Hypertensive reactions reported rarely in patients receiving selegiline hydrochloride 10 mg daily (the maximum recommended dosage);1 at dosages >10 mg daily, the likelihood of hypertensive reactions increases.1 2 5 9 10 11 12 113 Use selegiline with caution regardless of the dosage.1 (See Interactions and also Advice to Patients.)

Concomitant use of highly serotonergic drugs (e.g., SSRIs, tricyclic antidepressants) and MAO inhibitors, including selegiline, is potentially hazardous and may result in serotonin syndrome.1 2 13 16 17 97 99 100 101 112 Manifestations may include mental status changes (e.g., agitations, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).1 126 131 133 Generally avoid concomitant use.1 2 (See Interactions.)

Because of the complexity of the MAO enzyme system, observe patients closely for atypical responses.1

General Precautions

Selegiline may exacerbate levodopa-associated adverse effects (e.g., dyskinesias1 2 5 49 50 64 66 68 ), presumably by increasing dopaminergic activity; effects generally can be mitigated by reducing the levodopa dosage by 10–30%.1 2 5 68

Epidemiologic studies indicate patients with Parkinson’s disease have a twofold to approximately sixfold greater risk of developing melanoma than the general population.1 2 Unclear whether increased risk is due to Parkinson’s disease or other factors (e.g., drugs used to treat the disease).1 2

Monitor for melanoma on a frequent and regular basis.1 2 Manufacturers recommend periodic skin examinations performed by qualified clinicians (e.g., dermatologists).1 2

Intense urges (e.g., urge to gamble, increased sexual urges, other intense urges) and inability to control these urges reported in some patients receiving antiparkinsonian agents that increase central dopaminergic tone (including selegiline).1 2 Although causal relationship not established, urges stopped in some cases when dosage was reduced or drug was discontinued.1 2

Consider reducing dosage or discontinuing selegiline if a patient develops such urges.1 2

Specific Populations

Category C.1

Not known whether selegiline is distributed into milk.1 2 Give consideration to discontinuing the use of all but absolutely essential drug therapy in nursing women.1 2

Safety and efficacy not established.1

Safety and efficacy in geriatric patients not studied specifically to date; however, parkinsonian syndrome, for which safety and efficacy have been established, occurs principally in patients >50 years of age.1 2 4 5 6 7 8 34 35 36 37 38 39 40 53 54 55 56

Common Adverse Effects

Nausea;1 2 5 6 39 50 66 dizziness, lightheadedness, or fainting; abdominal pain; hallucinations; dry mouth; vivid dreams; dyskinesias; headache.1

Many of the adverse effects in patients receiving selegiline plus levodopa result from increased dopaminergic activity and can be mitigated by reducing levodopa dosage; these effects include exacerbation of dyskinesias, confusion, and hallucinations.1 2 5 49 50 64 66 67 68

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

• To gain the most benefit, do not miss doses.
• Keep using this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Take Eldepryl with food.

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.

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.

Eldepryl (selegiline) prevents the breakdown of a chemical in your brain called dopamine. Low levels of dopamine are associated with Parkinson's disease.

Eldepryl capsules are used together with levodopa and carbidopa to treat symptoms of Parkinson's disease.

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

You should not use Eldepryl if you are allergic to selegiline, or if you have taken fluoxetine (Prozac, Sarafem and others) within the past 5 weeks.

Some medicines can cause unwanted or dangerous effects when used with Eldepryl. Your doctor may need to change your treatment plan if you use any of the following drugs:

• cough medicine that contains dextromethorphan;

• cyclobenzaprine (Flexeril);

• meperidine (Demerol) or other narcotic (opioid) pain medicine;

• methadone;

• St. John's wort;

• tramadol (Ultram, Ultracet);

• an antidepressant - citalopram, desvenlafaxine, duloxetine, escitalopram, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, nefazodone, paroxetine, venlafaxine, vilazodone, vortioxetine, and others; or

• p>an MAO inhibitor - isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

After you stop taking Eldepryl, you must wait at least 14 days before taking any of the medications listed above.

To make sure Eldepryl is safe for you, tell your doctor if you have:

• liver or kidney disease;

• high blood pressure; or

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether Eldepryl will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether selegiline passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Avoid drinking alcohol while you are taking Eldepryl.

While taking Eldepryl and for 14 days after you stop, you must NOT eat foods that are high in tyramine, including:

• air dried meats, aged or fermented meats, sausage or salami (including cacciatore and mortadella), pickled herring;

• any spoiled or improperly stored beef, poultry, fish, or liver;

• beer from a tap, beer that has not been pasteurized;

• aged cheeses (such as blue, Swiss, cheddar, Parmesan, or Romano cheese);

• over-the-counter supplements or cough and cold medicines that contain tyramine;

• sauerkraut, soy beans, soy sauce, tofu, fava beans; or

• yeast extracts (such as Marmite).

Eating tyramine while you are using selegiline can raise your blood pressure to dangerous levels which could cause life-threatening side effects. You should become very familiar with the list of foods to avoid while you are using Eldepryl.

Eldepryl may impair your thinking or reactions. Some people taking this medicine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Be careful if you drive or do anything that requires you to be alert.

Animal studies have failed to reveal evidence of teratogenicity. Reproductive toxicity was seen at high multiples of human doses and developmental toxicity at doses greater than those used clinically. There are no controlled data in human pregnancy. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug is only recommended for use during pregnancy when benefit outweighs risk. AU TGA pregnancy category: B2 US FDA pregnancy category: C