Pronunciation:

se-LE-ji-leen

Brand Names:

• Eldepryl
• Zelapar

Dosage Forms:

• Capsule
• Tablet
• Tablet, Disintegrating

Classifications:

Therapeutic—

Antiparkinsonian

Pharmacologic—

Monoamine Oxidase Inhibitor, Type B

Uses of This Medicine:

Selegiline is used in combination with levodopa or levodopa and carbidopa combination to treat Parkinson's disease (sometimes called shaking palsy or paralysis agitans). This medicine works to increase and extend the effects of levodopa, and may help to slow the progress of Parkinson's disease.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of selegiline in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of selegiline in the elderly. However, elderly patients are more likely to have unwanted effects, which may require caution for patients receiving selegiline.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amitriptyline
• Amoxapine
• Amphetamine
• Apraclonidine
• Atomoxetine
• Benzphetamine
• Brimonidine
• Carbamazepine
• Carbinoxamine
• Citalopram
• Clomipramine
• Cyclobenzaprine
• Cyproheptadine
• Desipramine
• Desvenlafaxine
• Dexfenfluramine
• Dexmethylphenidate
• Dextroamphetamine
• Dextromethorphan
• Diethylpropion
• Doxylamine
• Duloxetine
• Ephedrine
• Escitalopram
• Fenfluramine
• Fluoxetine
• Fluvoxamine
• Guanadrel
• Guanethidine
• Imipramine
• Isocarboxazid
• Isometheptene
• Levodopa
• Levomethadyl
• Linezolid
• Lisdexamfetamine
• Maprotiline
• Mazindol
• Meperidine
• Methadone
• Methamphetamine
• Methotrimeprazine
• Methyldopa
• Methylene Blue
• Methylphenidate
• Milnacipran
• Mirtazapine
• Nefopam
• Nortriptyline
• Opipramol
• Oxcarbazepine
• Paroxetine
• Phendimetrazine
• Phenelzine
• Phenmetrazine
• Phentermine
• Phenylalanine
• Phenylephrine
• Phenylpropanolamine
• Procarbazine
• Propoxyphene
• Protriptyline
• Pseudoephedrine
• Rasagiline
• Reserpine
• Selegiline
• Sertraline
• Sibutramine
• St John's Wort
• Sumatriptan
• Tapentadol
• Tetrabenazine
• Tramadol
• Tranylcypromine
• Trazodone
• Trimipramine
• Venlafaxine
• Vilazodone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Albuterol
• Altretamine
• Arformoterol
• Avocado
• Bambuterol
• Bitter Orange
• Bromocriptine
• Buspirone
• Clenbuterol
• Clovoxamine
• Colterol
• Difenoxin
• Diphenoxylate
• Dothiepin
• Doxepin
• Droperidol
• Ethchlorvynol
• Femoxetine
• Fenoterol
• Fentanyl
• Formoterol
• Guarana
• Hexoprenaline
• Hydromorphone
• Hydroxytryptophan
• Indacaterol
• Iobenguane I 123
• Isoetharine
• Kava
• Levalbuterol
• Licorice
• Lofepramine
• Lorcaserin
• Ma Huang
• Mate
• Mephentermine
• Metaproterenol
• Metaraminol
• Metoclopramide
• Morphine
• Morphine Sulfate Liposome
• Nefazodone
• Oxycodone
• Pentazocine
• Pirbuterol
• Procaterol
• Reboxetine
• Reproterol
• Ritodrine
• Salmeterol
• St John's Wort
• Terbutaline
• Tretoquinol
• Tryptophan
• Tulobuterol
• Tyrosine
• Vilanterol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Acetohexamide
• Benfluorex
• Chlorpropamide
• Desogestrel
• Dienogest
• Dopamine
• Drospirenone
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Ginseng
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Guar Gum
• Insulin
• Insulin Aspart, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Levonorgestrel
• Medroxyprogesterone Acetate
• Mestranol
• Metformin
• Miglitol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Repaglinide
• Tolazamide
• Tolbutamide
• Troglitazone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tyramine Containing Food

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dyskinesia (trouble controlling your muscles) or
• Postural hypotension (dizziness, lightheadedness, or fainting when getting up from a lying or sitting position) or
• Stomach ulcer, history of—Selegiline may make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. Higher blood levels of selegiline may result, and cause an increase in side effects.

• Phenylketonuria (PKU)—The disintegrating tablet form of this medicine contains phenylalanine, which can make this condition worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

It is best to take this medicine before breakfast and without liquids.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet on the top of your tongue, where it will melt quickly. Do not eat food or drink liquids for 5 minutes before or after taking this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For Parkinson's disease:
    • Adults—At first, 1.25 milligrams (mg) once a day for at least 6 weeks. After 6 weeks, your doctor may increase your dose to 2.5 mg once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.

Do not take selegiline if you have used meperidine (e.g., Demerol®) or an MAO inhibitor (MAOI) (e.g., isocarboxazid, phenelzine, tranylcypromine, Marplan®, Nardil®, or Parnate®) within the past 14 days. If you do, you may develop agitation, confusion, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.

Do not take cough medicines (e.g., dextromethorphan, Robitussin®, Pediacare®) or pain medicines (e.g., methadone, propoxyphene, tramadol, Darvon®, Dolophine®, Ultram®) while you are using this medicine. Using these medicines together can cause unwanted effects.

Selegiline may cause serious side effects when used together with some antidepressants. Tell your doctor if you have used amitriptyline, doxepin, fluoxetine, fluvoxamine, nortriptyline, paroxetine, sertraline, Elavil®, Luvox®, Pamelor®, Paxil®, Prozac®, or Zoloft® within the past 14 days.

When selegiline is taken at doses of 10 mg or less per day for the treatment of Parkinson's disease, there are no restrictions on food or beverages you eat or drink. However, the chance exists that dangerous reactions, such as sudden high blood pressure, may occur if doses higher than those used for Parkinson's disease are taken with certain foods, beverages, or other medicines. These foods, beverages, and medicines include:

• Foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses; fava or broad bean pods; yeast or meat extracts; smoked or pickled meat, poultry, or fish; fermented sausage (bologna, pepperoni, salami, summer sausage) or other fermented meat; sauerkraut; or any overripe fruit. If a list of these foods and beverages is not given to you, ask your doctor to provide one.
• Alcoholic beverages or alcohol-free or reduced-alcohol beer and wine.
• Large amounts of caffeine-containing food or beverages such as coffee, tea, cola, or chocolate.
• Any other medicine unless approved or prescribed by your doctor. This especially includes nonprescription (over-the-counter [OTC]) medicine, such as that for colds (including nose drops or sprays), cough, asthma, hay fever, and appetite control; “keep awake” products; or products that make you sleepy.

Also, for at least 2 weeks after you stop taking this medicine, these foods, beverages, and other medicines may continue to react with selegiline if it was taken in doses higher than those usually used for Parkinson's disease.

Check with your doctor or hospital emergency room immediately if severe headache, stiff neck, chest pains, fast heartbeat, or nausea and vomiting occur while you are taking this medicine. These may be symptoms of a serious side effect that should have a doctor's attention.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

Selegiline may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

It is important that your doctor check your skin for melanoma (tumor) regularly if you have Parkinson's disease.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.

Hallucinations may occur in some patients. This is more common with elderly patients. If you have hallucinations, check with your doctor.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased sex drive while using this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chest pain (severe)

enlarged pupils

fast or slow heartbeat

headache (severe)

increase in unusual movements of the body

increased sensitivity of the eyes to light

increased sweating (possibly with fever or cold, clammy skin)

mood or other mental changes

nausea and vomiting (severe)

stiff or sore neck

Less common or rare

Bloody or black, tarry stools

bruising

convulsions (seizures)

decreased urine

difficult or frequent urination

difficulty with breathing

difficulty with speaking

difficulty with swallowing

dizziness or lightheadedness, especially when getting up from a lying or sitting position

dry mouth

hallucinations (seeing, hearing, or feeling things that are not there)

increased thirst

irregular heartbeat

large, flat, blue, or purplish patches in the skin

lip smacking or puckering

loss of appetite

loss of balance control

muscle pain or cramps

nausea or vomiting

numbness or tingling in the hands, feet, or lips

puffing of the cheeks

rapid or worm-like movements of the tongue

restlessness or desire to keep moving

severe stomach pain

shakiness in the legs, arms, hands, or feet

shortness of breath

swelling of the feet or lower legs

swelling or inflammation of the mouth

tightness in the chest

trembling or shaking of the hands or feet

twisting movements of the body

uncontrolled chewing movements

uncontrolled movements of the face, neck, back, arms, or legs

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation or irritability

chest pain

difficulty opening the mouth or lockjaw

dizziness (severe) or fainting

fast or irregular pulse (continuing)

high fever

high or low blood pressure

severe spasm where the head and heels are bent backward and the body arched forward

troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach pain

dizziness or feeling faint

runny nose

sneezing

stuffy nose

trouble with sleeping

Less common or rare

Anxiety

back or leg pain

blurred or double vision

body aches or pain

burning of the lips, mouth, or throat

chills

constipation

cough

diarrhea

drowsiness

dryness or soreness of the throat

frequent urge to urinate

headache

heartburn

inability to move

increased sweating

irritability (temporary)

memory problems

nervousness

pounding or fast heartbeat

rash

red, raised, or itchy skin

ringing or buzzing in the ears

slow or difficult urination

slowed movements

taste changes

uncontrolled closing of the eyelids

unusual feeling of well-being

unusual weight loss

voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.