Pronunciation:

se-LE-ji-leen

Brand Names:

• Eldepryl
• Zelapar

Dosage Forms:

• Tablet
• Tablet, Disintegrating
• Capsule

Warnings:

• Suicidality and Antidepressant Drugs
• Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of selegiline or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised for the need for close observation and communication with the prescriber. Selegiline is not approved for use in pediatric patients. Furthermore, selegiline transdermal patch at any dose should not be used in children under the age of 12, even when administered with dietary modifications .

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. The transdermal patch should not be used in pediatric patients under the age of 12, at any dose, even with dietary modifications .

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.

Selegiline 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—

Studies on this medicine have been done only in adult patients and there is no specific information about its use in children. Therefore, be sure to discuss with your doctor the use of this medicine in children.

Older adults—

In studies done to date that included elderly people, selegiline did not cause different side effects or problems in older people than it did in younger adults.

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—

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
• Bupropion
• Carbamazepine
• Citalopram
• Clomipramine
• Cyclobenzaprine
• Cyproheptadine
• Desipramine
• Desvenlafaxine
• Dexfenfluramine
• Dexmethylphenidate
• Dextroamphetamine
• Dextromethorphan
• Diethylpropion
• Duloxetine
• Ephedrine
• Escitalopram
• Fenfluramine
• Fluoxetine
• Imipramine
• Isometheptene
• Levodopa
• Levomethadyl
• Linezolid
• Lisdexamfetamine
• Maprotiline
• Mazindol
• Meperidine
• Methadone
• Methamphetamine
• Methotrimeprazine
• Methyldopa
• Methylphenidate
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nefopam
• Nortriptyline
• Opipramol
• Oxcarbazepine
• Paroxetine
• Phendimetrazine
• Phenelzine
• Phenmetrazine
• Phentermine
• Phenylalanine
• Phenylephrine
• Phenylpropanolamine
• Propoxyphene
• Protriptyline
• Pseudoephedrine
• Rasagiline
• Reserpine
• Sertraline
• Sibutramine
• St John's Wort
• Tetrabenazine
• Tramadol
• Trimipramine
• Venlafaxine

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:

• Stomach ulcer (history of)—Selegiline may make the 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.

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 the treatment of Parkinson's disease, the usual dose of selegiline is 5 mg two times a day, taken with breakfast and lunch. Some patients may need less than this.

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.

Precautions While Using This Medicine:

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 health care professional 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.

Side Effects of This Medicine:

When you start taking selegiline in addition to levodopa or carbidopa and levodopa combination, you may experience an increase in side effects. If this occurs, your doctor may gradually reduce the amount of levodopa or carbidopa and levodopa combination you take.

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.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Symptoms of unusually high blood pressure (caused by reaction of higher than usual doses of selegiline with restricted foods or medicines)

Chest pain (severe)

enlarged pupils

fast or slow heartbeat

headache (severe)

increased sensitivity of eyes to light

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

nausea and vomiting (severe)

stiff or sore neck

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Increase in unusual movements of body

mood or other mental changes

Less common or rare

Bloody or black, tarry stools

difficult or frequent urination

difficulty in breathing

difficulty in speaking

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

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

irregular heartbeat

lip smacking or puckering

loss of balance control

puffing of cheeks

rapid or worm-like movements of tongue

restlessness or desire to keep moving

severe stomach pain

swelling of feet or lower legs

tightness in chest

twisting movements of body

uncontrolled chewing movements

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

vomiting of blood or material that looks like coffee grounds

wheezing

Symptoms of overdose

Agitation or irritability

chest pain

convulsions (seizures)

difficulty opening mouth or lockjaw

dizziness (severe) or fainting

fast or irregular pulse (continuing)

high fever

high or low blood pressure

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

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

dryness of mouth

nausea

trouble in sleeping

vomiting

Less common or rare

Anxiety

back or leg pain

blurred or double vision

body ache

burning of lips, mouth, or throat

chills

constipation

diarrhea

drowsiness

headache

heartburn

high or low blood pressure

inability to move

frequent urge to urinate

increased sensitivity of skin to light

increased sweating

irritability (temporary)

loss of appetite

memory problems

muscle cramps

nervousness

numbness of fingers or toes

pounding or fast heartbeat

red, raised, or itchy skin

restlessness

ringing or buzzing in ears

slow or difficult urination

slowed movements

taste changes

uncontrolled closing of eyelids

unusual feeling of well-being

unusual tiredness or weakness

unusual weight loss

With doses higher than 10 mg a day

Clenching, gnashing, or grinding teeth

sudden jerky movements of body

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