SELEGILINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Carbex
• Eldepryl

In Canada?

• Apo-Selegiline
• Eldepryl
• Gen-Selegiline
• Novo-Selegiline
• Nu-Selegiline
• SD Deprenyl
• Selegiline-5

Generic name product may be available in the U.S.

Other commonly used names are depreniland deprenyl.

Category

• Antidyskinetic

Description

Selegiline (seh-LEDGE-ah-leen) is used in combination with levodopaor levodopa and carbidopa combination to treat Parkinson's disease, sometimescalled shaking palsy or paralysis agitans. This medicine works to increaseand extend the effects of levodopa, and may help to slow the progress of Parkinson'sdisease.

Selegiline is available only with your doctor's prescription, in the followingdosage form:

Oral
• Capsules (U.S.)
• Tablets (U.S. and Canada)

Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to selegiline. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Selegiline has not been studied in pregnant women.However, this medicine has not been shown to cause birth defects or otherproblems in animal studies.

Breast-feeding?It is not known whether selegiline passes intothe breast milk.

Children?Studies on this medicine have been done only in adultpatients 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 peoplethan it did in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases 2 different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingselegiline, it is especially important that your health care professionalknow if you are taking any of the following:

• Antidepressants, tricyclic (amitriptyline [e.g., Elavil], amoxapine[e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin],doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g.,Pamelor], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])or
• Fluoxetine (e.g., Prozac) or
• Fluvoxamine (e.g., Luvox) or
• Meperidine (e.g., Demerol) or
• Nefazodone (e.g., Serzone) or
• Paroxetine (e.g., Paxil) or
• Sertraline (e.g., Zoloft) or
• Venlafaxine (e.g., Effexor)?Using these medicines togethermay increase the chance of serious side effects

Other medical problems?The presence of other medicalproblems may affect the use of selegiline. Make sure you tell your doctorif you have any other medical problems, especially:

• Stomach ulcer (history of)?Selegiline may make the conditionworse

Proper Use of This Medicine

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

Dosing?The dose of selegiline will be different fordifferent patients. Your doctor will determine the proper dose of selegilinefor you. Follow your doctor's orders or the directionson the label.

For the treatment of Parkinson's disease, the usual dose of selegilineis 5 mg two times a day, taken with breakfast and lunch. Some patients mayneed less than this.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if you do not remember the missed dose until lateafternoon or evening, skip the missed dose and go back to your regular dosingschedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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

• Foods that have a high tyramine content (most common in foods thatare aged or fermented to increase their flavor), such as cheeses; fava orbroad bean pods; yeast or meat extracts; smoked or pickled meat, poultry,or fish; fermented sausage (bologna, pepperoni, salami, summer sausage) orother fermented meat; sauerkraut; or any overripe fruit. If a list of thesefoods and beverages is not given to you, ask your health care professionalto 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, hayfever, and appetite control; ?keep awake? products; or productsthat 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 itwas taken in doses higher than those usually used for Parkinson's disease.

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

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

Selegiline may cause dryness of the mouth. For temporary relief, use sugarlesscandy 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, checkwith your medical doctor or dentist. Continuing dryness of the mouth may increasethe chance of dental disease, including tooth decay, gum disease, and fungusinfections.

Side Effects of This Medicine

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

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

Stop taking this medicineand get emergency help immediately if any of the following side effectsoccur:

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

Chest pain (severe); enlarged pupils; fast or slow heartbeat; headache (severe); increased sensitivity of eyesto light; increased sweating (possibly with feveror cold, clammy skin); nausea and vomiting (severe); stiff or sore neck

Check with your doctor assoon 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; difficultor frequent urination; difficulty in breathing; difficulty in speaking; dizziness orlightheadedness, especially when getting up from a lying or sitting position; hallucinations (seeing, hearing, or feeling thingsthat are not there); irregular heartbeat; lip smacking or puckering; loss of balancecontrol; puffing of cheeks; rapid or worm-like movements of tongue; restlessnessor desire to keep moving; severe stomach pain; swelling of feet or lower legs; tightnessin chest; twisting movements of body; uncontrolled chewing movements; uncontrolledmovements of face, neck, back, arms or legs; vomitingof 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 lowblood pressure; increased sweating (possibly withfever or cold, clammy skin); severe spasm where thehead and heels are bent backward and the body arched forward; troubled breathing

Other sideeffects may occur that usually do not need medical attention. These side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effects continue or arebothersome:

More common

Abdominal or stomach pain; dizzinessor 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 lowblood pressure; inability to move; frequent urge to urinate; increased sensitivity ofskin to light; increased sweating; irritability (temporary); loss of appetite; memory problems; muscle cramps; nervousness; numbness of fingers ortoes; pounding or fast heartbeat; red, raised, or itchy skin; restlessness; ringing or buzzing in ears; slow ordifficult urination; slowed movements; taste changes; uncontrolled closingof eyelids; unusual feeling of well-being; unusual tiredness or weakness; unusualweight loss

With doses higher than 10 mg a day

Clenching, gnashing, or grinding teeth; sudden jerky movements of body

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.