Pronunciation:

se-LE-ji-leen

Brand Names:

• Emsam

Dosage Forms:

• Patch, Extended Release

Warnings:

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—

Antidepressant

Pharmacologic—

Monoamine Oxidase Inhibitor, Type B

Uses of This Medicine:

Selegiline transdermal is used to treat mental depression. This medicine is a monoamine oxidase (MAO) inhibitor .

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 performed to date have not demonstrated any benefit to using selegiline transdermal in children with depression. Studies have shown that some children, teenagers, and young adults think about suicide or attempt suicide when taking this medicine. Because of this toxicity, use in children is not recommended .

Selegiline transdermal should not be used in children below 12 years of age .

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of selegiline transdermal in the elderly .

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
• Bupropion
• 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
• Dopamine
• Ginseng
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Guar Gum
• Insulin
• Insulin Aspart, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Metformin
• Miglitol
• 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:

• Heart attack, recent or
• Heart problems or
• Low blood pressure or
• Seizures—Use with caution. This medicine may worsen these conditions .

• Mania or hypomania (history of)—Use of selegiline transdermal may activate these conditions .

• Pheochromocytoma (a tumor of the adrenal gland)—Should not be used in patients with this condition .

Proper Use of This Medicine:

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions .

To use the skin patch:

• Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch. Wear only one patch at a time.
• Apply the patch to a dry, smooth skin area on your upper chest or back (below the neck and above the waist), upper thigh, or to the outer surface of the upper arm. Do not put the patch over hairy, oily, irritated, broken, scarred, or calloused skin. Avoid putting the patch on areas where it could be rubbed off by tight clothing.
• Press the patch firmly in place with your fingertips to make sure that the edges of the patch stick well.
• Put on a new patch if the old one has fallen off and cannot be reapplied.
• After 24 hours, remove the patch. Choose a different place on your skin to apply the new patch. Do not put the new patch on the same place you wore the last one. Try to change the patch at the same time each day.
• After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.
• Wash the area of skin where you will apply the patch gently with soap and warm water. Rinse completely and dry with a clean dry towel.
• Do not expose the patch to direct sources of heat, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, or direct sunlight for long periods of time.
• Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands .

Do not stop using this medicine without asking your doctor. If you have not used your medicine for several days in a row, do not start using it again without talking to your doctor first .

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 transdermal dosage form (patch):
  • For mental depression:
    • Adults—At first, one 6 milligram (mg) patch once a day. Your doctor may increase your dose if needed.
    • Children 12 years of age and older—Use and dose must be determined by your doctor.
    • Children below 12 years of age—Use is not recommended .

Missed dose—

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage—

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

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 make sure this medicine is working properly and to check for unwanted effects .

Selegiline transdermal may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away .

When selegiline transdermal is used at low doses, 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 higher doses are used with certain foods or beverages. These foods or beverages 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; any spoiled or improperly stored meat, poultry, fish, or animal livers; or any overripe fruit. These may also include alcoholic beverages or alcohol-free or reduced-alcohol beer and wine. Also, for at least 2 weeks after you stop using this medicine, these foods or beverages may continue to react with selegiline transdermal. If a list of these foods and beverages is not given to you, ask your health care professional to provide one .

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 using this medicine. These may be symptoms of a serious side effect that should have a doctor's attention .

You should not use this medicine if you are taking other medicines to treat depression (such as amitriptyline, bupropion, doxepin, duloxetine, fluoxetine, imipramine, mirtazapine, nortriptyline, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Elavil®, Lexapro™, Paxil®, Prozac®, Tofranil®, Wellbutrin®, or Zoloft®), anxiety medicine (such as buspirone or BuSpar®), MAO inhibitors (MAOI) (such as Eldepryl®, Marplan®, Nardil®, or Parnate®), St. John's wort, or pain medicines (such as meperidine, methadone, propoxyphene, tramadol, Darvon®, Demerol®, Dolophine®, or Ultram®). Do not use this medicine if you are taking seizure medicines (such as carbamazepine, oxcarbazepine, Tegretol®, or Trileptal®), cough medicines (such as dextromethorphan or Benylin®), medicine to treat muscle spasms (such as cyclobenzaprine or Flexeril®), over-the-counter diet pills, herbal weight-loss products, cold medicines (such as ephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine, Neo-Synephrine®, Novafed®, or Sudafed®), any herbal or dietary supplement that contains tyramine, or medicines called amphetamines (also called stimulants or "uppers"). Do not use this medicine if you take selegiline capsules or tablets .

Before you have any kind of surgery, tell the medical doctor in charge that you are taking this medicine. Using selegiline together with medicines that are sometimes used during surgery may increase the effects of these medicines .

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 .

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

Chills

cold sweats

confusion

dizziness, faintness, or lightheadedness when getting up from lying or sitting position

headache

sleeplessness

trouble sleeping

unable to sleep

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

Burning, itching, redness, skin rash, swelling, or soreness at site

diarrhea

dry mouth

Less common

Acid or sour stomach

belching

body aches or pain

change or problem with discharge of semen

congestion

cough

dryness or soreness of throat

fever

heartburn

hoarseness

indigestion

pain or tenderness around eyes and cheekbones

rash

runny nose

shortness of breath or troubled breathing

stomach discomfort, upset, or pain

stuffy or runny nose

tender, swollen glands in neck

tightness of chest or wheezing

trouble in swallowing

voice changes

weight changes

Rare

Decreased interest in sexual intercourse

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

not able to have an orgasm

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.