emsam

Emsam is a transdermal skin patch containing selegiline. Selegiline prevents the breakdown of chemicals in the brain that are often imbalanced in people with depression.

Emsam is used to treat major depressive disorder in adults.

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

Important information

You should not use Emsam if you have an adrenal gland tumor or if you are using certain other medicines. Serious drug interactions can occur when certain medicines are used together with selegiline. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Emsam should never be used on a child younger than 12 years old because dangerous side effects could occur.

If you need surgery, tell the surgeon ahead of time that you are using Emsam patches. You will need to stop using the patches for at least 10 days before a planned surgery. Do not stop using Emsam without first talking to your doctor. While using the 9-mg or 12-mg patches, do not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while using Emsam?" section of this leaflet. Eating tyramine while you are using Emsam can raise your blood pressure to dangerous levels and cause life-threatening symptoms.

You may have thoughts about suicide when you first start using an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Before using this medicine

You should not use Emsam if you are allergic to selegiline, or if you have pheochromocytoma (tumor of the adrenal gland).

Some medicines can cause unwanted or dangerous effects when used with Emsam. Your doctor may need to change your treatment plan if you have used any of the following drugs within the past 14 days:

• carbamazepine (Equetro, Tegretol);

• dextromethorphan (cough medicine);

• meperidine, methadone, pentazocine, or tramadol; or

• any type of "SSRI" or "SNRI" antidepressant, such as citalopram (Celexa), clomipramine, duloxetine (Cymbalta), fluoxetine (Prozac), imipramine, paroxetine, sertraline (Zoloft), venlafaxine, and others.

After you stop using Emsam, you must wait at least 14 days before taking any medicine listed above. You must wait at least 5 weeks after stopping fluoxetine (Prozac) before you can start using Emsam.

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

• heart disease, high or low blood pressure;

• seizures or epilepsy; or

• a personal or family history of bipolar disorder (manic depression) or suicide attempt.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

It is not known whether this medicine will harm an unborn baby. However, you may have a relapse of depression if you stop using your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop Emsam during pregnancy without your doctor"s advice.

It is not known whether selegiline passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Emsam is not approved for use by anyone younger than 18 years old. This medicine should never be used on a child younger than 12 years old because dangerous side effects could occur.

How should I use Emsam?

Use Emsam patches exactly as prescribed by your doctor. 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.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Apply the Emsam patch to clean, dry, and hairless skin on your chest, back, thigh, or the outer part of your upper arm. Press the patch firmly into place. You may leave the patch on while bathing, showering, or swimming. Remove the skin patch after 24 hours and replace it with a new one. Choose a different place on your body to wear the patch each time you put on a new one.

Wash your hands with soap and water after applying an Emsam patch, and after removing one.

If a patch falls off, try sticking it back into place. If it does not stick well, put on a new patch and leave it on only for the rest of your wearing time. Do not change your patch removal schedule.

Do not wear more than one Emsam patch at a time. Using extra skin patches will not make the medication more effective. Never cut a skin patch. While you are wearing the patch, do not expose it to sunlight or other sources of heat such as a heating pad, electric blanket, hot tub, or sauna.

If you need surgery, tell the surgeon ahead of time that you are using Emsam. You may need to stop using the medicine for at least 10 days before a planned surgery. Do not stop using Emsam without first talking to your doctor.

Store the skin patches at room temperature away from heat and moisture. Keep each patch in the foil pouch until you are ready to apply one.

Keep both used and unused Emsam skin patches out of the reach of children or pets. The amount of selegiline in a used skin patch could be fatal to a child or pet who accidentally chews on the patch. Seek emergency medical attention if this happens.

Emsam dosing information

Usual Adult Dose for Depression:

Initial dose: Apply one 6 mg/24 hours transdermal patch to intact skin once every 24 hours
Maintenance dose: One 6 mg/24 hours to 12 mg/24 hours transdermal patch applied to the skin once a day
Maximum dose: 12 mg/24 hours transdermal patch applied to the skin once a day

Comments:
-Episodes of depression may require several months or more of sustained pharmacologic therapy
-If dose adjustments are necessary, they should be made in increments of 3 mg/24 hours at intervals of at least 2 weeks
-Full antidepressant effect may be delayed

Use: Treatment of major depressive disorder (MDD)

What happens if I miss a dose?

Apply an Emsam skin patch as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra patches to make up the missed dose.

If a patch becomes loose, press it back in place. If a patch falls off, apply a new one and go back to your regular schedule for patch changes.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may occur up to 12 hours after the overdose, and could get worse over the next 24 to 48 hours.

Overdose symptoms may include severe headache, hallucinations, vision problems, sweating, fever, cold or clammy skin, fast or uneven heart rate, chest pain, trouble breathing, feeling drowsy or lightheaded, twisting muscle movements, unusual arching in your back or neck, fainting, or seizure.

What should I avoid while using Emsam?

While using the 9-mg or 12-mg patches, 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, and 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 Emsam 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 Emsam.

Avoid drinking alcohol while you are using Emsam.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Emsam side effects

Get emergency medical help if you have signs of an allergic reaction to Emsam: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Remove the skin patch and get emergency medical help if you have any of these signs of dangerously high blood pressure: sudden and severe headache, vision problems, pounding in your neck or ears, confusion, anxiety, sweating, vomiting, neck stiffness, chest pain, fast or pounding heartbeats, or shortness of breath.

Call your doctor at once if you have:

• sudden numbness or weakness (especially on one side of the body);

• problems with speech or balance; or

• high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common Emsam side effects may include:

• redness or itching where the patch is worn;

• headache;

• diarrhea, upset stomach, dry mouth;

• sleep problems (insomnia);

• rash; or

• sinus pain or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Emsam?

There are many other medicines that can cause serious medical problems if you take them while using Emsam. Tell your doctor about all your current medicines and any you start or stop using, especially:

• buspirone (BuSpar);

• any other antidepressant;

• cough or cold medicine that contains a decongestant such as phenylephrine or pseudoephedrine;

• prescription or over-the-counter diet pills;

• an herbal or dietary supplement that contains tyramine; or

• stimulant medicine such as Adderall or other medicines to treat attention deficit hyperactivity disorder (ADHD).

This list is not complete and many other drugs can interact with selegiline. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Give a list of all your medicines to any healthcare provider who treats you.