Selegiline (transdermal)

Selegiline helps stop the breakdown of brain chemicals that are often unbalanced in people with depression.

Selegiline (transdermal) is used to treat major depressive disorder in adults and adolescents who are at least 12 years old.

Selegiline may also be used for other reasons not mentioned in this medication guide.

Follow all instructions on your prescription label. Your doctor may change your dose from time to time. Do not use this medicine in larger or smaller amounts or for longer than what is 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 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 area on your body each time you put on a new patch.

Wash your hands with soap and water after applying a patch and after removing one.

If a patch falls off, try to stick it back in 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 selegiline patch at a time. Using extra 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 in advance that you are using selegiline. You may need to stop using the medicine for at least 10 days before a planned surgery. Do not stop using selegiline 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 it.

Keep both used and unused selegiline 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 help if this happens.

You should not use selegiline if you have an adrenal gland tumor or if you are taking certain other medicines. Many drugs can interact with selegiline, and some should not be used together.

Some young people may have thoughts about suicide when they first start using an antidepressant. Pay attention to any changes in your mood or symptoms. Let your doctor know about any new or worsening symptoms.

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

Some medicines can cause unwanted or dangerous effects when used with selegiline. Your doctor may need to change your treatment plan if you have used any of the following drugs in the past 2 to 5 weeks:

• carbamazepine;
• dextromethorphan (cough medicine);
• meperidine, methadone, pentazocine, or tramadol; or
• certain antidepressants--citalopram, clomipramine, desvenlafaxine, duloxetine, fluoxetine, imipramine, milnacipran, paroxetine, sertraline, venlafaxine, Cymbalta, Effexor, Savella, Pristiq, Prozac, Zoloft, and others.

To make sure selegiline is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure;
• seizures or epilepsy; or
• bipolar disorder (manic depression) or a 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 selegiline 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 selegiline 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 and for at least 5 days after your last dose.

Selegiline (transdermal) is not approved for use by anyone younger than 12 years old.

Get emergency medical help if you have signs of an allergic reaction: 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, confusion, vision problems, chest pain, pounding in your neck or ears, sweating, vomiting, neck stiffness, fast or slow heartbeats, or dilated pupils.

Selegiline may cause serious side effects. Call your doctor at once if you have:

• sudden numbness or weakness (especially on one side of the body);
• problems with speech or balance;
• manic episodes--racing thoughts, increased energy, unusual risk-taking behavior, extreme happiness, being irritable or talkative.

Remove the patch and seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects of selegiline 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.

Usual Adult Dose for Parkinson's Disease:

Oral capsule and tablet: 5 mg orally twice a day taken at breakfast and lunchMaximum dose: 10 mg orally per dayOral disintegrating tablet:-Initial dose: 1.25 mg orally once a day for at least 6 weeks -After 6 weeks, the dose may be increased to 2.5 mg orally once a day if neededMaintenance dose: 1.25 to 2.5 mg orally once a day before breakfastMaximum dose: 2.5 mg orally once a dayComments:-Two to 3 days after initiating therapy with this drug, an attempt may be made to reduce the dose of levodopa-carbidopa; typically a 10% to 30% reduction is needed; further reductions may be possible during continued concomitant use. -There is no evidence that this drug has beneficial effect in the absence of concurrent levodopa therapy. Use: As an adjunct in the management of Parkinson's disease in patients being treated with levodopa-carbidopa who exhibit deterioration in the quality of their response to this therapy.

Usual Adult Dose for Depression:

Transdermal System: Initial dose: 6 mg/24 hours patch applied topically once a day-Based on clinical judgement, doses may be increased in increments of 3 mg/24 hours at intervals of no less than 2 weeks Maintenance dose: 6 mg/24 hours to 12 mg/24 hours patch applied topically once a day Maximum dose: 12 mg/24 hours Comments:-Full antidepressant effect may be delayed.-Tyramine-rich food should be avoided beginning on the first day of therapy with a dose of 9 mg/24 hours or 12 mg/24 hours and continued to be avoided for 2 weeks after these doses are reduced to 6 mg/24 hours or less. Use: Treatment of major depressive disorder (MDD)

Apply a skin patch as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not use extra patches to make up for the missed dose.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Symptoms of overdose may appear up to 12 hours after taking too much and could worsen over the next 24 to 48 hours.

Symptoms of overdose may include severe headache, hallucinations, fever, cold or clammy skin, fast or irregular heartbeat, trouble breathing, feeling agitated or irritable, twisting muscle movements, unusual arching in your back or neck, fainting, or seizure.

Do not drink alcohol while using selegiline.

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 using selegiline 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 using selegiline 9-mg or 12-mg patches.

selegiline may affect your thinking or reactions. Be cautious if you drive or do anything that needs you to be alert.

If you have been taking fluoxetine (Prozac, Sarafem), you must stop taking it for 5 weeks before you begin using selegiline (transdermal).

Many drugs can interact with selegiline, and some should not be taken together. Tell your doctor about all your current medications and any that 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 used 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 medications, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

After you stop using selegiline, you may need to wait at least 2 weeks before you start using other medications.