Selegiline

What it is used for

Selegiline Hydrochloride Tablets USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy.

Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of 'off' time, and patient self-rating of treatment success.

Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).

The most important thing to know

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions.

These include people who have or have a family history of bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated, restless, angry or irritable panic attacks trouble sleeping new or worse irritability acting aggressive, being angry or violent acting on dangerous impulses an extreme increase in activity or talking (mania) other unusual changes in behavior or mood 3.

EMSAM is not for children less than 12 years of age. EMSAM may cause a severe increase in blood pressure in children less than 12 years of age. What is EMSAM? EMSAM is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). EMSAM belongs to the class of medicines known as monoamine oxidase inhibitors (MAOI).

EMSAM is a transdermal system (patch) you apply to your skin. It is important to talk with your healthcare provider about the risks of treating depression and also the risk of not treating it. You should discuss all treatment choices with your healthcare provider. Talk to your healthcare provider if you do not think that your condition is getting better with EMSAM treatment.

Who should not use EMSAM? Using EMSAM with certain antidepressants and certain pain, cold and cough symptom medicines may cause a potentially life-threatening problem called serotonin syndrome (See “

Side effects, and when to stop

”). Do not use EMSAM if you: take certain medicines including: o selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, sertraline, or paroxetine o serotonin and norepinephrine reuptake inhibitors (SNRI) such as venlafaxine or duloxetine o clomipramine or imipramine (tricyclic antidepressants) o meperidine, tramadol, methadone, pentazocine, propoxyphene (opioid medicines) o dextromethorphan o carbamazepine are less than 12 years of age have a tumor on your adrenal gland called a pheochromocytoma Ask your healthcare provider or pharmacist if you are not sure if you take these medicines.

Before you use EMSAM, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure have mania or bipolar disorder (manic depression) have or had seizures or convulsions drink alcohol have any other medical conditions are pregnant or plan to become pregnant. EMSAM may harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if EMSAM passes into your breast milk. Do not breastfeed during treatment with EMSAM and for 5 days after the final dose. Talk to your healthcare provider about the best way to feed your baby if you use EMSAM. Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

EMSAM and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together. Especially tell your healthcare provider if you take: other medicines to treat depression (antidepressants) including other MAOI medicines decongestant medicines to treat cold or cough symptoms over-the-counter diet pills or herbal weight-loss products any herbal or dietary supplement that contains tyramine medicines called stimulants or uppers (amphetamines) buspirone, an anxiety medicine Some of these medicines need to be stopped for up to 5 weeks before you can start using EMSAM and for 2 weeks after you stop using EMSAM.

Ask your healthcare provider or pharmacist if you are not sure if you take these medicines. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. How should I use EMSAM? Read the “Instructions for Use” at the end of this Medication Guide for information about the right way to use EMSAM.

Use EMSAM exactly as your healthcare provider tells you to use it. Use only 1 patch at a time. Apply your patch right after you open the sealed pouch. Change your patch 1 time each day at the same time each day. Choose a time of day that works best for you. Your healthcare provider may need to change your dose of EMSAM until it is the right dose for you.

If you use too much EMSAM (overdose) you may have the following symptoms: o drowsiness o irritable o severe headache o your head, neck and spine arch backwards o fast or irregular pulse o blood circulation problem o high fever o dizziness o hyperactive o seeing things that are not there o seizures o high blood pressure o chest pain o sweating o fainting o agitated o stiff jaw o coma o low blood pressure o trouble breathing o cool, clammy skin If you have any of these symptoms of EMSAM overdosage, remove your patch right away and call your healthcare provider or go to the nearest hospital emergency room right away.

It may take up to 12 hours before you have these symptoms, and they may be worse 24 to 48 hours after you apply your EMSAM patch.

What to avoid

Avoid exposing the EMSAM application site to external sources of direct heat, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight. Do not eat foods or drink beverages that contain high amounts of tyramine while using EMSAM 9 mg or EMSAM 12 mg or for 2 weeks after you stop using EMSAM 9 mg or EMSAM 12 mg.

Continue to avoid tyramine-rich foods or beverages for 2 weeks after a dose reduction to EMSAM 6 mg. If you start and continue EMSAM 6 mg you do not need to make any diet changes. The table below lists foods and drinks you should avoid while you use EMSAM 9 mg and EMSAM 12 mg. Type of Food and Drink Foods and drinks you should avoid that contain Tyramine Meat, Poultry, and Fish air dried, aged and fermented meats, sausages and salamis pickled herring any spoiled or improperly stored meat, poultry, and fish.

These are foods that have a change in color, odor, or become moldy. spoiled or improperly stored animal livers Vegetables broad bean pods (fava bean pods) Dairy (milk products) aged cheeses Drinks all tap beers and other beers that have not been pasteurized Other concentrated yeast extract (such as Marmite) sauerkraut most soybean products (including soy sauce and tofu) over-the-counter supplements containing tyramine All foods you eat must be fresh or properly frozen.

Avoid foods when you do not know how those foods should be stored. Ask your healthcare provider if you are not sure if certain foods and drinks contain tyramine. Do not drive, operate heavy machinery or do other dangerous activities until you know how EMSAM affects you. You should not drink alcohol while using EMSAM. What are the possible side effects of EMSAM?

EMSAM may cause serious side effects, including: serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you use EMSAM while you take certain medicines called MAOIs. Symptoms of serotonin syndrome include: o agitation o coma o dizziness o fever o stiff muscles o nausea o seeing things that are not there (hallucinations) o rapid pulse o sweating o seizures o muscle twitching o vomiting o confusion o low blood pressure o flushing o tremors o become unstable o diarrhea If you suddenly have these symptoms, stop using EMSAM immediately by removing the patch and go to the nearest hospital emergency room right away.

a sudden, severe increase in blood pressure (hypertensive crisis). A hypertensive crisis can happen when you eat certain foods and drink certain beverages while you use EMSAM. A hypertensive crisis can lead to stroke and death. See “What should I avoid while using EMSAM?” A hypertensive crisis can also happen if you use EMSAM with certain other medicines.

See “Who should not use EMSAM?” Symptoms of a hypertensive crisis include: o sudden, severe headache o vomiting o a fast heartbeat (palpitations) or a change in the way your heart beats o the pupils in your eyes increase in size o fast or slow heart beat with chest pain o nausea o stiff or sore neck o excessive sweating, sometimes with fever or cold clammy skin o light bothers your eyes o bleeding in your brain If you suddenly have these symptoms, go to the nearest hospital emergency room right away.

mania or hypomania (manic episodes) in people who have a history of mania. Symptoms of manic episodes include: o greatly increased energy o severe problems sleeping o racing thoughts o reckless behavior o unusually grand ideas o excessive happiness or irritability o talking more or faster than usual The most common side effects of EMSAM include: a skin reaction where the patch is placed.

You may see mild redness at the site when a patch is removed. This redness should go away within several hours after removing the patch. If irritation or itching continues, tell your healthcare provider. headache trouble sleeping

Storing it

Store EMSAM at room temperature between 68°F to 77°F (20°C to 25°C). Store EMSAM in the sealed pouch it comes in until you are ready to use it. Keep EMSAM and all medicines out of the reach of children.