Emsam

Emsam is a prescription medication used to treat depression in adults. Emsam belongs to a group of drugs called monamine oxidase (MAO) inhibitors, which affect levels of certain natural substances in the brain. These substances are involved with mental balance.

This medication comes in the form of a skin patch. It is applied once a day to the upper chest or back, upper thigh, or upper arm.

Common side effects of Emsam include redness in the application area, a large and sudden increase in blood pressure (hypertensive crisis), and low blood pressure (hypotension).  Do not drive or operate machinery until you know how Emsam will affect you.

Emsam is used to treat depression in adults.

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

• Somerset Pharmaceuticals, Inc.

• Emsam can cause a sudden, large increase in blood pressure (‘‘hypertensive crisis’’) if you eat certain foods and drinks during treatment. See “Drug Precautions”. A hypertensive crisis can lead to stroke and death. Symptoms of a hypertensive crisis include the sudden onset of severe headache, nausea, stiff neck, a fast heartbeat or a change in the way your heart beats (palpitations), a lot of sweating, and confusion. If you suddenly have these symptoms, get medical care right away.
• Emsam can cause serious and potentially life-threatening reactions if used with certain other medicines. See “Emsam Drug Precautions”.
• Emsam may worsen your depression, give you suicidal thoughts, or cause unusual changes in behavior.  Call your doctor right away if you feel worse with Emsam.
• Emsam may cause a mental condition called mania or hypomania (mental condition which causes high moods) in people who have a history of mania.
• Emsam can cause low blood pressure. Lie down if you feel dizzy, faint, or lightheaded. Change your position slowly if low blood pressure is a problem for you. Tell your doctor if you have these symptoms. You may need a lower dose of Emsam.

The most common side effect of Emsam is 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 doctor.

These are not all the side effects of Emsam. For more information, ask your doctor or pharmacist.

Emsam can cause serious and potentially life-threatening reactions if used with certain other medicines. Do not take the following medicines while using Emsam, and for 2 weeks after stopping Emsam:

• other medicines to treat depression (antidepressants) including other MAOI medicines
• medicine which contains selegiline (such as Eldepryl)
• St. John’s wort (a herbal supplement)
• Demerol (meperidine), or medicines that contain meperidine (a narcotic pain medicine) or the pain medicines tramadol, methadone, or propoxyphene
• Tegretol (carbamazepine), or other medicines that contain carbamazepine (a seizure medicine)
• Trileptal (oxcarbazepine), or other medicines that contain oxcarbazepine (a seizure medicine)
• Cold or cough preparations that contain dextromethorphan
• Flexeril or other medicines that contain cyclobenzaprine (a medicine used to treat muscle spasms)
• decongestant medicines, found in many products to treat cold symptoms
• over-the-counter diet pills or herbal weight-loss products
• any herbal or dietary supplement that contains tyramine
• medicines called amphetamines, also called stimulants or “uppers”
• BuSpar (buspirone), an anxiety medicine

Some of these medicines will have to be stopped for at least a week before you can start using Emsam. Be sure to tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

This is not a complete list of Emsam drug interactions. Ask your doctor or pharmacist for more information.

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

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.

Watch for and try to prevent suicidal thoughts and actions:

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, 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 the 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 or your family member has 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 very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

USING ANTIDEPRESSANTS IN CHILDREN AND TEENAGERS

Emsam at any dose should not be used in children under the age of 12 years even when administered with dietary modifications. Emsam is not approved for use in pediatric patients.

• Emsam contains a medicine called a monoamine oxidase inhibitor, also called a MAOI. MAOI medicines, including Emsam, can cause a sudden, large increase in blood pressure (hypertensive crisis) if you eat foods and drinks that contain high amounts of tyramine. A hypertensive crisis can be a life-threatening condition. See "Emsam Side Effects" for signs and symptoms of a hypertensive crisis.
  • You must avoid (not eat or drink) certain foods and drinks while using Emsam and for 2 weeks after stopping Emsam.
    • You do not have to make any diet changes with the Emsam 6 mg/24 hours patch.
  • See "Emsam Food Interactions" section for more information regarding foods to avoid.

• Emsam can cause serious and potentially life-threatening reactions if used with certain other medicines. Do not take the following medicines while using Emsam, and for 2 weeks after stopping Emsam
       ▪ other medicines to treat depression (antidepressants) including other MAOI medicines
       ▪ medicine which contains Emsam (such as Eldepryl)
       ▪ St. John’s wort (a herbal supplement)
       ▪ Demerol (meperidine), or medicines that contain meperidine (a narcotic pain medicine) or the pain medicines tramadol, methadone, or propoxyphene
       ▪ Tegretol (carbamazepine), or other medicines that contain carbamazepine (a seizure medicine)
       ▪ Trileptal (oxcarbazepine), or other medicines that contain oxcarbazepine (a seizure medicine)
       ▪ Cold or cough preparations that contain dextromethorphan
       ▪ Flexeril or other medicines that contain cyclobenzaprine (a medicine used to treat muscle spasms)
       ▪ decongestant medicines, found in many products to treat cold symptoms
       ▪ over-the-counter diet pills or herbal weight-loss products
       ▪ any herbal or dietary supplement that contains tyramine
       ▪ medicines called amphetamines, also called stimulants or “uppers”
       ▪ BuSpar (buspirone HCl), an anxiety medicine
• Some of these medicines will have to be stopped for at least a week before you can start using Emsam.
• Do not use Emsam if you are allergic to anything in this medication
• You must not eat foods or drink beverages that contain high amounts of tyramine while using Emsam. You do not have to make any diet changes with the Emsam 6 mg/24 hours patch. 
• Do not take other medicines while using Emsam or for 2 weeks after you stop using it unless your doctor has told you it is okay. See “Emsam Drug Precautions".
• Do not drive or operate dangerous machinery until you know how Emsam affects you. Emsam may reduce your judgment, ability to think, or coordination.
• Drinking alcoholic beverages is not recommended while using Emsam.
• Emsam is not to be used if you are also taking meperidine (Demerol). This contraindication is often extended to other opioid medications.

Tyramine is a naturally occurring compound found in some cheeses and other foods that may cause dangerously high blood pressure in people taking monoamine oxidase inhibitors (MAOIs) like selegiline. You must not eat foods or drink beverages that contain high amounts of tyramine. You do not have to make any diet changes with the selegiline 6 mg/24 hours patch. See “Emsam Drug Precautions” for a list of tyramine-rich foods.

You should avoid eating very large amounts of foods containing high amounts of tyramine such as:

• cheese (particularly strong or aged varieties)
• sour cream
• Chianti wine
• sherry
• beer (including non-alcoholic beer)
• liqueurs
• pickled herring
• anchovies
• caviar
• liver
• canned figs
• raisins
• bananas
• avocados (particularly if overripe)
• chocolate
• soy sauce
• sauerkraut
• the pods of broad beans (fava beans)
• yeast extracts
• yogurt
• meat extracts
• meat prepared with tenderizers
• dry sausage

Some of the signs and symptoms of dangerously high blood pressure (hypertensive crisis) are:

• severe headache
• vision problems
• confusion
• stupor (mental numbness)
• coma
• seizures
• chest pain
• unexplained nausea or vomiting
• stroke-like symptoms (sudden numbness or weakness - especially on one side of the body)

Get emergency medical help if you experience these symptoms.

Tell your doctor about all your medical conditions, including if you:

• have any heart problems
• have or had manic episodes (a mental condition that causes “high” moods)
• have or had seizures (convulsions or “fits”)
• tend to get dizzy or faint
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Emsam passes into your milk or if it can harm your baby.

Use Emsam exactly as prescribed by your doctor. Use only one patch at a time. Change the patch once a day (every 24 hours). Choose a time of day that works best for you.

• Your doctor will prescribe a dose of Emsam based on your condition. Your doctor may change your dose if needed.
• Talk to your doctor often about your condition. You may notice an improvement in your condition with Emsam therapy after several weeks. Do not stop or change your treatment with Emsam without talking to your doctor.
• Make sure you do not eat foods or drink beverages that contain high amounts of tyramine while using Emsam 9 mg/24 hours or Emsam 12 mg/24 hours patches, and for 2 weeks after you stop using them. (See "Food Interactions" section.)
• If you use more than one Emsam patch at a time, remove Emsam patches right away and call your doctor or local Poison Control Center.
• 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.
• Tell your doctor if you plan to have surgery. Also, tell your surgeon that you take Emsam. Emsam should be stopped 10 days before you have elective surgery.
• Do not take other medicines while using selegiline or for 2 weeks after you stop using it unless your doctor has told you it is okay. See “Drug Precautions".
• Do not drive or operate dangerous machinery until you know how Emsam affects you. Selegiline may reduce your judgment, ability to think, or coordination.
• Drinking alcoholic beverages is not recommended while using Emsam.

How to use and apply an Emsam patch

• Apply a new Emsam patch every day (24 hours).
• Wear only one Emsam patch at a time. Wear one Emsam patch all the time until it is time to apply a new one.
• Remove a used patch before applying a new one.
• Change the patch at the same time each day.
• Apply an Emsam patch to dry, smooth skin on your upper chest or back (below the neck and above the waist), upper thigh, or to the outer surface of the upper arm. Choose a new site each time you change your patch. Do not use the same site 2 days in a row.
• Apply an Emsam patch to an area of skin that is not hairy, oily, irritated, broken, scarred, or calloused. Do not place the patch where your clothing is tight, which could cause the patch to rub off.
• After you have selected the site for your patch, wash the area gently and well with soap and warm water. Rinse until all soap is removed. Dry the area with a clean dry towel.
• Just before you apply the patch, remove it from its sealed pouch. Do not keep or store the patch outside of the sealed pouch. Never cut an Emsam patch into smaller pieces to use.
• Remove half of the protective backing and throw it away. Try not to touch the exposed side (sticky side) of the patch, because the medicine could come off on your fingers. With your fingertips, press the sticky side of the patch firmly against the skin site that was just washed and dried. Remove the second half of the protective liner and press the remaining sticky side firmly against your skin. Make sure that the patch is flat against the skin (there should be no bumps or folds in the patch) and is sticking securely. Be sure the edges are stuck to the skin surface.
• After you have applied the patch, wash your hands well with soap and water to remove any medicine that may have gotten on them. Do not touch your eyes until after you have washed your hands.
• After 24 hours, remove the patch slowly and carefully to avoid damaging the skin. Do not touch the sticky side. As soon as you have removed the patch, fold it so that the sticky side sticks to itself.
• Throw away the folded patch so that children and pets cannot reach it. This patch still contains some medicine and could harm a child or pet.
• Gently wash the old application site with warm water and a mild soap to remove any sticky material (adhesive) that stays on your skin after removing the patch. A small amount of baby oil may also be used to remove any adhesive. You may need to use a medical adhesive removal pad that you can get from your pharmacist. Alcohol or other dissolving liquids such as nail polish remover may cause skin irritation and should not be used.
• Wash your hands with soap and water.
• If the patch becomes loose, press it back in place. If your Emsam patch falls off, apply a new Emsam patch to a new site and resume your normal schedule for changing patches.
• If you forget to change your patch after 24 hours, remove the old patch, put on a new patch in a different area and continue to follow your original schedule.

Apply the Emsam patch exactly as prescribed. Follow the directions on your prescription label carefully.

• The recommended starting dose and target dose for Emsam (selegiline) is 6 mg/24 hours. Emsam has been shown to be effective in a dose range of 6 mg/24 hours to 12 mg/24 hours. 

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Emsam patch in its sealed pouch until use.
• Keep Emsam and all medicines out of the reach of children and away from pets.

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Emsam or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised for the need for close observation and communication with the prescriber. Emsam is not approved for use in pediatric patients. Furthermore, Emsam at any dose should not be used in children under the age of 12, even when administered with dietary modifications.