Selegiline transdermal

Selegiline prevents the breakdown of chemicals in the brain that are often imbalanced in people with depression.

Selegiline transdermal is used to treat major depressive disorder in adults.

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

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, 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 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.

Usual Adult Dose for Parkinson's Disease:

Oral tablet:
Recommended dose: 5 mg orally twice a day
Maximum dose: 10 mg orally per day

Oral 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 needed.
Maintenance dose: 1.25 to 2.5 mg orally once a day
Maximum dose: 2.5 mg orally once a day

Comments:
-After two to three days of treatment, an attempt may be made to reduce the dose of concomitant levodopa-carbidopa by 10% to 30%. Further reductions may be possible during continued selegiline therapy.

Use: Adjunct in the management of Parkinson's disease patients being treated with levodopa-carbidopa who exhibit deterioration in the quality of their response to this therapy.

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)

In the U.S.

• Emsam

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Antidepressant

Pharmacologic Class: Monoamine Oxidase Inhibitor, Type B

Selegiline skin patch is used to treat mental depression in adults. selegiline is a monoamine oxidase inhibitor (MAOI).

selegiline is available only with your doctor's prescription.

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 selegiline, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to selegiline 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.

Pediatric

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

Selegiline skin patch should not be used in children younger than 12 years of age.

Geriatric

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

Pregnancy

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.

Interactions with 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 selegiline, 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 selegiline 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
• Codeine
• Cyclobenzaprine
• Cyproheptadine
• Desipramine
• Desvenlafaxine
• Deutetrabenazine
• Dexfenfluramine
• Dexmethylphenidate
• Dextroamphetamine
• Dextromethorphan
• Diethylpropion
• Doxylamine
• Duloxetine
• Ephedrine
• Escitalopram
• Fenfluramine
• Fluoxetine
• Fluvoxamine
• Furazolidone
• Guanadrel
• Guanethidine
• Hydroxytryptophan
• Imipramine
• Iproniazid
• Isocarboxazid
• Isometheptene
• Levomethadyl
• Levomilnacipran
• Linezolid
• Lisdexamfetamine
• Maprotiline
• Mazindol
• Meperidine
• Methamphetamine
• Methotrimeprazine
• Methyldopa
• Methylene Blue
• Methylphenidate
• Milnacipran
• Mirtazapine
• Moclobemide
• Nefopam
• Nialamide
• Nortriptyline
• Opipramol
• Paroxetine
• Phendimetrazine
• Phenelzine
• Phenmetrazine
• Phentermine
• Phenylalanine
• Phenylephrine
• Phenylpropanolamine
• Procarbazine
• Propoxyphene
• Protriptyline
• Pseudoephedrine
• Rasagiline
• Reserpine
• Safinamide
• Sertraline
• Sibutramine
• St John's Wort
• Sumatriptan
• Tapentadol
• Tetrabenazine
• Tramadol
• Tranylcypromine
• Trazodone
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine

Using selegiline 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.

• Alfentanil
• Alizapride
• Altretamine
• Amineptine
• Amisulpride
• Amitriptylinoxide
• Atropine
• Bromperidol
• Buprenorphine
• Buspirone
• Butorphanol
• Clovoxamine
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Dolasetron
• Domperidone
• Dothiepin
• Doxepin
• Droperidol
• Ethchlorvynol
• Femoxetine
• Fentanyl
• Fluspirilene
• Frovatriptan
• Granisetron
• Guarana
• Haloperidol
• Hydrocodone
• Hydromorphone
• Iobenguane I 123
• Kava
• Levorphanol
• Licorice
• Lofepramine
• Lorcaserin
• Ma Huang
• Mate
• Melitracen
• Mephentermine
• Metaraminol
• Methadone
• Metoclopramide
• Metopimazine
• Midodrine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Palonosetron
• Penfluridol
• Pentazocine
• Pimozide
• Reboxetine
• Remifentanil
• Sufentanil
• Sulpiride
• Sultopride
• Tianeptine
• Tiapride
• Tyrosine
• Valbenazine
• Veralipride
• Ziprasidone

Using selegiline 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
• Chlorpropamide
• Dopamine
• Ginseng
• Glimepiride
• Glipizide
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Metformin
• Nateglinide
• Repaglinide
• Tolazamide
• Tolbutamide

Interactions with Food/Tobacco/Alcohol

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 selegiline 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 selegiline, or give you special instructions about the use of food, alcohol, or tobacco.

• Avocado
• Bitter Orange
• Tyramine Containing Food

Other Medical Problems

The presence of other medical problems may affect the use of selegiline. Make sure you tell your doctor if you have any other medical problems, especially:

• Bipolar disorder (manic depressive disorder), at risk or family history of or
• Heart problems or
• Hypotension (low blood pressure) or
• Mania or hypomania, family history of or
• Mental illness, history of—Use with caution. May make these conditions worse.

• Pheochromocytoma (an adrenal gland problem)—Should not be used in patients with this condition. .

It is very important that your doctor check your or your child's progress at regular visits to make sure selegiline is working properly and to check for unwanted effects.

You should not use selegiline if you or your child are taking carbamazepine (Tegretol®), other medicines to treat depression (eg, clomipramine, duloxetine, fluoxetine, imipramine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Paxil®, Prozac®, Zoloft®), certain pain medicines (eg, meperidine, methadone, pentazocine, propoxyphene, tramadol, Darvon®, Demerol®, Dolophine®, Ultram®), or cough medicines (eg, dextromethorphan, Benylin®). Do not use selegiline if you also take selegiline capsules or tablets.

Selegiline skin patch 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. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

When selegiline skin patch is used at low doses, there are no restrictions on the food or beverages that you can 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 selegiline, 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 doctor to provide one.

Selegiline may cause a serious condition called serotonin syndrome when used together with certain MAO inhibitors (eg, phenelzine, rasagiline, tranylcypromine) and medicines to treat depression (eg, amitriptyline, doxepin, fluoxetine, fluvoxamine, nortriptyline, paroxetine, sertraline, Elavil®, Luvox®, Pamelor®, Paxil®, Prozac®, Zoloft®). Symptoms of serotonin syndrome include: anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or seeing or hearing things that are not there.

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 or your child are using selegiline. These may be symptoms of a serious side effect that should have a doctor's attention.

Do not expose the applied skin patch to direct heat, such as heating pads, electric blankets, heat lamps, sauna, hot tubs, heated water beds, and prolonged direct sunlight.

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

selegiline may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you or your child know how selegiline affects you. Standing up slowly from a sitting or lying position can lessen the chance of getting dizzy.

The use of alcohol is not recommended in patients who are taking selegiline.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or over-the-counter diet pills, herbal weight-loss products, cold medicines (eg, ephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine, Neo-Synephrine®, Novafed®, Sudafed®), any herbal or dietary supplement that contains tyramine, or medicines called amphetamines (also called stimulants or "uppers").

Selegiline is an antidepressant (monoamine oxidase inhibitor) that treats depression by restoring the balance of certain natural substances (neurotransmitters) in the brain. Selegiline can improve your mood and feelings of well-being. This medication is a patch for use on the skin.

How to use Selegiline Patch, Transdermal 24 Hours

Read the Medication Guide available from your pharmacist before you start using selegiline and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Follow the package instructions for using this medication. Make sure you understand how to apply a new patch and dispose of the used product. Do not cut the patch into smaller sizes. Do not use the patch if it appears broken, cut or damaged. If you have any questions, consult your doctor or pharmacist.

Before applying the patch, wash the area you will be using for the patch gently and thoroughly with soap and water. Rinse and dry with a clean dry towel. Do not apply the patch to hairy/oily/red/cut/irritated/broken or scarred/calloused skin. Remove the patch from the foil pouch and apply as directed by the manufacturer. Apply one patch to an area of clean dry skin on the upper body (torso), upper thigh, or on the outside of the upper arm where it will not be rubbed by tight clothing. Change the patch daily at about the same time each day. Apply the patch to a different area on your body each time to avoid irritation. If your patch falls off, apply a new patch to a new area and continue on your same schedule.

Be sure to remove the old patch, fold it in half so it sticks to itself, and throw it away out of the reach of children and pets. Do not touch the sticky side with your fingers. Wash your hands with soap and water after handling the patch.

To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose. Usually, your daily dose will not be more than 12 milligrams. Once your condition improves and you are better for a while, your doctor may work with you to reduce your regular dose. Follow your doctor's instructions carefully. Do not apply more patches or leave the patch on for longer than prescribed. Your condition will not improve any faster and your risk of side effects will increase.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. It may take several weeks for the full benefits of this medication to be noticed. Do not stop using this medication without consulting your doctor.

Inform your doctor if your condition persists or worsens.