Description
Selegiline skin patch is used to treat mental depression in adults. This medicine is a monoamine oxidase inhibitor (MAOI).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Patch, Extended Release
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 this medicine. 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.
Breastfeeding
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.
Drug Interactions
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 this medicine, 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 this medicine 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
- Dihydrocodeine
- Doxylamine
- Duloxetine
- Ephedrine
- Escitalopram
- Fenfluramine
- Fluoxetine
- Fluvoxamine
- Furazolidone
- Gepirone
- Guanadrel
- Guanethidine
- Hydroxytryptophan
- Imipramine
- Iproniazid
- Isocarboxazid
- Isometheptene
Using this medicine 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.
- Albuterol
- Alfentanil
- Alizapride
- Amineptine
- Amitriptylinoxide
- Atropine
- Benzhydrocodone
- Bromperidol
- Buprenorphine
- Buspirone
- Butalbital
- Butorphanol
- Carbidopa
- Clovoxamine
- Dibenzepin
- Difenoxin
- Diphenoxylate
- Dolasetron
- Domperidone
- Dothiepin
- Doxepin
- Droperidol
- Epinephrine
- Ethchlorvynol
- Femoxetine
- Fentanyl
- Fluspirilene
- Formoterol
- Frovatriptan
- Granisetron
- Guarana
- Haloperidol
- Hydrocodone
- Hydromorphone
- Iobenguane I 123
- Iobenguane I 131
- Kava
- Lasmiditan
- Levodopa
- Levorphanol
Using this medicine 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
Other Interactions
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 this medicine 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 this medicine, 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 this medicine. 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. .
Proper Use
Use this medicine exactly as directed by your doctor. Do not use more patches or apply them more often than your doctor tells you to.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
To use the skin patch:
- Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch. Wear only one patch at a time.
- Wash the area of skin where you will apply the patch gently with soap and warm water. Rinse completely and dry with a clean dry towel.
- Apply the patch to a dry, smooth, intact skin area on your upper chest or back (below the neck and above the waist), upper thigh, or to the outer surface of the upper arm. Do not put the patch over hairy, oily, irritated, broken, scarred, or calloused skin. Avoid putting the patch on areas where it could be rubbed off by tight clothing.
- Press the patch firmly in place with your fingertips to make sure that the edges of the patch stick well.
- Put on a new patch if the old one has fallen off and cannot be reapplied.
- After 24 hours, remove the patch. Choose a different place on your skin to apply the new patch. Do not put the new patch on the same place you wore the last one. Try to change the patch at the same time each day.
- Do not expose the patch to direct sources of heat, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, or direct sunlight for long periods of time.
- Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.
- After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.
Do not stop using this medicine without asking your doctor. If you have not used your medicine for several days in a row, do not start using it again without talking to your doctor first.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For transdermal dosage form (skin patch):
- For depression:
- Adults—At first, one 6-milligram (mg) patch once a day. Your doctor may increase your dose if needed.
- Children 12 years of age and older—Use and dose must be determined by your doctor.
- Children younger than 12 years of age—Use is not recommended.
- For depression:
Missed Dose
If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.
Do not store this medicine outside of its sealed pouch.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
You should not use this medicine 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 this medicine 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 this medicine, 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 this medicine. 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 this medicine. Using selegiline together with medicines that are sometimes used during surgery may increase the effects of these medicines.
This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you or your child know how this medicine 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 this medicine.
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").
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Chills
- cold sweats
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
Incidence not known
- Confusion about identity, place, and time
- seeing things that are not there
- seizures
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Burning, itching, redness, skin rash, swelling, or soreness where the patch was placed
- diarrhea
- dry mouth
- headache
- trouble sleeping
Less common
- Belching
- body aches or pain
- change or problem with discharge of semen
- congestion
- cough
- dryness or soreness of the throat
- fever
- heartburn
- hoarseness
- indigestion
- pain or tenderness around the eyes and cheekbones
- rash
- runny nose
- stomach discomfort, upset, or pain
- stuffy or runny nose
- tender, swollen glands in the neck
- tightness of the chest
- trouble swallowing
- troubled breathing
- voice changes
- weight changes
Rare
- Decreased interest in sexual intercourse
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- not able to have an orgasm
Incidence not known
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- tension
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
