Donepezil (Transdermal)

Donepezil skin patch is used for mild, moderate, and severe dementia (memory loss and mental changes) related to Alzheimer's disease.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress while you are using this medicine. This will help your doctor see if the medicine is working properly and decide if you should keep taking it. Blood tests may be needed to check for unwanted effects.

This medicine may cause skin reactions at the site of the patch, including allergic contact dermatitis. Check with your doctor right away if you have blistering, burning, crusting, dryness, or flaking of the skin, or itching, scaling, severe redness, soreness, or swelling of the skin where the patch is applied.

Donepezil may cause heart problems. Check with your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness, or fainting, slow or irregular heartbeat, trouble breathing, or unusual tiredness.

Tell your doctor right away if you have severe nausea, vomiting, and diarrhea.

This medicine may cause bleeding in your stomach or bowels. Check with your doctor right away if you have bloody or black, tarry stools, constipation, severe stomach pain, or vomiting of blood or material that looks like coffee grounds.

Keep the patch away from heat, including excessive sunlight, saunas, sun rooms, or heating pads.

Make sure any doctor who treats you knows that you have this patch before having surgery or other medical procedures.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the beneficial it will do. This is a decision you and your clinician will make. For this medication, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medication or any other medications. Additionally 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 have not been performed on the relationship of age to the effects of donepezil skin patch in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

Breast Feeding

There are no adequate studies in women for determining infant chance when using this drug during breastfeeding. Weigh the potential benefits against the potential chances before using this medicine while breastfeeding.

Interactions with Drugs

Although certain medicines should not be used together at all, in other cases two different drugs 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 drug, it is especially critical that your healthcare professional know if you are using 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 drug with any of the following medicines is not advised. Your doctor may decide not to treat you with this medication or change some of the other drugs you take.

• Bepridil
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following drugs 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 frequently you use one or both of the medications.

• Abiraterone Acetate
• Acetophenazine
• Aclidinium
• Acrivastine
• Adagrasib
• Alcaftadine
• Alfentanil
• Alfuzosin
• Amantadine
• Ambenonium
• Amdinocillin
• Amdinocillin Pivoxil
• Amifampridine
• Amineptine
• Aminophylline
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Ampicillin
• Anagrelide
• Anisotropine
• Antazoline
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Atomoxetine
• Atropine
• Azatadine
• Azelastine
• Azithromycin
• Azlocillin
• Bacampicillin
• Baclofen
• Bedaquiline
• Belladonna Alkaloids
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Bepotastine
• Bornaprine
• Bromodiphenhydramine
• Bromperidol
• Brompheniramine
• Buclizine
• Bupivacaine
• Buprenorphine
• Bupropion
• Buserelin
• Butorphanol
• Butriptyline
• Butylscopolamine
• Carbenicillin
• Carbinoxamine
• Ceritinib
• Chlorambucil
• Chloroquine
• Chlorotrianisene
• Chlorpheniramine
• Chlorphenoxamine
• Chlorpromazine
• Cimetropium
• Cinacalcet
• Cinnarizine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clemastine
• Clemizole
• Clidinium
• Clofazimine
• Clomipramine
• Clothiapine
• Cloxacillin
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conjugated Estrogens
• Crizotinib
• Cyclacillin
• Cyclizine
• Cyclobenzaprine
• Cyclopentolate
• Cyclosporine
• Cyproheptadine
• Dabrafenib
• Darifenacin
• Dasatinib
• Degarelix
• Delamanid
• Demecarium
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexbrompheniramine
• Dexchlorpheniramine
• Dexmedetomidine
• Dextroamphetamine
• Dibenzepin
• Dicloxacillin
• Dicyclomine
• Dienestrol
• Diethylstilbestrol
• Difenoxin
• Dihydrocodeine
• Dimenhydrinate
• Dimethindene
• Diphenhydramine
• Diphenylpyraline
• Disopyramide
• Distigmine
• Dixyrazine
• Dofetilide
• Dolasetron
• Domperidone
• Dothiepin
• Doxepin
• Doxylamine
• Droperidol
• Duloxetine
• Ebastine
• Echothiophate
• Edrophonium
• Efavirenz
• Eliglustat
• Emedastine
• Encorafenib
• Enflurane
• Entrectinib
• Epinastine
• Eribulin
• Erythromycin
• Escitalopram
• Esterified Estrogens
• Estradiol
• Estramustine
• Estriol
• Estrone
• Estropipate
• Ethinyl Estradiol
• Ethopropazine
• Etrasimod
• Etravirine
• Famotidine
• Felbamate
• Fentanyl
• Fesoterodine
• Fexinidazole
• Fingolimod
• Flavoxate
• Flecainide
• Floxacillin
• Flunarizine
• Fluoxetine
• Fluphenazine
• Fluvoxamine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glycopyrrolate
• Gonadorelin
• Goserelin
• Granisetron
• Guanidine
• Halofantrine
• Haloperidol
• Hetacillin
• Histrelin
• Homatropine
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxyamphetamine
• Hydroxychloroquine
• Hyoscyamine
• Ibutilide
• Iloperidone
• Imipramine
• Indalpine
• Inotuzumab Ozogamicin
• Iprindole
• Isoflurophate
• Isoniazid
• Isopropamide
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketamine
• Ketotifen
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levocabastine
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Lidocaine
• Lindane
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Loxapine
• Lumefantrine
• Macimorelin
• Mebeverine
• Mebhydrolin
• Meclizine
• Mefenamic Acid
• Mefloquine
• Melitracen
• Melperone
• Mepenzolate
• Meperidine
• Mestranol
• Methadone
• Methamphetamine
• Methantheline
• Methdilazine
• Methicillin
• Methixene
• Methotrimeprazine
• Methylphenidate
• Metopimazine
• Metronidazole
• Mezlocillin
• Mifepristone
• Milnacipran
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Morphine
• Moxifloxacin
• Nafarelin
• Nafcillin
• Nalbuphine
• Nalidixic Acid
• Nefazodone
• Nelfinavir
• Neostigmine
• Niaprazine
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Olopatadine
• Ondansetron
• Opipramol
• Orphenadrine
• Osilodrostat
• Osimertinib
• Oxacillin
• Oxaliplatin
• Oxatomide
• Oxybutynin
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Peginterferon Alfa-2b
• Penicillin G
• Penicillin V
• Pentamidine
• Pentazocine
• Perazine
• Periciazine
• Perphenazine
• Phenindamine
• Pheniramine
• Phenobarbital
• Phenylpropanolamine
• Phenyltoloxamine
• Physostigmine
• Pimavanserin
• Pinaverium
• Pipamperone
• Piperacillin
• Pipotiazine
• Pirenzepine
• Pitolisant
• Pivampicillin
• Pizotyline
• Polyestradiol Phosphate
• Ponesimod
• Primidone
• Probucol
• Procainamide
• Procaine
• Prochlorperazine
• Promazine
• Promestriene
• Promethazine
• Propafenone
• Propantheline
• Propicillin
• Propiverine
• Propizepine
• Propoxyphene
• Protriptyline
• Pyrilamine
• Quetiapine
• Quinestrol
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Remifentanil
• Ribociclib
• Rilpivirine
• Risperidone
• Ritonavir
• Rivastigmine
• Scopolamine
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Sibutramine
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Succinylcholine
• Sufentanil
• Sulbenicillin
• Sulpiride
• Sultamicillin
• Sunitinib
• Tacrine
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Temocillin
• Terbinafine
• Tetrabenazine
• Theophylline
• Thiethylperazine
• Thiopropazate
• Thioproperazine
• Thonzylamine
• Tianeptine
• Tibolone
• Ticarcillin
• Timiperone
• Tiotropium
• Tolterodine
• Toremifene
• Tramadol
• Trazodone
• Triclabendazole
• Trifluoperazine
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tripelennamine
• Triprolidine
• Triptorelin
• Tropicamide
• Trospium
• Umeclidinium
• Valethamate
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain adverse effects, but using both drugs may be the best therapy for you. If both medications are prescribed together, your doctor may change the dose or how frequently you use one or both of the drugs.

• Ramelteon

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 drugs may as well 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 medication with any of the following is typically not advised, but may be unavoidable in some cases. If used together, your physician may change the dose or how frequently you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Bitter Orange
• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you inform your physician if you have any other medical issues, especially:

• Heart problems or
• Lung or breathing problems (eg, asthma), history of or
• Seizures
• Stomach ulcers, history of or
• Trouble urinating—Use with caution. May make these conditions worse.

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

• Diarrhea
• nausea
• vomiting

Less common

• Aggressive, angry
• back pain
• bleeding gums
• blurred vision
• chest pain
• confusion
• coughing up blood
• decreased urination
• difficulty in breathing or swallowing
• discouragement
• dizziness
• dry mouth
• fainting
• feeling sad or empty
• headache
• increase in heart rate
• increased menstrual flow or vaginal bleeding
• irritability
• lack of appetite
• lightheadedness
• loss of bladder control
• loss of interest or pleasure
• nervousness
• nosebleeds
• paralysis
• pounding in the ears
• prolonged bleeding from cuts
• rapid breathing
• red or dark brown urine
• red or black, tarry stools
• seeing, hearing, or feeling things that are not there
• sleepiness or unusual drowsiness
• slow or fast heartbeat
• sunken eyes
• thirst
• trouble concentrating
• trouble sleeping
• unusual tiredness or weakness
• wrinkled skin

Incidence not known

• Anxiety
• back, leg, or stomach pains
• blistering, burning, crusting, dryness, or flaking of the skin where the patch is applied
• bloating
• blood in the vomit
• chest pain, discomfort, or tightness
• chills
• coma
• constipation
• dark urine
• fever
• general body swelling
• increased thirst
• indigestion
• itching, scaling, severe redness, soreness, or swelling of the skin where the patch is applied
• light-colored stools
• muscle aches, pain, stiffness, or cramps
• pains in stomach, side, or abdomen, possibly radiating to the back
• pale skin
• seizures
• severe or continuing stomach pain
• shaking
• sore throat
• sweating
• swelling of the face, ankles, or hands
• upper right abdominal or stomach pain
• vomiting of blood or material that looks like coffee
• yellowing of the eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred vision
• chest pain or discomfort
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• increased watering of the mouth
• irregular, fast or slow, or shallow breathing
• lightheadedness, dizziness or fainting
• nausea
• pale or blue lips, fingernails, or skin
• seizures
• sweating
• trouble breathing
• unusual tiredness or weakness
• vomiting

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

• Accident
• bruising
• large, flat, blue or purplish patches in the skin

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.

In the U.S.

• Adlarity

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: Cholinesterase Inhibitor, Centrally Acting

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with patient instructions and patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have questions.

To use the patch:

• Make sure you wash your hands with soap and water before and after applying the patch.
• Remove the patch from the refrigerator. Allow the pouch to reach room temperature before opening and applying the patch. Do not apply a cold patch. Do not use heat (including microwave, hair dryer, heating pad, or direct sunlight) to warm the patch.
• Donepezil skin patches are packaged in sealed pouches. Do not use this medicine if the pouch seal is broken, or if the patch is cut, damaged, or changed in any way. Do not remove the patch from the sealed pouch until you are ready to apply it.
• This medicine is available in 2 different strengths and patch sizes. Make sure you have the right strength patch that has been prescribed for you.
• When handling the skin patch, be careful not to touch the adhesive (sticky) surface with your hand. The adhesive part of the system contains some donepezil, which can be absorbed into your body too fast through the skin of your hand.
• Do not put cream, lotion, or powder on the skin area where the patch will be placed.
• Apply the patch to clean, dry, intact skin on your upper back, lower back, upper buttocks, or upper outer thighs that has very little to no hair. Do not shave the skin where you will apply the patch. You may cut the hair with a pair of scissors. Do not put the patch over burns, cuts, or irritated skin. Avoid putting the patch over skin folds, across the spine, or on areas where it could be rubbed by tight clothing or undergarments.
• Remove the liner covering the sticky side of the skin patch. Place the sticky side against the skin. Slowly peel the blue tinted liner while applying gentle pressure with fingers of your other hand to smooth the patch firmly in place, press the patch firmly with the palm of your hands for 30 seconds to make sure there is good contact with your skin, especially around the edges of the patch.
• If the patch falls off after applying it, throw it away and apply a new patch in a different area.
• Do not touch your eyes after applying the patch. Rinse it off right away with water if it does get in your eyes or if your eyes becomes red after touching the patch.
• Remove the patch after 7 days, or as directed by your doctor. Choose a different place on your skin to apply the next patch. If possible, use a place on the other side of your body. Wait at least 2 weeks (14 days) before using the first area again.
• After you remove the patch, you may use baby or mineral oil to remove any excess medicine. Do not use alcohol or nail polish remover.

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 dementia: Adults—At first, 5 milligrams (mg) once a week. After 4 to 6 weeks, your doctor may adjust your dose as needed. However, the dose is usually not more than 10 mg per day. Children—Use and dose must be determined by your doctor.

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 in the refrigerator. Do not freeze.

Store the patches in the original package. Use the patch within 24 hours of removing from the refrigerator.

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