Description
Donepezil skin patch is used to mild, moderate, and severe dementia (memory loss and mental changes) associated with Alzheimer's disease.
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 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 problems that would limit the usefulness of donepezil 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.
- Bepridil
- Cisapride
- Dronedarone
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
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.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acetophenazine
- Aclidinium
- Acrivastine
- Adagrasib
- Alcaftadine
- Alfentanil
- Alfuzosin
- Amantadine
- Ambenonium
- Amdinocillin
- Amifampridine
- Amineptine
- Aminophylline
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Ampicillin
- Anagrelide
- Anisotropine
- Antazoline
- Apomorphine
- Aripiprazole
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atomoxetine
- Atropine
- Azatadine
- Azelastine
- Azithromycin
- Azlocillin
- Bacampicillin
- Baclofen
- Bedaquiline
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.
- Ramelteon
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.
- Bitter Orange
- Grapefruit Juice
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:
- 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.
Proper Use
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.
- For dementia:
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.
Precautions
It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
This medicine may cause skin site reactions, 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 a 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.
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
- 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.
DRG-20531859
