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This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.
If you are using asenapine in combination with other medication to treat depression, also carefully read the drug information for the other medication.
This medication is used to treat certain mental/mood disorders (such as schizophrenia). Asenapine helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there) and prevent severe mood swings. Asenapine is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).
Read the Instructions for Use leaflet if available from your pharmacist before you start using asenapine patch and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
The asenapine patch is for use only on the skin. Apply the patch to the skin as directed by your doctor, usually once daily (every 24 hours). Remove the old patch first before applying a new patch. Do not wear 2 patches at the same time. To prevent skin irritation, change where you apply a new patch each time. When changing your patch, remove the old patch, fold it in half with the sticky sides together, and throw it away out of reach of children and pets.
Do not open the sealed pouch for the new patch until you are ready to use it. Open the pouch and remove the protective liner from the patch as directed. Do not cut the patch. Apply the patch as directed to a clean, dry, hairless area on the upper arm, upper back, abdomen, or hip. Do not apply the patch on skin that has cuts, scrapes, burns, rash, redness, or other skin problems. Do not apply the patch on skin that has lotions, oils, or powders on it. Avoid applying it to areas where tight clothing may rub the patch off. Wash your hands with soap and water after applying the patch. Do not wear the patch longer than 24 hours.
You may shower with the patch on. However, avoid bathing or swimming while wearing the patch, since these may cause the patch to fall off. Avoid heat sources (such as a hair dryer, heating pad, electric blanket, or heated water bed) at the application site.
Check the patch regularly during the day to make sure it is still firmly stuck to your skin, especially after showering, using the bathroom, changing clothes, sleeping, or sweating. If the patch edges lift off your skin, smooth them down and press them firmly back in place. If the patch falls off before it is due to be changed, apply a new patch right away. Replace the new patch at the regular time the next day. Do not try to reapply the old patch or use tape to keep a loose patch from falling off.
The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Use this medication regularly to get the most benefit from it. To help you remember, apply it at the same time each day.
It is very important to continue using this medication exactly as prescribed, even if you are feeling better and thinking more clearly. Do not increase your dose or use this drug more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Do not stop using this medication without consulting your doctor.
Tell your doctor if your condition does not get better or if it gets worse.
Redness, itching, pain, or irritation at the application site may occur. Drowsiness, dizziness, lightheadedness, or weight gain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This drug may cause muscle/nervous system problems (extrapyramidal symptoms-EPS). Your doctor may prescribe another medication to decrease these side effects. Tell your doctor right away if you notice any of the following side effects:
Rarely, this medication may cause face/muscle twitching and uncontrollable movements (tardive dyskinesia). In some cases, this condition may be permanent. Tell your doctor right away if you develop any uncontrollable movements such as lip smacking, mouth puckering, tongue thrusting, chewing, or unusual arm/leg movements.
This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. Weight gain from this drug may increase the risk of this side effect. Tell your doctor right away if you have symptoms of high blood sugar, such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
In rare cases, asenapine may increase your level of a certain substance made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.
Rarely, with similar drugs, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.
Tell your doctor right away if you have any serious side effects, including:
Get medical help right away if you have any very serious side effects, including:
This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms:
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
See also Warning section.
Before using asenapine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of:
Asenapine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using asenapine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using asenapine safely.
This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.
Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, and QT prolongation (see above). Drowsiness, dizziness, and lightheadedness can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor promptly.
Since untreated mental/mood problems (such as schizophrenia, bipolar disorder, depression) can be a serious condition, do not stop using this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor right away about the benefits and risks of using this medication during pregnancy.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Asenapine can slow down the removal of other medications from your body, which may affect how they work. One example is paroxetine, among others.
Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/deep sleep, agitation, confusion, fainting.
Do not share this medication with others.
Lab and/or medical tests (such as weight, blood sugar, blood pressure, complete blood counts, cholesterol/triglyceride levels) should be done while you are using this medication. Keep all medical and lab appointments.
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2021.
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