Use in older adults:
Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as asenapine have an increased risk of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or ministroke during treatment.
Asenapine is not approved by the Food and Drug Administration (FDA) for the treatment of behavioral problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking asenapine. For more information visit the FDA website: Web Site.
Talk to your doctor about the risk(s) of taking asenapine.
Asenapine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Asenapine is used alone or in combination with other medications to treat or prevent episodes of mania (frenzied, abnormally excited mood) or mixed mania (frenzied, abnormally excited mood and symptoms of depression) in adults and children 10 years of age and older with bipolar I disorder (manic depressive disorder; a disease that causes episodes of mania, episodes of depression and other abnormal moods). Asenapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Asenapine comes as a sublingual tablet to dissolve under the tongue. It is usually taken twice a day. Take asenapine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take asenapine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Do not remove asenapine sublingual tablets from the package until just before you are ready to take them, and be sure that your hands are dry when you handle the tablets. When you are ready to take a tablet, follow the package directions to remove the tablet from the case without pushing the tablet through the tablet pack or breaking the tablet. After you remove the tablet, place it under your tongue and wait for it to dissolve. Do not swallow, split, chew, or crush the tablet. Do not eat or drink anything for 10 minutes after the tablet dissolves.
Your doctor may need to increase or decrease your dose depending on how well the medication works for you and the side effects you experience. Tell your doctor how you are feeling during your treatment with asenapine.
Asenapine may help to control your symptoms but will not cure your condition. Continue to take asenapine even if you feel well. Do not stop taking asenapine without talking to your doctor.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking asenapine,
Unless your doctor tells you otherwise, continue your normal diet.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Asenapine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms, or those listed in the SPECIAL PRECAUTION section, call your doctor immediately or get emergency medical treatment:
Asenapine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site ) or by phone (1-800-332-1088).
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
Keep all appointments with your doctor and the laboratory. Your weight should be checked regularly while you are receiving this medication.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: July 15, 2017.