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.
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: http://www.fda.gov/Drugs.
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 people 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.
If you are taking asenapine to treat bipolar disorder, your doctor may decrease your dose if you experience side effects. 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.
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.
increase in amount of saliva in the mouth
change in taste
loss of feeling in the lips or mouth
restlessness or constant urge to keep moving
difficulty falling asleep or staying asleep
missed menstrual periods
breast enlargement in males
discharge from the breasts
decreased sexual ability
pain in the joints, arms, or legs
difficulty breathing or swallowing
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
muscle stiffness or pain
spasm or tightening of the neck muscles
fast or irregular heartbeat
uncontrollable movements of the arms, legs, face, mouth, tongue, jaw, lips or cheeks
sore throat, chills, cough, and other signs of infection
red or brown colored urine
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 [at http://www.fda.gov/Safety/MedWatch] 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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
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.
Last Revised - 12/15/2011
AHFS® Consumer Medication Information. © Copyright, 2014. 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.