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Asenapine (a SEN a peen)

Brand Names: U.S.

Saphris

Brand Names: Canada

Saphris®

Warning

  • There is a higher chance of death in older adults who take this drug for mental problems caused by dementia. Most of the deaths were linked to heart disease or infection. This drug is not approved to treat mental problems caused by dementia.

What is this drug used for?

  • It is used to treat schizophrenia.
  • It is used to treat bipolar problems.
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take this drug?

  • If you have an allergy to asenapine or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Liver problems, low magnesium levels, low potassium levels, or slow heartbeat.
  • If you have ever had a long QT on ECG or other heartbeat that is not normal.
  • If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

  • Tell dentists, surgeons, and other doctors that you use this drug.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly over a few minutes when sitting or lying down. Be careful climbing stairs.
  • Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of getting an infection. Deadly infections have rarely happened. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat. Talk with your doctor.
  • Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these strokes have been deadly. This drug is not approved to treat mental problems caused by dementia. Talk with your doctor.
  • Have your blood work checked often. Talk with your doctor.
  • If you have high blood sugar (diabetes), talk with your doctor. This drug may raise blood sugar.
  • Check your blood sugar as you have been told by your doctor.
  • This drug may cause weight gain. You may need to have your weight checked often.
  • Avoid beer, wine, or mixed drinks.
  • Talk with your doctor before you use other drugs and natural products that slow your actions.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • If you are planning to harm yourself or the want to harm yourself gets worse.
  • A heartbeat that does not feel normal.
  • Fast or slow heartbeat.
  • Shortness of breath.
  • Very bad dizziness or passing out.
  • Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
  • Period (menstrual) changes.
  • Enlarged breasts.
  • Nipple discharge.
  • Change in sex ability.
  • Mouth sores.
  • Very bad mouth pain or irritation.
  • Seizures.
  • A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
  • Some people who take this drug may get a very bad muscle problem called tardive dyskinesia. The risk may be greater in older adults, especially women. The chance that this will happen or that it will never go away is greater in people who take this drug in higher doses or for a long time. Muscle problems may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or if you have muscle problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Feeling sleepy.
  • Dizziness.
  • Headache.
  • Restlessness.
  • Throwing up.
  • Numbness or tingling in your mouth.
  • Weight gain.
  • Not able to sleep.
  • Hard stools (constipation).
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read and follow the dosing on the label closely.
  • Take as you have been told, even if you feel well.
  • To gain the most benefit, do not miss doses.
  • Wash and dry your hands before you take this drug. Do not touch the tablet with wet or damp hands.
  • Do not remove the tablet from the tablet pack until you are ready to take this drug. Take the tablet right away after opening the blister pack. Do not store the removed tablet for future use.
  • Place tablet under your tongue and let melt.
  • Do not swallow whole. Do not chew, break, or crush.
  • Do not eat or drink for at least 10 minutes after taking this drug.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

How do I store and/or throw out this drug?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

General drug facts

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, pharmacist, or other health care provider.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only your healthcare provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your healthcare provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Copyright

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