Generic Name: asenapine (a SEN a peen)
Brand Name: Saphris, Saphris Black Cherry

What is asenapine?

Asenapine is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Asenapine is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression) in adults.

Asenapine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about asenapine?

Asenapine can cause serious neurologic problems. Stop taking this medicine and call your doctor at once if you have: very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling light-headed, tremors, twitching, or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

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Asenapine is not approved for use in psychotic conditions related to dementia. Asenapine may increase the risk of death in older adults with dementia-related conditions.

What should I discuss with my healthcare provider before taking asenapine?

You should not use asenapine if you are allergic to it.

Asenapine is not approved for use in psychotic conditions related to dementia. Asenapine may increase the risk of death in older adults with dementia-related conditions.

To make sure asenapine is safe for you, tell your doctor if you have any of these other conditions:

  • liver disease;

  • heart disease, high blood pressure, heart rhythm problems;

  • a history of heart attack or stroke;

  • a history of breast cancer;

  • seizures or epilepsy;

  • diabetes (asenapine may raise your blood sugar);

  • trouble swallowing;

  • Parkinson's disease;

  • a history of low white blood cell (WBC) counts; or

  • a personal or family history of Long QT syndrome.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking asenapine, do not stop taking it without your doctor's advice.

It is not known whether asenapine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone younger than 18 years old without the advice of a doctor.

How should I take asenapine?

Asenapine is usually taken 2 times per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

To take asenapine sublingual (under the tongue) tablets:

  • Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the colored tab from the tablet blister. Do not push a tablet through the blister or you may damage the tablet.

  • Using dry hands, gently remove the tablet and place it under your tongue. It will begin to dissolve right away.

  • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

  • Do not eat or drink anything for 10 minutes after the tablet has dissolved.

Asenapine may cause you to have high blood sugar (hyperglycemia). Symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, and blurred vision. If you are diabetic, check your blood sugar levels on a regular basis while you are taking asenapine.

Your doctor will need to check your progress while you are using asenapine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking asenapine?

While you are taking asenapine, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking asenapine.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase some of the side effects of asenapine.

Asenapine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using asenapine and call your doctor at once if you have:

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors;

  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

  • slow heart rate, feeling like you might pass out;

  • ulcers, blisters, swelling, or peeling of your gums after using the sublingual tablet;

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • sudden ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing;

  • seizure (convulsions); or

  • unusual thoughts or behavior, hallucinations, or thoughts about hurting yourself.

Common side effects may include:

  • dizziness, drowsiness, restless feeling;

  • numbness or tingling inside or around your mouth;

  • sleep problems (insomnia); or

  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect asenapine?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking asenapine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with asenapine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about asenapine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.02. Revision Date: 2014-06-13, 8:55:07 AM.

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