Slideshows Images Quizzes

Saphris

Last reviewed on RxList: 3/21/2017
Saphris Patient Information Including Side Effects

Brand Names: Saphris

Generic Name: asenapine (Pronunciation: a SEN a peen)

What is asenapine (Saphris)?

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 are the possible side effects of asenapine (Saphris)?

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 any of these serious side effects:

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking);
  • trouble swallowing;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden and severe headache, or problems with vision, speech, or balance;
  • easy bruising or bleeding, fever, chills, body aches, flu symptoms;
  • white patches or sores inside your mouth or on your lips;
  • seizure (convulsions); or
  • unusual thoughts or behavior, hallucinations, or thoughts about hurting yourself.

Less serious side effects may include:

  • dizziness, drowsiness;
  • restless feeling;
  • numbness or tingling inside or around your mouth;
  • constipation;
  • dry mouth;
  • sleep problems (insomnia);
  • upset stomach; 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.

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

Asenapine is not for use in psychotic conditions related to dementia. Asenapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

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.

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

Before taking asenapine, tell your doctor if you have liver disease, heart disease, high blood pressure, seizures, low white blood cell counts, diabetes, trouble swallowing, or a history of breast cancer, heart attack, stroke, or "Long QT syndrome."

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

Stop taking asenapine and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.

Saphris Patient Information including How Should I Take

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

Asenapine is not for use in psychotic conditions related to dementia. Asenapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

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

To make sure you can safely take asenapine, 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.

Asenapine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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

How should I take asenapine (Saphris)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Asenapine is usually taken 2 times per day. Follow your doctor's instructions.

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.
  • Swallow several times as the tablet dissolves. 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, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. 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 on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat.

Saphris Patient Information including If I Miss a Dose

What happens if I miss a dose (Saphris)?

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 (Saphris)?

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

Overdose symptoms may include agitation, confusion, and restless muscle movements in your eyes, tongue, jaw, or neck.

What should I avoid while taking asenapine (Saphris)?

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.

What other drugs will affect asenapine (Saphris)?

Before using asenapine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by asenapine.

Many drugs can interact with asenapine. Below is just a partial list. Tell your doctor if you are using:

  • any blood pressure medication;
  • arsenic trioxide (Trisenox);
  • bupropion (Wellbutrin, Zyban);
  • droperidol (Inapsine);
  • tramadol (Ultram, Ultracet);
  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);
  • an antidepressant such as amitriptylline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), or desipramine (Norpramin);
  • anti-malaria medications such as chloroquine (Arelan), or mefloquine (Lariam);
  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dronedarone (Multaq), dofetilide (Tikosyn), flecaininde (Tambocor), ibutilide (Corvert), mexiletine (Mexitil), procainamide (Pronestyl), propafenone, (Rythmol), quinidine (Quin-G), or sotalol (Betapace);
  • medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran);
  • other medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);
  • migraine headache medicine such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig); or
  • narcotic medication such as methadone (Methadose, Diskets, Dolophine).

This list is not complete and there are many other drugs that can interact with asenapine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

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.

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 1996-2013 Cerner Multum, Inc. Version: 5.01. Revision date: 3/14/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Health Solutions From Our Sponsors