Saphris (Asenapine) Patient Information

Generic Name: Asenapine
Brand Name: Saphris

Pronounced: a SEN a peen

Find out why Saphris is prescribed, Saphris side effects, Saphris warnings and drug interactions, more - in plain English.

Saphris (asenapine) full prescribing information

What is Saphris (asenapine)?

Asenapine (Saphris) 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 other purposes not listed in this medication guide.

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

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 can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and 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 heart breast cancer, heart attack, stroke, or "Long QT syndrome."
Avoid drinking alcohol, which 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.

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

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.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• 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. It is not known whether asenapine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. 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 Saphris (asenapine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Take this medicine with a full glass of water.

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.

To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store asenapine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include agitation, confusion, and restless muscle movements in your eyes, tongue, jaw, or neck.

What should I avoid while taking Saphris (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. Asenapine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and 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.
Avoid drinking alcohol, which can increase some of the side effects of asenapine.

Asenapine (Saphris) 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 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 other drugs will affect Saphris (asenapine)?

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.

The following drugs can interact with asenapine. Tell your doctor if you are using

• arsenic trioxide (Trisenox);
• blood pressure medications;
• droperidol (Inapsine);
• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);
• an antidepressant such as amitriptylline (Elavil, Vanatrip), clomipramine (Anafranil), desipramine (Norpramin), fluoxetine (Prozac), or paroxetine (Paxil);
• anti-malaria medications such as chloroquine (Arelan), or mefloquine (Lariam);
• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quinidex, Quin-Release 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) or zolmitriptan (Zomig); or
• narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose).

This list is not complete and there may be other drugs that can interact with asenapine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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.

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Last revision: 09/2009

Saphris (asenapine) full prescribing information

back to: Psychiatric Medication Patient Information Index