Saphris

Generic Name: asenapine (a SEN a peen)
Brand Names: Saphris

What is Saphris?

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

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

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

Important information about Saphris

Saphris is not for use in psychotic conditions related to dementia. Saphris may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. While you are taking Saphris, 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. Saphris may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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Before taking Saphris, 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 Saphris. Stop taking Saphris 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.

Before taking Saphris

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

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

To make sure you can safely take Saphris, 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."

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 Saphris, do not stop taking it without your doctor's advice.

FDA pregnancy category C. 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 Saphris to anyone younger than 18 years old without the advice of a doctor.

See also: Saphris pregnancy and breastfeeding warnings (in more detail)

How should I take Saphris?

Take Saphris 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.

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

To take Saphris 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.

Saphris 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 Saphris.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store Saphris at room temperature away from moisture and heat.

See also: Saphris dosage (in more detail)

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?

While you are taking Saphris, 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 this medication.

Saphris 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.

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

Saphris side effects

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

See also: Saphris side effects (in more detail)

What other drugs will affect Saphris?

Before using Saphris, 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 Saphris.

Many drugs can interact with Saphris. 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 Saphris. 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 Saphris.