saphris

Saphris (asenapine) 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, and for bipolar disorder in pediatric patients (ages 10–17).

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

Important information

Saphris 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.

Saphris 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.

Before taking this medicine

Saphris is not approved for use in psychotic conditions related to dementia. It 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 Saphris is safe for you, tell your doctor if you have:

• 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.

It is not known whether asenapine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Saphris.

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.

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 Saphris?

Saphris 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 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.

• Swallow several times as the tablet dissolves. 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, 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 Saphris.

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

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 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 Saphris.

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 Saphris.

Saphris side effects

Get emergency medical help if you have any 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:

• 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 Saphris 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 Saphris?

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

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Saphris, especially:

• methadone;

• tacrolimus;

• arsenic trioxide, vandetanib, vemurafenib;

• an antibiotic--azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine;

• an antidepressant--amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluvoxamine, paroxetine;

• anti-malaria medication--artemether and lumefantrine, chloroquine, halofantrine, mefloquine;

• heart rhythm medicine--amiodarone, dofetilide, disopyramide, dronedarone, flecainide, ibutilide, procainamide, propafenone, quinidine, sotalol;

• medicine to prevent or treat nausea and vomiting--dolasetron, droperidol, ondansetron;

• medicine to treat a psychiatric disorder--chlorpromazine, clozapine, haloperidol, mesoridazine, pimozide, thioridazine, ziprasidone; or

• migraine headache medicine--sumatriptan, zolmitriptan.

This list is not complete. Other drugs may interact with asenapine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.