asenapine (sublingual)

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

What is asenapine?

Asenapine is an antipsychotic medicine that is used to treat schizophrenia in adults, and bipolar I disorder in adults and children who are at least 10 years old.

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

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

• severe liver disease.

Tell your doctor if you have ever had:

• heart problems;
• high blood pressure;
• a heart attack or stroke;
• diabetes (asenapine may raise your blood sugar);
• a seizure;
• liver disease;
• breast cancer;
• trouble swallowing;
• Parkinson's disease;
• low white blood cell (WBC) counts; or
• long QT syndrome (in you or a family member).

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking asenapine without your doctor's advice.

How should I take asenapine?

Asenapine is usually taken 2 times per day. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Keep the tablet in its blister pack until you are ready to take the medicine. Using dry hands, gently remove the tablet and place it under your tongue.

Do not swallow the sublingual tablet. Allow it to dissolve under your tongue 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.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking asenapine?

Avoid becoming overheated or dehydrated during exercise and in hot weather. 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.

What are the possible side effects of asenapine?

High doses or long-term use of asenapine can cause a serious movement disorder that may not be reversible. The longer you use asenapine, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• ulcers, blisters, swelling, o peeling in your mouth;
• a light-headed feeling, like you might pass out;
• breast pain or swelling, nipple discharge;
• low white blood cell counts --fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; or
• severe nervous system reaction --very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects may include:

• dizziness, drowsiness, tiredness;
• feeling restless or agitated;
• numbness or tingling in or around your mouth;
• muscle stiffness, jerky muscle movements;
• nausea, altered sense of taste; or
• increased appetite, 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 asenapine?

Other drugs may affect asenapine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about asenapine.