Asenapine transdermal (skin patch) is an antipsychotic medicine that is used to treat schizophrenia in adults.

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

You should not use asenapine if you are allergic to it, or if you have severe liver disease.

Asenapine is not approved for use in older adults with dementia-related psychosis.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Transdermal medicine is for use only on the skin.

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

Apply the patch to clean, dry, and hairless skin on your stomach, hip, or the outer part of your upper arm. Press the patch firmly into place. You may leave the patch on while showering.

Remove the skin patch after 24 hours and replace it with a new one.

If a patch falls off, put on a new patch and leave it on only for the rest of your wearing time. Do not change your patch removal schedule.

Choose a different place on your body to wear the patch each time you put on a new one.

Do not wear more than one asenapine patch at a time. Never cut a skin patch.

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 using asenapine.

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

Store at room temperature away from moisture and heat.

You should not use asenapine if you are allergic to it, or if you have:

• severe liver disease.

Asenapine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

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).

Using 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 using asenapine without your doctor's advice.

It may not be safe to breastfeed while using asenapine. Ask your doctor about any risk.

Asenapine transdermal is not approved for use by anyone younger than 18 years old.

Apply a patch as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two patches at one time.

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

Avoid sources of heat while wearing the patch. Do not use a heating pad or electric blanket, hair dryer, or heated waterbed. Heat can increase the amount of drug you absorb through your skin and may cause an overdose or death.

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 using asenapine.

Avoid driving or hazardous activity until you know how asenapine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction: hives; fast heartbeats, feeling light-headed; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

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.

Asenapine may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• 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 of asenapine may include:

• muscle stiffness, jerky muscle movements;

• weight gain; or

• skin pain, redness, itching, swelling, or other irritation where the patch was worn.

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.

Using asenapine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

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.