Asenapine

Conditions Treated

Asenapine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Asenapine is also used to treat or prevent episodes of mania (frenzied, abnormally excited mood) or mixed mania (frenzied, abnormally excited mood and symptoms of depression) in people with bipolar I disorder (manic depressive disorder; a disease that causes episodes of mania, episodes of depression and other abnormal moods). Asenapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Possible Side Effects

What Side Effects Can This Cause?

Asenapine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth
• stomach pain
• constipation
• vomiting
• increased appetite
• increased amount of saliva in the mouth
• changes in sense of taste
• toothache
• weight gain
• loss of feeling in the lips or mouth
• dizziness
• excessive tiredness
• restlessness
• irritability
• nervousness
• depression
• difficulty falling asleep or staying asleep
• missed menstrual periods
• breast enlargement in males
• discharge from the breasts
• decreased sexual ability
• pain in the joints, arms, or legs

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTION sections, call your doctor immediately:

• fever
• muscle stiffness
• confusion
• fast or irregular heartbeat
• sweating
• uncontrollable movements of the arms. legs, face, tongue, or lips
• sore throat, chills, and other signs of infection
• seizures
• tightening of the neck muscles or throat
• difficulty swallowing

Asenapine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Asenapine comes as a sublingual tablet to dissolve under the tongue. It is usually taken twice a day. Take asenapine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take asenapine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Do not remove asenapine sublingual tablets from the package until just before you are ready to take them, and be sure that your hands are dry when you handle the tablets. When you are ready to take a tablet, follow the package directions to remove the tablet from the case without breaking the tablet. After you remove the tablet, place it under your tongue and wait for it to dissolve. Do not swallow, split, chew, or crush the tablet. Do not eat or drink anything for 10 minutes after the tablet dissolves. If you are taking asenapine to treat bipolar disorder, your doctor may decrease your dose if you experience side effects. Tell your doctor how you are feeling during your treatment with asenapine. Asenapine may help to control your symptoms but will not cure your condition. Continue to take asenapine even if you feel well. Do not stop taking asenapine without talking to your doctor.

What Dietary Instructions Should I Follow

Unless your doctor tells you otherwise, continue your normal diet.

Are There Any Special Instructions

Before taking asenapine, tell your doctor and pharmacist if you are allergic to asenapine, any other medications, or any of the ingredients in asenapine tablets. Ask your pharmacist for a list of the ingredients. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antibiotics including gatifloxacin (Tequin) (not available in the U.S.) and moxifloxacin (Avelox); antidepressants; clomipramine (Anafranil); dextromethorphan (in Delsym, in Mucinex); duloxetine (Cymbalta); medications for anxiety and high blood pressure; certain medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), procainamide, quinidine, and sotalol (Betapace, Sorine); medications for mental illness such as chlorpromazine, thioridazine, and ziprasidone (Geodon); paroxetine (Paxil, Pexeva); sedatives; sleeping pills; and tranquilizers.Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you or anyone in your family has or has ever had diabetes, if you have severe diarrhea or vomiting or you think you may be dehydrated, and if you have or have ever had a prolonged QT interval (a rare heart problem that may cause irregular heart beat, fainting, or sudden death, low blood pressure, a heart attack, a stroke, a slow or irregular heartbeat, seizures, breast cancer, a low level of white blood cells, a low level of potassium or magnesium in your blood, a decrease in the number of white blood cells in your body caused by a medication that you took, or heart or liver disease. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking asenapine. you should know that asenapine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you. ask your doctor about the safe use of alcoholic beverages while you are taking asenapine. Alcohol can make the side effects of asenapine worse. you should know that asenapine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking asenapine. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. you should know that asenapine may make it harder for your body to cool down when it gets very hot. While you are taking asenapine, you should avoid excessive exercise, stay inside as much as possible and dress lightly in hot weather, stay out of the sun, and drink plenty of fluids. you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking asenpine or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking asenapine: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.