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Use in elderly people:

Studies have shown that older adults who take antipsychotics (medications for mental illness) like asenapine have a higher risk of dying while receiving treatment. Dementia is a brain disorder that affects memory, thinking clearly, communication, and daily activities as well as possibly causing changes in mood and personality. Additionally, older people with dementia may be more likely to get a stroke or ministroke while receiving treatment.

The Food and Drug Administration (FDA) has not approved asenapine for the management of behavioural issues in dementia-affected older individuals. If you, a family member, or a person you care for has dementia and is taking asenapine, speak with the doctor who recommended it. Visit the FDA website at for further details.

Discuss the potential risks of taking asenapine with your doctor.

Why is this medication prescribed?

Treatment for schizophrenia symptoms with asenapine (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Asenapine is used to treat or prevent episodes of mania (frenzied, abnormally excited mood) or mixed mania (frenzied, abnormally excited mood and symptoms of depression) in adults and children 10 years of age and older with bipolar I disorder. It can be taken by itself or in combination with other medications (manic depressive disorder; a disease that causes episodes of mania, episodes of depression and other abnormal moods). Asenapine belongs to the group of drugs known as atypical antipsychotics. It functions by altering the way that a few organic brain chemicals behave.

How should this medicine be used?

Sublingual tablets of asenapine are available to dissolve beneath the tongue. Typically, it is taken twice daily. Asenapine should be taken every day at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Asenapine should be used as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

When handling the asenapine sublingual tablets, make sure your hands are dry and do not take them out of the package until you are about to take them. When you’re ready to use a tablet, follow the instructions on the packaging to remove it from the case without squeezing it through the tablet pack or damaging it. Place the tablet under your tongue after removing it and wait for it to dissolve. The tablet should not be chewed, crushed, or swallowed. After the tablet dissolves, wait 10 minutes before eating or drinking anything.

Depending on how well the drug works for you and the adverse effects you encounter, your doctor may need to change your dose. As you receive asenapine treatment, let your doctor know how you are feeling.

Although it won’t treat your disease, asenapine may help you manage your symptoms. Even if you feel OK, keep taking asenapine. Without first consulting your physician, do not stop taking asenapine.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking asenapine,

  • If you have an allergy to asenapine, any other medications, or any of the ingredients in asenapine sublingual tablets, let your doctor and pharmacist know right once. Request a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: antidepressants including clomipramine (Anafranil), duloxetine (Cymbalta), fluvoxamine (Luvox), and paroxetine (Paxil, Pexeva); some antibiotics such gatifloxacin (Tequin) (not available in the United States) and moxifloxacin (Avelox); antihistamines; dextromethorphan (in Delsym, in Mucine); ipratropium, drugs for anxiety and high blood pressure, some drugs for irregular heartbeat like amiodarone (Cordarone, Pacerone), procainamide, quinidine, and sotalol (Betapace, Sorine), drugs for glaucoma, IBD, motion sickness, myasthenia gravis, Parkinson’s disease, ulcers, or urinary issues, drugs for mental illness like chlorpromazine (Thorazine), thioridazin Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • If you or anyone in your family has diabetes or has ever had it, let your doctor know; if you experience frequent vomiting or diarrhoea or suspect you may be dehydrated; if you have ever misused prescription pharmaceuticals or illicit substances; and if you currently or in the past have considered hurting or killing yourself; Low blood pressure, a heart attack, heart failure, a slow or irregular heartbeat, a stroke or TIA (ministroke), seizures, breast cancer, a prolonged QT interval (a uncommon heart condition that may result in irregular heartbeat, fainting, or sudden death); a low white blood cell count or a drop in white blood cells brought on by a drug you’ve taken; a low potassium or magnesium level in your blood; dyslipidemia (high cholesterol levels); issues with balance; any illness that makes it difficult for you to swallow; or liver or heart problems.
  • If you are pregnant, particularly if you are in the last few months of your pregnancy, if you plan to get pregnant, or if you are breastfeeding, let your doctor know. Call your doctor if you conceive while taking asenapine. If asenapine is taken in the final months of pregnancy, it may have negative effects on babies after birth.
  • Inform your doctor or dentist that you are taking asenapine if you are having surgery, including dental surgery.
  • You should be aware that asenapine may cause you to feel sleepy. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • Inquire with your doctor if drinking alcohol is okay for you to do so while taking asenapine. Asenapine side effects can be exacerbated by alcohol.
  • You should be aware that asenapine can make you feel faint, lightheaded, and dizzy if you stand up suddenly from a reclining position. When you initially start taking asenapine, this happens more frequently. Get out of bed gradually and rest your feet on the floor for a few minutes before standing up to help prevent this issue.
  • You should be aware that asenapine might make it more difficult for your body to cool off when it becomes extremely hot. You should limit your physical activity while taking asenapine, spend as much time indoors as you can, dress comfortably in warm weather, avoid the sun, and drink lots of water.
  • You should be aware that even if you do not currently have diabetes, you could develop hyperglycemia (an increase in blood sugar) while taking this medication. Asenapine or other comparable drugs may increase the risk of developing diabetes if you have schizophrenia, which increases your risk compared to persons without the condition. If you experience any of the following side effects while taking asenapine: severe thirst, frequent urination, intense hunger, blurred vision, or weakness, call your doctor right away. Calling your doctor as soon as you experience any of these symptoms is crucial because elevated blood sugar can result in the deadly disease known as ketoacidosis. If ketoacidosis is not treated right away, it could become life-threatening. Dry mouth, nausea, vomiting, shortness of breath, fruity-smelling breath, and diminished consciousness are all signs of ketoacidosis.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

There may be adverse effects from asenapine. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Mouth ache
  • Abdominal pain
  • Constipation
  • Vomiting
  • Heartburn
  • Higher appetite
  • Saliva production in the mouth increasing
  • Taste changing
  • Toothache
  • Gaining weight
  • Loss of sensation in the mouth or lips
  • Feeling lightheaded, unstable, or having difficulties balancing
  • Excessive fatigue
  • Vacillation or a persistent want to move about
  • Irritability
  • Anxiety
  • Depression
  • Having trouble falling or staying asleep
  • Experiencing joint, arm, or leg pain

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you experience any of these symptoms or those in the SPECIAL PRECAUTION section:

  • Hives
  • Rash
  • Itching
  • Breathing or swallowing challenges
  • Swelling of the lower legs, hands, feet, ankles, or face, neck, tongue, lips, eyes, or mouth
  • Hoarseness
  • Wheezing
  • Fever
  • Muscle discomfort or stiffness
  • Tightness or spasm of the neck muscles
  • Confusion
  • Rapid or erratic heartbeat
  • Sweating
  • Arms, legs, face, mouth, tongue, jaw, lips, or cheeks moving erratically
  • Falling
  • Seizures
  • Chills, a cough, a sore throat, and other symptoms of illness
  • Urine with a crimson or brown colour

Other negative effects of asenapine may occur. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Confusion
  • Agitation

What other information should I know?

Keep all of your appointments with your physician and the lab. While you are on this medicine, you should have regular weight checks.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Saphris®
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