Generic Name: asenapine (a-SEN-a-peen)
Brand Name: Saphris
Saphris is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Saphris is not approved to treat mental problems caused by dementia. Discuss any questions or concerns with your doctor.
Saphris is used for:
Treating schizophrenia. It is also used alone or along with lithium or valproate to treat acute manic or mixed episodes associated with bipolar disorder (manic-depression). It may also be used for other conditions as determined by your doctor.
Saphris is an atypical antipsychotic. Exactly how it works is not known. It may work by blocking certain substances in the brain.
Do NOT use Saphris if:
- you are allergic to any ingredient in Saphris
- you have severe liver problems, low blood potassium or magnesium levels, slow heartbeat, or a history of irregular heartbeat (eg, long QT syndrome, congenital prolongation of the QT interval)
- you are taking an antiarrhythmic (eg, amiodarone, sotalol, procainamide, quinidine), certain other antipsychotic medicines (eg, ziprasidone, chlorpromazine, thioridazine), citalopram, metoclopramide, a phenothiazine (eg, thioridazine), or a quinolone antibiotic (eg, gatifloxacin, moxifloxacin)
- if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
Contact your doctor or health care provider right away if any of these apply to you.
Before using Saphris:
Some medical conditions may interact with Saphris. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have diabetes or are at risk of diabetes (eg, overweight, family history of diabetes)
- if you have a history of heart problems (eg, fast, slow, or irregular heartbeat; heart failure; ischemic heart disease), a heart attack, low blood pressure, blood vessel problems, a stroke, or low white blood cell levels
- if you have a history of liver problems, neuroleptic malignant syndrome (NMS), seizures, suicidal thoughts or attempts, or alcohol abuse or dependence
- if you have Alzheimer disease, dementia, Parkinson disease, or esophagus problems (eg, trouble swallowing), or if you are at risk of aspiration (inhaling foreign matter into the airways or lungs)
- if you are dehydrated, have a low blood volume, drink alcohol, or will be exposed to very high or very low temperatures
- if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk of breast cancer
- if you are taking a medicine to treat high blood pressure
- if you have never taken an antipsychotic medicine before. You may be more likely to experience dizziness when you sit or stand up
Some MEDICINES MAY INTERACT with Saphris. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Many prescription and nonprescription medicines (eg, used for allergies, cancer, depression or other mental or mood problems, immune system suppression, infections, irregular heartbeat or other heart problems, narcotic or other substance abuse or dependence, nausea or vomiting, pain, reflux disease, seizures, stomach or bowel problems, Tourette syndrome), multivitamin products, or herbal or dietary supplements because they may interact with Saphris. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Saphris
This may not be a complete list of all interactions that may occur. Ask your health care provider if Saphris may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Saphris:
Use Saphris as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Wash and completely dry your hands before you take Saphris. Do not handle the tablet with wet or damp hands.
- Do not remove the tablet from the tablet pack until you are ready to take Saphris. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.
- To remove Saphris from the tablet pack, firmly press and hold the thumb button, then pull out the tablet pack. Peel back the colored tab and gently remove the tablet. Do not push the tablet through the tablet pack. Do not cut or tear the tablet pack.
- Do not swallow, crush, or chew sublingual tablets. Place the tablet under your tongue and allow it to completely dissolve. Do not eat, drink, or smoke while the tablet is dissolving.
- Do not eat or drink anything for 10 minutes after you take Saphris.
- After you have taken your dose, slide the tablet pack into the case until it clicks.
- Taking Saphris at the same time each day will help you remember to take it.
- Take Saphris on a regular schedule to get the most benefit from it.
- Continue to take Saphris even if you feel well. Do not miss any doses.
- If you miss a dose of Saphris, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Saphris.
Important safety information:
- Saphris may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Saphris with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are taking Saphris.
- Talk with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Saphris; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Saphris may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Do not suddenly stop taking Saphris without checking with your doctor.
- Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions. Contact your doctor right away if you think you may be dehydrated.
- Saphris may increase your risk for developing diabetes or increase blood sugar levels. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Saphris may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- NMS is a possibly fatal syndrome that can be caused by Saphris. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
- Some patients who take Saphris may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Saphris in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Saphris.
- Saphris may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
- Lab tests, including complete blood cell counts, electrolyte levels, weight checks, or fasting blood sugar levels, may be performed while you use Saphris. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Saphris with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements or dizziness when sitting or standing up.
- Saphris should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Saphris while you are pregnant. Using Saphris during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if Saphris is found in breast milk. Do not breast-feed while taking Saphris.
Possible side effects of Saphris:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; drowsiness; dry mouth; headache; increased appetite; increased saliva production; indigestion; joint aches; restlessness; taste changes; temporary numbness or tingling around the mouth; tiredness; trouble sleeping; upset stomach; vomiting; weight gain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; wheezing); change in the amount of urine produced; chest pain; fainting or loss of consciousness; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mouth blisters, sores, or irritation; muscle pain, weakness, or stiffness; new or worsening mental or mood changes (eg, aggression, agitation, depression, severe anxiety); seizures; severe or persistent dizziness or light-headedness; shortness of breath; suicidal thoughts or actions; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; flushing; rapid breathing; fruit-like breath odor; weakness); symptoms of high prolactin levels (eg, enlarged breast size, decreased sexual ability, missed menstrual period, nipple discharge); trouble swallowing; uncontrolled muscle movements (eg, of the arms, legs, tongue, jaw, or cheeks; tremors; twitching); unusual sweating.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; confusion; fainting; severe dizziness; uncontrolled muscle movements.Proper storage of Saphris:
Store Saphris at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Saphris out of the reach of children and away from pets.
- If you have any questions about Saphris, please talk with your doctor, pharmacist, or other health care provider.
- Saphris is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Saphris or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Saphris. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Saphris. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Saphris.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.