The drug is also used by itself or with other medications to treat or prevent episodes of mania (abnormal, frenzied excitement) or mixed mania (abnormal, frenzied excitement along with depression) in people with bipolar disorder.
Saphris is in a class of drugs known as atypical antipsychotics.
The medication was approved by the Food and Drug Administration (FDA) in 2009 to treat schizophrenia and bipolar disorder. It's manufactured by Forest Pharmaceuticals, Inc.
Saphris Black-Box Warning
Saphris carries a black-box warning because it may increase the risk of death in older adults with dementia.Saphris isn't FDA approved to treat behavioral problems in this group of people.
Saphris can cause serious neurologic problems. You should call your doctor immediately if you experience:
- Stiff muscles
- High fever
- Sweating
- Confusion
- Fast or uneven heartbeat
- Lightheadedness
- Tremors
- Twitching
- Uncontrollable movement of the eyes, lips, tongue, face, arms, or legs
- Diabetes (or a family history of the disease)
- Signs of dehydration, including severe diarrhea or vomiting
- Prolonged QT interval (a problem with the heart that may cause an irregular heartbeat)
- Low blood pressure
- A heart attack
- A slow or irregular heartbeat
- A stroke or mini stroke
- Seizures
- Breast cancer
- A low white blood cell count
- Low levels of potassium or magnesium in your blood
- Heart disease
- Liver disease
This drug may make it harder for your body to cool down when it gets hot. Avoid vigorous exercise and excessive heat while taking Saphris. Also, make sure you consume plenty of fluids.
You might experience dizziness, fainting, or lightheadedness when you get up from a lying position too quickly while taking Saphris.
Try resting your feet on the floor for a few minutes before standing to avoid this side effect.
Tell your doctor you are taking Saphris before having any kind of surgery, including a dental procedure.
Saphris may cause an increase in blood sugar and may increase your risk for diabetes. Tell your doctor if you experience frequent urination, extreme thirst, extreme hunger, blurred vision, or weakness.
This medicine will help control your symptoms, but it won't cure your condition. Continue to take Saphris even if you feel well.
Saphris Withdrawal
You shouldn't stop taking Saphris without first talking to your doctor.Stopping the medication suddenly could cause unwanted withdrawal symptoms.
Your doctor might decide to take you off the drug slowly to avoid this potential effect.
Pregnancy and Saphris
Saphris is an FDA Pregnancy Category C drug, which means harm to an unborn baby is possible.Tell your doctor if you are pregnant or plan to become pregnant while taking this drug.
Taking antipsychotic medications during the last three months of pregnancy can cause withdrawal symptoms in newborns.
However, you might have withdrawal symptoms if you stop taking the drug during pregnancy.
Talk to your doctor about the risks and benefits of taking Saphris while pregnant.
It's not known whether Saphris passes into breast milk or could harm a breastfeeding baby.
You shouldn't breastfeed while taking this medicine without first talking to your doctor.
Saphris (Asenapine) Side Effects
Common Side Effects of Saphris
You should tell your doctor if any of the following symptoms become severe or don't go away while taking Saphris:- Stomach pain
- Heartburn
- Dry mouth
- Constipation
- Vomiting
- Increased appetite
- Increase in saliva
- Change in taste
- Loss of feeling in the mouth or lips
- Toothache
- Excessive fatigue
- Irritability, restlessness, anxiety, or depression
- Difficulty falling asleep and staying asleep
- Breast enlargement in men
- Missed menstrual periods in women
- Breast discharge
- Decreased sexual ability
- Pain in the joints, arms, or legs
Saphris and Weight Gain
Weight gain is a common side effect of many atypical antipsychotic drugs such as Saphris. Check your weight regularly while taking this medicine.One year-long study found 14.7 percent of people who took Saphris experienced significant weight gain (of at least 7 percent of their body weight).
To counter this unwanted side effect, try to eat a healthy diet, lower your alcohol consumption, and perform light exercises regularly.
Serious Side Effects of Saphris
You should contact your doctor immediately if you experience any of the symptoms listed in the Warning section or any of the following serious side effects:- Hives, rash, or itching
- Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- Difficulty swallowing or breathing
- Hoarseness
- Wheezing
- Spasm or tightening in the neck muscles
- Seizures
- Red or brown colored urine
- Chills, sore throat, cough, or other signs of infection
Saphris (Asenapine) Interactions
- Certain antibiotics including gatifloxacin (Tequin) (not available in the U.S.) and moxifloxacin (Avelox)
- Antidepressants including clomipramine (Anafranil), duloxetine (Cymbalta), fluvoxamine (Luvox), and paroxetine (Paxil, Pexeva)
- Antihistamines
- Dextromethorphan (in Delsym, in Mucinex)
- Ipratropium
- Drugs for anxiety and high blood pressure
- Certain drugs for irregular heartbeat such as amiodarone (Cordarone, Pacerone), procainamide, quinidine, and sotalol (Betapace, Sorine)
- Medications for glaucoma, inflammatory bowel disease, motion sickness, myasthenia gravis, Parkinson's disease, ulcers, or urinary problems
- Drugs for mental illness such as chlorpromazine (Thorazine), thioridazine, and ziprasidone (Geodon)
- Medications for seizures
- Sedatives
- Sleeping pills
- Tranquilizers
Saphris and Alcohol
Alcohol can worsen the side effects of Saphris.Talk to your doctor about the risks of consuming alcoholic beverages while taking this medicine.
Saphris and Other Interactions
Saphris can make you drowsy.You should exercise caution when driving or performing any activity that requires alertness.
Saphris (Asenapine) Dosage
This medicine comes as a sublingual tablet to dissolve under your tongue.
It's typically taken twice a day, around the same time each day.
Follow the instructions on your prescription label carefully. Don't take more or less of the drug than is prescribed.
Don't remove the tablets from the package until you are ready to take them. Make sure your hands are dry when you handle the tablets.
Remove the sublingual tablet without pushing it through the pack or breaking the tablet.
After you remove it, place the tablet under your tongue and let it dissolve.
Don't split, chew, swallow, or crush the tablets.
You shouldn't eat or drink anything for 10 minutes after the tablet dissolves in your mouth.
You can get in touch with a poison control center at (800) 222-1222.
However, if it's almost time for your next dose, skip the missed dose and continue on your regular dosing schedule.
Don't take extra medicine to make up for a missed dose.
It's typically taken twice a day, around the same time each day.
Follow the instructions on your prescription label carefully. Don't take more or less of the drug than is prescribed.
Don't remove the tablets from the package until you are ready to take them. Make sure your hands are dry when you handle the tablets.
Remove the sublingual tablet without pushing it through the pack or breaking the tablet.
After you remove it, place the tablet under your tongue and let it dissolve.
Don't split, chew, swallow, or crush the tablets.
You shouldn't eat or drink anything for 10 minutes after the tablet dissolves in your mouth.
Saphris Overdose
If you suspect an overdose, you should contact a poison control center or emergency room immediately.You can get in touch with a poison control center at (800) 222-1222.
Missed Dose of Saphris
If you miss a dose of Saphris, take it as soon as you remember.However, if it's almost time for your next dose, skip the missed dose and continue on your regular dosing schedule.
Don't take extra medicine to make up for a missed dose.
Saphris Pictures
