Saphris

Saphris is a prescription medication used to treat a mental illness known as schizophrenia. Saphris is also indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder. Saphris is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

This medication comes in a sublingual tablet that is placed under the tongue. To ensure optimal absorption, place the tablet under the tongue and allow it to dissolve completely. The tablet will dissolve in saliva within seconds.

It is taken typically 2 times a day, without food and without liquid. Do not eat or drink for 10 minutes after taking Saphris. Do not spit, crush, chew, or swallow Saphris tablets.

Common side effects of Saphris include feelings of restlessness, numbness of the mouth, extrapyramidal symptoms, and weight gain.

Saphris can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Saphris affects you.

Saphris is a prescription medication used to treat schizophrenia. Saphris is used alone or in combination with other medications for the acute treatment of manic or mixed episodes associated with bipolar I disorder.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Forest Laboratories, Inc.

• Organon Pharmaceuticals USA

Serious side effects have been reported with Saphris. See the “Saphris Precautions” section.

Common side effects of Saphris include the following:

• akathisia (feeling of inner restlessness)
• oral hypoesthesia (numbness of mouth)
• extrapyramidal symptoms
• weight gain
• drowsiness
• dizziness
• constipation
• vomiting
• insomnia (trouble falling asleep or staying asleep)

This is not a complete list of Saphris side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The risks of using Saphris in combination with other drugs have not been extensively evaluated.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take the following medications as these medications may interact with Saphris.

• fluvoxamine (Luvox)
• paroxetine (Paxil)
• imipramine (Tofranil)
• cimetidine (Tagamet)
• carbamazepine (Equetro, Tegretol)
• valproate (Depakote)
• alcohol

This is not a complete list of Saphris drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Saphris including the following:

• Saphris is not approved for the treatment of patients with dementia-related psychosis. Elderly patients with a diagnosis of psychosis related to dementia treated with antipsychotics are at an increased risk of death when compared to patients who are treated with placebo (a sugar pill).
  • There is an increased risk for cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis.
• Neuroleptic Malignant Syndrome (NMS). Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with Saphris and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.
• Tardive Dyskinesia (TD). Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with Saphris and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.
• High blood sugar and diabetes. High blood sugar and diabetes have been reported with Saphris and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with Saphris. Complications of diabetes can be serious and even life-threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.
• Hyperprolactinemia. Saphris and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.
• Body Temperature Regulation. Saphris may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.  While you are taking Saphris, 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.
• Orthostatic Hypotension and Syncope. Saphris may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position (orthostatic hypotension). This is more common when you first start taking it. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• Weight Gain: Weight gain has been reported in patients taking medicines like Saphris, so you and your healthcare provider should check your weight regularly.
• Dysphagia (difficulty swallowing). This may lead to aspiration and choking. Tell your doctor if you have trouble swallowing.
• Low blood counts. Blood problems such as low numbers of white blood cells have been reported in patients taking Saphris and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your doctor may choose to test your blood as you start therapy with Saphris.
• Seizures. Saphris should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
• QT prolongation. This is a condition when changes in the electrical activity of your heart occur, causing irregular heartbeats that can be life threatening. Talk to your healthcare provider about other medicines you are taking before you start taking Saphris. Tell your healthcare provider right away if you have notice feeling faint, lightheadedness, dizziness, feeling like your heart is beating irregularly or quickly.
• Suicide. Call your doctor right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
  • attempts to commit suicide
  • acting on dangerous impulses
  • acting aggressive or violent
  • thoughts about suicide or dying
  • new or worse depression
  • new or worse anxiety or panic attacks
  • feeling agitated, restless, angry or irritable
  • trouble sleeping
  • an increase in activity or talking more than what is normal for you
  • other unusual changes in behavior or mood
• Cognitive and Motor Impairment. Saphris may affect your thinking, judgment, and ability to move. Do not drive a car or operate machinery until you know how this medication affects you.

Saphris can cause drowsiness. Do not drive or operate heavy machinery until you know how Saphris affects you.

Ask your doctor about the safe use of alcoholic beverages while you are taking Saphris. Alcohol can make the side effects of Saphris worse.

Do not take Saphris if you are allergic to Saphris or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Saphris, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Saphris, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Saphris or to any of its ingredients
• or anyone in your family has or has ever had diabetes
• have severe diarrhea or vomiting or you think you may be dehydrated
• have ever used street drugs or misused prescription medications
• have or have ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death)
• have or have ever had low blood pressure
• have or have ever had a heart attack or a slow or irregular heartbeat
• have or have ever had a stroke or TIA (ministroke)
• have or have ever had seizures
• have or have ever had breast cancer
• have or have ever had a low level of white blood cells in your blood or a decrease in white blood cells caused by a medication you have taken
• have or have ever had a low level of potassium or magnesium in your blood
• have or have ever had heart or liver disease
• are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant. If you become pregnant while taking Saphris, call your doctor. Saphris may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
• are breast-feeding
• if you are having surgery, including dental surgery

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Saphris falls into category C.  There are no well-controlled studies that have been done in pregnant women. Saphris should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Saphris crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Saphris. It is recommended that women receiving Saphris  should not breast feed.

Take Saphris exactly as prescribed.

This medication comes in a sublingual tablet and is taken typically 2 times a day, without food and without liquid.

To ensure optimal absorption, place the tablet under the tongue and allow it to dissolve completely. The tablet will dissolve in saliva within seconds.

Do not crush, chew, or swallow sublingual tablet. Do not eat or drink for 10 minutes after taking Saphris.

Administration of Saphris:

• Do not remove tablet until ready to administer.
• Use dry hands when handling tablet.

Step 1. Firmly press and hold thumb button, then pull out tablet pack.
Do not push tablet through tablet pack.
Do not cut or tear tablet pack.

Step 2. Peel back colored tab.

Step 3. Gently remove tablet. Do not crush tablet.

Step 4. Place tablet under tongue and allow it to dissolve completely.

Do not chew or swallow tablet.
Do not eat or drink for 10 minutes.

Step 5. Slide tablet pack into case until it clicks.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Saphris at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose range of Saphris for the treatment of schizophrenia is 10-20 mg/day given in two doses.

The recommended dose range of Saphris, if used alone, for the treatment of bipolar disorder is 10-20 mg/day given in two doses.

The recommended dose range of Saphris, if used with another medication, for the treatment of bipolar disorder is 10-20 mg/day given in two doses.

If you take too much Saphris, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Saphris at 15°-30°C (59°-86°F).
• Keep this and all medicines out of the reach of children.