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  • Generic Name: (asenapine)
    Other Brands: N/A
  • Last Revised: 05/2015
    • What is this medication and its most common uses?

      Saphris is a medicine used to treat schizophrenia. Saphris is also used to treat bipolar disorder alone or in combination with lithium or valproate.

    • What should I know when beginning and continuing on this medication?

      How does this medication work?

      The symptoms of schizophrenia and bipolar disorder are thought to be caused by chemical imbalances in the brain. Although it is unclear exactly how Saphris works, it seems to help balance the chemicals in the brain, thereby helping to improve your symptoms.

      What are the beneficial effects of this medication and when should I begin to have results?

      What:

      Schizophrenia: Saphris has been shown to relieve symptoms of schizophrenia as measured by a symptom rating scale that is commonly used by healthcare providers to evaluate the effectiveness of the medicine in people with this condition.

      Bipolar Disorder: Saphris may effectively work to treat two types of bipolar disorder episodes: mania (highs) and mixed (highs and lows).

      When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's directions. It is important that you take Saphris exactly as your healthcare provider has prescribed.

      How do I know it is working?

      Your healthcare provider may ask you questions from time to time to assess how well your symptoms are controlled.

    • What are the possible side effects of this medication?

      The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.

      Saphris is not approved to treat mental problems caused by dementia (an illness involving loss of memory and judgment, and confusion) in the elderly. It can be life-threatening when used in elderly people with mental problems caused by dementia.

      Schizophrenia

      More common side effects may include: restlessness, numbing of the mouth, drowsiness.

      Bipolar Disorder (Alone)

      More common side effects in adults may include: drowsiness, dizziness, uncontrolled movements, weight gain.

      More common side effects in children may include: drowsiness, dizziness, changes in taste, numbing of the mouth, nausea, increased appetite, tiredness, weight gain.

      Bipolar Disorder (In Combination with Lithium or Valproate)

      More common side effects may include: drowsiness, numbing of the mouth.

      Less common side effects of Saphris may include:

      Neuroleptic malignant syndrome (NMS) (a life-threatening brain disorder) with symptoms such as high fever, excessive sweating, muscle rigidity, confusion, changes in your breathing, fast or irregular heartbeat, or changes in your blood pressure.

      High blood sugar with symptoms such as excessive thirst, an increase in urination, increased appetite, weakness, confusion, fruity smelling breath, or feeling sick to your stomach.

      Tardive dyskinesia, defined as abnormal muscle movements, including tremor, shuffling, and uncontrolled, involuntary movements.

      Serious allergic reactions with symptoms such as itching, and swelling of your face, tongue, or throat that may cause trouble breathing.

      Sudden fall in blood pressure with symptoms such as dizziness, lightheadedness, or fainting when rising too quickly from a sitting or lying position.

      Low white blood cell counts with symptoms of an infection (such as fever, sore throat, rash, or chills).

      Saphris may also cause weight gain and increase your cholesterol and triglycerides (types of fats in your blood).

    • Who should not take this medication?

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

      Do not take Saphris if you have severe liver problems.

    • What should I tell my healthcare provider before I take the first dose of this medication?

      Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Saphris. Also, talk to your healthcare provider about your complete medical history, especially if you have diabetes; high or low blood pressure; low white blood cell counts; seizures; high prolactin (a hormone that can affect lactation, menstruation, and fertility) levels; heart or liver problems; or if you are pregnant, plan to become pregnant, or are breastfeeding.

    • What is the usual dosage?

      The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.

      Schizophrenia

      Adults: The recommended dose is 5 milligrams (mg) twice a day. Your healthcare provider may increase your dose as needed, until the desired effect is achieved.

      Bipolar Disorder (Alone)

      Adults: The recommended starting dose is 10 mg twice a day. Your healthcare provider may adjust your dose based on how you tolerate the medicine.

      Children 10-17 years: The recommended starting dose is 2.5 mg twice a day. Your healthcare provider may increase your dose as needed, until the desired effect is achieved.

      Bipolar Disorder (In Combination with Lithium or Valproate)

      Adults: The recommend starting dose is 5 mg twice a day. Your healthcare provider may increase your dose as needed, until the desired effect is achieved.

    • How should I take this medication?

      Take Saphris exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Saphris without first talking to your healthcare provider.

      Place the tablet under your tongue, and let it dissolve completely.The tablet will dissolve in your saliva within seconds.

      Do not swallow, crush, split, or chew Saphris tablets.

      Do not eat or drink for 10 minutes after taking Saphris.

      Please review the instructions that came with your prescription on how to properly take Saphris.

    • What should I avoid while taking this medication?

      Do not drive, operate machinery, or engage in other dangerous activities until you know how Saphris affects you.

      Do not get overheated or dehydrated while you are taking Saphris. Drink plenty of water and do not over-exercise. Stay out of the sun, and do not wear too much clothing or heavy clothing. In hot weather, stay in a cool place if possible.

    • What are the possible food and drug interactions associated with this medication?

      If Saphris is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your healthcare provider before combining Saphris with the following: amiodarone, certain blood pressure medicines, chlorpromazine, fluvoxamine, gatifloxacin, moxifloxacin, paroxetine, procainamide, quinidine, sotalol, thioridazine, or ziprasidone.

    • May I receive this medication if I am pregnant or breastfeeding?

      The effects of Saphris during pregnancy and breastfeeding are unknown. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

    • What should I do if I miss a dose of this medication?

      If you miss a dose of Saphris, take it as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular dosing schedule. Do not take two doses at once.

    • How should I store this medication?

      Store at room temperature.

    • Who should I contact in case of emergency or overdose?
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      In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
      National Poison Control#: Call 1-800-222-1222

      This PDR+ drug information has been developed by the Physicians’ Desk Reference Network (PDRN), a source of medication information trusted by doctors for over 65 years.

      This monograph summarizes the most important information about your medication and does not cover all the information you may need. If you have any questions or concerns or want to learn more about your medication, ask your healthcare provider; he/she will be able to provide answers to your questions. This medication should only be used by the patient for whom it was prescribed and should not be shared with other people.
    • Additional patient resources.
      back to top Use your PDR® Pharmacy Discount Card when you or a family member fills a prescription and ask for your PDR® Discount every
      time!
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    This discount plan is NOT insurance or a Medicare prescription drug plan. The plan is not intended as a substitute for insurance and does not meet creditable coverage requirements under state or federal law. The plan provides discounts at participating pharmacies on certain pharmaceutical supplies, prescription drugs, or medical equipment and supplies. The range of discounts will vary depending on the products received. Members are obligated to pay the pharmacy the entire amount of the discounted rate for such products at the point of sale. The plan does not pay pharmacies for products provided to members. No enrollment or periodic fees apply. The pharmacy may pay the plan a fee from amounts the pharmacy collects from the member. The discount plan organization is ProCare Pharmacy Benefit Manager, Inc.,1267 Professional Parkway, ProCare Office Park, Gainesville, GA 30507, 1-888-299-5383. Customer service is provided by PDR, LLC., 5 Paragon Drive, Montvale, NJ, 07645, 1-800-232-7379, www.pdr.net/DiscountCard, customerservice@pdr.net.