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Formulation : Sublingual Tablet
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Indications

Saphris is an antipsychotic medication used to treat symptoms of schizophrenia and bipolar I disorder in adults and children who are over the age of 10.

Asenapine is a drug that antagonizes receptors in your brain to balance and improve your levels of chemicals like dopamine, serotonin, norepinephrine, and epinephrine. By altering the availability of these chemicals in your brain, Saphris helps reduce and relieve symptoms associated with schizophrenia and bipolar I disorder.

Dosage and Administration

The dose of Saphris that is prescribed will vary depending on the individual and mental disorder being treated. Follow all directions given by your healthcare provider and read packaging instructions carefully to ensure the best results during therapy. Do not take larger or smaller quantities of this medication more or less frequently than prescribed.

  • Place sublingual tablet under tongue and let dissolve completely
  • Do not crush, chew, or swallow tablets
  • Wait at least 10 minutes before eating after taking Saphris
  • Store at room temperature away from children and pets

To treat schizophrenia:

  • Most adults take 5mg twice daily
  • Doses may increase up to 10mg twice daily after one week of treatment
  • Do not take more than 20g a day

To treat acute manic or mixed bipolar I episodes:

  • Most adults take 5 to 10mg twice daily
  • When administered with lithium or valproate, most adults take 5mg twice a day
  • Children aged 10 to 17 should start by taking 2.5mg twice daily
  • After 3 days, children can increase their dose to 5mg twice a day and then up to 10mg twice daily after another 3 days of treatment

Maintenance treatment for bipolar I disorder:

  • Adults should continue the dose prescribed during stabilization from manic or mixed episodes
  • Most patients take 5 to 10mg twice a day
  • Do not take more than 20mg each day

Side Effects

Saphris may cause some side effects to develop when affecting the chemicals in your brain. Speak with your healthcare provider to learn more about any symptoms that you might encounter when taking this antipsychotic medication.

Common Saphris side effects:

  • Dizziness, drowsiness, tiredness
  • Restlessness, agitation
  • Numbness or tingling in or around your mouth
  • Muscle stiffness or jerky muscle movements
  • Nausea, altered sense of taste
  • Increased appetite, weight gain

Serious Side Effects

Some more serious adverse effects may occur when taking Saphris. Stop using this medication and contact your healthcare provider right away if you develop any of the following symptoms:

  • Uncontrolled facial muscle movements
  • Ulcers, blisters, swelling, or peeling in your mouth
  • Light-headedness, feeling faint
  • Breast pain or swelling, nipple discharge
  • Low white blood cell count (fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing)
  • Severe nervous system reaction (stiff or rigid muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling faint)

Allergic Reactions

Do not take Saphris if you are allergic to asenapine. If you notice signs of an allergic reaction, stop using this medication and call your healthcare provider.

Saphris allergy symptoms may include:

  • Hives
  • Fast heartbeats
  • Feeling light-headed
  • Wheezing, difficulty breathing
  • Swelling of face, lips, tongue, or throat

Cautions

Elderly patients with dementia-related psychosis who take antipsychotic medications including Saphris may be at a greater risk of death from cerebrovascular reactions. Do not use this medication if you have psychosis related to dementia.

Do not use Saphris if you have severe liver disease.

Some users of antipsychotic medications have reported developing neuroleptic malignant syndrome. Stop using Saphris and contact your healthcare provider if you notice any of the following symptoms: extreme fever, rigid muscles, delirium, autonomic instability.

Saphris patients, especially older women, may be at risk of developing tardive dyskinesia, a syndrome where you have uncontrollable and involuntary muscle movements.

Avoid taking Saphris with other drugs that prolong your QT interval, especially if you have risk factors for prolonged QT interval.

Avoid drinking alcohol while taking Saphris because it can increase the medication’s drowsy and dizzy effects.

Be careful when driving or performing any hazardous activities because Saphris may cause you to become dizzy or tired which can impair your thinking and reactions.

Avoid becoming overheated or dehydrated during treatment with Saphris.

To ensure your safety when taking Saphris, tell your healthcare provider if you have ever had any of the following:

  • Heart problems
  • High blood pressure
  • Heart attack, stroke
  • Diabetes
  • Seizure
  • Liver disease
  • Breast cancer
  • Trouble swallowing
  • Parkinson’s disease
  • Low white blood cell counts
  • Long QT syndrome

Tell your healthcare provider right away if you become pregnant while taking Saphris. If used in the last 3 months of pregnancy, antipsychotic medicines including Saphris can cause breathing and feeding problems as well as symptoms of withdrawal in your newborn. Do not stop taking this medication without consulting your healthcare provider.

Ask your doctor about the safety of breastfeeding while taking Saphris.

Some drugs may interact with Saphris and cause adverse reactions. Tell your healthcare provider about all the medications you take, including over the counter medicines, but especially any of the following:

  • Fluvoxamine
  • Dextromethorphan
  • Paroxetine
  • Opioid medications
  • Sleeping pills
  • Muscle relaxants
  • Anxiety or seizure medications

Saphris is not an approved bipolar treatment for anyone under the age of 10 and is not approved for the treatment of schizophrenia in anyone younger than 18.

Form and Strength

This antipsychotic medication is available in the form of sublingual tablets.

Saphris sublingual tablet strengths:

  • 5mg
  • 10mg

The 5 and 10mg Saphris tablets are both available in quantities of 60 while the 10mg tablets are also available in quantities of 100.

FAQ

How does Saphris make you feel?

Saphris is designed to reduce and relieve symptoms of schizophrenia and treat manic or mixed episodes of bipolar I disorder. Side effects that are most reported include dizziness, drowsiness, tiredness, restlessness, agitation, nausea, and numbness or tingling around your mouth.

What precautions should be taken when taking Saphris?

Saphris may cause you to become dizzy or drowsy, so you should be cautious when driving or performing hazardous tasks, especially until you know how this medication will affect you. You should also avoid drinking alcohol during treatment because it can increase adverse effects including drowsiness.

Resources:

  1. https://www.drugs.com/saphris.html
  2. https://pdf.hres.ca/dpd_pm/00060860.PDF
  3. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5429f134-839f-4ffc-9944-55f51238def8&type=display

Additional information

Scientific Name:

Asenapine

Formulation:

Sublingual Tablet, Sublingual Tablets

Strength(s):

5mg, 10mg

Quantities Available:

60, 90, 100, 120, 180