Saphris

Generic name: Asenapine (sublingual)
Drug class: Atypical antipsychotics

Usage of Saphris

Saphris is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Saphris sublingual tablets are used to treat schizophrenia in adults, and bipolar I disorder in adults and children who are at least 10 years old.

Saphris may used alone. In adults it may be used in conjuction with lithium or valproate.

Saphris side effects

Get emergency medical help if you have signs of an allergic reaction to Saphris: hives; fast heartbeats, feeling light-headed; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of Saphris can cause a serious movement disorder that may not be reversible. The longer you use Saphris, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Call your doctor at once if you have:

uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

ulcers, blisters, swelling, o peeling in your mouth;

a light-headed feeling, like you might pass out;

breast pain or swelling, nipple discharge;

low white blood cell counts - fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; or

severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common Saphris side effects may include:

dizziness, drowsiness, tiredness;

feeling restless or agitated;

numbness or tingling in or around your mouth;

muscle stiffness, jerky muscle movements;

nausea, altered sense of taste; or

increased appetite, weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Saphris

You should not use Saphris if you are allergic to asenapine, or if you have:

severe liver disease.

Asenapine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Saphris is safe for you, tell your doctor if you have:

heart problems;

high blood pressure;

a heart attack or stroke;

diabetes (asenapine may raise your blood sugar);

a seizure;

liver disease;

breast cancer;

trouble swallowing;

Parkinson's disease;

low white blood cell (WBC) counts; or

long QT syndrome (in you or a family member).

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking Saphris without your doctor's advice.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Saphris should not be given to a child younger than 10 years old. Saphris is not approved for schizophrenia in anyone younger than 18 years old.

Relate drugs

How to use Saphris

Usual Adult Dose for Schizophrenia:

Initial dose: 5 mg sublingually 2 times a day Maintenance dose: 5 mg sublingually 2 times a day, if tolerated may increase to 10 mg sublingually 2 times a day after 1 week if necessary Maximum dose: 20 mg/day Comments: -Controlled trials revealed no added benefit with the higher dose, but a clear increase in certain adverse reactions. -The safety of doses above 20 mg/day has not been evaluated in clinical studies. Use: Treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder:

Monotherapy: -Initial dose: 10 mg sublingually 2 times a day -Maintenance dose: 5 to 10 mg sublingually 2 times a day -Maximum dose: 20 mg/day Adjunctive Therapy: -Initial dose: 5 mg sublingually 2 times a day -Maintenance dose: 5 to 10 mg sublingually 2 times a day -Maximum dose: 20 mg/day Comments: -The safety of doses above 20 mg/day has not been evaluated in clinical studies. -In controlled trials, the starting dose in monotherapy was 10 mg twice daily. On the second and subsequent days, the dose could be lowered to 5 mg twice daily, though approximately 90% of patients remained on the initial dose. -The dose should be titrated based on clinical response and tolerability. -There is no available evidence to answer the question of how long the patient should remain on therapy; however, it is generally recommended that responding patients be continued beyond the acute response. Uses: -Acute monotherapy of manic or mixed episodes of bipolar I disorder -Adjunctive treatment to lithium or valproate in bipolar I disorder -Maintenance monotherapy treatment of bipolar I disorder

Usual Pediatric Dose for Bipolar Disorder:

10 years and older -Initial dose: 2.5 mg sublingually 2 times a day -Titration regimen: After 3 days, may increase to 5 mg sublingually 2 times a day, and after an additional 3 days to 10 mg sublingually 2 times a day, as needed and as tolerated -Maintenance dose: 2.5 to 10 mg sublingually 2 times a day -Maximum dose: 20 mg/day Comments: -Pediatric patients appear to be more sensitive to dystonia with initial dosing and therefore gradual dose escalation is recommended. -The safety of doses above 20 mg/day has not been studied. Use: Acute monotherapy of manic or mixed episodes of bipolar I disorder

Warnings

You should not use Saphris if you are allergic to asenapine, or if you have severe liver disease.

Saphris is not approved for use in older adults with dementia-related psychosis.

Saphris can cause serious neurologic problems. Stop taking this medicine and call your doctor at once if you have: very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling light-headed, tremors, twitching, or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

What other drugs will affect Saphris

Taking Saphris with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with asenapine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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