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Generic name: asenapine (sublingual) [a-SEN-a-peen]
Drug class: atypical antipsychotics

What is Saphris?

Saphris can be described as an antipsychotic drug. It affects the action of chemical substances within the brain.Saphris sublingual tablets are prescribed for treating schizophrenia in adults and bipolar type I disorder in children and adults who are 10 years old.

Saphris can be used as a stand-alone In adults, it could be used in conjunction with lithium or valproate.


It is not recommended to take Saphris if you have an allergy to asenapine or suffer from a severe liver disease.Saphris is not recommended for use in older adults suffering from dementia-related psychosis.

Saphris can trigger serious neurologic issues. Take a break from this medication and consult your physician immediately if you notice extremely rigid (rigid) muscles, excessive sweating, high fever in a haze, confusion, rapid or irregular heartbeats, or experiencing lightheadedness, tremors, or twitching eye movements on your lips, tongue, arms, face, or legs.

Prior to use this drug

It is not recommended to use Saphris in the event that you are allergic to asenapine or you are:

  • A severe liver illness that causes severe liver

Asenapine can increase the likelihood of death for elderly patients suffering from dementia-related psychosis. It isn't recommended for use in this situation.

To be sure Saphris isn't harmful for you, consult your physician about whether you suffer from:

  • Heart issues;
  • Hypertension;
  • A heart attack or stroke
  • Diabetes (asenapine may raise your blood sugar);
  • A seizure;
  • Liver disease;
  • Breast cancer;
  • Difficulty swallowing
  • Parkinson's disease;
  • Low white blood cell (WBC) count
  • The long QT disorder (in the case of you or someone in your family).

Antipsychotic medication taken within the last 3 months of pregnancy could result in breathing issues or feeding problems. It could also cause withdrawal symptoms in the infant. You should not cease taking Saphris without consulting your physician.

It is not recommended to breastfeed while taking this medication. Consult your doctor regarding possible risks.Saphris should not be administered to children younger than 10 years of age. Saphris is not a prescription drug for the treatment of schizophrenia in children who are younger than 18.

How to take Saphris?

The usual dosage is twice daily. Follow the instructions on your prescription label, and review all medication guides and instructions sheets.

Take note of and follow the instructions for use that come with your medication. Consult your physician or pharmacist for clarification if you are unsure of the instructions.Place the tablet in the blister pack until you're in a position to take the medicine. Use your hands that are dry to gently lift the tablet from its packaging and place it on your tongue.Don't swallow the tablet sublingually. Let it dissolve under your tongue without chewing.Avoid eating or drinking anything for a minimum of 10 minutes after the tablet has disintegrated.

Saphris can result in excessive levels of blood sugar (hyperglycemia). The symptoms include an increase in thirst, more frequent urination, thirst, dry mouth, a fruity breath odor, and drowsiness. The appearance of dry, flaky skin as well as blurred or hazy vision. If you suffer from diabetes, you should check your blood sugar levels regularly during your treatment with Saphris.

Your doctor will be required to monitor your progress when you are taking Saphris.Place it in a cool, dry place far from heat and moisture.

Dosing information

Usual Adult Dose for Schizophrenia:

Initial dosage: 5 mg sublingually, 2 times per day.
Maintenance dosage 5 mg sublingually two times per day, if tolerated; may increase by 10 mg, 2 times per day for 1 week, if required.
Maximum dose: 20 mg/day
The controlled trials showed no added benefit from the increased dosage, but there was a noticeable rise in the severity of certain adverse reactions.
The safety of doses that exceed 20 mg/day hasn't been studied in clinical studies.
Treatment for schizophrenia through use

Usual Adult Dose for Bipolar Disorder:

Initial dosage: 10 mg sublingually, twice a day.
Maintenance dose: 5–10 mg sublingually, twice every day.
Maximum dose: 20 mg/day
Adjunctive Therapy:
Initial dosage 5 mg sublingually, 2 times per day
Dose for maintenance 5 to 10 mg sublingually twice each day
Maximum dose: 20 mg/da
The safety of doses that exceed 20 mg/day hasn't been studied in clinical studies.
In controlled trials, the initial dose for the monotherapy regimen was 10 mg once every day. In the following days, it was possible to reduce the dosage to 5 mg twice daily; however, about 90 percent of the patients continued at the dose they were on initially.
The dose should be adjusted in accordance with the response of patients and their tolerance.
There is no evidence to support how long a patient needs to remain on therapy. However, it is generally advised that patients with a response remain on therapy beyond their initial response.
Acute monotherapy for manic and mixed bipolar disorders
Adjunctive treatment for lithium or valproate for bipolar I disorder
Maintenance monotherapy treatment for bipolar I disorder

Usual Pediatric Dose for Bipolar Disorder:

10 years or older
Initial dosage: 2.5 mg sublingually, 2 times per day.
The titration schedule after 3 days could rise to 5 mg underlingually, two times per day. Then, after a further 3 days, up to 10 mg sublingually two times a day, if necessary and in the manner that is tolerated,
Dose for maintenance: 2.5 to 10 mg sublingually, twice daily.
Maximum dose: 20 mg/day
Children are more susceptible to the symptoms of dystonia after the first dose, so a gradual dose increase is advised.
The safety of doses higher than 20 mg/day hasn't been investigated.
Treatment: A person who is a myotherapist for a short period for manic or mixed bipolar I disorder.

What happens if I miss the dose?

Do not take the medicine for as long as you are able, but avoid any missed doses if it's nearing the time to take the next dose. Don't take two doses at a time.

What happens if I overdose?

Get medical attention in an emergency or contact the poison help line at 1-800-222-1222.

What should be avoided?

Avoid getting dehydrated or too hot when exercising and during hot temperatures. Take plenty of water, particularly in hot weather or during exercises. It is much easier to get hyperhydrated and dangerously dehydrated while you're taking Saphris.

Avoid driving and other hazardous activities until you understand the effects of this medication on your body. The way you react could be affected. Be careful not to get up too quickly from a lying or seated position. You could be dizzy.

Side effects of Saphris

See a doctor immediately in the event that you show symptoms that you are experiencing an allergic reaction, such as hives and rapid heartbeats. You may also be lightheaded, wheezing, having difficulty breathing, or swelling your lips, face, and tongue.

Long-term or high-dose use of saphris could cause a severe movement disorder that cannot be reversed. The longer you are using Saphris your more likely will be to be affected by this disorder, especially if you're either a woman or an adult.

See your doctor right away if you are suffering from:

  • Muscles that are not controlled in your facial muscles (chewing or smacking your lips, frowning, tongue movements, blinking, or eye movements);
  • Ulcers, blisters, swelling, or peeling in your mouth;
  • A feeling of lightheadedness, as if you're passing out;
  • Breast pain or swelling; discharge of the nipple;
  • Low white blood cells (fever, chills, skin sores, mouth sores, sore throat, difficulty breathing, cough,
  • Serious nervous system response Very hard (rigid) muscles and sweating, high fever and confusion, rapid or irregular heartbeats, tremors, and a feeling that you could faint.

Common Saphris side effects can include:

  • Dizziness, drowsiness, tiredness;
  • Being agitated or uneasy;
  • Numbness or tingling in your mouth
  • Muscle stiffness, jerky muscle movements;
  • Nausea and altered taste sense;
  • Increased appetite and weight gain.

This is not a comprehensive list of all side effects. Others could happen. Ask your doctor medical advice regarding adverse reactions. It is possible to report any adverse negative effects to the FDA by calling 1-800-FDA-1088.

Interaction with other drugs

The combination of Saphris with other medications that cause you to sleep or cause breathing problems can result in dangerous adverse effects or even deaths. Ask your doctor prior to taking opioids or a sleeping pill, a muscle relaxer, or medication for an anxiety disorder or seizures.

Other medications may be incompatible with asenapine, such as prescription and over-the-counter medicines, vitamins, and herbal products. Discuss with your physician all the medicines you are currently taking and any medication you begin or stop taking.



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