Saphris (Asenapine) General Drug Information

What Sprycel Is and What It’s Used For

Saphris is a psychiatric medication prescribed to help manage mental disorders such as schizophrenia and bipolar disorder. The active ingredient in Saphris is asenapine.It belongs to a class of drugs called atypical antipsychotics – medications which balance the production of neurotransmitters in the brain.

Patients who regularly take Saphris as prescribed often think more clearly and feel calmer, improving the way they function in everyday life. Saphris can also help reduce sound or visual hallucinations, as well as prevent severe mood swings.

The following overview contains basic safety information to inform patients about Saphris. It is not an exhaustive list and should not serve as a replacement for a consultation with a qualified physician.

Usage and Application

Patients must take Saphris exactly as prescribed by their acting physician. A doctor will determine the most appropriate treatment course based on the patient’s medical condition and gradual response to the treatment.

Most people are required to take this medication twice a day. The sublingual tablets should not be swallowed but instead placed under the tongue until they dissolve in saliva. Patients should not eat or drink anything for ten minutes after taking a dose of this medication.

To experience the greatest benefit, patients must take Saphris regularly, preferably at the same time each day. The full benefit of taking this medication may become apparent after several weeks. It is important that patients continue to take the exact prescribed dose regularly, even if they no longer experience any negative symptoms. It is only possible to quit Saphris after consulting with a patient’s treating physician. The patient or legal guardian must contact their physician immediately in the event their condition worsens.

Considerations Before Taking Saphris

Patients need to discuss a number of issues with their doctor before taking Saphris. This includes the possibility of allergic reactions, as well as any pre-existing conditions such as liver and heart problems, stroke, diabetes, obesity, low blood pressure or a history of seizures. Other medical problems to consider are low blood count, sleep apnea, breast cancer, dementia or Alzheimer’s disease, as well as any history involving substance abuse.

Some patients taking Saphris are at risk of developing QT prolongation, a condition in which normal heart rhythm is disrupted by fast heartbeats. This can lead to dizziness, fainting and even sudden death.

The risk of developing QT prolongation is increased for people with certain pre-existing medical conditions. Patients with heart failure, slow heartbeat or those showing QT prolongation in electrocardiograms need to speak with their doctor before starting a treatment course with Saphris.

Low levels of magnesium or potassium in the body may also increase the risk of developing QT prolongation. People who take diuretic drugs may experience severe sweating and a variety of other problems leading to severe loss of fluids (such as diarrhea and vomiting).

Dizziness and drowsiness are some of the most common side effects of Saphris, so patients should not drive or use machinery. Alcoholic drinks should be avoided. Side effects such as drowsiness and dizziness may increase the risk of falling. Older adults are particularly vulnerable to these risks.

Patients taking Saphris may sweat less than normal. This increases the likelihood of heat stroke. Patients should avoid activities that may cause them to overheat, such as sitting in hot tubs or exercising in hot weather.

Patients need to take caution on hot days by drinking plenty of fluids and remaining in the shade whenever possible. In case of overheating, patients need to react immediately and seek medical attention if symptoms such as headache, dizziness or mood swings persist.

Women planning on becoming pregnant need to discuss how to continue their treatment with their doctor. It is not possible to stop taking Saphris without the evaluation of a treating physician.

Babies born to mothers who have used the medication in the last trimester of pregnancy may develop muscle shakiness or stiffness, drowsiness and feeding difficulties, and may cry constantly. Mothers need to alert their physician immediately if they notice such symptoms in their babies.

Delayed and Omitted Doses

Patients who miss a dose should take it as soon as they remember. If this happens near the time for the next dose, patients should skip the missed dose and proceed as usual. In such cases, there is no need to double up the dose in order to catch up.

Other Medications and Saphris

Some drugs or supplements may interact with Saphris, leading to potentially serious side effects. Before starting this medication, patients need to have a thorough discussion with their physician or a pharmacist.

Alpha blockers such as prazosin, (e.g. Minipress) as well as anticholinergic and antispasmodic drugs like atropine, dicyclomine and scopolamine may negatively interact with Saphris. Drugs like Luvox may affect how Saphris is removed from the body, changing its intended effect. Saphris can slow down the removal of other drugs – like Paxil– from the body.

When taken together with Saphris, drugs such as amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol and macrolide antibiotics (e.g. erythromycin) may affect heart rhythm, creating the conditions for QT prolongation to develop.

Patients taking other medications such as cough or opioid pain relievers, anxiety medications, sleeping pills, muscle relaxants, antihistamines or any other medicines which may cause drowsiness need to tell their doctor or pharmacist.

Adverse Reactions

Many people using Saphris do not experience serious side effects.

The most common side effects of taking Saphris are drowsiness, dizziness and lightheadedness. These can increase the risk of falling, so patients should get up slowly when sitting or lying down.

Some patients may experience unexpected weight gain. Other possible side effects are numbness or tingling of the mouth, but these typically go away within an hour of taking this drug.

In some rare cases, mouth sores, blisters or pain under the tongue may occur. Patients need to consult their physician or pharmacist if any of these symptoms persist or worsen.

Saphris can cause muscle or nervous system problems in some people. In such cases, the treating physician may need to prescribe additional medications to alleviate these side effects.

Patients need to monitor for feelings of anxiety or agitation, trouble swallowing or drooling, restlessness, shaking, shuffling walk or stiff muscles. Severe muscle spasms and cramping – especially in the neck, back or eye area – may also occur.

A small number of people on this medication develop face muscle twitching and uncontrollable movements such as lip smacking, mouth puckering, tongue thrusting, or unusual arm and leg movements. Patients should immediately alert their treating physician if they experience any of the above.

Serious Side Effects

In some rare cases, Saphris may elevate blood sugar levels, which is a concern for diabetes patients. Taking this medication may also increase prolactin in the body. In women, this may lead to the production of breast milk, missed periods or difficulty in conceiving.

In men, rarer symptoms are decreased sexual ability, inability to produce sperm and enlarged breasts. Patients who develop these symptoms should alert their doctor immediately.

When used in tandem with similar drugs, Saphris may lead some men to develop painful and prolonged erections lasting four or more hours. Immediate medical attention is necessary to avoid permanent problems from occurring.

Other serious side effects include infections, severe dizziness, fainting, slow heartbeat, seizures, and interrupted breathing during sleep. Patients should be aware of the risk of developing neuroleptic malignant syndrome. This is a serious medical condition with symptoms including fever, muscle stiffness, pain, severe tiredness, confusion, and sweating. If the condition worsens, patients may experience irregular heartbeats, kidney problems, secreting dark urine or a change in amount of urine.

Allergic Reactions

Serious allergic reactions to Saphris are rare, yet patients should be aware of the symptoms: rash, itching, swelling, severe dizziness, and trouble breathing.

How to Store Saphris

Saphris should be stored at room temperature away from light and moisture. Do not store in the bathroom and keep away from children and pets.

Unwanted medication should be disposed of properly. It should not be poured into drains or flushed down the toilet. Patients should consult a pharmacist or their local waste disposal company to find out more about safe disposal methods.