Asenapine (Sublingual)

Asenapine is a drug that is used to treat the symptoms of some mental disorders, such as bipolar, schizophrenia, and mania.

Overview

Asenapine is a drug that is used to treat the symptoms of some psychotic disorders, such as bipolar, schizophrenia, and mania. The medication helps patients to think more clearly, to feel less anxious, and to be more able to participate in daily life. It can also help to reduce hallucinations and prevent severe mood swings.

Asenapine belongs to a class of drugs called atypical antipsychotics. The medication works very effectively by restoring the balance of certain naturally occurring neurotransmitters in the brain.

Asenapine is known under the brand name, Saphris in the US and comes in tablet form. Saphris is only available under prescription from your doctor.

Conditions treated

  • psychosis
  • bipolar disorder
  • schizophrenia
  • mania

Type of medicine

  • atypical antipsychotic
  • tablet

Side-effects

Although this medication will be beneficial to your well-being, it is possible that you may experience a few side-effects when you first begin taking it. Tell your doctor immediately if you have ever suffered from allergic reactions to any other prescription medication or if you have any known allergies to certain foods, preservatives, animal derivatives, or dyes.

The more commonly experienced side-effects of Asenapine include a decreased or abnormal touch sensation, being unable to move your eyes or excessive blinking or spasms of the eyelids. You may find that you are restless and you need to keep moving, you may feel unable to sit still or notice an increase in your body movements. Some patients experience lip puckering or lip smacking, uncontrolled chewing movements, puffing out their cheeks, rapidly moving their tongue or sticking it out.

Other people have reported shakiness or trembling of their legs, feet, arms, or hands, together with uncontrollable twitching or weakness of the arms and legs. Some patients find difficulty with swallowing, speaking, or breathing.

There are also a variety of side-effects in patients taking this medication that are seen less commonly, including:

  • visual disturbance, including blurred vision
  • headaches
  • dizziness
  • pounding in the ears
  • slow or rapid heartbeat

If you experience any of these side-effects, you should mention them to your doctor right away.

Some of the following side-effects that can be caused by Asenapine may resolve themselves without the need for further medical attention, as your body adjusts to the medication. You should ask your doctor's advice on how to manage or prevent these effects if they are persistent or particularly troublesome.

  • constipation
  • sleepiness, trouble sleeping, unusually deep or long duration of sleep
  • acid stomach, belching, heartburn
  • depression
  • difficulty with mobility
  • a dry mouth
  • unexplained fear, nervousness, or irritability
  • increased appetite
  • watering of the mouth
  • weight gain
  • indigestion
  • muscle pain and/or stiffness
  • discomfort in the joints, arms, or legs
  • stomach upset or pain
  • toothache

If any of the following dangerous side-effects occur, you should contact your doctor or medical professional as a matter of urgency:

  • extreme, unexplained fatigue
  • irregular, very slow or very rapid heart rate
  • unusually easy bleeding or bruising
  • fever
  • yellowing of the eyes or skin (jaundice)
  • itching or a rash on the face, throat or tongue
  • extreme dizziness or fainting
  • breathing difficulties
  • problems swallowing
  • black, tarry stools
  • blood present in the urine or stools
  • hives
  • red pinpoint spots on the skin

Any or all of these symptoms could indicate a serious allergic reaction (anaphylaxis) to the medication and you should seek medical advice immediately.

This list of recognised side-effects that have been experienced by patients taking Asenapine is not necessarily all-inclusive. If you do not feel that your health is improving or you think that you are feeling worse since starting your course of treatment with this medication, you should ask your doctor or psychiatrist for advice.

Dosage

Asenapine is only available on prescription from your doctor. The medication comes in tablet form.

The dose of Asenapine prescribed will vary between patients, depending on the condition being treated. Always follow your doctor's orders or the directions on the dispensed product label. The dosage outlined below reflects the average recommended dose for this medication. Do not change the dose that you have been prescribed, unless you are advised to do so by your treating physician.

Take your medication exactly as prescribed by your doctor. Do not take more than you have been prescribed, take it more frequently, or for a longer period than directed. To do so could increase the risk of you suffering side-effects. This drug will come with patient guidelines. Be sure to read the guidelines thoroughly and ask your treating physician if you have any queries.

Do not share this medication with anyone else.

Always make sure that your hands are clean and dry before handling the tablet. Only open the packaging when you are ready to take the tablet. When removing the tablet from the blister pack, peel back the protective foil, rather than pushing the tablet through the foil.

Place the tablet underneath your tongue and allow it to dissolve slowly. Do not swallow, crush, chew, or split the tablet.

Do not drink or eat anything for at least 10 minutes after taking this medication.

For the treatment of bipolar disorder in patients who are taking only Asenapine:

  • adults: initially, take 10mg twice daily; your doctor may then adjust your dosage as required
  • children aged 10 to 17 years: 2.5mg to 10 mg twice daily; your doctor may adjust your dose as required and depending on how well the patient tolerates the medication
  • children younger than 10 years of age: dose and use to be determined by your treating physician

For the treatment of bipolar disorder in patients who are taking Asenapine with valproate or lithium:

  • adults: initially, take 5mg twice daily; your doctor may then adjust your dosage as required up to 10mg twice daily
  • children: dose and use to be determined by your treating physician

For the treatment of schizophrenia:

  • adults: initially, take 5mg twice daily; your doctor may then adjust your dosage as required
  • children: dose and use to be determined by your treating physician

If you omit a dose of your medication, you should try to take it as soon as possible. If the time of your next dose is approaching, omit the missed dose and revert to your usual dosing schedule. Do not take a double dose.

If you or someone else overdoses on this medication and exhibits serious symptoms, including loss of consciousness or breathing difficulties, call 911 immediately. Other symptoms of overdose include severe drowsiness or deep sleep, confusion, agitation, and fainting. In this case, call your doctor or your local poison control centre.

Major drug interactions

Some forms of medication must never be used concurrently. However, in other cases various drugs can be used in tandem, even if an interaction is known to occur. Under these circumstances, your doctor may decide to change the dose of one or more of your prescribed drug therapy or they may advise you to take other precautions.

If you are prescribed Asenapine, it is extremely important that you tell your doctor if you are already taking any of the medication listed below. These drugs are known to have interactions with Asenapine and their use is NOT recommended.

  • Amisulpride
  • Amifampridine
  • Dronedarone
  • Bepridil
  • Bromopride
  • Cisapride
  • Pimozide
  • Terfenadine
  • Mesoridazine
  • Metoclopramide
  • Piperaquine
  • Saquinavir
  • Ziprasidone
  • Sparfloxacin
  • Thioridazine

The following medications can interact with Asenapine, but their use may be necessary in some patients. If both medications are prescribed for use together, your doctor may alter the dose or the frequency of use of both drugs together.

  • Paroxetine
  • Zuclopenthixol
  • Zotepine
  • Voriconazole
  • Vinflunine
  • Vemurafenib
  • Vardenafil
  • Vandetanib
  • Urapidil
  • Triptorelin
  • Trimipramine
  • Trifluoperazine
  • Trazodone
  • Tramadol
  • Toremifene
  • Tizanidine
  • Tetrabenazine
  • Terazosin
  • Telithromycin
  • Telavancin
  • Tedisamil
  • Tapentadol
  • Tacrolimus
  • Sunitinib
  • Sultopride
  • Sulpiride
  • Sufentanil
  • Sotalol
  • Sorafenib
  • Solifenacin
  • Sodium Phosphate, Monobasic
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate
  • Sevoflurane
  • Sertindole
  • Sematilide
  • Salmeterol
  • Risperidone
  • Remifentanil
  • Ranolazine
  • Quinine
  • Quinidine
  • Quetiapine
  • Protriptyline
  • Propafenone
  • Promethazine
  • Prochlorperazine
  • Procainamide
  • Prazosin
  • Prajmaline
  • Posaconazole
  • Pitolisant
  • Pirmenol
  • Pimavanserin
  • Phentolamine
  • Phenoxybenzamine
  • Periciazine
  • Perflutren Lipid Microsphere
  • Pentazocine
  • Pazopanib
  • Pasireotide
  • Panobinostat
  • Paliperidone
  • Oxymorphone
  • Oxycodone
  • Ondansetron
  • Ofloxacin
  • Octreotide
  • Nortriptyline
  • Norfloxacin
  • Nilotinib
  • Nafarelin
  • Moxisylyte
  • Moxifloxacin
  • Morphine Sulfate Liposome
  • Morphine
  • Mifepristone
  • Metronidazole
  • Methadone
  • Meperidine
  • Mefloquine
  • Lumefantrine
  • Lopinavir
  • Levofloxacin
  • Leuprolide
  • Lapatinib
  • Ketoconazole
  • Ivabradine
  • Imipramine
  • Iloperidone
  • Ibutilide
  • Hydroxyzine
  • Hydroxychloroquine
  • Hydroquinidine
  • Hydromorphone
  • Hydrocodone
  • Histrelin
  • Haloperidol
  • Halofantrine
  • Granisetron
  • Goserelin
  • Gonadorelin
  • Gemifloxacin
  • Gatifloxacin
  • Fluvoxamine
  • Fluoxetine
  • Fluconazole
  • Flibanserin
  • Flecainide
  • Fingolimod
  • Fentanyl
  • Escitalopram
  • Erythromycin
  • Enoxacin
  • Eliglustat
  • Efavirenz
  • Duloxetine
  • Droperidol
  • Doxylamine
  • Doxazosin
  • Donepezil
  • Domperidone
  • Dolasetron
  • Dofetilide
  • Disopyramide
  • Dihydrocodeine
  • Deslorelin
  • Desipramine
  • Delamanid
  • Degarelix
  • Dasatinib
  • Dabrafenib
  • Cyclobenzaprine
  • Crizotinib
  • Codeine
  • Clozapine
  • Clomipramine
  • Clarithromycin
  • Citalopram
  • Ciprofloxacin
  • Chlorpromazine
  • Chloroquine
  • Butorphanol
  • Buserelin
  • Buprenorphine
  • Bunazosin
  • Bromazepam
  • Bretylium
  • Bedaquiline
  • Azithromycin
  • Azimilide
  • Astemizole
  • Artemether
  • Arsenic Trioxide
  • Aripiprazole
  • Apomorphine
  • Anagrelide
  • Amoxapine
  • Amitriptyline
  • Amiodarone
  • Alfuzosin
  • Alfentanil
  • Ajmaline
  • Acecainide
  • Abiraterone

This list is not necessarily all-inclusive. If you already taking a medicine that is not included in the above list, tell your doctor before taking Asenapine.

Warnings

In addition to discussing any allergies and other drugs that you are taking, you should also mention to your doctor any existing health conditions that you have. When deciding to use this medication, you should weigh up the risks and benefits of taking it. Your doctor will discuss the pros and cons of using Asenapine with you in greater detail.

Tell your doctor if you have ever experienced any allergic reactions to any form of prescription or non-prescription medication, herbal remedies, or vitamin supplements. You should also mention any allergies that you have to foods, preservatives, dyes, or animal derivatives.

You should have regular blood tests to monitor your progress and to check for any side-effects while you are taking this medication. Your doctor will advise you further on this.

Taking this medication can pose a slightly increased risk of serious side-effects, including heart attack, stroke, irregular or increased heartbeat, pneumonia when used in older adults with dementia.

Asenapine can cause a rise in blood sugar levels, which could make diabetes worse. Weight gain caused by this drug could further exacerbate diabetes. If you experience excess thirst/urination, tell your doctor, as these are symptoms of elevated blood sugar.

Some patients may experience an increase in prolactin, a substance made by the body. In women, this can cause missed or stopped periods, problems in conception, or the production of unwanted breast milk. In men, decreased sexual ability may occur, together with an inability to produce sperm, and enlarged breasts.

Some men taking Asenapine may experience a prolonged or painful erection, which could last for over four hours. In this case, you should stop taking this drug immediately and seek medication attention.

Some patients taking this drug experience serious side-effects including, infection, severe dizziness or fainting, seizures, a slower than usual heartbeat, or interrupted breathing during sleep. If you experience any of these effects, contact your doctor immediately.

Asenapine can occasionally cause a very serious condition called neuroleptic malignant syndrome (NMS). If you experience any of the following effects, seek immediate medical attention:

  • fever
  • muscular stiffness, weakness, tenderness, or pain
  • extreme fatigue
  • confusion
  • sweating
  • irregular or very fast heartbeat
  • kidney problems (dark urine, change in the amount of urine produced)

The following medical conditions can affect the use of this medicine. You should tell your doctor if you currently suffer from any of them or if you have a history of them:

  • circulatory disorders
  • dehydration
  • heart disease, heart attack, heart failure, arrhythmia, QT prolongation, bradycardia
  • hypotension
  • hypovolemia
  • history of stroke
  • low potassium levels in the blood (hypokalemia)
  • low magnesium levels in the blood (hypomagnesemia)
  • diabetes
  • hyperglycemia
  • hyperprolactinemia
  • history of NMS
  • history of seizures
  • problems with swallowing

Asenapine should not be used in patients with a history of severe liver disease.

There is currently no evidence to suggest that taking Asenapine can harm unborn babies or that it can be passed into breast milk. However, you should tell your doctor if you are pregnant, if you are intending to get pregnant during the course of your treatment, or if you are breastfeeding.

If you experience sores or blisters in your mouth, or tingling or numbness in your throat after taking this medication, tell your doctor immediately.

Asenapine can cause tardive dyskinesia (a movement disorder). If you experience any of the following signs, tell your doctor immediately:

  • lip smacking or puckering
  • puffing out the cheeks
  • rapid tongue movements
  • uncontrollable chewing movements
  • uncontrollable movement of the legs and arms

This medication can cause anaphylaxis, a serious and life-threatening condition that always requires immediate, emergency medical attention. If you develop a rash, have breathing difficulties, feel dizzy, have swelling of your face, tongue, throat, face, or hands, within a few minutes of taking this drug, call 911 straight away.

Some people feel dizzy or faint when getting up quickly from a lying or sitting position. Try rising more slowly, but if the problem persists, consult your doctor for advice.

Asenapine can cause a temporary lowering of the number of white cells in your blood. This can increase your chances of contracting an infection. Try to avoid environments where you will be mixing with people who might have infections. If you feel feverish, develop a chill, hoarseness, a cough, pain in your lower pack or side, or if you begin to find urination difficult or painful, you should consult your doctor.

If you notice that your heart is beating faster than usual or if the rhythm feels irregular or ‘fibrillating', contact your doctor right away. This could indicate a condition called QT prolongation.

In some patients, this medication can cause excessive drowsiness, cognitive problems, loss of control of body movements, and dizziness. This can affect your ability to drive, operate machinery, and to think clearly. Always be sure that you know how your body will react to this medication before undertaking any of these activities.

Asenapine can cause some people to stop sweating or to experience a reduction in the amount of sweat they produce. This can cause your body to become too hot, causing you to feel dizzy, tired, weak, or confused. You may also feel nauseous, and you could vomit. Avoid becoming too hot while exercising, and try to keep away environments that are very hot. If you find that you are becoming too hot and cannot cool off, ask your doctor's advice on how to manage the problem.

This drug can cause some people to become irritable and agitated. Others report having suicidal thoughts and tendencies. If you or a caregiver notices any of these signs, make sure that you notify your treating physician immediately.

Asenapine can exacerbate the effects of other central nervous system depressant (CNS) drugs and alcohol, making you feel drowsy and less alert. The following CNS medications should not be used with Asenapine, unless you are directed to do so by your doctor:

  • antihistamines
  • sedatives
  • tranquilizers
  • sleeping medication
  • prescription narcotics (some pain medications)
  • barbiturates
  • muscle relaxants
  • anesthetics
  • dental anesthetics

While taking Asenapine, you should not take any other prescription medication, over-the-counter medication, herbal remedies, or vitamin supplements, unless you have first discussed and cleared their use with your doctor.

Storage

Always keep this medication in a sealed, airtight container and at room temperature. Do not freeze the medication. D not expose it the medication to direct sunlight or to sources of extreme heat.

Keep the medication away from children and pets. In the event that a pet consumes Asenapine, always seek veterinary advice immediately.

Do not keep any leftover Asenapine. Do not use any drugs that have become out-of-date.

Do not flush unwanted medication down the toilet or the drain. Do not throw any unused Asenapine out with your trash, as this could present a danger to small children and pets. Always ask your doctor or pharmacist for advice on the safe disposal of unwanted or unused medication.

Summary

Asenapine is an antipsychotic drug that is widely used in the treatment the symptoms of some psychotic disorders, such as bipolar, schizophrenia, and mania. The medication can help patients to think more clearly, to feel less anxious, and allows them to participate normally in daily life. It can also help to reduce hallucinations and prevent severe mood swings in some people.

Asenapine can cause many side-effects, including anaphylaxis in some susceptible patients. There are also a large number of historical and existing medical conditions that can be exacerbated by the use of this drug. For this reason, you should always tell your treating physician if you have a history of diabetes, liver or kidney disease, seizures, or heart conditions, including arrhythmia. The drug can cause extreme drowsiness and problems in thinking clearly, which could be problematic for some patients in jobs that involve driving or operating machinery.

Asenapine has been shown to be very effective in controlling many of the unpleasant symptoms of a number of mental disorders. It can be used alone or in conjunction with other antipsychotics under the direction of an appropriate treating physician. In order to get the best results from your treatment with Asenapine, it is important that you have full and frank discussions with your doctor to determine the appropriate dose and frequency of use for this medication. During your course of treatment, you will be required to attend your doctor for regular check-ups, which will include blood and urine tests to make sure that the drug is working effectively and that there are no unwanted side-effects.

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Last Reviewed:
December 25, 2017
Last Updated:
April 04, 2018
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