Saphris

The usual recommended dose for schizophrenia treatment is 5 mg taken twice daily.

The usual starting dose for bipolar disorder treatment is 5 mg twice daily. Depending on how well the medication works for you and how well it is tolerated, your doctor may recommend increasing the dose to 10 mg twice daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Saphris (Asenapine) tablets should be placed under the tongue and allowed to dissolve completely. The saliva in the mouth will dissolve the tablet within seconds. Do not crush, chew, or swallow Saphris (Asenapine) tablets.

Handle the tablet with dry hands and remove the tablet from the package only when you are ready to take it. To remove it from the package, pull the tab on the package back and remove the tablet gently. Do not crush the tablet.

In order for the medication to be properly absorbed into the body, do not eat or drink anything for 10 minutes after dissolving a tablet under the tongue. If you are taking other medications at the same time, take Saphris (Asenapine) last.

It is important that Saphris (Asenapine) be taken exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you miss 2 or more doses, contact your doctor. Store Saphris (Asenapine) between 2°C and 30°C in the original package. Keep Saphris (Asenapine) out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may increase your appetite; it may cause headaches; it may cause constipation - to prevent this, drink plenty of water or juice, and eat more dietary fibre; it may cause drowsiness - use caution when driving; it may cause vomiting; occasionally, it may cause trembling and involuntary movements (also known as dyskinesia). Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

5 mg
Each round, white-to-off-white, fast-dissolving sublingual tablet debossed with "5" on one side contains 5 mg of Saphris (Asenapine). Nonmedicinal ingredients: gelatin, mannitol.

10 mg
Each round, white-to-off-white, fast-dissolving sublingual tablet debossed with "10" on one side contains 10 mg of Saphris (Asenapine). Nonmedicinal ingredients: gelatin, mannitol.

Who should not take Saphris (Asenapine)?

Do not take Saphris (Asenapine) if you are allergic to Saphris (Asenapine) or any ingredients of the medication.

Do not take Saphris (Asenapine) if you are allergic to Saphris (Asenapine) or any ingredients of the medication.

There may be an interaction between Saphris (Asenapine) and any of the following:

• alcohol
• alpha agonists (e.g., Clonidine, methyldopa)
• alpha blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, Enalapril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., Candesartan, Irbesartan, Losartan)
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• Anti-Parkinsons medications (e.g., amantadine, Apomorphine, Bromocriptine, levodopa, Pramipexole, Ropinirole, Rotigotine)
• azelastine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., butalbital, pentobarbital Phenobarbital)
• benzodiazepines (e.g., Alprazolam, Diazepam, Lorazepam)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• beta-2 agonists (e.g., formoterol, salmeterol)
• brimonidine
• bromocriptine
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Cabergoline
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• cannabis
• chloral hydrate
• diabetes medications (e.g., Canagliflozin, Glyburide, Liraglutide, Lixisenatide, insulin, Metformin, Rosiglitazone)
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Donepezil
• Dronedarone
• efavirenz
• ergot alkaloids (e.g., ergotamine, Dihydroergotamine)
• Esketamine
• Flecainide
• Galantamine
• Hydralazine
• lithium
• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
• Methadone
• Methylphenidate
• Metoclopramide
• Mirtazapine
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Rasagiline, Selegiline, Tranylcypromine)
• muscle relaxants (e.g., Baclofen, Cyclobenzaprine, methocarbamol, orphenadrine)
• Nabilone
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• Octreotide
• other antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• procainamide
• protein kinase inhibitors (e.g., Crizotinib, Dasatinib, imatinib, Nilotinib, Sunitinib)
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, levofloxacin)
• Rivastigmine
• scopolamine
• seizure medications (e.g., Carbamazepine, Clobazam, Levetiracetam, phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• selective serotonin re-uptake inhibitors (SSRIs; e.g., Citalopram, Fluvoxamine, Paroxetine)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• Stiripentol
• Tapentadol
• Tetrabenazine
• thalidomide
• Tramadol
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Doxepin, Nortriptyline)
• Tryptophan
• Vardenafil
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Saphris (Asenapine). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Saphris (Asenapine).

Alcohol and other medications that cause drowsiness: Do not combine Saphris (Asenapine) with alcohol or other medications (e.g., antidepressants, sleeping pills, anxiety medications) that cause drowsiness since additive drowsiness can occur and be dangerous.

Allergy: Some people taking Saphris (Asenapine) have experienced severe allergic reactions. Get medical attention as soon as possible if you experience symptoms of a Anaphylaxis (severe allergic reaction) or anaphylactic reaction, such as:

• difficulty breathing
• itching
• swelling of the face, tongue, or throat
• feeling lightheaded or dizzy

Blood Clots: Saphris (Asenapine) may increase the chance of blood clot formation, causing reduced blood flow to the organs or extremities. If you have a history of clotting or if you have risk factors for developing blood clots (e.g., family history, age over 65, Obesity, recent major surgery, smoking, taking birth control pills), you may be at increased risk of experiencing blood-clot-related problems such as Heart Attack, Stroke, or clots in the deep veins of your leg. Discuss with your doctor how Saphris (Asenapine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Saphris (Asenapine), and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Body temperature: Saphris (Asenapine), like other antipsychotic medications, may disrupt the body's ability to control body temperature. If you exercise vigorously, are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., Benztropine, Oxybutynin), you are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool down while taking Saphris (Asenapine).

Drowsiness/reduced alertness: Saphris (Asenapine) may impair the mental and physical abilities required for driving a car or operating machinery. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how Saphris (Asenapine) affects you. Avoid drinking alcohol while taking Saphris (Asenapine), as it may produce extreme drowsiness.

Heart rhythm: Saphris (Asenapine) can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., if you have heart failure, Angina, or low potassium or magnesium levels, or if you take other medications that can affect heart rhythm), discuss with your doctor how Saphris (Asenapine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Saphris (Asenapine), and whether any special monitoring is needed.

High blood sugar: Saphris (Asenapine) may cause an increase in blood sugar levels. Your doctor may monitor your blood sugar levels while you are taking Saphris (Asenapine). If you have Diabetes or are at an increased risk of developing diabetes, discuss with your doctor how Saphris (Asenapine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Saphris (Asenapine), and whether any special monitoring is needed.

If you experience weakness, increased thirst, increased urination, and increased appetite while taking Saphris (Asenapine), contact your doctor as soon as possible, as these are signs that your blood glucose level may be high.

Infection: Saphris (Asenapine) can reduce the number of cells that fight infection in the body (white blood cells). Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe Diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Liver disease: Liver disease or reduced liver function may cause Saphris (Asenapine) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Saphris (Asenapine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Saphris (Asenapine), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Saphris (Asenapine). Saphris (Asenapine) should not be used by people with severely reduced liver function.

Low blood pressure: Saphris (Asenapine) may cause low blood pressure, especially when moving from a lying or sitting position to a standing position. Low pressure may cause dizziness, lightheadedness, or even fainting for some people. If you have heart disease, cerebrovascular disease, or conditions that increase the risk of developing low blood pressure (e.g., dehydration, treatment with blood pressure medications) you should be monitored by your doctor.

Neuroleptic malignant syndrome (NMS): Saphris (Asenapine), like other antipsychotic medications, may cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, confusion or loss of consciousness, racing or irregular heartbeat, muscle stiffness, or sweating, get immediate medical attention.

Medical conditions: Like other similar medications, Saphris (Asenapine) can increase the levels of the hormone prolactin in your body. If you have a medical condition called hyperprolactinemia (increased blood levels of the hormone prolactin), Saphris (Asenapine) may make the symptoms worse. Discuss with your doctor how Saphris (Asenapine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Saphris (Asenapine), and whether any special monitoring is needed.

Mouth numbness: Saphris (Asenapine) can cause a sensation of numbness in the mouth immediately after letting a tablet dissolve in your mouth. This usually goes away within an hour of taking the medication. Avoid eating or drinking anything for at least 10 minutes after taking the medication.

Prolonged erection: In rare cases, use of Saphris (Asenapine) by some men may cause them to develop priapism (a prolonged and painful erection). If you have an erection that lasts for more than 4 hours, seek immediate medical attention.

Seizures: Saphris (Asenapine) may increase the risk of seizures, especially if you have had seizures in the past. If you are at risk of seizures or have a history of seizures, discuss with your doctor how Saphris (Asenapine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Saphris (Asenapine), and whether any special monitoring is needed.

Suicide/Self-harm: People with schizophrenia or bipolar disorder are at risk of suicide and self-harm. If you feel like harming yourself or if you notice this behaviour in a friend or family member, seek immediate medical attention. You should be closely monitored by your doctor for emotional and behaviour changes while taking Saphris (Asenapine).

Tardive dyskinesia (TD): People who take certain antipsychotic medications, including Saphris (Asenapine), may develop TD, a syndrome consisting of potentially irreversible, involuntary, repetitive movements of the muscles. Although TD appears most commonly in seniors, especially women, it is impossible to predict who will develop TD. The risk of developing TD increases with higher doses and long-term treatment. If you experience muscle twitching or abnormal movements of the muscles in the face, tongue, or extremities, contact your doctor as soon as possible.

Weight gain: People who take Saphris (Asenapine) as a long-term treatment have experienced weight gain.

Pregnancy: Saphris (Asenapine) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Saphris (Asenapine), contact your doctor immediately.

Breast-feeding: It is not known if Saphris (Asenapine) passes into breast milk. If you are breast-feeding and are taking Saphris (Asenapine), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Saphris (Asenapine) have not been established for children under the age of 18.

Seniors: There may be a higher risk of death associated with the use of Saphris (Asenapine) by seniors with Dementia. Deaths have usually been related to cardiovascular causes or infection. Seek medical attention immediately if you notice the signs and symptoms of a stroke (e.g., sudden weakness or numbness, speech problems, vision problems, dizziness, confusion, sudden severe headache), heart attack (e.g., discomfort or pain in the chest, back, neck, jaw, arms; sweating; shortness of breath; nausea; lightheadedness), or infection (e.g., pneumonia). Saphris (Asenapine) should not be used by seniors with dementia.

Place the tablet under the tongue. Let it dissolve without chewing or swallowing it. This medication is typically used twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. Do not eat or drink within 10 minutes after taking this medication.