Description
Asenapine is used to treat schizophrenia in adults. It is also used alone or together with lithium or valproate to treat symptoms of psychotic (mental) disorders, such as mania or bipolar disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of asenapine in the pediatric population. Safety and efficacy have not been established in children younger than 10 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of asenapine in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Bromopride
- Cisapride
- Dronedarone
- Levoketoconazole
- Mesoridazine
- Metoclopramide
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acecainide
- Adagrasib
- Ajmaline
- Alfentanil
- Alfuzosin
- Alprazolam
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Astemizole
- Atazanavir
- Azimilide
- Azithromycin
- Bedaquiline
- Benzhydrocodone
- Bretylium
- Bromazepam
- Bunazosin
- Buprenorphine
- Buserelin
- Butalbital
- Butorphanol
- Calcium Oxybate
- Cannabidiol
- Cannabis
- Ceritinib
- Cetirizine
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clobazam
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Blood vessel or circulation problems or
- Dehydration or
- Heart attack, history of or
- Heart disease or
- Heart failure or
- Heart rhythm problems (eg, arrhythmia, QT prolongation) or
- Hypotension (low blood pressure) or
- Hypovolemia (low amount of blood) or
- Stroke, history of—May cause side effects to become worse.
- Bradycardia (slow heartbeat), history of or
- Heart rhythm problem (eg, congenital long QT syndrome) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood)—May increase risk for more serious side effects.
- Diabetes or
- Hyperglycemia (high blood sugar)—This medicine may raise your blood sugar levels.
- Hyperprolactinemia (high prolactin in the blood) or
- Neuroleptic malignant syndrome (NMS), history of or
- Seizures, history of or
- Trouble with swallowing—Use with caution. May make these conditions worse.
- Liver disease, severe—Should not be used in patients with this condition.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
To use the sublingual tablet:
- Make sure your hands are dry before you handle the tablet.
- Do not open the blister pack that contains the tablet until you are ready to take it.
- Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil.
- Place the tablet under your tongue. It should melt quickly.
- Do not split, crush, chew, or swallow the tablet.
- Do not eat or drink anything for at least 10 minutes after using this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (sublingual tablets):
- For bipolar disorder:
- For patients taking asenapine only:
- Adults—At first, 5 to 10 milligrams (mg) two times a day. Your doctor may adjust your dose as needed.
- Children 10 to 17 years of age—2.5 to 10 mg two times a day. Your doctor may adjust your dose as needed and tolerated.
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For patients taking asenapine together with lithium or valproate:
- Adults—At first, 5 milligrams (mg) two times a day. If needed, your doctor may adjust your dose to 10 mg two times a day.
- Children—Use and dose must be determined by your doctor.
- For patients taking asenapine only:
- For maintenance treatment of bipolar disorder:
- Adults—5 to 10 milligrams (mg) two times a day. Your doctor may increase your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For schizophrenia:
- Adults—At first, 5 milligrams (mg) two times a day. Your doctor may increase your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For bipolar disorder:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.
Tell your doctor right away if you have sores or blisters in the mouth, or numbness or tingling of the mouth or throat after using this medicine.
Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while using this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
For diabetic patients: This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.
This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.
This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, tongue, or throat while you are using this medicine.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
Asenapine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.
This medicine may cause dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that requires you to be alert, well-coordinated, or able to think well.
This medicine might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and cannot cool down.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicines including other narcotics, medicine for seizures (eg, barbiturates), muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Abnormal or decreased touch sensation
- inability to move the eyes
- inability to sit still
- increase in body movements
- increased blinking or spasms of the eyelid
- lip smacking or puckering
- need to keep moving
- puffing of the cheeks
- rapid or worm-like movements of the tongue
- restlessness
- shakiness in the legs, arms, hands, or feet
- sticking out of tongue
- trembling or shaking of the hands or feet
- trouble with breathing, speaking, or swallowing
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- uncontrolled chewing movements
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual facial expressions
- weakness of the arms and legs
Less common
- Blurred vision
- dizziness
- headache
- nervousness
- pounding in the ears
- slow or fast heartbeat
Rare
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- changes in patterns and rhythms of speech
- coma
- confusion
- convulsions
- decreased urine output
- fast, pounding, or irregular heartbeat or pulse
- increased thirst
- muscle pain or cramps
- nausea or vomiting
- pale skin
- pinpoint red spots on the skin
- slurred speech
- swelling of the face, ankles, or hands
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Constipation
- sleepiness or unusual drowsiness
- trouble sleeping
- unusually deep sleep
- unusually long duration of sleep
Less common
- Acid or sour stomach
- belching
- depression
- difficulty with moving
- dry mouth
- fear or nervousness
- heartburn
- increased appetite
- increased watering of the mouth
- increased weight
- indigestion
- irritability
- muscle pain or stiffness
- pain in the arms or legs
- pain in the joints
- stomach discomfort, upset, or pain
- toothache
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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