Asenapine

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Generic Name: Asenapine Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Asenapine used for?

Asenapine is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder). Asenapine helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there) and prevent severe mood swings. Asenapine is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

How should I take Asenapine?

Take this medication as directed by your doctor, usually 2 times a day. Gently remove the medication from the packaging with dry hands by peeling back the tab. Do not push the tablet through the packaging. Place your dose of this medication under the tongue and allow it to dissolve completely in your saliva. Do not chew, crush, split, or swallow the tablet whole. Do not eat or drink anything for 10 minutes after taking this medication.

The dosage is based on your medical condition and response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. It may take several weeks before you get the full benefit of this drug.

It is very important to continue taking this medication exactly as prescribed, even if you are feeling better and thinking more clearly. Do not increase your dose or take this drug more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Do not stop taking this medication without consulting your doctor.

Tell your doctor if your condition does not improve or if it worsens.

How do I store Asenapine?

Asenapine is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Asenapine in the bathroom or the freezer. There may be different brands of Asenapine that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Asenapine down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Asenapine?

Before taking asenapine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, heart problems (such as past heart attack, angina, abnormal heart rhythm), stroke, diabetes (including family history), obesity, low blood pressure, seizures, low white blood cell count, loss of too much body water (dehydration), breast cancer, drug/alcohol/substance abuse, Alzheimer’s disease, dementia, trouble swallowing, breathing trouble during sleep (sleep apnea).

Asenapine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using asenapine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using asenapine safely.

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, and QT prolongation (see above). Drowsiness, dizziness, and lightheadedness can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.

Since untreated mental/mood problems (such as schizophrenia, bipolar disorder, depression) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Asenapine during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Asenapine. Asenapine is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Asenapine?

Drowsiness, dizziness, lightheadedness, and weight gain may occur. Numbness/tingling of the mouth may also occur but usually goes away within 1 hour. Sores, blisters, or pain under the tongue may rarely occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.

This drug may cause muscle/nervous system problems (extrapyramidal symptoms-EPS). Your doctor may prescribe another medication to decrease these side effects. Tell your doctor right away if you notice any of the following side effects: feelings of anxiety/agitation/jitteriness, drooling/trouble swallowing, restlessness/constant need to move, shaking (tremor), shuffling walk, stiff muscles, severe muscle spasms/cramping (such as twisting neck, arching back, eyes rolling up), mask-like expression of the face.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may cause face/muscle twitching and uncontrollable movements (tardive dyskinesia). In some cases, this condition may be permanent. Tell your doctor right away if you develop any uncontrollable movements such as lip smacking, mouth puckering, tongue thrusting, chewing, or unusual arm/leg movements.

This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. Weight gain from this drug may increase the risk of this side effect. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

In rare cases, asenapine may increase your level of a certain substance made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.

Rarely, with similar drugs, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

Tell your doctor right away if you have any serious side effects, including: signs of infection (such as fever, persistent sore throat).

Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, slow heartbeat, seizures, interrupted breathing during sleep.

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Asenapine?

Some products that may interact with this drug include: alpha blockers (such as prazosin), anticholinergic/antispasmodic drugs (such as atropine, dicyclomine, scopolamine).

Other medications can affect the removal of asenapine from your body, which may affect how asenapine works. One example is fluvoxamine, among others.

Asenapine can slow down the removal of other medications from your body, which may affect how they work. One example is paroxetine, among others.

Many drugs besides asenapine may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Asenapine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Asenapine?

Asenapine may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Asenapine?

Asenapine may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Asenapine.

What is the dose of Asenapine for an adult?

Usual Adult Dose for Schizophrenia

Acute treatment:

Starting dose: 5 mg sublingually twice a day

Recommended dose: 5 mg sublingually twice a day, if tolerated may increase to 10 mg sublingually twice a day after 1 week if necessary

Maximum dose: 10 mg sublingually twice a day

Comments: Controlled trials revealed no added benefit with the higher dose, but a clear increase in certain adverse reactions. The safety of doses above 10 mg twice daily has not been evaluated in clinical studies.

Maintenance Treatment:

Recommended dose: 5 to 10 mg sublingually twice a day

Maximum dose: 10 mg sublingually twice a day

Comments: There is no available evidence to answer the question of how long the schizophrenic patient should remain on therapy; it is generally recommended that responding patients be continued beyond the acute response.

Use: Treatment of schizophrenia.

Usual Adult Dose for Bipolar Disorder

Monotherapy:

Starting dose: 10 mg sublingually twice a day

Recommended dose: 5 to 10 mg sublingually twice a day

Maximum dose: 10 mg sublingually twice a day

Comment: In controlled trials, the starting dose was 10 mg twice daily. On the second and subsequent days, the dose could be lowered to 5 mg twice daily, however less than 10% of patients had their dose reduced.

Adjunctive Therapy:

Starting dose: 5 mg sublingually twice a day

Maintenance dose: 5 to 10 mg sublingually twice a day

Maximum dose: 10 mg sublingually twice a day

Comments:

-The dose should be titrated based on clinical response and tolerability.

-There is no available evidence to answer the question of how long the patient should remain on therapy; it is generally recommended that responding patients be continued beyond the acute response.

Uses: For the acute treatment of manic or mixed episodes associated with bipolar 1 disorder either as monotherapy or as adjunctive therapy with either lithium or valproate.

Renal Dose Adjustments

CrCl 15 to 90 mL/min: No adjustment recommended

Liver Dose Adjustments

Severe hepatic impairment (Child-Pugh C): Use is contraindicated

Mild to moderate hepatic impairment (Child-Pugh A or B): No adjustment recommended

Dose Adjustments

Doses should be titrated from 5 mg to 10 mg based on clinical response and tolerability. Doses greater than 10 mg sublingually twice a day have not been studied.

Other Comments

Administration Advice:

-Do not remove tablet from package until ready to administer; do not push the tablet through the tablet pack, rather using dry hands pull out tablet pack and peel back colored tab gently removing the tablet

-Place whole tablet under tongue and allow to dissolve completely; do not split, crush, chew, or swallow the tablet

-Do not eat or drink for 10 minutes after administration

-When taken in combination with other medications, this drug should be taken last.

General:

-Controlled clinical trials assessing long-term use are not available; the physician who prescribes this drug should periodically re-evaluate the long-term risks and benefits for the individual patient.

-No specific recommendations are available regarding switching from other antipsychotics or for the use of concomitant antipsychotics.

Monitoring:

-Cardiovascular: Orthostatic vital signs in at-risk patients

-Hematologic: CBC frequently during the first few months in patients with preexisting low WBC and/or a prior history of drug-induced leukopenia or neutropenia.

-Metabolic: Monitor for increases in blood sugar, weight, and lipids

Patient Advice:

-Inform patients that application site reactions including oral ulcers, blisters, peeling/sloughing and inflammation may occur and they should contact their healthcare provider if this occurs.

-Inform patient that this drug may cause dizziness upon arising; it is best to get up slowly form a seated or lying position.

-This drug may impair judgment, thinking, or motor skills; have patient avoid driving or operating machinery until adverse effects are determined.

-Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.

-Advise patient that this drug may cause metabolic changes such as increases in blood sugar, body weight and lipids.

-Patients should avoid overheating and dehydration.

What is the dose of Asenapine for a child?

Usual Pediatric Dose for Bipolar Disorder

Age: 10 years or older

Starting dose: 2.5 mg sublingually twice a day

Dose titration: After 3 days, may increase to 5 mg sublingually twice daily, and after an additional 3 days to 10 mg twice a day, as needed and as tolerated

Recommended dose: 2.5 to 10 mg sublingually twice a day

Maximum dose: 10 mg sublingually twice a day

Comment: Pediatric patients appear to be more sensitive to dystonia with initial dosing and therefore gradual dose escalation is recommended. The safety of doses above 10 mg twice a day has not been studied.

Use: As monotherapy for the acute treatment of manic or mixed episodes associated with bipolar 1 disorder.

Precautions

Safety and efficacy have not been established in patients younger than 10 years.

How is Asenapine available?

Asenapine is available in the following dosage forms and strengths:

  • Sublingual tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Asenapine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: August 17, 2018 | Last Modified: August 17, 2018

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