ASENAPINE - HIKMA PHARMA 5 mg ( Asenapine ) 30 sublingual tablets 

Uses of Asenapine Sublingual Tablets:

It is used to treat schizophrenia.
It is used to treat bipolar problems.
It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Asenapine Sublingual Tablets?
If you have an allergy to asenapine or any other part of this medicine (asenapine sublingual tablets).
If you are allergic to this medicine (asenapine sublingual tablets); any part of this medicine (asenapine sublingual tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you have any of these health problems: Liver problems, low magnesium levels, low potassium levels, or slow heartbeat.
If you have ever had a long QT on ECG or other heartbeat that is not normal.
If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
This is not a list of all drugs or health problems that interact with this medicine (asenapine sublingual tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (asenapine sublingual tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Asenapine Sublingual Tablets?
Tell all of your health care providers that you take this medicine (asenapine sublingual tablets). This includes your doctors, nurses, pharmacists, and dentists.
Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (asenapine sublingual tablets) affects you.
To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
Have blood work checked as you have been told by the doctor. Talk with the doctor.
High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These may raise the chance of heart and brain blood vessel disease.
Check your blood sugar as you have been told by your doctor.
Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
Dizziness, sleepiness, and feeling less stable may happen with this medicine (asenapine sublingual tablets). These may lead to falling, which can cause broken bones or other health problems.
Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these have been deadly. This medicine is not approved to treat mental problems caused by dementia.
If you are 65 or older, use this medicine (asenapine sublingual tablets) with care. You could have more side effects.
Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
Taking this medicine (asenapine sublingual tablets) in the third trimester of pregnancy may lead to uncontrolled muscle movements and withdrawal in the newborn.

How is this medicine (Asenapine Sublingual Tablets) best taken?
Use this medicine (asenapine sublingual tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Wash and dry your hands before you take this medicine (asenapine sublingual tablets). Do not touch the tablet with wet or damp hands.
Do not take this medicine (asenapine sublingual tablets) out of the blister pack until you are ready to take it. Take this medicine (asenapine sublingual tablets) right away after opening the blister pack. Do not store the removed drug for future use.
Place tablet under the tongue and let dissolve.
Do not swallow whole. Do not chew, break, or crush.
Do not eat or drink for at least 10 minutes after taking this medicine (asenapine sublingual tablets).
Keep taking this medicine (asenapine sublingual tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

Take a missed dose as soon as you think about it.
If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
Fast, slow, or abnormal heartbeat.
Shortness of breath.
Very bad dizziness or passing out.
Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
Mouth irritation or mouth sores.
Seizures.
Enlarged breasts, nipple discharge, not able to get or keep an erection (in males), or period (menstrual) changes (in females).
A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping this medicine (asenapine sublingual tablets), but it may not go away. The risk is greater with diabetes and in older adults, especially older women. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.
What are some other side effects of Asenapine Sublingual Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Feeling dizzy, sleepy, tired, or weak.
Headache.
Restlessness.
Upset stomach or throwing up.
More hungry.
Weight gain.
Trouble sleeping.
Constipation.
Numbness or tingling in the mouth.
Change in taste.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Asenapine Sublingual Tablets?
Store at room temperature in a dry place. Do not store in a bathroom.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use
If your symptoms or health problems do not get better or if they become worse, call your doctor.
Do not share your drugs with others and do not take anyone else's drugs.
Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (asenapine sublingual tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Side Effects:

In Summary
Commonly reported side effects of asenapine include: akathisia, drowsiness, extrapyramidal reaction, headache, and dizziness. Other side effects include: gastric hypersecretory conditions, hypoesthesia, sialorrhea, and weight gain. See below for a comprehensive list of adverse effects.

Along with its needed effects, asenapine 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 while taking asenapine:

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 of asenapine 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

Usual Adult Dose for Schizophrenia
Initial dose: 5 mg sublingually 2 times a day
Maintenance dose: 5 mg sublingually 2 times a day, if tolerated may increase to 10 mg sublingually 2 times a day after 1 week if necessary
Maximum dose: 20 mg/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 20 mg/day has not been evaluated in clinical studies.

Use: Treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder
Monotherapy:
-Initial dose: 10 mg sublingually 2 times a day
-Maintenance dose: 5 to 10 mg sublingually 2 times a day
-Maximum dose: 20 mg/day

Adjunctive Therapy:
-Initial dose: 5 mg sublingually 2 times a day
-Maintenance dose: 5 to 10 mg sublingually 2 times a day
-Maximum dose: 20 mg/day

Comments:
-The safety of doses above 20 mg/day has not been evaluated in clinical studies.
-In controlled trials, the starting dose in monotherapy was 10 mg twice daily. On the second and subsequent days, the dose could be lowered to 5 mg twice daily, though approximately 90% of patients remained on the initial dose.
-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; however, it is generally recommended that responding patients be continued beyond the acute response.

Uses:
-Acute monotherapy of manic or mixed episodes of bipolar I disorder
-Adjunctive treatment to lithium or valproate in bipolar I disorder
-Maintenance monotherapy treatment of bipolar I disorder

Usual Pediatric Dose for Bipolar Disorder
10 years and older
-Initial dose: 2.5 mg sublingually 2 times a day
-Titration regimen: After 3 days, may increase to 5 mg sublingually 2 times a day, and after an additional 3 days to 10 mg sublingually 2 times a day, as needed and as tolerated
-Maintenance dose: 2.5 to 10 mg sublingually 2 times a day
-Maximum dose: 20 mg/day

Comments:
-Pediatric patients appear to be more sensitive to dystonia with initial dosing and therefore gradual dose escalation is recommended.
-The safety of doses above 20 mg/day has not been studied.

Use: Acute monotherapy of manic or mixed episodes of bipolar I disorder

Renal Dose Adjustments
Mild to severe renal dysfunction (Glomerular filtration rate [GFR] 15 to 90 mL/min): No adjustment recommended.
GFR less than 15 mL/min: Data not available

Liver Dose Adjustments
Mild to moderate liver dysfunction (Child-Pugh A and B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Contraindicated

Dose Adjustments
Doses should be titrated from 5 mg to 10 mg 2 times a day based on clinical response and tolerability.

Precautions
US BOXED WARNINGS:
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS:
-Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
-This drug is not approved for the treatment of patients with dementia-related psychosis.

CONTRAINDICATIONS:
-Hypersensitivity to the active component or any of the ingredients or a history of hypersensitivity reactions to this drug
-Severe liver dysfunction (Child-Pugh C)

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

Consult WARNINGS section for additional precautions.

Dialysis
Data not available

Other Comments
Administration Advice:
-Do not remove tablet from package until ready to administer.
-The tablet should not be pushed through the tablet pack.
-Patients should handle tablets with dry hands.
-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.

Storage requirements:
-Tablets should be kept in the tablet pack until ready to be used.

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.
-Patients should be reassessed periodically to determine continued need for treatment, and to determine the appropriate dosage for treatment.

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:
-Patients, families, and caregivers should be educated on the risks of suicidal thoughts and behaviors, as well as the risk of mania and hypomania; what to watch for and when to seek medical advice.
-This drug may impair judgment, thinking, or motor skills; patients should be told to avoid driving or operating machinery until adverse effects are determined.
-Advise patients to speak to physician or health care professional if they are pregnant, intend to become pregnant, or are breastfeeding.
-Advise patients that this drug may cause metabolic changes such as increases in blood sugar, body weight and lipids.
-Patients should be instructed to avoid overheating and dehydration.
-Patients should speak with their healthcare provider if they are taking, or plan to take any new prescription or over the counter medications because there is a potential for drug interactions; patients should be advised to avoid alcohol as it may make some side effects worse.

Interactions:

A total of 590 drugs are known to interact with asenapine.

81 major drug interactions
506 moderate drug interactions
3 minor drug interactions
 

Abilify (aripiprazole)
Benadryl (diphenhydramine)
BuSpar (buspirone)
clonazepam
Concerta (methylphenidate)
Cymbalta (duloxetine)
Depakote (divalproex sodium)
Exelon (rivastigmine)
Fanapt (iloperidone)
ibuprofen
Klonopin (clonazepam)
Lamictal (lamotrigine)
Lasix (furosemide)
Latuda (lurasidone)
Lithium Carbonate ER (lithium)
Prozac (fluoxetine)
Ritalin (methylphenidate)
Seroquel (quetiapine)
Synthroid (levothyroxine)
Tylenol (acetaminophen)
Zoloft (sertraline)
Zyprexa (olanzapine)
Zyprexa Zydis (olanzapine)
Asenapine alcohol/food interactions
There are 4 alcohol/food interactions with asenapine

Asenapine disease interactions
There are 14 disease interactions with asenapine which include:

severe hepatic impairment
dementia
QT Prolongation
NMS
tardive dyskinesia
depression
aspiration
seizure
hematologic abnormalities
hyperglycemia/diabetes
hypotension
lipid alterations
weight gain
hyperprolactinemia

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