Free East Timor: asenapine Sublingual

a-SEN-a-peen

Sublingual route(Tablet)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Asenapine is not approved for the treatment of patients with dementia-related psychosis .

Commonly used brand name(s)

In the U.S.

Saphris

Available Dosage Forms:

Tablet

Uses For asenapine

Asenapine is used to treat symptoms of psychotic (mental) disorders, such as schizophrenia, mania, or bipolar disorder. asenapine should not be used to treat behavioral problems in older adult patients who have dementia.

asenapine is available only with your doctor's prescription.

Before Using asenapine

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 asenapine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to asenapine 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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of asenapine in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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.

Interactions with Medicines

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 asenapine, 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 asenapine 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.

Cisapride

Dronedarone

Mesoridazine

Metoclopramide

Pimozide

Sparfloxacin

Using asenapine 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

Ajmaline

Alfuzosin

Amiodarone

Amisulpride

Amitriptyline

Amoxapine

Apomorphine

Arsenic Trioxide

Astemizole

Azimilide

Azithromycin

Bretylium

Chloroquine

Chlorpromazine

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Clozapine

Crizotinib

Dasatinib

Desipramine

Disopyramide

Dofetilide

Dolasetron

Droperidol

Erythromycin

Flecainide

Fluconazole

Gatifloxacin

Gemifloxacin

Granisetron

Halofantrine

Haloperidol

Hydroquinidine

Ibutilide

Iloperidone

Imipramine

Lapatinib

Levofloxacin

Lopinavir

Lumefantrine

Mefloquine

Methadone

Moxifloxacin

Nilotinib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Ondansetron

Paliperidone

Pazopanib

Perflutren Lipid Microsphere

Pirmenol

Posaconazole

Prajmaline

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Ranolazine

Risperidone

Salmeterol

Saquinavir

Sematilide

Sertindole

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Sultopride

Sunitinib

Tedisamil

Telavancin

Telithromycin

Terfenadine

Tetrabenazine

Thioridazine

Toremifene

Trazodone

Trifluoperazine

Trimipramine

Vandetanib

Vardenafil

Vemurafenib

Voriconazole

Ziprasidone

Zotepine

Using asenapine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Fluvoxamine

Paroxetine

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of asenapine

Take asenapine 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.

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 crush, chew, or swallow the tablet.

Do not eat or drink anything for at least 10 minutes after using asenapine.

Dosing

The dose of asenapine 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 asenapine. 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:
  - Adults—At first, 10 milligrams (mg) two times a day. Your doctor may adjust 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.

Missed 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 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 While Using asenapine

It is very important that your doctor check your progress at regular visits to make sure that asenapine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Stop using asenapine and check with your doctor right away if you have any of the following symptoms while using asenapine: 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).

asenapine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while using asenapine: 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: asenapine 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.

asenapine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using asenapine. Talk to your doctor about ways to prevent weight gain.

asenapine 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 asenapine.

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.

asenapine 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.

asenapine may cause dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements. Make sure you know how you react to asenapine before you drive, use machines, or do anything else that requires you to be alert, well-coordinated, or able to think well.

asenapine 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.

Asenapine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies. If you or your caregiver notice any of these side effects, tell your doctor right away.

asenapine 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 (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using asenapine.

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.

asenapine 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

shortness of breath

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

sleeplessness

trouble sleeping

unable to sleep

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.

See also: asenapine Sublingual side effects (in more detail)

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Free East Timor

Wednesday, September 21, 2016

asenapine Sublingual