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Iloperidone (Oral route)

Pronunciation:

eye-loe-PER-i-done

Brand Names:

  • Fanapt
  • Fanapt Titration Pack

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from the observational studies to what extent these mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Iloperidone is not approved for the treatment of patients with dementia-related psychosis .

Classifications:

Therapeutic—

Antipsychotic

Chemical—

Benzisoxazole

Uses of This Medicine:

Iloperidone is used to treat the symptoms of psychotic (mental) disorders, such as schizophrenia. 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.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of iloperidone in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of iloperidone in the elderly. However, elderly patients are more likely to have dementia or age-related liver problems, which may require caution in patients receiving iloperidone.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

Other 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 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.

  • Amifampridine
  • Cisapride
  • Dronedarone
  • Mesoridazine
  • Metoclopramide
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Sparfloxacin
  • Thioridazine

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
  • Ajmaline
  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Apomorphine
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azimilide
  • Azithromycin
  • Bedaquiline
  • Bretylium
  • Carbamazepine
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Cobicistat
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Desipramine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Erythromycin
  • Eslicarbazepine Acetate
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Formoterol
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Hydroquinidine
  • Ibutilide
  • Imipramine
  • Indinavir
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Levofloxacin
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Mifepristone
  • Mitotane
  • Moxifloxacin
  • Nefazodone
  • Nelfinavir
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Paliperidone
  • Pasireotide
  • Pazopanib
  • Perflutren Lipid Microsphere
  • Primidone
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinine
  • Ranolazine
  • Ritonavir
  • Salmeterol
  • Saquinavir
  • Sematilide
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sunitinib
  • Tacrolimus
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Terfenadine
  • Tetrabenazine
  • Tizanidine
  • Toremifene
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Ziprasidone

Using this medicine 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.

  • Paroxetine

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

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:

  • Alzheimer's disease or
  • Blood vessel disease or
  • Bradycardia (slow heartbeat), severe or
  • Dehydration or
  • Heart attack, recent or history of, or
  • Heart failure, history of or
  • Heart rhythm problems (e.g., prolonged QT interval), or a history of or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood) or
  • Hypotension (low blood pressure) or
  • Hypovolemia (low amount of blood) or
  • Stroke, history of—May cause side effects to become worse.
  • Blood or bone marrow problems or
  • Breast cancer, prolactin-dependent or
  • Diabetes or
  • Hyperglycemia (high blood sugar) or
  • Hyperprolactinemia (high prolactin in the blood) or
  • Neuroleptic malignant syndrome (NMS), history of or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Liver disease—Should not use in patients with this condition.

Proper Use of This Medicine:

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.

You may take this medicine with or without food.

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 (tablets):
    • For treatment of schizophrenia:
      • Adults—At first, 1 milligram (mg) two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 12 mg two times a day.
      • Children—Use and dose must be determined by your doctor.

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 While Using This Medicine:

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

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Call your doctor right away if you have any symptoms of heart rhythm problems, such as dizziness, feeling faint, or a fast, pounding, or irregular heartbeat.

Stop taking this medicine and 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 taking 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.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. 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.

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.

Iloperidone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

This medicine may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke.

Iloperidone 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 or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Avoid drinking alcohol 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 of This Medicine:

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
Fast, pounding, or irregular heartbeat or pulse
Less common
Blurred vision
body aches or pain
chills
cold sweats
confusion
cough
difficult or labored breathing
difficulty with moving
difficulty with speaking
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
drooling
ear congestion
fever
headache
inability to sit still
loss of balance control
loss of voice
muscle pain or stiffness
muscle trembling, jerking, or stiffness
nasal congestion
need to keep moving
pain in the joints
restlessness
runny nose
shakiness in the legs, arms, hands, or feet
shortness of breath
shuffling walk
sneezing
sore throat
stiffness of the limbs
sweating
tightness in the chest
trembling or shaking of the hands or feet
twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
uncontrolled movements, especially of the face, neck, and back
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
wheezing
Rare
Abdominal or stomach fullness
aching or discomfort in the lower legs or sensation of crawling in the legs
actions that are out of control
aggressive or angry
agitation
anxiety
attack, assault, or force
back pain
black, tarry stools
bloody nose
burning while urinating
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain or discomfort
coma
confusion as to time, place, or person
constipation
convulsions
decrease in the amount of urine
decrease in the frequency of urination
decrease in urine volume
decreased awareness or responsiveness
decreased urination
decreased weight
depression
difficult or painful urination
difficulty in passing urine (dribbling)
difficulty with walking
dilated neck veins
dizziness
dry mouth
dry skin and hair
extreme thirst
extremely high fever or body temperature
fainting
false beliefs that cannot be changed by facts
fast, shallow breathing
feeling cold
frequent urination
gaseous abdominal pain
groin pain
hair loss
hoarseness or husky voice
holding false beliefs that cannot be changed by fact
hostility
inability to move the eyes
increased blinking or spasms of the eyelid
increased thirst
irregular breathing
irritability
lightheadedness
loss of appetite
loss of bladder control
mimicry of speech or movements
mood swings
muscle aching or cramping
muscle spasms
muscle twitching
nausea or vomiting
nervousness
noisy breathing
noisy, rattling breathing
numbness or tingling in the hands, feet, or lips
pale, clammy skin
peculiar postures or movements, mannerisms, or grimacing
pounding, slow heartbeat
rapid breathing
rapid weight gain
recurrent fever
restlessness
seizures
severe sleepiness
slow movement
slow reflexes
sore throat
sore tongue
sores, ulcers, or white spots on the lips or in the mouth
sticking out of tongue
stupor
sunken eyes
swelling
swelling of the face, ankles, fingers, feet, or lower legs
swollen glands
swollen joints
swollen, tender prostate
talking, feeling, and acting with excitement
thirst
troubled breathing at rest
troubled breathing with exertion
uncontrolled twisting movements of the neck, trunk, arms, or legs
unusual bleeding or bruising
unusual excitement, nervousness, or restlessness
unusual facial expressions
weight gain
wrinkled skin
yellow eyes or skin

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
Diarrhea
sleepiness or unusual drowsiness
Less common
Abdominal or stomach discomfort
not able to ejaculate semen
rash
stuffy nose
Rare
Absent, missed, or irregular menstrual periods
blindness
blurred vision
breast pain
burning feeling in the chest or stomach
burning upper abdominal pain
canker sores
continuing ringing or buzzing or other unexplained noise in the ears
decreased interest in sexual intercourse
decreased vision
delusions of persecution, mistrust, suspiciousness, or combativeness
dry eyes
feeling of constant movement of self or surroundings
hearing loss
inability to have or keep an erection
increase in blood flow to the whites of the eyes
increased appetite
increased watering of the mouth
indigestion
irregular menstruation
irritation or soreness of the mouth
longer or heavier menstrual periods
loss in sexual ability, desire, drive, or performance
loss of bowel control
loss of memory
normal menstrual bleeding occurring earlier, possibly lasting longer than expected
problems with memory
redness, swelling, or itching of the eyelids
sensation of spinning
stomach upset
stopping of menstrual bleeding
swelling of the breasts or breast soreness in both females and males
swelling or inflammation of the mouth
tenderness in the stomach area
uncontrolled eye movements

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.


Last Updated: 4/4/2014

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