Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Fanapt
  2. Fanapt Titration Pack

Descriptions


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.

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 iloperidone 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 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

Information about this iloperidone-oral-route
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.

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.

  • Amifampridine
  • Cisapride
  • Dronedarone
  • Fluconazole
  • Ketoconazole
  • Mesoridazine
  • Metoclopramide
  • Nelfinavir
  • 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
  • Buserelin
  • Carbamazepine
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Cobicistat
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Delamanid
  • Desipramine
  • Deslorelin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Formoterol
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Histrelin
  • Hydroquinidine
  • Ibutilide
  • Idelalisib
  • Imipramine
  • Indinavir
  • Itraconazole
  • Ivabradine
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Mifepristone
  • Mitotane
  • Moxifloxacin
  • Nafarelin
  • Nefazodone
  • 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
  • Sertraline
  • Sevoflurane
  • Siltuximab
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sunitinib
  • Tacrolimus
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Terfenadine
  • Tetrabenazine
  • Tizanidine
  • Toremifene
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Triptorelin
  • 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

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

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

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

  1. Fast, pounding, or irregular heartbeat or pulse

Less common

  1. Blurred vision
  2. body aches or pain
  3. chills
  4. cold sweats
  5. confusion
  6. cough
  7. difficult or labored breathing
  8. difficulty with moving
  9. difficulty with speaking
  10. dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  11. drooling
  12. ear congestion
  13. fever
  14. headache
  15. inability to sit still
  16. loss of balance control
  17. loss of voice
  18. muscle pain or stiffness
  19. muscle trembling, jerking, or stiffness
  20. nasal congestion
  21. need to keep moving
  22. pain in the joints
  23. restlessness
  24. runny nose
  25. shakiness in the legs, arms, hands, or feet
  26. shortness of breath
  27. shuffling walk
  28. sneezing
  29. sore throat
  30. stiffness of the limbs
  31. sweating
  32. tightness in the chest
  33. trembling or shaking of the hands or feet
  34. twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  35. uncontrolled movements, especially of the face, neck, and back
  36. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  37. wheezing

Rare

  1. Abdominal or stomach fullness
  2. aching or discomfort in the lower legs or sensation of crawling in the legs
  3. actions that are out of control
  4. aggressive or angry
  5. agitation
  6. anxiety
  7. attack, assault, or force
  8. back pain
  9. black, tarry stools
  10. bloody nose
  11. burning while urinating
  12. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  13. chest pain or discomfort
  14. coma
  15. confusion as to time, place, or person
  16. constipation
  17. convulsions
  18. decrease in the amount of urine
  19. decrease in the frequency of urination
  20. decrease in urine volume
  21. decreased awareness or responsiveness
  22. decreased urination
  23. decreased weight
  24. depression
  25. difficult or painful urination
  26. difficulty in passing urine (dribbling)
  27. difficulty with walking
  28. dilated neck veins
  29. dizziness
  30. dry mouth
  31. dry skin and hair
  32. extreme thirst
  33. extremely high fever or body temperature
  34. fainting
  35. false beliefs that cannot be changed by facts
  36. fast, shallow breathing
  37. feeling cold
  38. frequent urination
  39. gaseous abdominal pain
  40. groin pain
  41. hair loss
  42. hoarseness or husky voice
  43. holding false beliefs that cannot be changed by fact
  44. hostility
  45. inability to move the eyes
  46. increased blinking or spasms of the eyelid
  47. increased thirst
  48. irregular breathing
  49. irritability
  50. lightheadedness
  51. loss of appetite
  52. loss of bladder control
  53. mimicry of speech or movements
  54. mood swings
  55. muscle aching or cramping
  56. muscle spasms
  57. muscle twitching
  58. nausea or vomiting
  59. nervousness
  60. noisy breathing
  61. noisy, rattling breathing
  62. numbness or tingling in the hands, feet, or lips
  63. pale, clammy skin
  64. peculiar postures or movements, mannerisms, or grimacing
  65. pounding, slow heartbeat
  66. rapid breathing
  67. rapid weight gain
  68. recurrent fever
  69. restlessness
  70. seizures
  71. severe sleepiness
  72. slow movement
  73. slow reflexes
  74. sore throat
  75. sore tongue
  76. sores, ulcers, or white spots on the lips or in the mouth
  77. sticking out of tongue
  78. stupor
  79. sunken eyes
  80. swelling
  81. swelling of the face, ankles, fingers, feet, or lower legs
  82. swollen glands
  83. swollen joints
  84. swollen, tender prostate
  85. talking, feeling, and acting with excitement
  86. thirst
  87. troubled breathing at rest
  88. troubled breathing with exertion
  89. uncontrolled twisting movements of the neck, trunk, arms, or legs
  90. unusual bleeding or bruising
  91. unusual excitement, nervousness, or restlessness
  92. unusual facial expressions
  93. weight gain
  94. wrinkled skin
  95. 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

  1. Diarrhea
  2. sleepiness or unusual drowsiness

Less common

  1. Abdominal or stomach discomfort
  2. not able to ejaculate semen
  3. rash
  4. stuffy nose

Rare

  1. Absent, missed, or irregular menstrual periods
  2. blindness
  3. blurred vision
  4. breast pain
  5. burning feeling in the chest or stomach
  6. burning upper abdominal pain
  7. canker sores
  8. continuing ringing or buzzing or other unexplained noise in the ears
  9. decreased interest in sexual intercourse
  10. decreased vision
  11. delusions of persecution, mistrust, suspiciousness, or combativeness
  12. dry eyes
  13. feeling of constant movement of self or surroundings
  14. hearing loss
  15. inability to have or keep an erection
  16. increase in blood flow to the whites of the eyes
  17. increased appetite
  18. increased watering of the mouth
  19. indigestion
  20. irregular menstruation
  21. irritation or soreness of the mouth
  22. longer or heavier menstrual periods
  23. loss in sexual ability, desire, drive, or performance
  24. loss of bowel control
  25. loss of memory
  26. normal menstrual bleeding occurring earlier, possibly lasting longer than expected
  27. problems with memory
  28. redness, swelling, or itching of the eyelids
  29. sensation of spinning
  30. stomach upset
  31. stopping of menstrual bleeding
  32. swelling of the breasts or breast soreness in both females and males
  33. swelling or inflammation of the mouth
  34. tenderness in the stomach area
  35. 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.