iloperidone

ROUTE	ONSET	PEAK	DURATION
PO	2–4 wk	2–4 hr‡	unknown

Contraindicated in:

Hypersensitivity;
Bradycardia, recent MI, or uncompensated HF(↑ risk of serious arrhythmias);
Congenital long QT syndrome, QTc interval >500 msec or history of cardiac arrhythmias;
Electrolyte abnormalities, especially hypomagnesemia or hypokalemia (correct prior to therapy);
Severe hepatic impairment;
Lactation: Lactation.

Use Cautiously in:

Known cardiovascular disease including HF, history of MI/ischemia, conduction abnormalities, cerebrovascular disease, or other conditions known to predispose to hypotension including dehydration, hypovolemia, concurrent antihypertensive therapy (↑ risk of orthostatic hypotension);
Known ↓ WBC or history of drug-induced leukopenia/neutropenia;
Circumstances that may result in ↑ body temperature, including strenuous exercise, exposure to extreme heat, concurrent anticholinergic activity, or dehydration (may impair thermoregulation);
Patients at risk for aspiration or falls;
Moderate hepatic impairment;
OB: Neonates at risk for extrapyramidal symptoms and withdrawal after delivery when exposed during the 3rd trimester; use only if potential maternal benefit justifies potential fetal risk;
Pedi: Safety and effectiveness not established in children;
Geri: Appears on Beers list. risk of stroke, cognitive decline, and mortality in older adults with dementia. Avoid use in older adults, except for schizophrenia.

Adv. Reactions/Side Effects ⬆ ⬇

CV: orthostatic hypotension, tachycardia, palpitations, QTc interval prolongation

EENT: nasal congestion

Endo: hyperglycemia, hyperprolactinemia

GI: dry mouth, nausea, abdominal discomfort, diarrhea, weight loss

GU: priapism, urinary incontinence

Metab: weight gain, dyslipidemia

MS: ↓bone density, musculoskeletal stiffness

Neuro: dizziness, drowsiness, fatigue, agitation, delusions, extrapyramidal disorders, NEUROLEPTIC MALIGNANT SYNDROME, restlessness, SUICIDAL THOUGHTS, tardive dyskinesia

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

Avoid concurrent use of QT interval prolonging medications, including quinidine, procainamide, amiodarone, sotalol, chlorpromazine, thioridazine, moxifloxacin, pentamidine, and methadone.
Concurrent use of strong CYP2D6 inhibitors, including fluoxetine and paroxetine↑ levels and the risk of toxicity; ↓ dose.
Concurrent use of strong CYP3A4 inhibitors, including ketoconazole and clarithromycin↑ levels and the risk of toxicity; ↓ dose.
Concurrent use of antihypertensives including diuretics may ↑ risk of orthostatic hypotension.
Concurrent use of anticholinergics may ↑ risk of impaired thermoregulation.

Route/Dosage ⬆ ⬇

PO (Adults ): Initiate treatment with 1 mg twice daily on the first day, then 2 mg twice daily the 2nd day, then ↑ by 2 mg/day every day until a target dose of 12–24 mg/day given in two divided doses is reached; Concurrent use of strong CYP2D6 or CYP3A4 inhibitors:↓ dose by 50%; if inhibitor is withdrawn ↑ dose to previous amount. Retitration is required if iloperidone is discontinued >300 days; Poor metabolizers of CYP2D6:↓ dose by 50%.

Availability ⬆ ⬇

(Generic available)

Tablets: 1 mg; 2 mg; 4 mg; 6 mg; 8 mg; 10 mg; 12 mg

Assessment ⬆ ⬇

Monitor patient’s mental status (delusions, hallucinations, and behavior) before and periodically during therapy.
Monitor mood changes. Assess for suicidal tendencies, especially during early therapy. Restrict amount of drug available to patient.
Monitor BP (sitting, standing, lying down) and pulse before and periodically during therapy. May cause prolonged QT interval, tachycardia, and orthostatic hypotension. Protect patient from falls.
Observe patient when administering medication to ensure that medication is actually swallowed and not hoarded.
Monitor patient for onset of extrapyramidal side effects (akathisia: restlessness; dystonia: muscle spasms and twisting motions; or pseudoparkinsonism: mask-like face, rigidity, tremors, drooling, shuffling gait, dysphagia). Report these symptoms; reduction of dose or discontinuation of medication may be necessary.
Monitor for tardive dyskinesia (involuntary rhythmic movement of mouth, face, and extremities). Report immediately and discontinue therapy; may be irreversible.
Monitor for development of neuroleptic malignant syndrome (fever, respiratory distress, tachycardia, seizures, diaphoresis, hypertension or hypotension, pallor, tiredness). Discontinue iloperidone and notify health care professional immediately if these symptoms occur.
Monitor for symptoms related to hyperprolactinemia (menstrual abnormalities, galactorrhea, sexual dysfunction).
Assess weight and BMI initially and during therapy. Refer as appropriate for nutritional/weight and medical management.
Assess for falls risk. Drowsiness, orthostatic hypotension, and motor and sensory instability increase risk. Institute prevention if indicated.

Lab Test Considerations:

Monitor fasting blood glucose before and periodically during therapy in diabetic patients.
- Monitor CBC frequently during initial mo of therapy in patients with pre-existing or history of low WBC. May cause leukopenia, neutropenia, or agranulocytosis. Discontinue therapy if this occurs.
- Monitor serum potassium and magnesium levels in patients at risk for electrolyte disturbances.
- Monitor serum prolactin prior to and periodically during therapy. May cause ↑ serum prolactin levels.

Implementation ⬆ ⬇

Do not confuse Fanapt with Xanax.
PO: Administer twice daily without regard to food.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication exactly as directed. If doses are missed for >3 days, restart at initiation dose. Advise patient that appearance of tablets in stool is normal and not of concern.
Inform patient of the possibility of extrapyramidal symptoms, neuroleptic malignant syndrome, and tardive dyskinesia. Instruct patient to report these symptoms immediately to health care professional.
Advise patient to change positions slowly to minimize orthostatic hypotension. Protect from falls.
Inform patient of potential for weight gain and hyperglycemia, and the need for monitoring weight and blood glucose periodically during therapy.
May cause drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Extremes in temperature should also be avoided; this drug impairs body temperature regulation.
Instruct patient to notify health care professional promptly if sore throat, fever, unusual bleeding or bruising, rash, tremors, palpitations, fainting, menstrual abnormalities, galactorrhea, or sexual dysfunction occur.
Advise patient and family to notify health care professional if thoughts about suicide or dying, attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood occur.
Caution patient to avoid concurrent use of alcohol and other CNS depressants.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient to notify health care professional of medication regimen before treatment or surgery.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, and to avoid breastfeeding during therapy. Monitor neonates exposed to iloperidone during the third trimester of pregnancy for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. Monitor breastfed infants for excessive drowsiness, lethargy, and developmental delays. Encourage women who become pregnant while taking iloperidone to enroll in the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
Emphasize the need for continued follow-up for psychotherapy and monitoring for side effects.

Evaluation/Desired Outcomes ⬆ ⬇

Decrease in excited, paranoid, or withdrawn behavior.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0378- Mylan Pharmaceuticals Inc.
- 0378-0630- Iloperidone
  - 0378-0630-01- 100 TABLET in 1 BOTTLE (0378-0630-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-0630- Iloperidone
  - 0378-0630-88- 10 BLISTER PACK in 1 CARTON (0378-0630-88) > 10 TABLET in 1 BLISTER PACK

0378- Mylan Pharmaceuticals Inc.
- 0378-0630- Iloperidone
  - 0378-0630-91- 60 TABLET in 1 BOTTLE (0378-0630-91)

0378- Mylan Pharmaceuticals Inc.
- 0378-0631- Iloperidone
  - 0378-0631-01- 100 TABLET in 1 BOTTLE (0378-0631-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-0631- Iloperidone
  - 0378-0631-88- 10 BLISTER PACK in 1 CARTON (0378-0631-88) > 10 TABLET in 1 BLISTER PACK

0378- Mylan Pharmaceuticals Inc.
- 0378-0631- Iloperidone
  - 0378-0631-91- 60 TABLET in 1 BOTTLE (0378-0631-91)

0378- Mylan Pharmaceuticals Inc.
- 0378-0632- Iloperidone
  - 0378-0632-01- 100 TABLET in 1 BOTTLE (0378-0632-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-0632- Iloperidone
  - 0378-0632-88- 10 BLISTER PACK in 1 CARTON (0378-0632-88) > 10 TABLET in 1 BLISTER PACK

0378- Mylan Pharmaceuticals Inc.
- 0378-0632- Iloperidone
  - 0378-0632-91- 60 TABLET in 1 BOTTLE (0378-0632-91)

0378- Mylan Pharmaceuticals Inc.
- 0378-0633- Iloperidone
  - 0378-0633-01- 100 TABLET in 1 BOTTLE (0378-0633-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-0633- Iloperidone
  - 0378-0633-88- 10 BLISTER PACK in 1 CARTON (0378-0633-88) > 10 TABLET in 1 BLISTER PACK

0378- Mylan Pharmaceuticals Inc.
- 0378-0633- Iloperidone
  - 0378-0633-91- 60 TABLET in 1 BOTTLE (0378-0633-91)

0378- Mylan Pharmaceuticals Inc.
- 0378-0634- Iloperidone
  - 0378-0634-01- 100 TABLET in 1 BOTTLE (0378-0634-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-0634- Iloperidone
  - 0378-0634-88- 10 BLISTER PACK in 1 CARTON (0378-0634-88) > 10 TABLET in 1 BLISTER PACK

0378- Mylan Pharmaceuticals Inc.
- 0378-0634- Iloperidone
  - 0378-0634-91- 60 TABLET in 1 BOTTLE (0378-0634-91)

0378- Mylan Pharmaceuticals Inc.
- 0378-0635- Iloperidone
  - 0378-0635-01- 100 TABLET in 1 BOTTLE (0378-0635-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-0635- Iloperidone
  - 0378-0635-88- 10 BLISTER PACK in 1 CARTON (0378-0635-88) > 10 TABLET in 1 BLISTER PACK

0378- Mylan Pharmaceuticals Inc.
- 0378-0635- Iloperidone
  - 0378-0635-91- 60 TABLET in 1 BOTTLE (0378-0635-91)

0378- Mylan Pharmaceuticals Inc.
- 0378-0636- Iloperidone
  - 0378-0636-01- 100 TABLET in 1 BOTTLE (0378-0636-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-0636- Iloperidone
  - 0378-0636-88- 10 BLISTER PACK in 1 CARTON (0378-0636-88) > 10 TABLET in 1 BLISTER PACK

0378- Mylan Pharmaceuticals Inc.
- 0378-0636- Iloperidone
  - 0378-0636-91- 60 TABLET in 1 BOTTLE (0378-0636-91)

43068- Vanda Pharmaceuticals Inc.
- 43068-101- Fanapt
  - 43068-101-02- 60 TABLET in 1 BOTTLE (43068-101-02)

43068- Vanda Pharmaceuticals Inc.
- 43068-102- Fanapt
  - 43068-102-02- 60 TABLET in 1 BOTTLE (43068-102-02)

43068- Vanda Pharmaceuticals Inc.
- 43068-104- Fanapt
  - 43068-104-02- 60 TABLET in 1 BOTTLE (43068-104-02)

43068- Vanda Pharmaceuticals Inc.
- 43068-106- Fanapt
  - 43068-106-02- 60 TABLET in 1 BOTTLE (43068-106-02)

43068- Vanda Pharmaceuticals Inc.
- 43068-108- Fanapt
  - 43068-108-02- 60 TABLET in 1 BOTTLE (43068-108-02)

43068- Vanda Pharmaceuticals Inc.
- 43068-110- Fanapt
  - 43068-110-02- 60 TABLET in 1 BOTTLE (43068-110-02)

43068- Vanda Pharmaceuticals Inc.
- 43068-112- Fanapt
  - 43068-112-02- 60 TABLET in 1 BOTTLE (43068-112-02)

43068- Vanda Pharmaceuticals Inc.
- 43068-113- Fanapt
  - 43068-113-04- 1 BLISTER PACK in 1 DOSE PACK (43068-113-04) > 1 KIT in 1 BLISTER PACK

43068- Vanda Pharmaceuticals Inc.
- 43068-901- Fanapt
  - 43068-901-14- 14 TABLET in 1 BOTTLE (43068-901-14)

43068- Vanda Pharmaceuticals Inc.
- 43068-902- Fanapt
  - 43068-902-14- 14 TABLET in 1 BOTTLE (43068-902-14)

43068- Vanda Pharmaceuticals Inc.
- 43068-903- Fanapt
  - 43068-903-08- 1 BLISTER PACK in 1 DOSE PACK (43068-903-08) > 1 KIT in 1 BLISTER PACK

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4178- Iloperidone
  - 51672-4178-4- 60 TABLET in 1 BOTTLE (51672-4178-4)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4179- Iloperidone
  - 51672-4179-4- 60 TABLET in 1 BOTTLE (51672-4179-4)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4180- Iloperidone
  - 51672-4180-4- 60 TABLET in 1 BOTTLE (51672-4180-4)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4181- Iloperidone
  - 51672-4181-4- 60 TABLET in 1 BOTTLE (51672-4181-4)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4182- Iloperidone
  - 51672-4182-4- 60 TABLET in 1 BOTTLE (51672-4182-4)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4183- Iloperidone
  - 51672-4183-4- 60 TABLET in 1 BOTTLE (51672-4183-4)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4184- Iloperidone
  - 51672-4184-4- 60 TABLET in 1 BOTTLE (51672-4184-4)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4213- Iloperidone
  - 51672-4213-7- 1 BLISTER PACK in 1 DOSE PACK (51672-4213-7) > 1 KIT in 1 BLISTER PACK

70518- REMEDYREPACK INC.
- 70518-1867- Fanapt
  - 70518-1867-0- 30 POUCH in 1 BOX, UNIT-DOSE (70518-1867-0) > 1 TABLET in 1 POUCH (70518-1867-1)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇