ILOPERIDONE 12 mg/1
iloperidone · TABLET · Mylan Pharmaceuticals Inc.
Iloperidone is an atypical antipsychotic medication taken by mouth that is used to treat schizophrenia. This prescription tablet comes in a 12 mg strength.
Key Facts
- Brand Name
- ILOPERIDONE
- Generic Name
- iloperidone
- NDC Code (Product)
0378-0636- Manufacturer
- Mylan Pharmaceuticals Inc.
- Strength
- 12 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207231
- Drug Class
- Atypical Antipsychotic [EPC]
- Marketing Start
- 03/20/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Iloperidone tablets is indicated for: Treatment of schizophrenia in adults [see Clinical Studies ( 14.1 )]. Iloperidone tablets is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 , 14.1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer Iloperidone orally twice daily without regard to meals. ( 2.1 ) Titrate the dosage of Iloperidone to avoid orthostatic hypotension. See Full Prescribing Information for titration schedule. ( 2.1 ) Recommended Dosage: Indication Starting Dosage Recommended Dosage Schizophrenia ( 2.1 ) 1 mg twice daily 6 mg to 12 mg twice daily CYP2D6 Poor Metabolizers: See Full Prescribing Information for titration schedule and recommended dosage. ( 2.2 ) 2.1 Recommended Dosage Titrate Iloperidone to avoid orthostatic hypotension [see Warnings and Precautions ( 5.7 )]. Administer Iloperidone orally with or without food. Table 1 includes dosage recommendations for Iloperidone for the treatment of schizophrenia in adults. Indication and Titration schedule Recommended Dosage Population Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Schizophrenia 1mg twice daily 2 mg twice daily 4 mg twice daily 6 mg twice daily 8 mg twice daily 10 mg twice daily 12 mg twice daily 6 mg to 12 mg twice daily 2.2 Dosage Recommendations for Use in Patients Who Are Known CYP2D6 Poor Metabolizers Reduce the dose of Iloperidone by one-half for CYP2D6 poor metabolizers [see Clinical Pharmacolog…
Contraindications
4 CONTRAINDICATIONS Iloperidone is contraindicated in individuals with a known hypersensitivity reaction to the product. Anaphylaxis, angioedema, and other hypersensitivity reactions have been reported [see Adverse Reactions (6.2) ]. Known hypersensitivity to Iloperidone or to any components in the formulation. ( 4 , 6.2 )
Drug Interactions
7 DRUG INTERACTIONS The dose of Iloperidone Tablets should be reduced in patients co-administered a strong CYP2D6 or CYP3A4 inhibitor. ( 2.2 , 7.1 ) 7.1 Clinically Important Drug Interactions with Iloperidone Table 7 presents clinically important drug interactions with Iloperidone. Table 7: Clinically Important Drug Interactions with Iloperidone Strong CYP2D6 Inhibitors Clinical Impact Coadministration of fluoxetine with iloperidone increased exposure (area under curve, [AUC]) of iloperidone and its metabolite P88, by about 2- to 3- fold, and decreased the AUC of its metabolite P95 by one-half [see Clinical Pharmacology ( 12.3 , 12.5 )]. Coadministration of paroxetine with iloperidone resulted in increased mean steady- state peak concentrations of iloperidone and its metabolite P88, by about 1.6- fold, and decreased mean steady-state peak concentrations of its metabolite P95 by one-half [see Clinical Pharmacology ( 12.3 , 12.5 )]. Intervention Reduce the dose of iloperidone by one-half when administered with strong CYP2D6 inhibitors. When a strong CYP2D6 inhibitor is withdrawn from the combination therapy, the iloperidone dose should be returned to the previous level [see Dosage an…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions ( 5.1 )] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions ( 5.2 )] QT Prolongation [see Warnings and Precautions ( 5.3 )] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions ( 5.4 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] Metabolic Changes [see Warnings and Precautions ( 5.6 )] Orthostatic Hypotension and Syncope [see Warnings and Precautions ( 5.7 )] Falls [see Warnings and Precautions ( 5.8 )] Seizures [see Warnings and Precautions ( 5.9 )] Leukopenia, Neutropenia and Agranulocytosis [see Warnings and Precautions ( 5.10 )] Hyperprolactinemia [see Warnings and Precautions ( 5.11 )] Body Temperature Regulation [see Warnings and Precautions ( 5.12 )] Dysphagia [see Warnings and Precautions ( 5.13 )] Priapism [see Warnings and Precautions ( 5.14 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.15 )] Intraoperative Flopp…
Frequently Asked Questions
What is ILOPERIDONE used for?
Iloperidone is an atypical antipsychotic medication taken by mouth that is used to treat schizophrenia. This prescription tablet comes in a 12 mg strength.
Is ILOPERIDONE a controlled substance?
ILOPERIDONE is not classified as a controlled substance by the DEA.
What is the generic name for ILOPERIDONE?
The generic name for ILOPERIDONE is iloperidone. There are 9 other brand versions of iloperidone.
What is the NDC code for ILOPERIDONE 12 mg/1?
The NDC (National Drug Code) for ILOPERIDONE 12 mg/1 is 0378-0636, listed by Mylan Pharmaceuticals Inc..