ILOPERIDONE 10 mg/1
iloperidone · TABLET · Mylan Pharmaceuticals Inc.
Iloperidone is an atypical antipsychotic medication taken by mouth as a tablet to treat schizophrenia and related psychotic disorders. This prescription medication works by affecting certain chemicals in the brain to help reduce symptoms like hallucinations, delusions, and disorganized thinking.
Key Facts
- Brand Name
- ILOPERIDONE
- Generic Name
- iloperidone
- NDC Code (Product)
0378-0635- Manufacturer
- Mylan Pharmaceuticals Inc.
- Strength
- 10 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 as a tablet to treat schizophrenia and related psychotic disorders. This prescription medication works by affecting certain chemicals in the brain to help reduce symptoms like hallucinations, delusions, and disorganized thinking.
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 10 mg/1?
The NDC (National Drug Code) for ILOPERIDONE 10 mg/1 is 0378-0635, listed by Mylan Pharmaceuticals Inc..