These highlights do not include all the information needed to use PALIPERIDONE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PALIPERIDONE EXTENDED-RELEASE TABLETS. PALIPERIDONE extended-release tablets, for oral use Initial U.S. Approval: 2006

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Boxed Warning Section

Elderly patients with dementia-related psychos is treated with antipsychotic drugs are at an increased risk of death. Paliperidone extended-release tablets are not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1)]

1 INDICATIONS AND USAGE

Indications & Usage Section

2 DOSAGE AND ADMINISTRATION

Dosage & Administration Section

3 DOSAGE FORMS AND STRENGTHS

Dosage Forms & Strengths Section

Paliperidone extended-release tablets are available in the following strengths and colors: 1.5 mg (brown), 3 mg (white to off-white), 6 mg (yellow), and 9 mg (pink). All tablets are circular shaped and are imprinted with either “744”, “765”, “766”, or “767”.

4 CONTRAINDICATIONS

Contraindications Section

Paliperidone is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone extended-release tablet formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.

5 WARNINGS AND PRECAUTIONS

Warnings And Precautions Section

6 ADVERSE REACTIONS

Adverse Reactions Section

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 Boxed Warning and Warnings and Precautions (5.1)] Cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.2)] Neuroleptic malignant syndrome [see Warnings and Precautions (5.3)] QT prolongation [see Warnings and Precautions (5.4)] Tardive dyskinesia [see Warnings and Precautions (5.5)] Metabolic changes [see Warnings and Precautions (5.6)] Hyperprolactinemia [see Warnings and Precautions (5.7)] Potential for gastrointestinal obstruction [see Warnings and Precautions (5.8)] Orthostatic hypotension and syncope [see Warnings and Precautions (5.9)] Falls [see Warnings and Precautions (5.10)] Leukopenia, neutropenia, and agranulocytosis [see Warnings and Precautions (5.11)] Potential for cognitive and motor impairment [see Warnings and Precautions (5.12)] Seizures [see Warnings and Precautions (5.13)] Dysphagia [see Warnings and Precautions (5.14)] Priapism [see Warnings and Precautions (5.15)] Disruption of body temperature regulation [see Warnings and Precautions (5.16)]

7 DRUG INTERACTIONS

Drug Interactions Section

8 USE IN SPECIFIC POPULATIONS

Use In Specific Populations Section

9 DRUG ABUSE AND DEPENDENCE

Drug Abuse And Dependence Section

10 OVERDOSAGE

Overdosage Section

11 DESCRIPTION

Description Section

Paliperidone extended-release tablet contains paliperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-­benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-­pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23 H 27 FN 4 O 3 and its molecular weight is 426.49. The structural formula is: Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (brown), 3 mg (white to off-white), 6 mg (yellow), and 9 mg (pink) strengths. Paliperidone extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use. Inactive ingredients are polyethylene oxide, hypromellose, anhydrous lactose, magnesium stearate, ethyl cellulose, triethyl citrate, talc, titanium dioxide and polyethylene glycol. The 1.5 mg and 6 mg tablets also contain lactose monohydrate, iron oxide yellow and iron oxide red. The 9 mg tablets also contain lactose monohydrate and iron oxide red. Imprinting ink contains shellac glaze, iron oxide black, N-butyl alcohol, propylene glycol and ammonium hydroxide.

12 CLINICAL PHARMACOLOGY

Clinical Pharmacology Section

13 NONCLINICAL TOXICOLOGY

Nonclinical Toxicology Section

14 CLINICAL STUDIES

Clinical Studies Section

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied Section

Paliperidone extended-release tablets are available in the following strengths and packages. 1.5 mg tablets are brown, circular, biconvex, beveled edged, film-coated tablets imprinted with “744” in black ink on one side and plain on the other side. NDC Number Size 16714-866-01 Bottle of 30 Tablets with Child Resistant Cap 3 mg tablets are white to off-white, circular, biconvex, beveled edged, film-coated tablets imprinted with “765” in black ink on one side and plain on the other side. NDC Number Size 16714-867-01 Bottle of 30 Tablets with Child Resistant Cap 6 mg tablets are yellow, circular, biconvex, beveled edged, film-coated tablets imprinted with “766” in black ink on one side and plain on the other side. NDC Number Size 16714-868-01 Bottle of 30 Tablets with Child Resistant Cap 9 mg tablets are pink, circular, biconvex, beveled edged, film-coated tablets imprinted with “767” in black ink on one side and plain on the other side. NDC Number Size 16714-869-01 Bottle of 30 Tablets with Child Resistant Cap Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

Information For Patients Section

Physicians are advised to discuss the following issues with patients for whom they prescribe paliperidone. Neuroleptic Malignant Syndrome (NMS) Counsel patients about a potentially fatal adverse reaction, Neuroleptic Malignant Syndrome (NMS), that has been reported in association with administration of antipsychotic drugs. Advise patients, family members, or caregivers to contact their healthcare provider or report to the emergency room if they experience signs and symptoms of NMS, including hyperpyrexia, muscle rigidity, altered mental status including delirium, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) [see Warnings and Precautions (5.3)] . Tardive Dyskinesia Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur [see Warnings and Precautions (5.5)] . Metabolic Changes Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight [see Warnings and Precautions (5.6)] . Orthostatic Hypotension Educate patients about the risk of orthostatic hypotension and syncope, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose [see Warnings and Precautions (5.9)] . Leukopenia/Neutropenia Advise patients with a pre-existing low WBC or a history of drug-induced leukopenia/neutropenia they should have their CBC monitored while taking paliperidone [see Warnings and Precautions (5.11)] . Hyperprolactinemia Counsel patients on signs and symptoms of hyperprolactinemia that may be associated with chronic use of paliperidone. Advise them to seek medical attention if they experience any of the following: amenorrhea or galactorrhea in females, erectile dysfunction or gynecomastia in males [see Warnings and Precautions (5.7)] . Interference with Cognitive and Motor Performanc e Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery, or operating a motor vehicle, until they are reasonably certain that paliperidone therapy does not affect them adversely [see Warnings and Precautions (5.12)] . Priapism Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.15)] . Heat Exposure and Dehydratio n Counsel patients on the importance of avoiding overheating and dehydration [see Warnings and Precautions (5.16)] . Concomitant Medication Advise patients to inform their healthcare providers if they are taking, or plan to take, any prescription or over-the-counter drugs, as there is a potential for interactions [see Drug Interactions (7)] . Alcohol Advise patients to avoid alcohol while taking paliperidone [see Drug Interactions (7.1)] . Administration Patients should be informed that paliperidone should be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed [see Dosage and Administration (2.3)] . Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with paliperidone. Advise patients that paliperidone may cause extrapyramidal and/or withdrawal symptoms in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to paliperidone extended-release tablets during pregnancy [see Use in Specific Populations (8.1)] . Lactation Advise breastfeeding women using paliperidone to monitor infants for somnolence, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)] . Infertility Advise females of reproductive potential that paliperidone may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Use in Specific Populations (8.3)] . *Brands listed are the trademarks of their respective owner. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India. Rev. 02/2025 5259918

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1.5mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx only NDC 16714-866-01 Paliperidone Extended-Release Tablets 1.5 mg Tablets should be swallowed whole. Do not divide, crush or chew. Paliperidone extended-release tablets should be taken once daily. 30 Tablets NORTHSTAR

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-3mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx only NDC 16714-867-01 Paliperidone Extended-Release Tablets 3 mg Tablets should be swallowed whole. Do not divide, crush or chew. Paliperidone extended-release tablets should be taken once daily. 30 Tablets NORTHSTAR

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-6mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx only NDC 16714-868-01 Paliperidone Extended-Release Tablets 6 mg Tablets should be swallowed whole. Do not divide, crush or chew. Paliperidone extended-release tablets should be taken once daily. 30 Tablets NORTHSTAR

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-9mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx only NDC 16714-869-01 Paliperidone Extended-Release Tablets 9 mg Tablets should be swallowed whole. Do not divide, crush or chew. Paliperidone extended-release tablets should be taken once daily. 30 Tablets NORTHSTAR