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Drug overview for PALIPERIDONE ER (paliperidone):
Generic name: PALIPERIDONE (PAL-ee-PER-i-done)
Drug class: Antipsychotics
Therapeutic class: Central Nervous System Agents
Paliperidone is considered an atypical or second-generation antipsychotic agent.
No enhanced Uses information available for this drug.
Generic name: PALIPERIDONE (PAL-ee-PER-i-done)
Drug class: Antipsychotics
Therapeutic class: Central Nervous System Agents
Paliperidone is considered an atypical or second-generation antipsychotic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for PALIPERIDONE ER (paliperidone) have been approved by the FDA:
Indications:
Schizoaffective disorder
Schizophrenia
Professional Synonyms:
Dementia praecox
Parergasia
Indications:
Schizoaffective disorder
Schizophrenia
Professional Synonyms:
Dementia praecox
Parergasia
The following dosing information is available for PALIPERIDONE ER (paliperidone):
No enhanced Dosing information available for this drug.
Paliperidone extended-release tablets are administered orally once daily, usually in the morning, with or without food. Paliperidone extended-release tablets should be swallowed whole with fluids and should not be chewed, divided, or crushed. Patients should be advised not to become concerned if they notice a tablet-like substance in their stools; this is normal since the tablet is designed to remain intact and slowly release the drug from a nonabsorbable shell during passage through the GI tract.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| PALIPERIDONE ER 1.5 MG TABLET | Maintenance | Adults take 2 tablets (3 mg) by oral route once daily in the morning |
| PALIPERIDONE ER 3 MG TABLET | Maintenance | Adults take 1 tablet (3 mg) by oral route once daily in the morning |
| PALIPERIDONE ER 6 MG TABLET | Maintenance | Adults take 1 tablet (6 mg) by oral route once daily in the morning |
| PALIPERIDONE ER 9 MG TABLET | Maintenance | Adults take 1 tablet (9 mg) by oral route once daily in the morning |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| PALIPERIDONE ER 3 MG TABLET | Maintenance | Adults take 1 tablet (3 mg) by oral route once daily in the morning |
| PALIPERIDONE ER 6 MG TABLET | Maintenance | Adults take 1 tablet (6 mg) by oral route once daily in the morning |
| PALIPERIDONE ER 9 MG TABLET | Maintenance | Adults take 1 tablet (9 mg) by oral route once daily in the morning |
| PALIPERIDONE ER 1.5 MG TABLET | Maintenance | Adults take 2 tablets (3 mg) by oral route once daily in the morning |
The following drug interaction information is available for PALIPERIDONE ER (paliperidone):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for PALIPERIDONE ER (paliperidone):
Drug contraindication overview.
Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients receiving risperidone or paliperidone. Paliperidone is therefore contraindicated in patients with a known hypersensitivity to paliperidone, risperidone, or any ingredient in the paliperidone formulation.
Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients receiving risperidone or paliperidone. Paliperidone is therefore contraindicated in patients with a known hypersensitivity to paliperidone, risperidone, or any ingredient in the paliperidone formulation.
There are 3 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Congenital long QT syndrome |
| Neuroleptic malignant syndrome |
| Parkinsonism |
There are 17 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Acute myocardial infarction |
| Agranulocytosis |
| Cataract surgery |
| Chronic kidney disease stage 2 (mild) GFR 60-89 ml/min |
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Dehydration |
| Esophageal compression |
| Esophageal dysmotility |
| Hypokalemia |
| Hypomagnesemia |
| Hypovolemia |
| Priapism |
| Senile dementia |
| Tardive dyskinesia |
| Torsades de pointes |
There are 21 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Acquired dystonia |
| Acute cognitive impairment |
| Angina |
| Carcinoma of breast |
| Cerebrovascular disorder |
| Chronic heart failure |
| Diabetes mellitus |
| Diffuse lewy body disease |
| Hyperlipidemia |
| Hyperprolactinemia |
| Intraoperative floppy iris syndrome |
| Leukopenia |
| Lower seizure threshold |
| Metabolic syndrome x |
| Neutropenic disorder |
| Obesity |
| Orthostatic hypotension |
| Predisposition to aspiration |
| Seizure disorder |
| Suicidal ideation |
| Weight gain |
The following adverse reaction information is available for PALIPERIDONE ER (paliperidone):
Adverse reaction overview.
Adverse effects reported in 5% or more of adults receiving paliperidone for schizophrenia and at a frequency at least twice that reported with placebo include extrapyramidal symptoms, tachycardia, and akathisia. Adverse effects reported in 5% or more of adolescents receiving paliperidone for schizophrenia and at a frequency at least twice that reported with placebo include somnolence, extrapyramidal symptoms (e.g., akathisia, tremor, dystonia, cogwheel rigidity), anxiety, increased weight, and tachycardia. Adverse effects reported in 5% or more of adults receiving paliperidone for schizoaffective disorder and at a frequency at least twice that reported with placebo include extrapyramidal symptoms, somnolence, dyspepsia, constipation, increased weight, and nasopharyngitis.
Adverse effects reported in 5% or more of adults receiving paliperidone for schizophrenia and at a frequency at least twice that reported with placebo include extrapyramidal symptoms, tachycardia, and akathisia. Adverse effects reported in 5% or more of adolescents receiving paliperidone for schizophrenia and at a frequency at least twice that reported with placebo include somnolence, extrapyramidal symptoms (e.g., akathisia, tremor, dystonia, cogwheel rigidity), anxiety, increased weight, and tachycardia. Adverse effects reported in 5% or more of adults receiving paliperidone for schizoaffective disorder and at a frequency at least twice that reported with placebo include extrapyramidal symptoms, somnolence, dyspepsia, constipation, increased weight, and nasopharyngitis.
There are 44 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Akathisia Dyskinesia Extrapyramidal disease Parkinsonism Tachycardia |
Bundle branch block Hyperglycemia Hypotension Orthostatic hypotension |
| Rare/Very Rare |
|---|
|
Abnormal ECG Accidental fall Agranulocytosis Anaphylaxis Angioedema Aspiration pneumonia Atrioventricular block Bradycardia Catatonia Cerebral ischemia Cerebrovascular accident Diabetes mellitus Esophageal dysmotility Fever Gastrointestinal obstruction Heart block Hypertension Ileus Increased alanine transaminase Increased aspartate transaminase Leukopenia Muscle rigidity Neuroleptic malignant syndrome Neutropenic disorder Oculogyric crisis Opisthotonus Priapism Prolonged QT interval Rhabdomyolysis Seizure disorder Sinus node dysfunction Sinus tachycardia Tardive dyskinesia Tongue swelling Transient cerebral ischemia |
There are 64 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acquired dystonia Constipation Dizziness Drowsy Dyspepsia Fatigue Headache disorder Injection site sequelae Pharyngitis Sialorrhea Tremor Vomiting Weight gain Xerostomia |
Acute abdominal pain Anorexia Back pain Blurred vision Cough Dysarthria Galactorrhea not associated with childbirth General weakness Hypercholesterolemia Hyperkinesis Hyperprolactinemia Hypertriglyceridemia Increased appetite Insomnia Menstrual disorder Myalgia Nausea Palpitations Rhinitis Sore throat Symptoms of anxiety Upper respiratory infection |
| Rare/Very Rare |
|---|
|
Acute cognitive impairment Agitation Altered mental status Amenorrhea Anticholinergic toxicity Arthralgia Complex sleep behavior Dysphagia Dyspnea Edema Epistaxis Flatulence Gynecomastia Hypoesthesia Muscle spasm Musculoskeletal pain Nasal congestion Nervousness Pruritus of skin Retrograde ejaculation Skin rash Sleep disorder Sleep walking disorder Syncope Urinary incontinence Urinary retention Urinary tract infection Vertigo |
The following precautions are available for PALIPERIDONE ER (paliperidone):
Safety and efficacy of oral paliperidone in the treatment of schizophrenia in adolescents 12-17 years of age have been established in a double-blind, placebo-controlled study of 6 weeks' duration. Safety and efficacy of oral paliperidone in the treatment of schizophrenia have not been established in pediatric patients younger than 12 years of age. Safety and efficacy of oral paliperidone in the treatment of schizoaffective disorder have not been established in pediatric patients younger than 18 years of age.
Weight gain has been associated with atypical antipsychotic use and monitoring of weight is recommended. However, in paliperidone-treated adolescents, weight gain should be assessed against that expected with normal growth. Weight gain in adolescents receiving paliperidone in an open-label, long-term study was not considered clinically substantial when compared with normative data. The manufacturer states that the long-term effects of paliperidone on growth and sexual maturation have not been fully evaluated in children and adolescents.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Weight gain has been associated with atypical antipsychotic use and monitoring of weight is recommended. However, in paliperidone-treated adolescents, weight gain should be assessed against that expected with normal growth. Weight gain in adolescents receiving paliperidone in an open-label, long-term study was not considered clinically substantial when compared with normative data. The manufacturer states that the long-term effects of paliperidone on growth and sexual maturation have not been fully evaluated in children and adolescents.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.) Neonates exposed to antipsychotic agents during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Symptoms reported to date have included agitation, hypertonia, hypotonia, tardive dyskinetic-like symptoms, tremor, somnolence, respiratory distress, and feeding disorder.
Neonates exhibiting such symptoms should be monitored. The complications have varied in severity; some neonates recovered within hours to days without specific treatment while others have required intensive care unit support and prolonged hospitalization. For further information on extrapyramidal and withdrawal symptoms in neonates, see Cautions: Pregnancy, Fertility, and Lactation, in the Phenothiazines General Statement 28:16.08.24.
Neonates exhibiting such symptoms should be monitored. The complications have varied in severity; some neonates recovered within hours to days without specific treatment while others have required intensive care unit support and prolonged hospitalization. For further information on extrapyramidal and withdrawal symptoms in neonates, see Cautions: Pregnancy, Fertility, and Lactation, in the Phenothiazines General Statement 28:16.08.24.
Paliperidone is distributed into milk in humans. The benefits of breastfeeding should be weighed against the unknown risks of infant exposure to the drug.
In clinical studies, approximately 7% of nearly 1800 patients were 65 years of age or older. In addition, the short-term efficacy and safety of paliperidone have been demonstrated in a placebo-controlled trial of 6 weeks' duration in 114 geriatric patients with schizophrenia. While no substantial differences in efficacy or safety relative to younger adults were observed in these studies or in other clinical experience with the drug, increased sensitivity cannot be ruled out.
Because geriatric patients may have reduced renal function, dosage adjustment may be required based on renal function status; consider monitoring renal function. (See Dosage and Administration: Special Populations.) Geriatric patients with dementia-related psychosis treated with atypical antipsychotic drugs appear to be at an increased risk of death compared with that among patients receiving placebo. Paliperidone is not approved for the treatment of dementia-related psychosis. (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Warnings/Precautions: Warnings, in Cautions.)
Because geriatric patients may have reduced renal function, dosage adjustment may be required based on renal function status; consider monitoring renal function. (See Dosage and Administration: Special Populations.) Geriatric patients with dementia-related psychosis treated with atypical antipsychotic drugs appear to be at an increased risk of death compared with that among patients receiving placebo. Paliperidone is not approved for the treatment of dementia-related psychosis. (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Warnings/Precautions: Warnings, in Cautions.)
The following prioritized warning is available for PALIPERIDONE ER (paliperidone):
WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor. If you are using paliperidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.
WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor. If you are using paliperidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.
The following icd codes are available for PALIPERIDONE ER (paliperidone)'s list of indications:
| Schizoaffective disorder | |
| F25 | Schizoaffective disorders |
| F25.0 | Schizoaffective disorder, bipolar type |
| F25.1 | Schizoaffective disorder, depressive type |
| F25.8 | Other schizoaffective disorders |
| F25.9 | Schizoaffective disorder, unspecified |
| Schizophrenia | |
| F20 | Schizophrenia |
| F20.0 | Paranoid schizophrenia |
| F20.1 | Disorganized schizophrenia |
| F20.2 | Catatonic schizophrenia |
| F20.3 | Undifferentiated schizophrenia |
| F20.5 | Residual schizophrenia |
| F20.8 | Other schizophrenia |
| F20.81 | Schizophreniform disorder |
| F20.89 | Other schizophrenia |
| F20.9 | Schizophrenia, unspecified |
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