PALIPERIDONE 3 mg/1
PALIPERIDONE · TABLET, EXTENDED RELEASE · ANI Pharmaceuticals, Inc.
PALIPERIDONE is a tablet, extended release containing paliperidone at 3 mg/1, taken oral. Manufactured by ANI Pharmaceuticals, Inc..
Key Facts
- Brand Name
- PALIPERIDONE
- Generic Name
- PALIPERIDONE
- NDC Code (Product)
43975-350- Manufacturer
- ANI Pharmaceuticals, Inc.
- Strength
- 3 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204452
- Drug Class
- Atypical Antipsychotic [EPC]
- Marketing Start
- 11/27/2019
Recall History
Mylan Pharmaceuticals Inc.
Failed Dissolution Specifications; three month stability time point.
Teva Pharmaceuticals
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Teva Pharmaceuticals USA
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Teva Pharmaceuticals USA
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
The Harvard Drug Group
Failed Dissolution Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1) Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1) Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. (1.2) Efficacy was established in two 6-week trials in adult patients. (14.2) 1.1 Schizophrenia Paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ]. The efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. 1.2 Schizoaffective Disorder Paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see Clinical Studies (14.2) ] . The efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Initial Dose Recommended Dose Maximum Dose Schizophrenia - adults (2.1) 6 mg/day 3 to 12 mg/day 12 mg/day Schizophrenia-adolescents (2.1) Weight < 51 kg 3 mg/day 3 to 6 mg/day 6 mg/day Weight ≥ 51 kg 3 mg/day 3 to 12 mg/day 12 mg/day Schizoaffective disorder - adults (2.2) 6 mg/day 3 to 12 mg/day 12 mg/day Tablet should be swallowed whole and should not be chewed, divided, or crushed. (2.3) 2.1 Schizophrenia Adults The recommended dose of paliperidone extended-release tablets for the treatment of schizophrenia in adults is 6 mg administered once daily. Initial dose titration is not required. Although it has not been systematically established that doses above 6 mg have additional benefit, there was a general trend for greater effects with higher doses. This must be weighed against the dose-related increase in adverse reactions. Thus, some patients may benefit from higher doses, up to 12 mg/day, and for some patients, a lower dose of 3 mg/day may be sufficient. Dose increases above 6 mg/day should be made only after clinical reassessment and generally should occur at intervals of more than 5 days. When dose increases are indicated, increments of 3 mg/day …
Contraindications
4 CONTRAINDICATIONS Paliperidone extended-release tablets are 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. Known hypersensitivity to paliperidone, risperidone, or to any excipients in paliperidone. (4)
Drug Interactions
7 DRUG INTERACTIONS Centrally-acting drugs: Due to CNS effects, use caution in combination. Avoid alcohol. (7.1) Drugs that may cause orthostatic hypotension: An additive effect may be observed when co-administered with paliperidone. (7.1) Strong CYP3A4/P-glycoprotein (P-gp) inducers: It may be necessary to increase the dose of paliperidone when a strong inducer of both CYP3A4 and P-gp (e.g., carbamazepine) is co-administered. Conversely, on discontinuation of the strong inducer, it may be necessary to decrease the dose of paliperidone. (7.2) Co-administration of divalproex sodium increased C max and AUC of paliperidone by approximately 50%. Adjust dose of paliperidone if necessary based on clinical assessment. (7.2) 7.1 Potential for Paliperidone to Affect Other Drugs Given the primary CNS effects of paliperidone [see Adverse Reactions (6.1, 6.2) ] , paliperidone should be used with caution in combination with other centrally acting drugs and alcohol. Paliperidone may antagonize the effect of levodopa and other dopamine agonists. Because of its potential for inducing orthostatic hypotension, an additive effect may be observed when paliperidone is administered with other therapeuti…
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 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) ] Disrupt…
Frequently Asked Questions
What is PALIPERIDONE used for?
PALIPERIDONE contains PALIPERIDONE. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is PALIPERIDONE a controlled substance?
PALIPERIDONE is not classified as a controlled substance by the DEA.
What is the generic name for PALIPERIDONE?
The generic name for PALIPERIDONE is PALIPERIDONE. There are 11 other brand versions of PALIPERIDONE.
What is the NDC code for PALIPERIDONE 3 mg/1?
The NDC (National Drug Code) for PALIPERIDONE 3 mg/1 is 43975-350, listed by ANI Pharmaceuticals, Inc..
Other PALIPERIDONE Dosages
Other Paliperidone Brands
See all →- Paliperidone6 mg/172162-2650
- Paliperidone1.5 mg/116714-866
- Paliperidone9 mg/116714-869
- Paliperidone9 mg/127241-279
- Paliperidone3 mg/147335-765
- Paliperidone9 mg/147335-767
- INVEGA SUSTENNA117 mg/.75mL50458-562
- INVEGA TRINZA273 mg/.88mL50458-606
- Erzofri extended-release78 mg/.5mL72526-106
- Paliperidone9 mg/10904-6937
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)